louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06037226: A National Observation Study on Pelvic Floor Dysfunction Diseases in China
Official title: A National Observation Study on Pelvic Floor Dysfunction Diseases Based on Electrophysiological Technology and a Newly Established Prevention and Treatment System in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Dysfunction
Keywords: Pelvic floor dysfunction, postpartum women
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All adult women in early postnatal period, 42 days+15 days after delivery, are eligible to participate.

Brief summary: In this protocol, our team intend to conduct a nation-wide multicenter cohort research to screening for PFD symptoms in early postnatal women in China. Beside clinically significant symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to determine the clinically significant alterations that are sensitive to predict the PFD risks. This is an observational prospective cohort study, following a natural regular clinical visit process. Patients will voluntarily decide whether to receive PFD related treatments and the types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of treatments.


Eligibility criteria: Inclusion Criteria:

1. Postpartum women: 42 days+15 days after delivery
2. Age:20-45
3. Consent to participate in the research.

Exclusion Criteria:

1. Refuse gynecological and/or obstetrical examinations.
2. Diagnosed with psychiatric disorders
3. Diagnosed with other severe illnesses
4. Received pelvic floor treatments
5. Other factors that may confound with the research

Primary outcomes:
measure: Urinary incontinence
timeFrame: 6 months
Secondary outcomes:
measure: Pelvic organ prolapse
timeFrame: 6 months
Other outcomes:
measure: Pelvic muscle function
timeFrame: 6 months
Locations:
Study officials:
References:
Clinical trial NCT00405626: Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH
Official title: Phase 2 Study of the Effect of Bellis Perenis and Arnica Montana on Post Partum Hemmorhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hemorrhage
Keywords: post partum hemmorhage,Arnica montana,Bellis Perenis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
First posted: 2006-11-30
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana

Detailed description: To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana compare it with placebo

Eligibility criteria: Inclusion Criteria:

* healthy women during delivery

Exclusion Criteria:

* Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis

Primary outcomes:
measure: hemoglobin levels 2 days post partum
Secondary outcomes:
measure: pain
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Haddasah Medical Organization
Study officials:
affiliation: Hadassah University Medical Organization
name: David Mankuta
role: STUDY_CHAIR
References:
citation: Oberbaum M, Galoyan N, Lerner-Geva L, Singer SR, Grisaru S, Shashar D, Samueloff A. The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results. Complement Ther Med. 2005 Jun;13(2):87-90. doi: 10.1016/j.ctim.2005.03.006.
Clinical trial NCT05504226: Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 214
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin


Eligibility criteria: Inclusion Criteria:

* Patients with Type II diabetes mellitus aged 19 years or older
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or secondary diabetes
* Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
* Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
* Body mass index greater than 40 kg/m2 at the screening visit
* Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Primary outcomes:
measure: Changes from baseline HbA1c at week 24
timeFrame: Baseline (week 0) and week 24
Secondary outcomes:
measure: Changes from baseline FPG at week 24
timeFrame: Baseline (week 0) and week 24
measure: Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
timeFrame: Baseline (week 0) and week 24
measure: Changes from baseline in BMI at week 24
timeFrame: Baseline (week 0) and week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00004426: Leuprolide in Determining the Cause of Gonadotropin Deficiency
Official title: Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency
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: 90
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: The body's response to one injection of leuprolide may provide more information than the standard test for gonadotropin deficiency in determining whether the cause of gonadotropin deficiency is related to the hypothalamus or the pituitary gland.

PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in determining the cause of gonadotropin deficiency.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over to receive the other test.

Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood samples drawn periodically. One month later, patients receive the other test.

Another cohort of patients are randomized to receive leuprolide acetate once daily on days 0, 4, and 8, or days 0, 5, and 10.

Patients are followed for up to 2 years.

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

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Prepubertal children with constitutionally delayed puberty At least 2 years retardation of bone age Spontaneously progress into puberty within 1 year Boys: Testes long diameter 2.5-3.5 cm and plasma testosterone 40-300 ng/dL Girls: Breast development, but premenarcheal OR Hypogonadotropinism Delayed onset of pubertal milestones associated with anterior panhypopituitarism OR Kallman's syndrome No spontaneous progression into puberty within 2 years after 6 months replacement sex steroid treatment

--Prior/Concurrent Therapy--

* At least 2 months since prior sex hormone treatment

--Patient Characteristics--

* Age: 14-18 for children with hypogonadotropinism 9-13 for normal children
* Other: No chronic systemic disease No metabolic disease No endocrine disease No growth hormone deficiency

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 NCT02061826: Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
Official title: Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug-induced Liver Injury
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample and primary care clinic

Brief summary: The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.

Detailed description: Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.

Eligibility criteria: Inclusion Criteria:

* Males and females between the age of 18 to 70 years
* Women in child-bearing period taking some contraception measures
* Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
* Written informed consent can be obtained, some patients agree with liver biopsy

Exclusion Criteria:

* Viral hepatitis
* Alcoholic liver disease or non-alcoholic liver disease
* Wilson's disease or other inherited metabolic liver diseases
* Auto-immune liver diseases
* Any dysfunction of liver
* Malnutrition
* Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
* Patients who can not complete follow-ups on time

Primary outcomes:
measure: histological features of drug-induced liver injury obtained by liver biopsy
timeFrame: within six months of the DILI onset date
measure: clinical features of drug-induced liver injury assessed by serum parameters of liver function
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
Study officials:
affiliation: Beijing Ditan Hospital
name: Wen Xie, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT01519726: CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
Official title: CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.


Eligibility criteria: Inclusion Criteria:

* BMI\>40
* undergoing bariatric surgery

Exclusion Criteria:

* use of drug inducing or inhibiting CYP3A4 activity
* pregnancy, breastfeeding
* renl insufficiency

Primary outcomes:
measure: Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
timeFrame: 0.5-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
Study officials:
References:
Clinical trial NCT03058926: Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
Official title: Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Diabetes
Pancreatic Cancer
Keywords: Chronic Pancreatitis
Diabetes
Pancreatic Cancer
Data Management
Protocol compliance
Regulatory compliance
Consortium studies
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2017-02-23
Enrollment: 25000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from external sites.

Brief summary: The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data Management Center (CDMC) will provide high quality, efficient and consistent leadership and services in all aspects of data quality and assurance; data harmonization and management; while providing assistance to the projects in disseminating and interpreting those data. The CDMC PI will provide statistical (study design, analysis plans, data analysis, and interpretation), data management, and data monitoring/auditing (data quality assurance and harmonization) expertise for the proposed projects. The Cancer Center will have access to identifiable data from studies; analysis of this data will not be conducted under this protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will be conducted under a separate IRB approved data or lab protocol.

The CDMC will leverage existing support, infrastructure, and resources from the Data Management and Coordinating Center for the Global Cancer Early Detection and the clinical expertise of the Division of Pathology/Lab Medicine at MDACC.


Eligibility criteria: Inclusion Criteria:

* Participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through Consortium.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ying Yuan, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010426: Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystinosis
Keywords: cystinosis
rare disease
renal and genitourinary disorders
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Leadiant Biosciences, Inc.
First posted: 2001-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal cystine accumulation.

II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00 unit when treated with this regimen.

Detailed description: PROTOCOL OUTLINE: This is a randomized, multicenter study Patients are randomized to receive the current formulation of cysteamine hydrochloride as drops in one eye and the new formulation of cysteamine hydrochloride as drops in the other eye.

Patients receive the two formulations of cysteamine hydrochloride in their assigned eyes every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy study).

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of cystinosis with more than 2 nmole half-cystine/mg protein in leukocytes OR presence of corneal crystals consistent with cystinosis and distributed in corneal stroma observed by slit lamp biomicroscopy
* Clinical history consistent with cystinosis
* Safety study: History of adherence with current eye drop and follow-up schedule on protocol #86-El-0062 Any crystal density score, including zero, on photographs, that has been stable or improved over the past year
* Efficacy study: Crystal density score at least 1.00 on photographs Concurrently on cysteamine for at least the past 6 months

--Prior/Concurrent Therapy--

* No prior cysteamine drops (efficacy study)

--Patient Characteristics--

* Age: 1 to 50 (safety study) 2 to 12 (efficacy study)
* Other: Willingness and ability to tolerate corneal photographs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Leadiant Biosciences, Inc.
name: Edward F. Lemanowicz
role: STUDY_CHAIR
References:
Clinical trial NCT02549326: Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Official title: Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Vitamin D
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD) concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A direct assay for free 25OHD was introduced recently.

The aim of the study was to evaluate differences in vitamin D metabolism between young adults with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* weight-for-height ratio exceeding 60% before the age of 7 years, according to Finnish growth standards and persistence of severe obesity for at least three years in childhood
* referral to the Children's Hospital, Helsinki University Hospital due to severe obesity
* at the age of 7 years lived in the greater Helsinki area

Exclusion Criteria:

* endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes

Primary outcomes:
measure: change in S-25OHD
timeFrame: baseline, 6 and 12 weeks
measure: baseline S-25OHD
timeFrame: baseline
Secondary outcomes:
measure: baseline vitamin D-binding protein (DBP)
timeFrame: baseline
measure: correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin
timeFrame: baseline, 6 and 12 weeks
measure: change in vitamin D-binding protein (DBP)
timeFrame: baseline, 6 and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Helena Valta, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02887326: Keratoconus - Biomarkers and Questionnaire
Official title: Keratoconus - Biomarkers and Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 287
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with keratoconus residing in the Central Denmark Region

Brief summary: The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the investigators examine wether the biomarker levels are in correlation with the disease level and duration of disease.

The questionnaire study focuses on the patients perspective. With a validated questionnaire fore keratoconus patient it examine the patients self.-evaluated visual challenges and quality of life


Eligibility criteria: Inclusion Criteria:

* Keratoconus residint in the Central Denmark Region

Exclusion Criteria:

* Other eye diseases
* Ocular traumas.

Primary outcomes:
measure: Protein levels in tear fluid, saliva and blood(plasma)
timeFrame: fall 2018
measure: Ranch analysis of questionnaire
timeFrame: fall 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: