cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)

A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. In the opinion of the Investigator able to comply with the study assessments and follow-up
3. New diagnosis of AML (i.e. \>20 % blasts) as defined by the World Health Organization (WHO) classification (Vardiman 2009) or relapsed or refractory AML as defined by the persistence or recurrence of \>5% blasts in bone marrow or peripheral blood following treatment.
4. ECOG Performance status ≤ 2
5. Age \> 18 years and ≤ 70 years
6. Adequate hepatic function as evidenced by the following laboratory tests:

   1. Total serum bilirubin ≤ 1.5 x ULN or direct (conjugated) bilirubin ≤ 1.5 ULN unless attributable to suspected hepatic involvement with AML
   2. Serum AST and ALT ≤ 1.5 x ULN unless attributable to suspected hepatic involvement with AML
7. Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN
8. Women of childbearing potential must have a negative serum pregnancy test. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives
9. Left Ventricular Ejection Fraction (LVEF) \> 50%, as determined by multiplegated acquisition scan (MUGA) or echocardiogram (ECHO) within 28 days prior to administration of 1st dose of remission induction chemotherapy

Exclusion Criteria:

1. Unwilling to accept the required per protocol blood and urine sample collection
2. An initial diagnosis of acute promyelocytic leukemia as defined by French- American-British criteria (Bennett 1976) (otherwise known as FAB M3)
3. Clinically active CNS leukemia
4. History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide or cytarabine
5. Pregnant or breast feeding
6. Known HIV positive
7. Known active hepatitis B or C, or any other active liver disease
8. Evidence of pulmonary infection. Patients with evidence of pulmonary infection on screening chest x-ray should have chest computed tomography (CT) prior to starting remission induction therapy to confirm absence or presence of pulmonary infection.
9. Any major surgery or radiation therapy within 30 days prior to study entry
10. Previously received treatment with amonafide
11. Treatment with other investigational agents for any reason within 30 days prior to study entry
12. Prior remission induction therapy for AML within 30 days of starting amonafide therapy
13. Persistent non-hematologic toxicity (other than alopecia) greater than Grade 2 from prior therapy for MDS or AML
14. Serious concomitant illnesses (for example, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart
Be Sweet to Babies During Nasolaryngoscopy

The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.

This study aims to evaluate the impact of oral sucrose on pain or distress in outpatient infants undergoing flexible nasolaryngoscopy during a scheduled appointment at the SickKids Pediatric Otolaryngology Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patient \<12 months of age;
* Scheduled for an appointment with Dr. Nikolaus Wolter or Dr. Jennifer Siu, who are Staff Pediatric Otolaryngologists at the Hospital for Sick Children, or Meghan Tepsich, a complex airway Nurse Practitioner at SickKids;
* Requiring flexible nasolaryngoscopy for diagnostic purposes;
* Accompanied by caregivers who provided consent.

Exclusion Criteria:

* Patient \>12 months of age
* Infants \<37 weeks corrected gestational age
* Infants with decreased level of consciousness or delayed neuromuscular development with limited pain response
* Infants who have received acute/urgent /emergent airway assessment such as respiratory distress or a foreign body, etc.
* Infants who have received topical anesthesia (topical decongestant/anesthetic spray)
* Infants with the following conditions, where oral sucrose is contraindicated or ineffective:

  * Carbohydrate intolerance
  * Decreased level of consciousness or heavy sedation
  * Absent gag reflex
  * Non-functional gastrointestinal tract
  * History of aspiration, tracheoesophageal fistula
  * Necrotizing enterocolitis
* Infants whose parents did not consent to enrolling their child in the study, including randomization into either arm of the study due to preference for a given intervention
* Any other circumstance in which consent for participation in the study was not obtained prior to the scope

Infants will also be excluded from the study if they present with conditions in which FNL is contraindicated:

* Severe respiratory distress
* Post-palliative systemic artery to pulmonary artery shunt
* Single ventricle congenital heart disease
Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis

Bacterial vaginosis (BV) is under-reported, misdiagnosed and inappropriately treated in Nigeria. Treatment option rely on antibiotics that eliminates both good and pathogenic bacteria, with gross impact on the gut and vaginal microbiome. Our primary objective in this study is to determine the effects of Lactobacillus on the gut and vagina when taken orally.

Antibiotics reduces in considerable proportion both the healthy bacteria especially Lactobacilli and those associated with BV, thus the vaginal microecology and gut is adversely affected. It is widely acknowledged that Lactobacilli and other genera that produces some metabolites such as lactic acid, contributes to vaginal health by maintaining the low pH of the vagina.

The objectives of this study are three folds, first to determine the effects before and after 14 days oral feeding of Lactobacillus pentosus KCA1 on the vaginal and gut microbiota compositions of women diagnosed with BV. Second to measure the level of two proinflammatory cytokines IL-1 beta and IL-6 before and after KCA1 consumption and third to determine in silico, the relative abundance of microbial genes involved in metabolic functions using the 16S rRNA datasets.

Eligibility Criteria:
Inclusion Criteria:

* Not on antibiotic therapy within the last one month
* Not menstruating at the time of inclusion.

Exclusion Criteria:

Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours

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Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand

Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM).

As access to HIV care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.

As Thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system, it is crucial to document and learn from pilot antiretroviral treatment programs, in particular the medical outcomes and logistical, and organizational issues faced by hospital teams and patients in order to adapt the ARV delivery and monitoring system to various local settings.

Specific objectives

1. Analyze data collected in patients participating in the PHPT antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions.
2. To determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels
3. To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level (counseling, referral systems, biological monitoring), the impact on other health activities, mobilization of human and financial resources, affordability and sustainability.

The population of the study consists of approximately 2,000 consenting HIV-infected patients, including one-third of children, receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs, presenting at any of the PHPT network hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children (children are defined as less than 18 years old) patients are eligible for the inclusion in the cohort if they meet all the following inclusion criteria:

  * Participation in the GFATM or Oxfam Access to Antiretroviral Programs
  * For adults, consent to have their clinical or biological data used for this research study, and willingness to be followed at one of the PHPT network hospitals. For children, caregiver's consent to participate, willingness to bring the child to the scheduled visits for the duration of the treatment, and to have the child's clinical or biological data used for this research study.

Exclusion Criteria:

* This is an observational study of an access to treatment program, therefore all patients who require treatment and are willing to be followed by the medical team and have their data collected can be enrolled in the study. The only exclusion criteria would be refusal to participate and the discontinuation criteria would be withdrawal of consent.
Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium

The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective CABG
* chronic irreversible myocardial scar
* coronary vessel supplying the scar must be amenable to bypass grafting

Exclusion Criteria:

* significant valvular heart diseases
* major organ failures, eg. heart, liver, renal etc
* pre-existing bone marrow conditions
Purdue University Parenting Program Attrition

The purpose of this study is to examine the efficacy of techniques to enhance participation in parenting programs.

This project addresses the problem of involving parents in interventions that promote parenting effectiveness and child coping-competence in preschoolers as a means of reducing risk of child maltreatment (and related adverse developmental outcomes). Purdue University will examine the impact of partnership (organizational involvement in recruitment and retention), cash incentives, and a motivational goal setting component on participation and engagement in the Parenting Our Children to Excellence program, a group intervention for parents and caregivers of preschool children.

Eligibility Criteria:
Inclusion Criteria:

* Parents with children 3-5 years old who attend centers in which interventions are offered

Exclusion Criteria:

* See above. No other exclusion criteria will be used.
Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. However, to date, no data are available to estimate the number of women concerned. These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.


Eligibility Criteria:
Inclusion Criteria:

* major women
* who understand french language

Exclusion Criteria:

* Women refusing to participate
* having given birth at home
* whose fetus or newborn has died
Effect of Interval Training on Arterial Stiffness in Women With Hypertension

this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension


Eligibility Criteria:
Inclusion Criteria:

* physically inactive
* BMI 30-40
* Stage 1 and 2 hypertension
* Elevated BP as systolic BP ≥130 mm Hg and/or diastolic BP ≥85 mm Hg measured at the brachial artery.

Exclusion Criteria:

* Medications known to affect weight or appetite
* Any disease associated with exercise intolerance.
* Women were taking hormone replacement therapy
Abdominal Exploration Without Incisions

This study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.

We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection.

We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic Cancer undergoing staging laparoscopy
* Staging or diagnostic laparoscopy in anyone needing enteral access

Exclusion Criteria:

* Lack of consent
* Intra-abdominal adhesions precluding diagnostic laparoscopy
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).


Eligibility Criteria:
This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a 24-week treatment period in which all patients will receive teduglutide (Stage 2), and a long-term extension (Stage 3).

During the long-term extension (Stage 3), patients will continue to receive teduglutide for up to an additional 24 months or until teduglutide is commercially available, whichever comes earlier.
Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease

This study will estimate the incidence of invasive pneumococcal disease in members of the Northern Kaiser Permanente healthcare system during each of the 5 following introduction of Prevnar 13.

No sampling as no subjects are enrolled

Eligibility Criteria:
Inclusion Criteria:

* Documented invasive pneumococcal disease (IPD), defined as recovery of an isolate of S pneumoniae from a normally sterile site in a member of the surveillance population.

Exclusion Criteria:

None
NeuMoDx PrEDiCTiNG Study Evaluation Plan

This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).

Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.

Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects of at least 14 years of age or older.
2. Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
3. Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
4. Subject is willing to provide all required specimens.

Exclusion Criteria:

1. Female subject reports that she had a hysterectomy.
2. Subject self-reports use of antibiotics within 28 days of study enrollment.
Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.


Eligibility Criteria:
Inclusion Criteria:

The patients have to meet all of the following criteria to be eligible to enter the study:

* Willing and able to provide informed consent.
* Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as clinically diagnosed and with symptoms appearing within less 7 days at the time of giving informed consent.
* Using adequate contraceptive measures

Exclusion Criteria:

* Known or suspected allergy to any ingredient of the IMP or placebo.
* Symptoms correlating with EKC since more than 7 days.
* Diagnosis of other significant disease(s) than EKC in the eye.
* Diagnosis of bacterial or fungal ocular infections.
* Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited during the study.
* Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
* Use of antiviral medications within 7 days prior to inclusion.
* Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
* Usage of any medication or herbal medicinal product for ocular administration at inclusion.
* Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
* Known or suspected drug abuse.
* Usage of contact lenses during the study.
* Participation in any other interventional clinical study within 30 days prior to inclusion
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

Eligibility Criteria:
* INCLUSION CRITERIA:

All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.

Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.

Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.

Performance status of less than or equal to ECOG 2.

Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.

All patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.

EXCLUSION CRITERIA:

Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).

History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.

Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.

History of active GI bleeding within the last 30 days.

Prior therapy other than surgery for this malignancy.

Abnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.

Previous history of invasive malignancy.

Patients with ureteral obstruction must have this corrected prior to starting therapy.

Patients with germ cell, mixed Muellerian and borderline histologies are specifically excluded.
Retrospective Evaluation of Combination Treatment With the Ulthera System

A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.

This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 25 to 70 years.
* Subject in good health
* Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.
* Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.
* Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.
* Subjects who are identified with good photography, must have the ability to be contacted to provide authorization to disclose photographs for usage of previously taken photography, if photos are deemed worthy of publication.

Exclusion Criteria:

* Subjects who have had any and all Ultherapy treatment(s) before April 2013.
* Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.
* Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.