louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00260923: A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
aliskiren
blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 years of age and older
* Patients who are eligible and able to participate in the study

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 8 weeks
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose--response relationship of aliskiren, a direct renin inhibitor, in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clin Ther. 2009 Dec;31(12):2839-50. doi: 10.1016/j.clinthera.2009.12.006.
Clinical trial NCT00004438: Leuprolide in Treating Adults With Hypogonadotropism
Official title: Study of Leuprolide in Adults With Hypogonadotropism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypogonadism
Keywords: endocrine disorders
hypogonadism
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of gonadotropins, a group of hormones that stimulate the parts of the reproductive system that produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may stimulate the production of gonadotropins and be effective in increasing testosterone in men and inducing ovulation in women.

PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have hypogonadotropism.

Detailed description: PROTOCOL OUTLINE: Male patients receive leuprolide subcutaneously every 5 days for up to one year and are followed at weeks 4, 6, 8, and 12, then every 2 months.

Female patients receive leuprolide subcutaneously on days 1, 6, and possibly 11. Patients are followed 2 months after the last injection.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of hypogonadotropism

Men: Small testes, abnormal semen analysis, and subnormal plasma testosterone levels without an elevation in gonadotropin levels

Women: Amenorrhea and subnormal plasma estradiol levels, or lack of cornification of the vaginal mucosa without an elevation in gonadotropin levels OR Hypothalamic amenorrhea in normally estrogenized women with amenorrhea or oligomenorrhea and normal plasma free testosterone and gonadotropin levels

Patients with hyperprolactinemia eligible only if hypogonadotropism persists after correction of hyperprolactinemia by dopamine agonist therapy

--Prior/Concurrent Therapy-- At least 2 months since sex hormone treatment

--Patient Characteristics--

Other:

* Not pregnant
* No chronic systemic, metabolic, or endocrine disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Children's Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert L. Rosenfield
role: STUDY_CHAIR
References:
Clinical trial NCT00482638: Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.


Eligibility criteria: Inclusion Criteria:

* Patient is between 21 and 65 years
* Patient is able to read and understand and complete study questionnaires
* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period

Exclusion Criteria:

* Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
* Patient is HIV positive as determined by medical history
* Patient has undergone surgical treatment for obesity
* Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
* Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
* Patient is currently a heavy consumer of alcohol (\>2 drinks per day or \>14 drinks per week \[1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer\], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Krishna R, Gumbiner B, Stevens C, Musser B, Mallick M, Suryawanshi S, Maganti L, Zhu H, Han TH, Scherer L, Simpson B, Cosgrove D, Gottesdiener K, Amatruda J, Rolls BJ, Blundell J, Bray GA, Fujioka K, Heymsfield SB, Wagner JA, Herman GA. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. Clin Pharmacol Ther. 2009 Dec;86(6):659-66. doi: 10.1038/clpt.2009.167. Epub 2009 Sep 9.
Clinical trial NCT03966638: Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal Injection of Platelet-rich Plasma (PRP)
Official title: Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meniscus Lesion
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with symptomatic non-surgical meniscal injury treated with percutaneous intravenous injection of platelet-rich plasma (PRP)

Brief summary: Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.

Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.

PRP has been injected under ultrasound in tendons or intra-articularly for several years.

This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.

All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.

The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.


Eligibility criteria: Inclusion Criteria:

* isolated symptomatic meniscal lesion
* lesion confirmed by MRI
* grade II or III lesion touching the peripheral involvement of the middle segment,
* lesion treated by percutaneous intra meniscal PRP's injection
* IKDC score measured before injection and 6 months post-injection

Exclusion Criteria:

* other painful etiology of the knee
* emergency surgical management (luxation, bucket handle) or not (indication validated by the surgeon, meniscectomy or meniscal suture)
* impossibility to perform the procedure (non visible lesion, morphology of the patient, cutaneous infection, coagulation treatment in progress)

Primary outcomes:
measure: Variation of International Knee Documentation Committee (IKDC) score
timeFrame: Between 0 and 6 months post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Radiology, Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03190538: Nonalcoholic Steatohepatitis in Chinese Children
Official title: Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2017-06-16
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with NAFLD who attended the Children's Liver Disease Center, 302 Hospital, Beijing, China will be identified and recruited. Participants met above inclusion and exclusion criteria will be invited to the study.

Brief summary: Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.

A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.


Eligibility criteria: Inclusion Criteria:

* age 1-18 with biopsy-proven NAFLD
* Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively

Exclusion Criteria:

* with viral hepatitis, e.g. HBV, HCV
* with a1-anti-trypsin disease
* with autoimmune hepatitis
* with Wilson disease
* with liver impaired by drugs

Primary outcomes:
measure: Liver related death
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Complications of cirrhosis
timeFrame: Through study completion, an average of 1 year
measure: Liver biopsy
timeFrame: Through study completion, an average of 2 year
measure: Liver transplant
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Liver Disease Center, 302 Hospital
Study officials:
affiliation: Humanity and Health Medical Centre
name: George Lau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954338: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
Official title: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With Concomitant Multiple Oral Doses of DWC202307 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Eligibility criteria: Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteer

Exclusion Criteria:

* Eye disorders including cataracts
* Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Primary outcomes:
measure: Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543
timeFrame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
measure: Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543
timeFrame: At pre-dose (0 hour), and post-dose 1 to 120 hour.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02913638: A Post Breastfeeding Follow-Up Study
Official title: A Post-Breastfeeding Intervention Observational Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 196
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study involves mothers and their child at 30 months old as a follow up to the breastfeeding intervention study that they have participated in and completed during the period from the last trimester to 12 weeks postpartum

Brief summary: The purpose of this clinical study which is to evaluate the benefits of lactation support intervention, in conjunction with maternal nutritional supplementation during the last trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast feeding practices (primary objective), and 2) cognitive development in children within 28 months 16 days - 32 months 30 days (secondary objective).

Detailed description: This is an observational study involving mothers and their child at 30 months old as a follow up to the breastfeeding intervention study that they have participated in and completed during the period from the last trimester to 12 weeks postpartum.

The assessors will be blinded to subject's treatment group assignment from the intervention phase.

There are no products given to any subject.

The primary variable is duration of any breastfeeding from birth.

Eligibility criteria: Inclusion Criteria:

* Mother and child pair was enrolled in and completed the breastfeeding intervention (AL08) study.
* Age of child is within the allowable window (28 months 16 days - 32 months 30 days).
* Subject's parent/Legally Acceptable Representative (LAR) is willing and able to follow study procedures.
* Subject's parent/LAR has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion Criteria:

* Child has a diagnosis of developmental disorders e.g. cerebral palsy that require medical intervention prior to enrollment in this study.

Primary outcomes:
measure: Duration of any breastfeeding from birth
timeFrame: 32 months
Secondary outcomes:
measure: Cognitive outcomes
timeFrame: 32 months
measure: Language/Communication outcomes
timeFrame: 32 months
Other outcomes:
Locations:
city: Ha Nam
country: Vietnam
facility: Binh Luc District Health Center
city: Hai Phong
country: Vietnam
facility: An Lao District Health Center
city: Ninh Binh
country: Vietnam
facility: Yen Mo District Health Center
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Center
Study officials:
affiliation: Abbott Nutrition
name: Dieu Huynh, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02606838: Evaluation of an Ascensia Lancing System
Official title: User Performance of the Styx Lancing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and older
* People with type 1 or type 2 diabetes
* People who regularly perform self-tests (at least once/day) with their own lancing device
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual or neurological impairments that would make the person unable to perform testing
* Persons who have used the Styx device in a previous clinical evaluation
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Primary outcomes:
measure: Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
timeFrame: 1 hour
measure: Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)
timeFrame: 1 hour
measure: Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)
timeFrame: 1 hour
measure: Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Ascensia Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: Robert Morin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06801938: Evaluation of Perioperative Cystoscopy and Methylene Blue Test in Detecting Complications in TVT and TOT Procedures
Official title: Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence Stress
Keywords: tvt
tot
cystoscopy
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-30
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The ability of perioperative methylene blue test and postoperative cystoscopy to detect complications in patients with stress urinary incontinence will be compared.
Primary purpose: TREATMENT

Brief summary: Comparison of complications detected by perioperative cystoscopy combined with methylene blue test and postoperative cystoscopy in TVT and TOT operations.


Eligibility criteria: Inclusion Criteria:

* Providing consent to participate in the study
* Being between the ages of 18 and 85
* Having stress urinary incontinence
* No active cardiac disease
* No connective tissue disorders (e.g., Marfan syndrome)
* No known gynecological malignancy
* BMI under 30
* No chronic constipation
* No inflammatory bowel disease

Exclusion Criteria:

* Not providing consent to participate in the study
* Being under 18 or over 85 years old
* Not having stress urinary incontinence
* Having active cardiac disease
* Having connective tissue disorders (e.g., Marfan syndrome)
* Having a known gynecological malignancy
* Having a BMI over 30
* Having chronic constipation
* Having inflammatory bowel disease

Primary outcomes:
measure: rate of complication detection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Training and Research Hospital
Study officials:
References: