louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01638988: Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
Official title: Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.


Eligibility criteria: Inclusion Criteria:

* Women aged from 18 to 35
* Infertility for a period of a year or more or 6 month of irregular menstrual cycle
* PCOS under the Rotterdam criteria
* Insulin resistance HOMA-IR \> 2.5
* Normal semen analysis values
* Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test

Exclusion Criteria:

* Tubular factor
* Normal ovarian reserve
* Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
* Neoplasia
* BMI \> 35
* Renal, hepatic or cardiac failure
* Lactic, acidosis antecedent

Primary outcomes:
measure: Biochemical pregnancy
timeFrame: 1 month
Secondary outcomes:
measure: Ovulation rate
timeFrame: 1 month
measure: Live birth rate
timeFrame: 6 months
measure: Spontaneous abortion rate
timeFrame: 6 months
measure: BMI and waist size changing
timeFrame: 6 months
measure: Insulin resistance changing
timeFrame: 6 months
measure: AMH correlation/variation in function of Metformin
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490788: A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Official title: A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Detailed description: Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Eligibility criteria: Inclusion Criteria: Healthy adults

* Male or female
* Non-smoker
* 18-55 years old
* BMI \> 18.5 and \< 30.0
* With medically acceptable form of contraception (female only).

Exclusion Criteria:

* Any clinically significant abnormality or vital sign abnormalities
* Any abnormal laboratory test
* History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
* Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
* Positive pregnancy test, breastfeeding or lactating
* Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
* Participation in an investigational study within 30 days prior to dosing
* Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of \> 499 mL (within 56 days) prior to dosing.

Primary outcomes:
measure: Mean Plasma Concentration (AUC) of Cyclobenzaprine
timeFrame: 0 to 96 hours
measure: Incidences of Adverse Events
timeFrame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Québec City
country: Canada
facility: PharmaNet, Inc.
state: Quebec
Study officials:
affiliation: PharmaNet
name: Denis Audet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06227988: ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE
Official title: ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CHRONIC LIVER DISEASE
Keywords: Fluid buildup in the belly (ascites)
Gallstones.
Muscle loss.
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. STUDY POPULATION Data of 53 patients with liver disease who undergoing surgery of interest will be included
2. DESIGN AND DURATION OF THE STUDY

Prospective observational study Duration 2 years

Brief summary: 4a. Primary To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score

4b. Secondary To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality

Detailed description: For each patient and surgery,we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \[INR\], albumin, platelet count.) The etiology of liver disease will be classified.

To ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.

Eligibility criteria: Inclusion Criteria:

* Patients with established cirrhosis Patients who had not received liver transplantation and who underwent surgery of interest were included These surgery categories will be the same as those used in the original VOCAL-Penn derivation study and will include the open abdominal, laparoscopic abdominal, and abdominal wall.

Exclusion Criteria:

* Patients with insufficient pre-operative data to compute the VOCAL-Penn score, Mayo risk score, or MELD-Na score will be excluded.

Patients undergoing liver surgeries Patients who received multiple surgeries Those who didn't give consent

Primary outcomes:
measure: To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score
timeFrame: 2 years
Secondary outcomes:
measure: To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr Prachiti Gokhe
state: Telangana
Study officials:
affiliation: AIG HOSPITALS
name: PRACHITI Gokhe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00323388: Identification of Risk Allels for Prostate Cancer
Official title: Identification of Risk Allels for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer

Brief summary: Identification of Risk Allels for Prostate Cancer

Detailed description: As above.

Eligibility criteria: Inclusion Criteria:

* Patients with prostate cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: John Scariano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04704388: Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care
Official title: Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paitent admitted between March 1 and May 10, 2020 in Bicêtre hospital for an infection with SARS-CoV-2

Brief summary: To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia


Eligibility criteria: Inclusion Criteria:

-

Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2

* Major
* Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
* proven SARS-CoV-2 infection
* Treated by invasive mechanical ventilation or high flow humidified oxygen with FiO2 ≥50% for more than 48 hours.

Group 2: patients hospitalized outside intensive care units

* Major
* Admitted between March 1 and May 10, 2020 in an area of Bicêtre hospital having cared for patients infected with SARS-CoV-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology.

Exclusion Criteria:

* Patients having refused the post consultation at 3 month
* Without social security coverage

Primary outcomes:
measure: post-intensive care syndrome (PICS)
timeFrame: 3 month after hospitalisation
Secondary outcomes:
measure: Evaluate the 3-month mortality of patients released alive from intensive care
timeFrame: 3 month after end of hospitalisation
measure: Describe the overall state of health and the main organ sequelae of these patients
timeFrame: 3 month after hospitalisation
measure: functional respiratory sequelae
timeFrame: 3 month after hospitalisation
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
affiliation: APHP
name: Tài PHAM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00102388: Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 104 weeks
timeFrame: 104 weeks
Secondary outcomes:
measure: Adverse event profile at 104 weeks
timeFrame: 104 weeks
measure: Change from baseline in fasting plasma glucose at 104 weeks
timeFrame: 104 weeks
measure: Patients with endpoint HbA1c <7% after 104 weeks
timeFrame: 104 weeks
measure: Patients with reduction in HbA1c >/= 0.7% after 104 weeks
timeFrame: 104 weeks
measure: Patients with reduction in HbA1x >/= 0.5% after 104 weeks
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24.
citation: Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19.
citation: Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.
Clinical trial NCT04164888: Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Official title: A Placebo-controlled, Randomized, Phase 2a, Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CIVI 007 in Patients on a Background of Stable Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Civi Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.


Eligibility criteria: Key Inclusion Criteria:

1. Body mass index (BMI) between 18.0 and 40.0
2. Stable (\>4 weeks prior to the Screening Visit) dose of statin therapy with or without ezetimibe
3. Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.
4. Fasting triglycerides (TGs) \<400 mg/dL

Key Exclusion Criteria:

1. Women who are pregnant, nursing or breast feeding
2. Currently prescribed a lipid lowering agent other than a statin or ezetimibe.
3. Clinically significant disorder or laboratory abnormality that could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results

Primary outcomes:
measure: Assessment of the Pharmacodynamic Effect of CIVI 007
timeFrame: Baseline, D29, D57, D85
Secondary outcomes:
measure: Assessment of the Lipid Efficacy of CIVI 007
timeFrame: Baseline, Day 29, Day 57, Day 85
measure: Assessment of CIVI 007 Adverse Events (AEs)
timeFrame: Baseline through 2 month follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Munroe Falls
country: United States
facility: Research Site
state: Ohio
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: CiVi Biopharma
name: Charles L Shear, DrPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT00656409: Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
Official title: Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ataxia Telangiectasia (AT)
Keywords: Ataxia telangiectasia,
Conjugated pneumococcal,
Prevenar,
Immunogenicity ,
Vaccine
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2008-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: BASIC_SCIENCE

Brief summary: Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the second year of life, and affecting predominantly the cerebellum. They also develop the characteristic superficial telangiectases. Between 60 and 80% of affected children are immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23 and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent sino-pulmonary infections but a recent study suggests poor correlation between immune status and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute to the development of chronic lung disease and bronchiectasis. Preventative management includes continuous prophylactic antibiotic treatment in some with the need for replacement immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably effective in this situation but the emergence of resistance amongst community acquired pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also have a role.

This study is designed to look at antibody responses in a one versus two dose regimen in a cohort of AT patients recruited through the AT Society a national charitable organisation involved in providing support to families with this condition and in fostering education and research in the field.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed diagnosis of AT

Primary outcomes:
measure: Immunogenicity of vaccine
Secondary outcomes:
measure: Incidence of adverse reactions to vaccine
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
References:
Clinical trial NCT03607409: Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Official title: Role of Inhibin A as Biomarker for Ovarian Response to Stimulation With Gonadotropins for IVF Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
Collaborators: name: Ansh Labs
First posted: 2018-07-31
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ovarian stimulation for IVF treatment

Brief summary: To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to Estradiol

Detailed description: Inhibin A could be an improved biomarker regarding the number of expected mature oocytes compared to estradiol.

Eligibility criteria: Inclusion Criteria:

Patients undergoing ovarian stimulation with gonadotropins in either a GnRH-agonist or GnRH-antagonist for IVF treatment due to primary / secondary infertility.

Exclusion Criteria:

Patients undergoing a modified natural cycle stimulation protocol (Taymour cycle) Patients at risk for development of ovarian hyperstimulation syndrome (OHSS)

Primary outcomes:
measure: Number of mature oocytes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: ART Fertility Clinics LLC
name: Barbara Lawrenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneyer AL, Fujiwara T, Fox J, Welt CK, Adams J, Messerlian GM, Taylor AE. Dynamic changes in the intrafollicular inhibin/activin/follistatin axis during human follicular development: relationship to circulating hormone concentrations. J Clin Endocrinol Metab. 2000 Sep;85(9):3319-30. doi: 10.1210/jcem.85.9.6767.
citation: Hohmann FP, Laven JS, de Jong FH, Fauser BC. Relationship between inhibin A and B, estradiol and follicle growth dynamics during ovarian stimulation in normo-ovulatory women. Eur J Endocrinol. 2005 Mar;152(3):395-401. doi: 10.1530/eje.1.01871.
citation: Abbara A, Vuong LN, Ho VNA, Clarke SA, Jeffers L, Comninos AN, Salim R, Ho TM, Kelsey TW, Trew GH, Humaidan P, Dhillo WS. Follicle Size on Day of Trigger Most Likely to Yield a Mature Oocyte. Front Endocrinol (Lausanne). 2018 Apr 25;9:193. doi: 10.3389/fendo.2018.00193. eCollection 2018.