cyrilzakka/clinical-trials huggingface dataset:
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20

This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose.

This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.

This trial is designed to define drug interactions following the combined administration of Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.

Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66 of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and tolerability of ISDN in pediatric patients have been reported.

Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living
* Males between the age of 18 and 27
* Normal ECG
* Body Mass Index of 19.0-29.0 (Kg/m2)
* Subject healthy in the opinion of the Investigator
* Signed informed consent after verbal and written information

Exclusion Criteria:

* Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
* Any Gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea, gastrointestinal surgery)
* History of the following cardiac diseases SBP \<120 mmHG or DBP \< 80 mmHg
* Platelet count \< 100000/mm3
* History of recurrent headache
* History of ongoing or clinically relevant glaucoma
* History of alcohol, drug or medication abuse within the past 2 years
* Treatment with norepinephrine, acetylcholine and histamine
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
* Participation in another study phase 1 with any investigational product within 6 months of screening
Safety of Sildenafil in Premature Infants

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source - FDA OOPD.

This will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants.

This is a Phase II study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.

Eligibility Criteria:
Inclusion Criteria:

* Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow \> 1LPM) or mechanical ventilation (high frequency or conventional)
* \<29 weeks gestational age at birth
* 7-28 (inclusive) days postnatal age at time of randomization

Exclusion Criteria:

* Currently receiving vasopressors
* Currently receiving inhaled nitric oxide
* Baseline mean arterial pressure \< gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration
* Known allergy to sildenafil
* Known sickle cell disease
* AST \> 225 U/L \< 72 hours prior to randomization
* ALT \> 150 U/L \< 72 hours prior to randomization
Web-Based Active Balance Childhood Study in Chinese-American

This study compares the feasibility and efficacy of an individually tailored, child-centered, Internet-based behavioral intervention with that of general Internet-based health information for improving health behaviors and relative weight in Chinese-American children during a 6-month period. A total of 60 children (age 10-14) and their families will be randomized to either the intervention group or control group. The intervention is based on the Social Cognitive Theory and Transtheoretical Model.

The proposed study will use a randomized experimental design to examine the effects of an individually tailored, Internet-based behavioral intervention program on improving health behavior (dietary intake and physical activity) and anthropometrics of Chinese-American children. A total of 60 children and their families will be recruited. The intervention will include a weekly Internet session tailored to each individual child for eight weeks and three Internet sessions for parents. Children and their parents in the control group will receive general health information on healthy eating, active lifestyles, dental care, smoking cessation, and risk taking issues via the Internet. The content of the sessions is described later. After informed consent is obtained from parents and verbal assent from the children, baseline data (T0) will be collected before assigning the children and parents to the intervention group or control group. Follow-up data for both groups will be collected at 2 months (T1), 4 months (T2) and 6 months (T3) after baseline.

Eligibility Criteria:
Inclusion Criteria:

Children:

* children between the ages of 10 and 14 years old who self-identify as Chinese or of Chinese origin
* reside in the Bay Area in the same household as at least one parent, can read and speak English, and have access to the Internet at home

Parents:

* parents who self-identify as Chinese or of Chinese origin
* have children between the ages of 11 and 14
* are able to read either Chinese or English
* are able to speak Mandarin, Cantonese, or English
* have access to the Internet at home

Exclusion Criteria:

* children with chronic health problems that include any dietary modifications or activity limitations will be excluded (e.g., diabetes, exercise-induced asthma)
Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia

Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

The aim of this study is to compare the levels of esttradiol and testosterone in seminal plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological test allows to predict a positive sperm extraction before the surgical testis biopsy is performed. Since the involvement of estradiol and testosterone in the regulation of spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool for these men before testis biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Azoospermia confirmed by two semen analysis (at minimum 74 days between the both analysis)
* Volume of seminal plasma \>0.6ml
* Testicular biopsy one month after the last semen analysis
* Informed consent signed by the patient

Exclusion Criteria:

* obstructive azoospermia
* cryptozoospermia
Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development

Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.


Eligibility Criteria:
Inclusion Criteria:

* healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
* Day 2-4 FSH \< 10 IU/ml, LH \<12 IU/ml, and E2 \<50 pg/ml
* Antimullerian Hormone (AMH) \>1.5
* Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
* BMI \>18 and \<32

Exclusion Criteria:

* Smokers
* Polycystic Ovarian Syndrome (PCO)
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.


Eligibility Criteria:
Inclusion Criteria:

1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.

2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:

* non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
* inflammatory degenerative joint disease such as rheumatoid arthritis;
* correction of functional deformity 3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit 4. Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.

Exclusion Criteria:

1. Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
2. Skeletally immature (less than 21 years of age) at time of implantation
3. Has or had an overt infection at the time of implantation
4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
6. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
7. Has or had neuropathic joints
8. Has or had hepatitis or HIV infection
9. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
10. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
11. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
12. Unwilling or unable to sign the Informed Consent document
13. Has documented substance abuse issue
14. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
15. Currently incarcerated or has impending incarceration
16. Has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol -
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft


Eligibility Criteria:
Inclusion Criteria:

* Age\> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age\<65 years with an ineligibility to allograft (contraindication to conditioning)
* HLA-partially matched family donors
* Affiliated to(or beneficiary of) the Social Security
* Informed consent signed

Exclusion Criteria:

* AML3
* Previous Hematopoietic Stem Cell TRansplantation
* Uncontrolled infection -PS\>3 -Other progressive cancer
* Psychiatric disease
* Vulnerable person or unable to provide informed consent
* Emergency
* Unable to comply with required study follow up
Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography (ERC) or percutaneous liver biopsy are needed when magnetic resonance cholangiopancreaticography remains inconclusive. As these procedures are associated with significant risks for the patient, the goal of this study is to evaluate, if endoscopic ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.

Different parameters of the common bile duct (wall thickness and irregularity, irregularity of the common bile duct and enlarged lymph nodes) are measured in patients with cholestatic hepatopathy of unknown causes via endoscopic ultrasound (EUS).

This EUS of the CBD is performed from the bulbar position in the duodenum and at least 5 cm of bile duct had to be visualized to correctly analyze bile duct structure.

Further diagnostic work-up of these patients is performed following current guidelines, and definite diagnosis is compared with results of EUS parameters measured. Thus, diagnostic yield of EUS in patients with suspected PSC is further evaluated.

Eligibility Criteria:
Inclusion Criteria:

* cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and
* elevated pANCA and / or medical history of inflammatory bowel disease

Exclusion Criteria:

* sign of significant intrahepatic cholestasis or any other cause of necessity of cholangiography on transabdominal ultrasound
Study of Dietary Composition in Crohn's Disease

Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.

A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 75 years old
* History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof

Exclusion Criteria:

1. History or current diagnosis of any of the following:

   * Stroke or Arrhythmia
   * Seizures
   * Liver Disease
   * Untreated hypertension (High Blood Pressure)
   * Active malignancy
   * Bleeding disorders
   * Heart Disease
   * Lung disease
   * Previous Heart surgery
   * Previous Gastrointestinal Surgery
   * Kidney Disease
   * Chronic Diarrhea
   * End enterostomy
   * Bulimia
   * Anorexia
   * Laxative Abuse
   * Endocrine Disorder
   * Current history of smoking tobacco
   * Urgent need for abdominal sugery
   * Severe Malnutrition
   * Active alcohol or non-cannabinoid substance abuse
2. Recent hospitalization within the last 30 days
3. Currently pregnant of lactating.
4. Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.
5. Concerns for non-compliance
6. If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.
Complications After Endosonography and Guided Bronchoscopy

The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years,
* Indication to undergo bronchoscopy, endosonography, or both.
* Signed informed consent

Exclusion Criteria:

* Absolute contraindications to the bronchoscopic examination based on international guidelines \[31\].
* Platelet count \<50000
Trial of Oral Melatonin in Elevated Blood Pressure

Since, lowering blood pressure (BP) in elevated blood pressure individuals represents an excellent opportunity to for primary prevention of hypertension (HTN). Therefore, it is planned to use a safe treatment option - oral melatonin supplementation - associated with lifestyle interventions according to the American college of cardiology/American heart association (ACC/AHA) 2013 guideline in elevated blood pressure individuals to mitigate systolic and diastolic BP and ultimately, to prevent the development of HTN.

Hypothesis:

Melatonin therapy can lower the systolic and diastolic BP of elevated blood pressure individuals Melatonin can attenuate levels of circulatory biomarkers of Hs- CRP, Cholesterol, LDL-c and triglyceride

Study design: Randomized controlled trial (RCT)

Study population: Elevated blood pressure individuals who present themselves at the outpatient clinics of Tehran Heart Centre(THC) , seeking blood pressure treatment and who have a systolic blood pressure of 120-129 mmHg or a diastolic blood pressure of =80 mmHg.

Treatment groups: Melatonin 3 mg versus placebo

sample size: 160 per group ( 320 overall)

Treatment allocation: After completing informed consent and prior to randomization, all participants undergo complete physical examination and laboratory test. Baseline levels of inflammatory biomarkers and pregnancy test (for women in reproductive age) will be performed. Sleep quality, actual sleep time, and sleep latency will be recorded.

Treatment plan: Three weeks melatonin 3 Mg or placebo one hour before bedtime has been planned. All of the melatonin and placebo capsules will be supplied from a single hospital pharmacy and free of charge to the participants. Melatonin and placebo capsules will be identical. Participants will receive a three weeks supply at the assignment time. Besides, all participants will receive a careful plan of adherence to a heart-healthy diet, regular exercise, instruction for avoidance of tobacco use and maintenance of a healthy body mass index (BMI) according to 2013ACC/ AHA guideline.

Follow up: Three weeks

Eligibility Criteria:
Inclusion Criteria:

* Individuals with systolic blood pressure120-129 and/or diastolic blood pressure =80mmHg
* Negative pregnancy test for women at productive age
* Baseline melatonin and biomarkers level and complete liver function tests within normal range

Exclusion Criteria:

* Previous history of hypersensitivity of melatonin
* Past history of using antihypertensive treatment
* Past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy and other physician documented diseases
* Use of beta-blockers, sleep aids, warfarin, flaxseed, soy and supplements
Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study

The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
* Older than 18 years of age
* Requires a clinically necessary esophagectomy for esophageal cancer or other indications.

Exclusion Criteria:

* Patient has esophageal narrowing limiting access to the intended sites of ablation
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.

Background and Aim:

Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and recurrence rate after 6 months .

Materials and Methods:

This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results,recurrence rate and probable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven BCCs

Exclusion Criteria:

* Rodent ulcer
* Morphea type
* ANA +
* History of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
* Pregnancy
* Breast feeding
* Age\< 18
* History of another therapeutic intervention for bcc during last 6 months