louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02953847: The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)
Official title: The Bioavailability of Rifampicin in Fixed Dose Combinations (FDCs) Widely Used in South Africa to Treat Drug-susceptible Tuberculosis (TB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 21
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: 3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers

Detailed description: In this study the 4- and 2-drug FDCs (for intensive and continuation phases respectively) widely used within the South African treatment program will be evaluated in a comparative bioavailability study against a single drug rifampicin product registered by the South African Medicines Control Council. A three-way, single dose, cross-over study will be conducted in 24 healthy volunteers

Eligibility criteria: Inclusion

* You need to be between the ages of 18-55 years
* Have a Body mass index (BMI) of 19-30 kg/m2
* Weigh 45 kg or more
* Be a non-smoker
* Be found to be in normal health on history and examination
* To have normal blood and urine test results
* If you are a woman of child-bearing age, you need to be prepared to not have sexual intercourse, or use a safe form of contraception, until the end of the study

Exclusion

* You are unable to fully understand and comply with the study procedures, requirements and time commitments.
* Are currently enrolled in any other study evaluating drugs, biologics or devices
* You have TB, or have had TB before
* You abuse or have abused drugs or alcohol
* You have, or have had, drug allergy, severe asthma, or active or recurrent allergic disease
* You are pregnant

Primary outcomes:
measure: Cmax
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: AUC to 12 h
timeFrame: 1 year
measure: AUC to infinity
timeFrame: 1 year
Locations:
city: Cape Town
country: South Africa
facility: Clinical Research Centre
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Helen M McIlleron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987347: Health Condition of Cannabis Consumers in the Canadian Population
Official title: Health Condition of Cannabis Consumers in the Canadian Population: A Population-based Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cannabis Use
Old Age
Health Risk
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People from Canada who were enrolled in the Canadian Longitudinal Study on Aging the last 20 years, and who have consumed different cannabis products for different reasons either recreational or medical.

Brief summary: This study evaluates the health condition and its evolution with time of Cannabis consumers in the Canadian population.

Detailed description: In Canada, legalization of recreational use is likely to have decreased the perception of risks associated with Cannabis use, and means that the reported adverse effects of Cannabis are not so important, suggesting that Cannabis may be useful for their illness as an alternative or complementary therapeutic.

More Canadian physicians prescribed Cannabis for their patients. Both Recreational and medical use of Cannabis increase and will continue to grow up in the next coming years. Regardless, the typology of Cannabis use, more information on the health condition of Cannabis consumers may be helpful for the medical prescription of Cannabis, in particular in older adults who are more at risk of side effects.

Eligibility criteria: Inclusion Criteria:

* Living in Canada the last 20 years
* Being 60 years and over
* Being consumer of cannabis

Exclusion Criteria:

* Living outside Canada the last 20 years
* Have never consumed cannabis

Primary outcomes:
measure: Neurocognitive disorder
timeFrame: around 20 years
Secondary outcomes:
measure: Depression
timeFrame: around 20 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05262647: 18F-FAPI PET in the Diagnosis of Liver Fibrosis
Official title: A Prospective Study for Effectiveness of 18F-FAPI PET in the Diagnosis of Liver Fibrosis: Comparison With Liver Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
FAP
Positron Emission Tomography
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients has been pathological diagnosis as Liver Fibrosis

Brief summary: It is an open label observation clinical trial, all participants are chronic liver disease. The investigators deem to make a novel evaluate criteria to hepatic fibrosis. The point of the clinical trial is to evaluate the novel biomaker 18F-FAPI-04 by PET-CT scan in the evaluation of the hepatic fibrosis.

Detailed description: Participants are with clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.

Participants are without liver tumor and other liver disease besides liver fibrosis Participants has no history of malignant tumors Participants agree to performe FAPI PET and liver biopsy

Eligibility criteria: Inclusion Criteria:

* Clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.
* Without liver tumor and other liver disease besides liver fibrosis
* No history of malignant tumors
* Agree to performe FAPI PET and liver biopsy

Exclusion Criteria:

* Pregnancy
* With anti-hepatic fibrosis treatment in 6 months
* With contraindications to percutaneous liver biopsy,for such as uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction,etc.

Primary outcomes:
measure: 18F-FAPI PET in the Diagnosis of Liver Fibrosis
timeFrame: 12.01.2021 to12.01.2022
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The affiliated hostpital of Qingdao University
name: Guangjie Yang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04168047: Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
Official title: Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: visceral hypersensitivity
Insomnia
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.

Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.

The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.

If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers

   - Person aged over 18 years with no IBS and no Insomnia
2. Patients with insomnia

   - Patient aged over 18 years with no IBS and no Insomnia
3. Patients with IBS

   - Patient aged over 18 years with IBS
4. patients with insomnia and IBS - Patient aged over 18 years with IBS

Exclusion Criteria:

* Active chronic organic disease
* Endometriosis
* Opioids consumption
* Change in chronic treatment in the last 30 days
* Hypersensitivity to Normacol
* Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
* Rectal pathology
* Intestinal occlusion
* Severe renal failure
* Sodium retention
* Anal pathology (anal fissure, hemorrhoidal thrombosis)
* Person with administrative or judicial decision or under legal protection measure
* Patient participating in another trial in the last 30 days
* Pregnant or breastfeeding women
* Impossibility to keep fasting for 12 hours

Primary outcomes:
measure: Pressure threshold measured during the barostat procedure
timeFrame: Day 35
Secondary outcomes:
measure: Score at HAD anxiety and depression scale
timeFrame: Day 35
measure: Score at Pittsburg sleep quality index
timeFrame: Day 35
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Chloé MECHIOR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052347: Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks
Official title: Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks: A Randomized Trial (DAWN Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Related
Elective Induction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks


Eligibility criteria: Inclusion Criteria:

* Low-risk nulliparous women- no previous pregnancy \> 23 weeks
* 18-50 years of age
* Singleton gestation
* Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.

Exclusion Criteria:

* 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):

  1. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
  2. Cerclage in the index pregnancy
  3. Diabetes mellitus-gestational or pre-gestational
  4. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
  5. Hypertension (chronic or pregnancy induced) before enrollment
  6. HIV (human immunodeficiency virus)
  7. Institutionalized individuals (prisoners)
  8. Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death
  9. Preterm labor or ruptured membranes before enrollment
  10. Psychiatric disorder (bipolar, depression) on medication
  11. Placenta previa / 3rd trimester bleeding
  12. Renal insufficiency (serum creatinine \> 1.5 mg/dL)
  13. Restrictive lung disease
  14. Fetal red blood cell isoimmunization
  15. Seizure disorder on medication
  16. Thyroid disease on medication
  17. Body Mass Index (BMI) above 40 kg/m 3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 4. Unable to understand consent in English or Spanish

Primary outcomes:
measure: Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
timeFrame: 4 weeks
Secondary outcomes:
measure: Composite neonatal morbidity
timeFrame: at delivery
measure: Maternal morbidities
timeFrame: 1 week
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT04240847: Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA
Official title: Comparison of Skin Numbness and Kneeling Ability Between Midline Skin Incision Medial to Tibial Tubercle With Lateral to Tibial Tubercle Skin Incision in Simultaneous Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Numbness and Kneeling Ability
Keywords: skin incision
numbness
kneeling
total knee arthroplasty
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA


Eligibility criteria: Inclusion Criteria:

* The patient undergoing simultaneous bilateral TKA
* Normal skin sensation on both knees
* Informed consent
* Good cognitive function

Exclusion Criteria:

* Previous surgical wound around the knee
* Peripheral vascular disease

Primary outcomes:
measure: Skin numbness
timeFrame: 6 weeks, 3, 6 , 9, 12 months after surgery
measure: Kneeling ability
timeFrame: 6 weeks, 3, 6 , 9, 12 months after surgery
Secondary outcomes:
measure: Functional outcome
timeFrame: 6 weeks, 3, 6 , 9, 12 months after surgery
measure: Knee range of motion
timeFrame: 6 weeks, 3, 6 , 9, 12 months after surgery
measure: Incision length
timeFrame: 3 months
measure: Complication
timeFrame: 6 weeks, 3, 6 , 9, 12 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 NCT01297647: Incidence of Urinary Tract Infection After Urodynamic Investigation
Official title: Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder
Keywords: urinary tract infection
urodynamics
spinal cord injury
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.

Detailed description: Patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic control examinations with CMG (urodynamic examination). The manipulation may cause urinary tract infections which have to be treated. Patients often noticed an infection after a CMG examination. Aim of this study is the determination of the infection rate and germs. Also should be noticed the pre-interventional infections and differences between the causing germs. Simultaneously the investigators test the reliability of the quicktest for urinary infection. Additionally the investigators will examine the Quality of Life in patients with neurogenic bladder dysfunction.

Eligibility criteria: Inclusion Criteria:

* Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
* No antibiotic treatment
* Written informed consent

Exclusion Criteria:

* Pregnancy and breastfeeding
* Current antibiotic therapy

Primary outcomes:
measure: Incidence of urinary tract infection following urodynamic investigation
timeFrame: 3 days after urodynamic investigation
Secondary outcomes:
measure: Name and number of identified bacterial species
timeFrame: 30 minutes before examination
measure: Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract
timeFrame: 3 days after examination
measure: Incidence of urinary tract infection before urodynamic investigation
timeFrame: 30 minutes before urodynamic investigation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Study officials:
References:
Clinical trial NCT01548547: Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol
Official title: Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Lumbar Puncture
Keywords: intravenous line
simulation education
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 210
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to compare the clinical efficacy of multimedia audiovisual training to hands on "practice till perfect" training for pediatric and emergency medicine residents' procedural skills. This initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.


Eligibility criteria: Inclusion Criteria:

Pediatric interns at POISE network hospitals

Primary outcomes:
measure: Rate of clinical success with lumbar puncture (LP) procedures
timeFrame: Up to one year
measure: Rate of clinical success with intravenous (IV) procedures
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: David Kessler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Martin Pusic, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02275247: Perioperative Neuroprotection of Stellate Ganglion Block
Official title: Preventive Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients Undergoing Aneurysm Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Stellate ganglion block
Aneurysm surgery
Cognitive recovery
Cerebral vasospasm
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

Detailed description: The vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. At present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.Stellate ganglion block （SGB）is an effective and well-tolerated approach to the treatment of CVS in various clinical settings.Resent study indicated that SGB has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.Therefore,we hypothesized that the preoperative SGB would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Eligibility criteria: Inclusion Criteria:

* aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
* ASA grade：Ⅱ-Ⅲ，
* Hunt～Hess grade :Ⅰ-Ⅲ,
* have a informed consent.

Exclusion Criteria:

* history of mental illness，
* local infection who can't do stellate ganglion block，
* pregnant or lactating，
* nausea cancer or diabetes，
* participated the study or other related research in the last 30 days，
* unruptured aneurysms patients

Primary outcomes:
measure: The incidence of cerebral vasospasm
timeFrame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Secondary outcomes:
measure: Perioperative cerebral oxygen metabolism
timeFrame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
measure: The difference of plasma endothelin, melatonin, and S100-β protein level between two groups at each time point
timeFrame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
measure: Postoperative cognitive function
timeFrame: Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery
Other outcomes:
measure: The postoperative recovery quality
timeFrame: Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: Gereral Hospital of Ningxia Medical University
name: Xu Wang
role: PRINCIPAL_INVESTIGATOR
References: