louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05578196: Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
Official title: Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Infections
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 110
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fecal microbial transplantation is to transplant functional microbiota from the feces of healthy people into the gastrointestinal tract of patients, reconstruct new intestinal microbiota, and realize the treatment of intestinal and extra-intestinal diseases. Compared with ordinary commercial probiotics, FMT is more consistent with the composition of the intestinal microecological structure and can recover intestinal flora to the maximum extent and faster. FMT increases intestinal bacteria production function and helps to restore the systemic immune response so that sepsis pathogens are removed. The aim of this trial was to investigate the clinical effect of FMT in the treatment of patients with severe infections.

Detailed description: The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15
* Aged ≥14 years
* Patients or their family members agreed to participate in this study

Exclusion Criteria:

* Advanced tumors or diseases associated with systemic immunosuppression
* Pregnant women
* Patients with severe intestinal ulcer or perforation
* Unable to complete oral administration and no effective artificial feeding pipeline.

Primary outcomes:
measure: Death
timeFrame: up to 28 days in ICU
Secondary outcomes:
measure: Gut microbiota distribution assessed by 16SrDNA
timeFrame: up to 6 days after fecal microbial transplantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: YuanZhuo Chen
role: STUDY_CHAIR
References:
citation: Haak BW, Prescott HC, Wiersinga WJ. Therapeutic Potential of the Gut Microbiota in the Prevention and Treatment of Sepsis. Front Immunol. 2018 Sep 10;9:2042. doi: 10.3389/fimmu.2018.02042. eCollection 2018.
Clinical trial NCT04933396: FGR Diagnostic Criteria in Predicting Adverse Neonatal Outcomes
Official title: Accuracy of the Recent Consensus Based Definition of FGR Encompassing Biometric and Doppler Parameters in Predicting Adverse Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: FGR
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all pregnancies with FGR (EFW \<10th percentile) who were admitted in Ain Shams University Maternity Hospital during the period from January 2016 till December 2020.

Brief summary: The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW \<10th percentile according to the Hadlock growth standard).


Eligibility criteria: Inclusion Criteria:

* Participants included in this study will have the following criteria:

  * Pregnancies complicated with FGR (EFW \<10th percentile).
  * Singleton pregnancy.

Exclusion Criteria:

* • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy.

  * Identified infectious etiologies detected during immediate postnatal examination or during pregnancy.
  * Gestational age cannot be calculated accurately.
  * Missing antenatal or perinatal outcome data.

Primary outcomes:
measure: adverse events
timeFrame: 30 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university maternity hospital
Study officials:
References:
Clinical trial NCT00593996: Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
Official title: Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Fecal Incontinence
Urinary Incontinence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function.


Eligibility criteria: Inclusion Criteria:

* Patients who present for evaluation to the UW Geriatric clinic including Dr. Pryzbelski's subspecialty, or Osteoporosis clinics
* Age 70 years or older
* Cognitively intact, as determined by the attending physicians at above mentioned clinics

Exclusion Criteria:

* History of, on ongoing, renal failure
* History of liver failure
* Known malabsorption
* Known disorders of parathyroid function, hyper/hypocalcemia, or other abnormalities of calcium or phosphate metabolism
* Known history of vitamin D intoxication or granulomatous disease
* active seizure disorder
* Pain associated with temporomandibular joint (TMJ)

Primary outcomes:
measure: change in lingual strength and perceived swallow function
timeFrame: 4 weeks
Secondary outcomes:
measure: change in perceived bowel and bladder function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Osteoporosis Clinical Research Program
state: Wisconsin
Study officials:
affiliation: Univ. of Wisconsin - Institute on Aging
name: Neil Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883596: Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.
Official title: Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanical Ventilation for More Than 48 Hours.
Lead sponsor: Sinaloa Pediatric Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Detailed description: Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 month to 18 years admitted to the intensive care unit.
* Intubated for more than 48 hours.

Exclusion Criteria:

* Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
* Allergy to chlorhexidine.
* Known immune deficiency.

Elimination Criteria:

* Transfer to another hospital.

Primary outcomes:
measure: Incidence of ventilator associated pneumonia
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
measure: Days of mechanical ventilation
timeFrame: From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
measure: Length of stay
timeFrame: From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks
Other outcomes:
Locations:
city: Culiacan
country: Mexico
facility: Sinaloa Pediatric Hospital
state: Sinaloa
Study officials:
affiliation: Sinaloa Pediatric Hospital
name: Jesus J Martinez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02096796: Arm Pump in Motorcross Training
Official title: Hand Strength Grip and Ergonomics of Driving as Risk Factors in the Etiology of Arm Pump in Motorcross Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Individuals
Patients With Arm Pump
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recreational or competitive motor cycle athletes

Brief summary: Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. No strategies nor methods have been used to diminish the risk to suffer from arm pump within motor cross.

This project aims to look at ergonomics of driving and its relationship with the occurrence of arm pump.

The investigators will first investigate the experience of motor cross athletes with arm pump through motor cross federations in Belgium and The Netherlands (survey).

Two groups of athletes will be selected (20 persons within each group) who will be invited to the motor cross track to investigate their hand grip strength, motor driving position, muscle activity.


Eligibility criteria: Inclusion Criteria:

* recreational or competitive motor cycling athletes
* with or without arm pump problems
* signing informed consent
* participation with their own motor bike
* Regular training hours

Exclusion Criteria:

* Inactive for more than 2 weeks before participation
* Pathology at shoulder, elbow or wrist level (except for arm pump)

Primary outcomes:
measure: motor ergonomics
timeFrame: March - June 2014 (3 months)
Secondary outcomes:
measure: hand grip strength
timeFrame: March - June 2014 (3 months)
Other outcomes:
measure: muscle activity
timeFrame: March - June 2014 (3 months)
Locations:
city: Lommel
country: Belgium
facility: Motor Cross Track
state: Limbur
Study officials:
References:
Clinical trial NCT00002196: A Study of CI-1012 in HIV-Infected Patients
Official title: A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Administration, Oral
Drug Administration Schedule
CD4 Lymphocyte Count
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

Detailed description: Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Serologic evidence of infection with HIV-1.
* CD4+ cell count \>= 200 cells/mm3.
* HIV-1 RNA \>= 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Viral, fungal, or bacterial infection requiring therapy other than topical medications.

Concurrent Medication:

Excluded:

* Prophylactic systematic antibacterial, antifungal or antiviral agents.
* Antiretroviral therapy. NOTE:
* Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.

Prior Medication:

Excluded:

* Experimental therapy for \>= 4 weeks prior to initiation of study medication.
* Antiretroviral treatment for 3 weeks prior to initiation of study medication.
* Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: Maitland
country: United States
facility: Central Florida Research Initiative
state: Florida
city: Bethesda
country: United States
facility: Natl Institutes of Health
state: Maryland
Study officials:
References:
Clinical trial NCT04972396: ALT-801 DDI Study in Healthy Volunteers
Official title: An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: NASH
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (OC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without ALT-801 administration and the second is with ALT-801 at steady state.


Eligibility criteria: Inclusion Criteria:

* Male or female healthy volunteers, age 18 to 55 years, inclusive
* Body mass index (BMI) 25.0- 40.0 kg/m2
* Able and willing to provide written informed consent prior to entry into the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
* History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
timeFrame: Baseline and Day 36
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
timeFrame: Baseline and Day 43
Secondary outcomes:
measure: Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
timeFrame: Day 36
measure: Cmax and Tmax of ethinylestradiol and levonorgestrel
timeFrame: Day 43
measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 77
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm
state: Queensland
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References:
Clinical trial NCT02248896: Antihypertensive Medications and the Risk of Sepsis
Official title: Antihypertensive Medications and the Risk of Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 1129062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of, or treatment for hypertension

Brief summary: The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death


Eligibility criteria: Inclusion Criteria:

- Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension

Exclusion Criteria:

- Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry

Primary outcomes:
measure: Occurence of sepsis, including severe sepsis
timeFrame: Up to 9 years and 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02961296: Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
Official title: Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Peptic Ulcer
Lymphoma
Gastric Cancer
Gastritis
Keywords: Helicobacter Pylori
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
First posted: 2016-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects required to the examination of Helicobacter pylori infection is necessary during upper gastrointestinal endoscopy due to peptic ulcer, lymphoma, gastric cancer, gastritis, et al.

Brief summary: The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.

Detailed description: Backgrounds:

The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.

Theories and Plans:

The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Eligibility criteria: Inclusion Criteria:

* Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
* No history of Helicobacter pylori eradication.
* No history of antibiotics within one month.
* Person who agree on the consent.

Exclusion Criteria:

* History of antibiotics more than 3 days sequentially within one month.
* History of subtotal gastrectomy.
* Person who does not agree on the consent.

Primary outcomes:
measure: The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method)
timeFrame: 6 more days
Secondary outcomes:
measure: The gap of the rate of the antibiotic resistance to H. pylori by regional groups
timeFrame: 6 more days
measure: The success rate of H. pylori strain separation
timeFrame: 6 more days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hwoon-Yong Jung, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00453596: Analysis of Implantation Failure and Establishment of Therapy for Implantation Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: infertile women
thin endometrial thickness
implantation failure
Lead sponsor: Yamaguchi University Hospital
Sponsor class: OTHER
First posted: 2007-03-29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Impaired endometrial growth (thin endometrial thickness) is a critical factor for implantation failure. In this study, effects of vitamin E on endometrial growth are studied.


Eligibility criteria: Inclusion Criteria:

* Endometrial thickness \< 8 mm

Exclusion Criteria:

* Women with fibroids
* Women receiving hormone therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ube
country: Japan
facility: Yamaguchi University Hospital
Study officials:
affiliation: Yamaguchi University Hospital
name: Norihiro Sugino, M.D., PhD.
role: STUDY_CHAIR
References: