louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04023903: A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Official title: A Clinical Pharmacology Study of RTA 402 (Investigation of the Effect of Food on the Pharmacokinetics of RTA 402 Capsules in Japanese Healthy Adults and Comparison of the Pharmacokinetics With Those in Caucasian Healthy Adults)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Keywords: Bardoxolone Methyl
Healthy subject
Food effect
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Food effect part:

To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations.

Caucasian subject part:

To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted state and compare the pharmacokinetics with those observed in Japanese healthy male adults in the food effect part


Eligibility criteria: Inclusion Criteria:

1) Written voluntary informed consent to participate in the study; 2) \[Food Effect Part\] Japanese men 20 to \<40 years of age at informed consent; \[Caucasian Subject Part\] Caucasian men 20 to \<40 years of age at informed consent; 3) BMI 18.5 kg/m2 to \<25.0 kg/m2 at screening

Exclusion Criteria:

1. Presence of any disease requiring treatment;
2. History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure);
3. Alcoholism or drug addiction, or any positive result on drug abuse testing;
4. History of or current drug allergy;
5. Any positive result on infectious disease testing. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study;

Primary outcomes:
measure: Cmax
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
measure: AUC0-t
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary outcomes:
measure: tmax
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
measure: AUC0-∞
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
measure: t1/2
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
measure: MRT
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
measure: kel
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
References:
Clinical trial NCT02884843: The New Intubating Laryngeal Tube Suction-Disposable
Official title: A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Laryngeal Tube
blind intubation
fiberoptic
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation.

The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

Detailed description: The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D).

It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr.

The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiology I and II

Exclusion Criteria:

* Difficult intubation, cervical pathology

Primary outcomes:
measure: Time of blind intubation measure in seconds
timeFrame: 30 seconds
Secondary outcomes:
measure: Time of Fiberoptic intubation measure in seconds
timeFrame: 60 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion Medical Center
name: Luis a Gaitini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002343: A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
Official title: An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: Rifabutin
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.

Detailed description: Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Required:

* AZT, d4T, ddI, or ddC.
* Antipneumocystis prophylaxis.

Allowed:

* Short course (\< 14 days) of ciprofloxacin for acute infections.

Patients must have:

* AIDS.
* CD4 count \<= 100 cells/mm3.
* NO prior or current MAC infection.

Prior Medication:

Required:

* Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.

Allowed:

* Prior rifabutin.
* Prior ethambutol.
* Prior clarithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Positive tuberculin skin test (PPD \> 5 mm).
* Active M. tuberculosis.
* Perceived as unreliable or unavailable for frequent monitoring.

Concurrent Medication:

Excluded:

* Other antiretrovirals not specifically allowed.
* All investigational drugs.
* Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\>= 14 days).

Patients with the following prior conditions are excluded:

Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.

Prior Medication:

Excluded within 4 weeks prior to study entry:

* Rifampin.
* Isoniazid.
* Clofazimine.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Univ of California - Davis Med Ctr / CARES
state: California
Study officials:
References:
Clinical trial NCT03008343: Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Liver Carcinoma
Keywords: Irreversible Electroporation
NK Immunotherapy
Recurrent Liver Carcinoma
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus natural killer (NK) immunotherapy to recurrent liver cancer.

Detailed description: By enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using IRE and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00275743: Use of MRI for Assessing Stomach Relaxation in Response to a Meal
Official title: Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyspepsia
Healthy Volunteers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).


Eligibility criteria: Inclusion criteria for Dyspeptic patients (30 required)

* One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR
* Patients fulfilling the ROME-II criteria for functional dyspepsia,
* AND no symptom improvement after standard dose PPI treatment,
* AND normal upper gastrointestinal endoscopy within six months prior to the study

Inclusion Criteria for Healthy Controls (20 required)

• Absence of current abdominal symptoms or depression

Exclusion Criteria for all Participants

* Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy);
* Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair;
* Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted;
* Pregnant or breast-feeding females;
* Known claustrophobia;
* Any metal objects in the body (e.g. metal implants, pacemaker, AICD)

Primary outcomes:
measure: Gastric Volume (fasting and postprandial)
measure: Antral Contractility
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adil E. Bharucha, M.B.B.S., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101343: Use of Fitbits During Breathing Meditation
Official title: Use of Fitbits During Breathing Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Winthrop University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-11-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will examine short breathing meditations paired with Fitbit technology in order to assess mindfulness and track physical activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years.
* Currently a student, faculty, or staff member at university where research is being completed.
* Able to wear a Fitbit close to 24 hours a day for two weeks.

Exclusion Criteria:

* Younger than 18 years.
* Has previously practiced meditation.

Primary outcomes:
measure: Change in Mindfulness
timeFrame: Baseline and 2 weeks post-baseline
measure: Change in Anxiety
timeFrame: Baseline and 2 weeks post-baseline
measure: Change in Well-being
timeFrame: Baseline and 2 weeks post-baseline
measure: Change in Worry
timeFrame: Baseline and 2 weeks post-baseline
measure: Change in Depression
timeFrame: Baseline and 2 weeks post-baseline
Secondary outcomes:
measure: Change in Sleep Minutes
timeFrame: Baseline and 2 weeks
measure: Change in Heart Rate
timeFrame: Baseline and 2 weeks
measure: Change in Steps
timeFrame: Baseline and 2 weeks
measure: Change in Physically Active Minutes
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Rock Hill
country: United States
facility: Winthrop University
state: South Carolina
Study officials:
affiliation: Winthrop University - Rock Hill, SC
name: Courtney Guenther
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831843: Effect of Breathing Circuits on Intraoperative Body Temperature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Keywords: core body temperature
humidity
circuit temperature
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit


Eligibility criteria: Inclusion Criteria:

* aged 18-70 years,
* ASA I or II
* patients scheduled for craniotomy under general anesthesia

Exclusion Criteria:

* ASA III or IV
* Duration of anesthesia time less than 4 hours
* emergency operation

Primary outcomes:
measure: trend of changes on body temperature
timeFrame: from the point of postintubation up to 5 hours
Secondary outcomes:
measure: total duration of airwarmer(Bair-Hurgger warming unit) using time
timeFrame: from the point of postintubation up to 5hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim E, Lee SY, Lim YJ, Choi JY, Jeon YT, Hwang JW, Park HP. Effect of a new heated and humidified breathing circuit with a fluid-warming device on intraoperative core temperature: a prospective randomized study. J Anesth. 2015 Aug;29(4):499-507. doi: 10.1007/s00540-015-1994-z. Epub 2015 Mar 14.
Clinical trial NCT06767943: Predicting Myocardial Infarction After Abdominal Surgery: Clinical Scores & Biomarkers
Official title: Clinical Scoring and Biomarkers for Prediction of Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome in Patients Undergoing Major Abdominal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients assigned for non-cardiac surgeries who fulfilled the inclusion criteria underwent preoperative evaluation using the assessment tools. All patients were admitted to the intermediate care unit for the 1st 24-h PO for follow-up for the possibility of developing acute myocardial infarction (AMI), which was diagnosed according to the 2017 ESC Guidelines and was differentiated as STEMI and NSTEMI.

Brief summary: All patients undergoing non-cardiac surgery who met the inclusion criteria underwent a preoperative evaluation using specific assessment tools.

Following surgery, patients were closely monitored in the intermediate care unit for the first 24 hours for the development of acute myocardial infarction (AMI). AMI was diagnosed based on the presence of chest pain, elevated cardiac biomarkers, and specific electrocardiogram (ECG) and echocardiogram findings.


Eligibility criteria: Inclusion Criteria:

* Patients older than 45,
* Patients of ASA-PS grade II-IV,
* Patients who prepared for non-cardiac surgeries of SSS of II-IV,
* Patients free of exclusion criteria,
* Patients signed the written consent for the study precipitation.

Exclusion Criteria:

* Patients of ASA-PS grade I or V,
* Patients younger than 60 years,
* Patients planned to undergo surgeries of SSS \>IV,
* Patients were severely frail with CFS\>6,
* Patients had abnormal preoperative electrocardiography (ECG),
* Patients had a history of previous major cardiac or cerebrovascular events,
* Patient had disturbed cognitive function, coagulopathy, severe anemia with hemoglobin concentration (HBC) \< 7 gm/dl.

Primary outcomes:
measure: The proportion of patients reported having at least a 50% incidence of Myocardial Infarction (measured by the Relevant Changes in 12-Leads ECG) in correlation with blood biomarkers.
timeFrame: 50 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT02921243: Schizophrenia and the Gut Microbiome
Official title: Schizophrenia and the Gut Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-participants with Schizophrenia

Brief summary: In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.


Eligibility criteria: Inclusion Criteria:

1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
2. Age 18-64 years;
3. currently hospitalized for at least 7 days
4. currently treated with an antipsychotic, with no dose changes in last 14 days
5. ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent

Exclusion Criteria:

1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
3. Mental retardation
4. Antibiotic or immune therapy within the last three months
5. Prebiotic or probiotic treatment within the last three months
6. Inability to understand English
7. Inability to cooperate with study procedures
8. Pregnant women
9. Prisoner status
10. For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).

Primary outcomes:
measure: 16S rRNA gene amplicons from stool samples
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
References: