cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.

Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal \[IP\] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy.

This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-cytoreductive surgery in women with ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.

Eligibility Criteria:
Inclusion Criteria:

* Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence \>6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
* Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
* Minimal or non-symptomatic ascites
* ≥18 years old
* Signed informed consent

Exclusion Criteria:

* Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
* Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
* Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
* Known sensitivity to any of the study medication components or the chemotherapy regimen
* History of prior malignancy other than ovarian that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy
* Ileostomy or hepatic resection during current cytoreductive surgery
* Women of childbearing potential not practicing adequate forms of birth control
Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention

The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout France, except in case of refusal.

Maternal clinical, biological and therapeutic data before and during pregnancy are collected at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and 24 months. An infant is considered as non infected if two virologic tests are negative beyond the prophylactic treatment or serology is negative after 18 months. An infant is considered as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific recommendation for HIV treatment and obstetrical care are made for women and children included in the cohort, although national guidelines for prevention of MTCT are regularly published and updated. Frozen maternal samples blood and plasma are stored in a centralized laboratory. A research of patients patients lost to follow-up (last visit \<24 months) and monitoring is performed regularly in all sites.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women \>= 18 years
* infected with HIV1 and/or HIV2

Exclusion Criteria:

-
Decrease Type II Diabetes in Gestational Diabetes Population

The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant individuals aged over 18 years old
* Diagnosed with Gestational Diabetes Mellitus (GDM) by 100gm oral glucose tolerance test (OGTT) done between week 24-28 of gestation, or by other criteria (50gm glucose challenge test (GCT) \>200 mg/dl22 or having one abnormal value in OGTT )
* Having pregestational diabetes (DM-I or DM-II)
* Can read and understand Hebrew

Exclusion Criteria:

* Delivery of a non-viable fetus
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.


Eligibility Criteria:
Inclusion Criteria:

* Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
* Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
* No or minimal smoking history (\</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report)
* Age 18 years or older
* Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.
* Enrollment on any other study, regardless of therapy is allowed.
* Enrollment on any other tumor or tissue banking study is allowed.
* Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery.

Exclusion Criteria:

* Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.
* Previous surgery for head and neck cancer unrelated to current disease.
* Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)
* Patients who have started induction chemotherapy prior to consideration for study eligibility.
* Another active cancer except nonmelanomatous skin cancer.
* History of cervical penile or anal cancer.
* Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.
* History of smoking in the past last 12 months 10 years
* History of 10 pack-years of cigarette smoking based on documented history and/or subject report
* Presence of sidespread leukoplakia or erythroplakia.
Screening for Advanced Heart Failure Treatment (SEE-HF)

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.


Eligibility Criteria:
Inclusion Criteria:

* CRT and or ICD device in place.
* NYHA class III - IV heart failure
* EF \</= 40%
* Patient is an out-patient
* Patient is on optimal medical management as tolerated and as defined by primary care physician.
* Patient has signed an informed consent for data collection.

Exclusion Criteria:

* Age \<18 years or \>80 years
* CRT device that has been implanted \< 3 months prior to enrollment
* Coronary revascularization within 3 months prior to enrollment
* Patient only has ICD but has CRT planned
* Non-cardiac disease resulting in life expectancy \< 2 yrs
* Patient is hospitalized or will be hospitalized at this time
* Known diagnosis of dementia
* Patient is currently on dialysis
* Oxygen dependent lung disease
* Previously or currently treated with LVAD or heart transplantation
Quantum Natural Family Planning Pilot

•The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices to monitor the menstrual cycle.

* The Mira fertility monitoring system (www.miracare.com) is a new home-use hormone tracking device with the ability to quantitatively measure reproductive hormones in the urine but is also synced to a smart phone App that provides a graphic representation of the hormonal levels throughout a menstrual cycle.
* The Mira monitor will be compared to the ClearBlue Fertility Monitor for its ease of use, satisfaction, and accuracy.
* The Mira hormonal monitor and App system has not been tested for its use in Natural Family Planning (NFP).
* The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices.
* Female participants invited to participate will need to meet the following criteria:
* Age 18 to 42 years
* Menstrual cycle ranging between 21-42 days
* At least 3 cycles after cessation of breastfeeding
* Not currently on medications that affect ovulation and 3 months prior
* Not currently pregnant or breastfeeding
* No known fertility problems
* Not planning on achieving pregnancy during the 3 menstrual cycles of the study

Eligibility Criteria:
Inclusion Criteria:

* • Menstrual cycle ranging between 21-42 days

  * At least 3 cycles after cessation of breastfeeding

Exclusion Criteria:

* • Not currently on medications that affect ovulation and 3 months prior

  * Not currently pregnant or breastfeeding
  * No known fertility problems
  * Not planning on achieving pregnancy during the 3 menstrual cycles of the study
Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is the fourth-leading cause of death. It is a progressive illness that requires life-long treatment.Promoting airway clearance (AC) using mucolytics together with airway clearance techniques (ACTs) form the basis for pulmonary therapy in COPD care.Therefore, new airway clearance modalities are required to decrease the detrimental effects of accumulated secretions in COPD.

One of the devices used in AC is the high frequency chest wall oscillation (The Vest). HFCWO involves the use of an inflatable vest/jacket that covers the chest and is attached to an air pulse-generating compressor which rapidly inflates and deflates the vest, producing oscillations to the chest wall of 5-25 Hz.

Another new airway clearance modality is oscillating positive expiratory pressure(Quake) which combines PEP therapy with high frequency oscillations.

The present study aimed to evaluate the effectiveness of the extra thoracic oscillations via high frequency chest wall oscillation vest (HFCWO) versus the intra thoracic oscillations via oscillatory positive expiratory pressure (OPEP) Quake device in COPD Group A: consists of 30 patients will be treated by high frequency chest wall oscillation vest along with their prescribed medical treatment. This program will be performed 4 times per week for 6 successive weeks.

Group B: consists of 30 patients will be treated by vibratory PEP (The Quake) along with their prescribed medical treatment. This program will be performed 4 times per week for 6 successive weeks.

Eligibility Criteria:
Inclusion Criteria:

* • All patients were diagnosed by chest physician based on the modified criteria defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2017.

  * All patients were diagnosed as COPD for at least two years.
  * All Patients must use their prescribed medications.

Exclusion Criteria:

* All patients that had one of the following were excluded from the study. History of osteoporosis, significant gastro-esophageal reflux, hiatus hernia. Recent acute cardiac event (6 weeks) or congestive cardiac failure. Any significant musculoskeletal disorders. Presence of active hemoptysis Presence of malignant disease
Search for Genes Influencing Childhood Absence Epilepsy (CAE) Study

The purpose of our study is to identify gene(s) involved in the cause of childhood absence epilepsy (CAE).

A high familial predisposition for epilepsy in patients with childhood absence epilepsy (CAE), also called petit mal epilepsy, suggests underlying genetic causes contributing to the disease. Several areas harboring potential absence epilepsy genes have been identified in the genome.

This study will further narrow down those areas and identify gene(s) involved in the cause of CAE by taking several approaches: 1. Comparing patients with CAE to healthy individuals without epilepsy and 2. Investigating whole families with many members affected with epilepsy).

Participation in this study requires an interview regarding medical and family history and saliva (spit) collection from all available family members of families with many epilepsy cases. For those families without a history of epilepsy, parents and children are asked to provide a small amount of saliva only. Healthy volunteers without epilepsy or a family history of seizures are asked to fill out an anonymous questionnaire and provide a small amount of saliva as well.

Although the study is based at Mount Sinai School of Medicine in New York, all study materials can be sent to your home at no cost to participants or their insurance. For the collection of saliva, special containers are provided and they can be shipped back to Mount Sinai in the pre-paid envelope provided. Study materials can be completed at your convenience.

Results from this study may enable scientists to understand the cause of absence seizures and, perhaps, other types of seizures as well and with this laying the foundation for better diagnosis and treatment of epilepsy patients in the future.

Eligibility Criteria:
Patients and their families:

Inclusion Criteria:

* Clinical diagnosis of classical (typical) Childhood Absence Epilepsy
* Good seizure control
* Must be able to give saliva sample

Exclusion Criteria:

* History of non-febrile seizures prior to the onset of typical absence seizures
* other neuropsychiatric or developmental disorders.
Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients.

As postoperative pulmonary complications are major concern in cardiac surgery patients and our local data is deficient for making better management guidelines. My study aims to provide a base for future research on this dimension and to decide better management plan for post cardiac surgical pulmonary complications. The hypothesis is Post extubation BiPAP is more effective than Incentive Spirometry (IS) in reducing postoperative pulmonary complications in cardiac surgical patients and the purpose of the study is to evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in cardiac surgical patients.

This Randomized Controlled Trial (RCT) study will be conducted at Chaudhary pervaiz elahi institute of cardiology ICU multan.

A sample size of 350 patients will be taken and effect of BiPAP and Incentive spirometry will be studied in reducing pulmonary complications post CABG surgery. Data will be analyzed through SPSS. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. Chi square test will be used to estimate association between qualitative variables. A p value \< 0.05 will be significant.

Eligibility Criteria:
Inclusion Criteria:

* CABG patients
* Patient willing to study
* Patients planned for on-pump cardiac surgical procedures
* Both genders (Male \& Female)
* Age 20-60 years
* Ejection fraction 40-60%

Exclusion Criteria:

* Patients with valvular lesions
* Off-pump cardiac surgery
* Refusal to give consent for BiPAP
* Emergency surgery
* Previous cardiac surgery
* Obesity BMI\>30
* ASA status V
Dermacyd Infantile - Acceptability.

Primary Objective:

To prove the safety of the formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral skin test in the region
* Use the same category of cosmetics
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time.

Exclusion criteria:

* Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local or general) in the evaluated area
* Disease which can cause immunosuppressant, such as diabetes, HIV
* Endocrine pathology
* Intensive solar exposure until 15 days before evaluation
* Treatment four months before selection.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island

In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years, third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is continuously increasing. Community 3GCREB prevalence has not been studied whereas several observations made in Reunion Island hospital suggest a diffusion in community. In this situation of world-wide and regional extension of bacterial resistance, the investigator offers to study bacterial resistance to antibiotic in Reunion Island community.

The investigator is focused on E. coli species exhibiting BLSE or metallo-betalactamases production that could be encountered du to the increasing level of migratory flow in Reunion Island.

Fecal sample collection will be used for further investigations on bacterial typology.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* aged over 18 years old
* admitted in emergency ward or intensive care of the university hospital of Reunion Island
* who received the patient information notice and who gave their consent
* who have a stool sample performed in the 48 hours following admission
* who understand and can read French

Exclusion Criteria:

Patients:

* transferred from a short-term, middle-term or long-term stay health facility
* who have a stool sample performed more than 48 hours following admission.
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

   * Fusiform (≥50 mm), or
   * Saccular (no diameter criteria)
2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

   * Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
3. Proximal and distal landing zone length greater than 2.0 cm

   * Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
4. Life expectancy \> 2 years
5. Subject is open surgical candidate defined as:

   * Able to tolerate thoracotomy
   * American Society of Anesthesiologists class I-IV (class V excluded)
   * New York Heart Association class I-III or not applicable (class IV excluded)
6. Male or infertile female
7. Age greater than 21 years
8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria:

1. Mycotic aneurysm
2. Hemodynamically unstable aneurysm rupture
3. Aortic dissection
4. Planned occlusion of left carotid or celiac arteries
5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
6. Myocardial infarction or stroke within 6 weeks of treatment
7. Pre-treatment creatinine \> 2.0 mg/dL
8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
9. Participation in another drug or device study within 1 year of treatment
10. History of drug abuse within 6 months of treatment
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects

Primary Objective:

To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.

Secondary Objectives:

* To assess the change in resting, basal and total daily energy expenditure.
* To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.
* To assess the change in body composition and core temperature.
* To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).
* To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.
* To assess the safety and tolerability.

Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.

Eligibility Criteria:
Inclusion criteria:

* Overweight to obese male and female subjects.
* Body mass index 28 - 40 kg/m2.
* 18 to 50 years of age
* Fasting plasma glucose ≤125 mg/dL.
* Glycated hemoglobine (HbA1c) ≤6.5%.
* Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia).
* No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker).
* Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.

Exclusion criteria:

* Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
* Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.
* Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.