louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01679769: Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B
Official title: Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2012-09-06
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection

Brief summary: The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

Detailed description: Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection
* agree to have liver biopsy

Exclusion Criteria:

* clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier
* liver diseases due to other origin

Primary outcomes:
measure: Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy
timeFrame: within two weeks after liver biopsy
Secondary outcomes:
measure: Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy
timeFrame: within two weeks after liver biopsy
Other outcomes:
Locations:
city: Bei Jing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Hong Zhao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06591169: Lifestyle Changes in PCOS with OSA and NAFLD
Official title: Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PCOS
NAFLD
OSA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended

Detailed description: Forty obese PCOS men with obstructive sleeping apnea and compaint of fatty liver will participate in this trial . Group (study group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes. Group (control group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver . for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake,

Eligibility criteria: Inclusion Criteria:

* forty women
* women complaint PCOS
* women complain obstructive sleep apnea
* women are obese
* women complain fatty liver

Exclusion Criteria:

* cardiac insult
* renal insult
* malignacy
* pregnancy

Primary outcomes:
measure: aspartate transamianse
timeFrame: it will be assessed in serum after eight weeks
Secondary outcomes:
measure: alanine transaminase
timeFrame: it will be assessed in serum after eight weeks
measure: triglycerides
timeFrame: it will be assessed in serum after eight weeks
measure: neck circumference
timeFrame: it will be assessed after eight weeks
measure: waist circumference
timeFrame: it will be assessed after eight weeks
measure: body mass index
timeFrame: it will be assessed after eight weeks
measure: testesterone
timeFrame: it will be assessed in serum after eight weeks
measure: ratio of luteinizing hormone and follicle-stimulating hormone
timeFrame: it will be assessed after eight weeks
measure: apnea hyopnea index
timeFrame: it will be assessed after eight weeks
measure: Epworth sleeping scale
timeFrame: it will be assessed after eight weeks
measure: Dehydroepiandrosterone
timeFrame: it will be assessed in serum after eight weeks
measure: waist hip ratio
timeFrame: it will be assessed after eight weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
References:
Clinical trial NCT03858569: Uterine Massage After Vaginal Delivery
Official title: Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The participants will be randomized into an oxytocin plus uterine massage group and an oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage group will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and placental delivery time will be recorded and compared between the groups.

Detailed description: Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage group will be will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus and will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. Collection of blood loss will be initiated immediately after delivery of the fetus by putting a drape under the woman's buttocks. Collected blood will be weighed and the amount will be recorded in grams.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old women delivering vaginally

Exclusion Criteria:

* women with bleeding disorder

Primary outcomes:
measure: Postpartum hemorrhage
timeFrame: during procedure
Secondary outcomes:
measure: Duration of third stage of the labor
timeFrame: during procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
References:
Clinical trial NCT00460369: Treatment of Uncomplicated Malaria in Benin
Official title: Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncomplicated Malaria
Keywords: uncomplicated malaria
children
treatment
effectiveness
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
First posted: 2007-04-13
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 119
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.

The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.

Expected total enrollment: 225 patients

Study start: April 2007; expected completion: December 2007


Eligibility criteria: Inclusion Criteria:

* 6-119 months old
* fever or history of fever of less than 24 hours
* p falciparum parasitemia \> 1000 trophozoïtes/µL
* informed consent signed

Exclusion Criteria:

* \< 5 kg
* danger or severity signs of malaria
* known underlying chronic disease
* Hb \< 5g/dL
* adequate malaria treatment taken within 3 days before visit

Primary outcomes:
measure: efficacy
timeFrame: day 28
Secondary outcomes:
measure: effectiveness comparisons (PCR corrected)
timeFrame: day 14 and day 42
measure: incidence of adverse events
timeFrame: day 42
Other outcomes:
Locations:
city: Allada
country: Benin
facility: Centre de santé
Study officials:
affiliation: Institut de recherche pour le développement UR010
name: Jean-François Faucher, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche pour le Développement UR010
name: Philippe Deloron, MD PhD
role: STUDY_DIRECTOR
References:
citation: Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houze P, Kossou H, Amedome H, Massougbodji A, Cot M, Deloron P. Comparison of sulfadoxine-pyrimethamine, unsupervised artemether-lumefantrine, and unsupervised artesunate-amodiaquine fixed-dose formulation for uncomplicated plasmodium falciparum malaria in Benin: a randomized effectiveness noninferiority trial. J Infect Dis. 2009 Jul 1;200(1):57-65. doi: 10.1086/599378.
Clinical trial NCT05012969: Investigation of Efficacy of Use of a Bandage
Official title: Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Dislocation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.

Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage.

Detailed description: This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.

Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage. Patients in the intervention group will use the bandage for 12 weeks and patients in the control group will receive the normal treatment which is information by a physiotherapist on movement restrictions.

50 patients will be allocated in the intervention group and 50 patients will be allocated to the control group.

We will investigate:

1. Whether there is a difference in number of dislocations between the two groups in the project period (12 weeks).
2. Patients' hip function, quality of life and satisfaction with the treatment in the two groups
3. The safety, wear and durability of the bandage after 12 weeks of use

Eligibility criteria: Inclusion Criteria:

* Has had at least one previous hip dislocation after total hip arthroplasty

Exclusion Criteria:

* Dislocation in other directions than posterior/superior
* Loose prosthesis
* wounds in the area of skin that is in contact with the bandage

Primary outcomes:
measure: number of dislocations
timeFrame: 12 weeks
Secondary outcomes:
measure: Hip function
timeFrame: 12 weeks
measure: Helat-related quality of life
timeFrame: 12 weeks
measure: Patient satisfaction
timeFrame: 12 weeks
measure: Safety, wear and durability of bandage
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Holstebro Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: University of Aarhus
name: Inger Mechlenburg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Maiken Stilling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758069: Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Official title: Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility criteria: Inclusion Criteria:

* Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria:

* Patients Have Type 1 Diabetes Mellitus

Primary outcomes:
measure: Change From Baseline in 24-hour Weighted Mean Plasma Glucose
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change From Baseline in Plasma Glucose
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.
Clinical trial NCT03933969: Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty
Official title: Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Arthroplasty
Knee and Hip
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.

Brief summary: Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.

Detailed description: Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.

Eligibility criteria: Inclusion Criteria:

* Patient's 18 years or older
* Patients who recently underwent a primary total hip or total knee arthroplasty
* Patient who recently underwent a total hip or total knee revision

Exclusion Criteria:

* Patients who lack the ability to provide informed consent
* Patients with previous total joint replacement within the last 6 months
* Patients with complications following surgery such as DVT/PE/Infection

Primary outcomes:
measure: Assistive Device Weaning
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively
timeFrame: Approximately 3-6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Ryan C McCoy, PT, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06930469: Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU
Official title: Application of Structured Team Model Based on Shared Decision Model in Obstetrics and Gynecology Joint Intensive Care Unit (ICU) Rescue of Critical Care Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Pregnant Women
Lead sponsor: Nantong First People's Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial was conducted with 100 critically ill pregnant women admitted to our hospital's obstetrics ICU between January 2023 and December 2024. Participants were allocated via random number table to either the control group receiving conventional multidisciplinary resuscitation care (n=50) or the observation group receiving the structured team model with shared decision-making (n=50). Comparative outcomes included resuscitation efficiency indicators (pre-hospital response time, intrahospital transport duration, emergency supply preparation time), complication rates, family psychological status measured by Hospital Anxiety and Depression Scale (HADS), and family satisfaction assessments


Eligibility criteria: Inclusion Criteria:

* Meeting diagnostic criteria for critical obstetric conditions:

  1. Amniotic fluid embolism
  2. Postpartum hemorrhage
  3. Emergency cesarean section was performed, etc
* Age ≥18 years
* Gestational age \>20 weeks
* Patient's family/legal representative capable of normal communication and providing signed informed consent

Exclusion Criteria:

* Pre-existing primary hematologic disorders:
* Fetal congenital anomalies confirmed by prenatal imaging
* Active malignant tumors (except carcinoma in situ)
* Severe organ dysfunction:
* Altered mental status (GCS ≤12) or documented psychiatric disorders

Primary outcomes:
measure: Maternal mortality in critically ill women
timeFrame: 28 days postpartum
measure: Neonatal survival rate
timeFrame: Seven days after birth
Secondary outcomes:
measure: pre-hospital response time
timeFrame: 1 day
measure: intrahospital transport duration
timeFrame: 1 day
measure: emergency supply preparation time
timeFrame: 1 day
measure: complication rates
timeFrame: 28 days postpartum
measure: family psychological status measured
timeFrame: 28 days postpartum
measure: Satisfaction of family members
timeFrame: 28 days postpartum
Other outcomes:
Locations:
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01000168: Treadmill Therapy and Brain Injuries
Official title: The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Hemiplegia
Moderate to Severe Functional Impairments
Keywords: Brain Injury
Rehabilitation
Treadmill therapy
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2009-10-22
Enrollment: 60
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: Introduction.

* There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke.

Design.

* A randomized controlled trial.

Material.

* Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation.

Method.

* Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training.

Study aim:

* Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.

Detailed description: See "Brief Summary".

Eligibility criteria: Inclusion Criteria:

* Cerebral stoke
* Hemiplegia
* Primary rehabilitation
* Medical stable
* Wheelchair user
* Dependent of assistance for walking
* Dependent of maximum one person for transfer
* No physical impairments that could prevent walking ability from being restored
* Able to participate in the training modalities

Exclusion Criteria:

* Medical unstable
* Orthopaedic or other impairments preventing relearning walking
* Cognitive impairments that prevents understanding the study information
* Cognitive or psychological impairments that prevents study collaboration

Primary outcomes:
measure: Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).
timeFrame: 0, 5 weeks and 10 weeks.
Secondary outcomes:
measure: EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview.
timeFrame: 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Department of Brain Injury, Sunnaas Rehabilitation Hospital
state: Bjørnemyrveien 11
Study officials:
affiliation: University of Bergen, Norway
name: Liv Inger Strand, Dr. philos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002840. doi: 10.1002/14651858.CD002840.pub2.