louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05521295: Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome
Official title: Microbiome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Microbiome
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Institutes of Life Science, Chinese Academy of Sciences
First posted: 2022-08-30
Enrollment: 3600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending Center of Reproductive Medicine

Brief summary: This study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility criteria: Inclusion Criteria:

1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
2. Female age: 20-45 years old;
3. Single frozen-thawed blastocyst Transferred
4. Endometrial thickness ≥7mm on the day of luteal transformation
5. Written informed consent.

Exclusion Criteria:

1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;
2. Untreated hyperprolactinemia, thyroid disease, adrenal disease
3. Antibiotic use within the past 7 days;
4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
5. Refused or unable to comply with protocol requirements;
6. Participation in any experimental drug study within 60 days prior to screening.

Primary outcomes:
measure: Conception
timeFrame: 09.01.2022 to 09.01.2024
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 09.01.2022 to 09.01.2024
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Xiuxia Wang
state: Liaoning
Study officials:
affiliation: Center of Reproductive Medicine, Shengjing Hospital of China Medical University
name: Xiuxia Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengyang Jinghua Hospital Co.,Ltd
name: Donghua Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Reproductive and Genetic Hospital of CITIC-Xiangya
name: Sufen Cai, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Reproductive Medical Center, the First Affiliated Hospital, Sun Yat-sen University
name: Yanwen Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of reproduction and genetics Suzhou Municipal Hospital
name: Hong Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320995: Perineal Echography in the Delivery Room for the Detection of Anal Lesions
Official title: Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parturition
Keywords: Second degree vaginal tear
Perineal ultrasound
Anal incontinence
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (\> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow up
* The patient is delivering her first child; vaginal delivery
* The patient has a minimum stage 2 perineal lesion
* The patient accepts perineal echography

Exclusion Criteria:

* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Cesarien section
* No perineal lesion (intact perineum)
* Emergency situation which hinders screening for anal lesions under good medical conditions
* Previous vaginal delivery

Primary outcomes:
measure: Presence/absence of anal incontinence
timeFrame: 3 months
Secondary outcomes:
measure: Wexner anal incontinence score
timeFrame: 3 months
measure: Visual Analog Scale for discomfort during perineal ultrasound
timeFrame: 2 hours
measure: Kappa coefficient for second reading of ultrasounds
timeFrame: 30 days
measure: Presence/absence of a sphincter tear
timeFrame: 2 hours
measure: Patient requires anal sutures (yes/no)
timeFrame: 2 hours
measure: Presence/absence of suture infection
timeFrame: 3 months
measure: Questionnaire PFIQ
timeFrame: 3 months
measure: Questionnaire PFDI
timeFrame: 3 months
measure: Questionnaire SF36
timeFrame: 3 months
measure: Questionnaire Euroqol
timeFrame: 3 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04244695: Oral Steroid in Controlling Pain After TKA
Official title: Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Acute
Keywords: oral corticosteroid
postoperative pain
dexamethasone
total knee arthroplasty
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare efficacy of oral steroid in controlling pain after TKA

Detailed description: To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy

Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis of the knee who undergoing unilateral TKA
* ASA class I-III
* Informed consent
* Good cognitive function

Exclusion Criteria:

* Uncontrolled DM (HbA1C \> 7)
* Uncontrolled HT
* Morbid obesity (BMI \> 40)
* History of bleeding in GI tract
* Corticosteroid used within 6 months
* Sever liver or renal impairments
* Studied drug allergy

Primary outcomes:
measure: Pain level
timeFrame: 12, 24 ,36, 48, 60 and 72 hours after surgery
Secondary outcomes:
measure: nausea and vomiting
timeFrame: in the first 72 hours after surgery
measure: Range of motion of the knee
timeFrame: 24, 72 hours then 2, 6, 12 weeks after surgery
measure: Functional outcome
timeFrame: 2, 6,12 weeks after surgery
measure: Blood sugar
timeFrame: At 8.00 am of 1, 2, 3 days after surgery
measure: inflammatory level
timeFrame: At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
measure: Wound complications
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
References:
Clinical trial NCT01894295: Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Vitamin D analogues
Resting Metabolic rate
obesity
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 96
Sex: ALL
Minimum age (years): 22
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. Moreover, the investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.


Eligibility criteria: Inclusion Criteria:

Age 22-52 years Body mass index equal or more than 30

Exclusion Criteria:

Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug

Primary outcomes:
measure: Resting Metabolic Rate
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Changes of Nesfatin-1, PPARγ and PGC1α protein levels
timeFrame: Change from baseline to 8 weeks
Other outcomes:
measure: Change of ACS and FASN Enzymes
timeFrame: Change from baseline to 8 weeks
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: TehranUMS
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mahmoud Jalali, PhD
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Khadijeh Mirzaei, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060695: Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
Official title: Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: movement disorder clinic

Brief summary: The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.

Observational study case-only

Detailed description: Objectives

1. how many patients will experience motor or nonmotor fluctuation during follow-up period?
2. in how many patients, does motor fluctuation precede nonmotor fluctuation?
3. in how many patients, does nonmotor fluctuation precede motor fluctuation?

Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation

Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
* early stage

Exclusion Criteria:

* dementia (MMSE\<26)
* persons who refuse participating

Primary outcomes:
measure: time period from the onset of disease to the occurrence of motor or nonmotor fluctuation
timeFrame: 6 months
Secondary outcomes:
measure: sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation
timeFrame: 3 years
Other outcomes:
measure: The proportion of participants with impulse control disorders
timeFrame: 6 months
measure: The proportion of participants with rapid eye movement (REM) sleep behavior disorder
timeFrame: 6 months
measure: The proportion of participants with smoking history
timeFrame: 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Cherif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. doi: 10.1212/wnl.59.3.408.
citation: Resnick RJ, Kole HK, Racker E. Multiple changes induced by cholera toxin contribute to the stimulation of aerobic lactate production in rat-1 fibroblasts. Arch Biochem Biophys. 1991 May 1;286(2):579-85. doi: 10.1016/0003-9861(91)90083-u.
citation: Stacy M, Hauser R. Development of a Patient Questionnaire to facilitate recognition of motor and non-motor wearing-off in Parkinson's disease. J Neural Transm (Vienna). 2007 Feb;114(2):211-7. doi: 10.1007/s00702-006-0554-y. Epub 2006 Aug 10.
Clinical trial NCT05393895: An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Official title: A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Orasis Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 178
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Subjects must have presbyopia

Exclusion Criteria:

* Have any contraindications to the study medications or diagnoses that would confound the study data

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events.
timeFrame: Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Orasis Investigative Site
state: California
city: Petaluma
country: United States
facility: Orasis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Orasis Investigative Site
state: Colorado
city: Danbury
country: United States
facility: Orasis Investigative Site
state: Connecticut
city: Rock Island
country: United States
facility: Orasis Investigative Site
state: Illinois
city: Overland Park
country: United States
facility: Orasis Investigative Site
state: Kansas
city: Elizabeth City
country: United States
facility: Orasis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Orasis Investigative Site
state: North Dakota
city: Cranberry Township
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Kingston
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Orasis Investigative Site
state: Tennessee
city: Cedar Park
country: United States
facility: Orasis Investigative Site
state: Texas
Study officials:
References:
Clinical trial NCT04039295: Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children
Official title: Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caudal Epidural Block
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the patients who are scheduled to undergo elective polydactyly / syndactyly / polysyndactyly correction surgery in Asan Medical Center, the patients who meet the inclusion criteria are included.

Brief summary: Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.


Eligibility criteria: Inclusion Criteria:

* age: 6-24months
* ASA 1-3
* body weight: 5-20kg

Exclusion Criteria:

* patients who refuse to participate
* local site infection, pilonidal cyst, spina bifida
* spinal/meningeal abnormality
* patients who discharge after surgery without admission
* patients who is judged ineligible for other reasons by the authors

Primary outcomes:
measure: Required volume of local anesthetics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyungtae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150995: Tetrathiomolybdate in Hormone Refractory Prostate Cancer
Official title: A Phase II Trail of Tetrathiomolybdate in Patients With Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.

Detailed description: Tetrathiomolybdate or TM, a drug developed for Wilson's Disease, removes copper from the bloodstream. Copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in the body but becomes uncontrolled in cancerous cells. Tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. Realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with Tetrathiomolybdate for different types of cancers. This clinical trial will evaluate the effectiveness of Tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment.

Eligibility criteria: Inclusion:

* Patients must have histologic diagnosis of adenocarcinoma of the prostate with progression following hormonal therapy and antiandrogen withdrawal.
* Patients must have minimal disease (defined as bone metastasis or visceral disease with no impairment of organ function or pain severe enough to require narcotics for control).
* Adequate bone marrow and renal function
* ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (a measure of general well being where 1 represents asymptomatic and 5 represents death)
* Life expectancy of at least 16 weeks
* Must have completed radiation more than 4 weeks prior to registration and must have a rising PSA (Prostate Specific Antigen) and lesion outside of the radiation field

Exclusion:

* Patients with an elevated PSA as the only evidence of disease
* Clinical evidence of spinal cord compression
* History of prior malignancy within the past 5 years (with the exception of in situ carcinoma of any site or nonmelanoma skin cancer)

Primary outcomes:
measure: Time to Progression
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: The University of Michigan Comprehensive Cancer Center
name: David C. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00243295: Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Official title: A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: osteoarthritis
deformity of knee
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:

* Injecting the desired volume of rhBMP-2/CPM within the defect
* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 45 to 70 years of age
* Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
* Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.

Other inclusion applies.

Exclusion Criteria:

* Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
* Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
* Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.

Primary outcomes:
measure: Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
measure: Feasibility measures include
measure: Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
measure: Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
Secondary outcomes:
measure: Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: