louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03181087: Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Official title: A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Uterine Scar
Keywords: Mesenchymal Stem Cells
Cesarean Section
Uterine Scar
Lead sponsor: Maternal and Child Health Hospital of Foshan
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.


Eligibility criteria: Inclusion Criteria:

* Primiparous women receiving cesarean delivery
* Ages between 21-35 years
* Gestation ages ≥ 37 weeks and \< 42 weeks
* Willing to comply with study dosing and completed the entire course of the study
* Willing to give and sign an informed consent form and a photographic release form

Exclusion Criteria:

* Fibroids
* Placenta previa
* Placenta abruption
* Multiple gestation
* Antepartum hemorrhage
* Preeclampsia/Eclampsia
* Hepatic or renal dysfunction
* Any systemic uncontrolled disease
* Inability to provide consent

Primary outcomes:
measure: Safety evaluation through vital signs, the results of clinical lab tests and adverse events
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Number of participants with uterine niche
timeFrame: 6 months post treatment
measure: Change of uterine scar thickness
timeFrame: 6 weeks, 3 and 6 months post treatment
measure: Change of uterine scar area
timeFrame: 6 weeks, 3 and 6 months post treatment
measure: Number of participants with endometritis
timeFrame: 6 months post treatment
measure: Number of participants with wound infection
timeFrame: 6 months post treatment
measure: Immunoglobulin concentrations in breast milk and serum
timeFrame: 6 weeks, 3 and 6 months post treatment
measure: Adverse events occurrence
timeFrame: 6 months post treatment
Other outcomes:
Locations:
city: Foshan
country: China
facility: Maternal and Child Health Hospital of Foshan
state: Guangdong
Study officials:
affiliation: Maternal and Child Health Hospital of Foshan
name: Zhengping Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205387: Cardiac Elastography to Determine Strain and Strain Rates in the Heart
Official title: Cardiac Elastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Keywords: echocardiography
cardiac elastography
Normal volunteers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers and patients with known heart disease caused by myocardial inarction or cardiomyopathy

Brief summary: Cardiac elastography is a new technique to analyze strain and strain rates in many organ systems, including the heart. In this study, cardiac elastography derived from the analysis of raw radiofrequency data obtained from a conventional clinical echocardiograph system will be compared to processed information that comes from the same echocardiograph system. The purpose of this study is to determine if cardiac elastography can accurately determine strain and strain rates as compared to more conventional means.


Eligibility criteria: Inclusion Criteria:

* Healthy normal volunteers between the ages of 18-70
* Patients scheduled for clinical echocardiogram between the ages of 18-70 who have known heart disease caused by myocardial infarction or cardiomyopathy

Exclusion Criteria:

* Patients less than 18 years old, or greater than 70 years old
* Patients who do not have adequate quality echocardiographic images.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Peter S Rahko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06657287: Postprandial Hypotension and Insulin Levels
Official title: Relationship Between Insulin Levels and Postprandial Hypotension in the Standard Mixed Meal Test in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postprandial Hypotension
Hypoglycemia
Keywords: Hypotension
hypoglycemia
insulin
mixed meal
adults
postprandial
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital.

Brief summary: The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is:

Is the incidence of postprandial hypotension high in patients who undergo mixed meal test?

Is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test?

Patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, C-peptide, blood pressure, and heart rate were measured at specific time points.


Eligibility criteria: Inclusion Criteria:

* Adults with postprandial symptoms

Exclusion Criteria:

* Individuals with prediabetes or diabetes,
* Those aged 65 and above,
* Patients using antihypertensive medications or with known hypertension,
* Those with active infections,
* Congestive heart failure,
* Peripheral artery disease,
* Advanced-stage dementia,
* Individuals who could not provide a history or were unable to cooperate,
* Patients using medications that could induce hypoglycemia (oral antidiabetics, insulin, beta-blockers, hydroxychloroquine, bromocriptine, etc.)
* Those with conditions that could cause hypoglycemia (uncontrolled hypothyroidism, adrenal insufficiency, growth hormone deficiency, etc.)

Primary outcomes:
measure: Systolic blood pressure
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
measure: Blood glucose
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
measure: Blood insulin
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Secondary outcomes:
measure: Blood C-peptide
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
measure: Diastolic blood pressure
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
measure: Heart rate
timeFrame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Rahime E Karakaya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815187: Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Official title: Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Meniere Disease
Allergic Rhinitis
Vertigo
Lead sponsor: House Ear Institute
Sponsor class: OTHER
Collaborators: name: Cures Within Reach
First posted: 2021-03-24
Enrollment: 39
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: The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Must meet all AAO-HNS 2020 criteria for definite or probable Meniere's Disease
* Must have a skin test positive for allergy
* Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments

Exclusion Criteria:

* Had a previous surgical procedure for treatment of vertigo
* Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker
* Pregnant or recent pregnancy ((≤ 8 weeks postpartum), or lactation)
* Current hospitalization for any reason
* Any active, acute, or chronic pulmonary disorder other than asthma
* History of intubation for asthma

Primary outcomes:
measure: Percentage of Patients with AAO-HNS Vertigo Control Class A or B
timeFrame: 1 month after treatment initiation
measure: Percentage of Patients with AAO-HNS Vertigo Control Class A or B
timeFrame: 3 months after treatment initiation
measure: Percentage of Patients with AAO-HNS Vertigo Control Class A or B
timeFrame: 6 months after treatment initiation
measure: Difference in Dizziness Between Treatment Arms
timeFrame: 3 months after treatment initiation
measure: Percentage of Subjects Experiencing Significant Hearing Fluctuation
timeFrame: 3 months after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Clinic
state: California
city: Los Angeles
country: United States
facility: House Institute Foundation
state: California
Study officials:
affiliation: House Institute Foundation
name: Mary J Derebery, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267787: Molecular Genetic and Pathological Studies of Anal Tumors
Official title: Molecular Genetic and Pathological Studies of Anal Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rectal Cancer
Colon Cancer
Colonic Neoplasms
Anal Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-12-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with anal cancer or high risk for anal cancer refered to Stanford.

Brief summary: Study the Genetics of Anal Cancer

Detailed description: To determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. Study of tissue samples and cells from biopsies of your lesion and blood sample. We hope to learn the role genes and proteins may play in the development of anal cancer. Experiments will be performed using this tissue and blood, include analysis of DNA, analysis of RNA expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.

Eligibility criteria: Inclusion Criteria:Inclusion Criteria:

* Patients with anal tumors
* Undergoing surgery for elective colon and rectal surgery Exclusion Criteria:No other patients other than adult patients with anal cancer or high risk for anal cancer refered to Stanford will be enrolled to the study. No Children will be included to the study

Primary outcomes:
measure: Genetic analysis of blood sample as well as tissues , will provide us with any possible tumor marker for a better prognostic indicator.
timeFrame: Annual assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Mark Lane Welton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902187: A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Official title: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Treatment of Overactive Bladder
Keywords: Bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects with evidence or history of clinically significant urologic diseases
* A positive urine drug screen
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

Primary outcomes:
measure: AUCinf, AUClast, and Cmax of 5-HMT
timeFrame: 6 weeks
Secondary outcomes:
measure: Tmax and half-life of 5-HMT as data permit
timeFrame: 6 weeks
measure: Safety laboratory tests and adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00546533: Study Evaluating the Efficacy and Safety of Etanercept
Official title: Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.


Eligibility criteria: Inclusion Criteria:

* A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).
* Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy).
* Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.

Exclusion Criteria:

* Uncooperative patients with a history of poor compliance.
* Known hypersensitivity to etanercept or any of its components.
* Known significant concurrent medical disease

Primary outcomes:
measure: To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01213433: Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Official title: Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated Malaria
Lead sponsor: Centre Muraz
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2010-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.


Eligibility criteria: Inclusion Criteria:

* Males and Females aged 6 months and above.
* Body weight of 5 Kg and above.
* RDT positive test.
* Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
* Signed (or thumb-printed whenever patients are illiterate) informed consent.
* Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion Criteria:

* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
* Known hypersensitivity to the study drugs.
* Severe malaria.
* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
* Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
* Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).

Primary outcomes:
measure: Treatment failure at day 28
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanoro
country: Burkina Faso
facility: CRUN
state: Boulkiemdé
Study officials:
References:
Clinical trial NCT04287933: Role of Drain in Decreasing Postoperative Complications
Official title: Role of Drain in Decreasing Postoperative Complications After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: postoperative complications are common after cesarean section

Detailed description: wound infection can occur after cesarean section

Eligibility criteria: Inclusion Criteria:

Women undergoing cesarean section

Exclusion Criteria:

* Women who deliver by normal vaginal delivery

Primary outcomes:
measure: The number of women who will have complications
timeFrame: within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02909933: Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Obesity
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.

We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry

Primary outcomes:
measure: The main outcome was change in body weight.
timeFrame: Patient's body weight was measured at the base point and after 12 weeks of clinical trial.
Secondary outcomes:
measure: The secondary outcome was change in body mass index (BMI)
timeFrame: Patient's body weight were measured at the base point and after 12 weeks of clinical trial. Patient's height was measured at the base point.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Andrej Janez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.