louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01409369: A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
Official title: A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-04
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
* Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.

Exclusion Criteria:

* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
* Any confirmed allergic reaction against any drug or multiple allergies
* Dietary restrictions that would prohibit the consumption of standardized meals
* Positive cotinine test and/or any use of nicotine containing products
* Clinically relevant history of constipation or bowel disorder
* Known intolerability to activated charcoal

Primary outcomes:
measure: C max: maximum observed plasma concentration
timeFrame: 18 weeks
measure: T max: time of maximum observed plasma concentration
timeFrame: 18 weeks
measure: T1/2: apparent terminal half-life
timeFrame: 18 weeks
measure: AUC: area under the plasma concentration-time curve
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05948969: Transform CV Risk in Diabetes
Official title: Transform CV Risk in Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: American College of Cardiology
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2023-07-17
Enrollment: 750
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: This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).


Eligibility criteria: Inclusion Criteria:

* T2D diagnosis in the medical record
* ASCVD, defined as follows:

  1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
  2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
  3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization

Exclusion Criteria:

* Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
* Currently receiving any SGLT2i or GLP-1RA
* Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
* Currently receiving comfort care or enrolled in hospice
* Life expectancy \<1 year
* History of or plan for heart transplantation or ventricular assist device
* Current or planned hemodialysis
* Decompensated end stage liver disease
* History of Fournier's Gangrene
* Type 1 diabetes
* Prior history of diabetic ketoacidosis
* Pregnancy or active breastfeeding
* History of Pancreatitis or pancreatic cancer
* History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Primary outcomes:
measure: New prescription of a SGLT2i and/or GLP-1RA
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Multiple sites nationwide
state: District of Columbia
Study officials:
References:
Clinical trial NCT01146769: Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
Official title: Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Rectum
Keywords: Cancer of rectum
Physiotherapy
Lead sponsor: Kwong Wah Hospital
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 50
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: The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period

Detailed description: The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo low anterior resection of rectum
* Patient consented for study

Exclusion Criteria:

* Patient unable to understand pelvic floor exercise
* Patient who underwent alternative procedure
* Patient who suffers anastomotic complications after surgery
* Patient who ileostomy not closed

Primary outcomes:
measure: Maximum Squeeze Pressure
timeFrame: 1 week before operation and 3 months after operation
Secondary outcomes:
measure: Functional Outcomes
timeFrame: 1 week before operation and 3 months post operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Kwong Wah Hospital
Study officials:
affiliation: Department of Surgery, Kwong Wah Hospital
name: Patrick Y LAU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625469: Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
Official title: Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Idiopathic Pulmonary Fibrosis
Keywords: pulmonary arterial hypertension
idiopathic pulmonary fibrosis
bosentan
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2008-02-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Detailed description: The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Pulmonary Fibrosis referred for lung transplantation
* Minimum 50 meter 6 minute walk distance
* No significant underlying liver disease

Exclusion Criteria:

* Significant liver disease or cirrhosis
* non ambulatory
* previous adverse reaction/allergy to Bosentan

Primary outcomes:
measure: 6 minute walk distance
timeFrame: monthly assessement until date of lung transplantation
Secondary outcomes:
measure: right heart catheterization hemodynamics
timeFrame: variable based on time between listing and actual lung transplantation
measure: chemokine peripheral blood analysis
timeFrame: monthly
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine UCLA
state: California
city: Los Angeles
country: United States
facility: Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rajan Saggar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02661269: Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
Official title: Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edema
Sepsis
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU population

Brief summary: Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.

Primary outcome:

- Total vessel density (TVD)

Secondary outcome:

* Fluid balance
* BIVA measurements (reactance \& resistance)

Detailed description: There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.

With sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.

To give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record.

Eligibility criteria: Inclusion Criteria:

* after cardiac surgery
* septic patient with a fluid balance of 4L +

Exclusion Criteria:

* recent maxillofacial surgery

Primary outcomes:
measure: Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
timeFrame: Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.
Secondary outcomes:
measure: The correlation between a increasing fluid balance and the total vessel density in both groups separately.
timeFrame: The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
state: Friesland
Study officials:
affiliation: Frisius Medisch Centrum
name: E.C. Boerma, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04531969: Comparison of Outpatient and Inpatient Spa Therapy
Official title: Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Spa therapy
Electrotherapy
Ultrasound
Hotpack
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Detailed description: Osteoarthritis (OA) has an important place in musculoskeletal diseases and is the most common rheumatic joint disorder characterized by progressive cartilage degeneration. Osteoarthritis of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain, joint stiffness, limited daily activities, and decreased quality of life.

In this study, it was aimed to compare the effects of inpatient and outpatient applications of HP, US, TENS, spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary knee osteoarthritis

Exclusion Criteria:

* Patients who have secondary knee osteoarthritis due to various diseases
* Patients with pronounced pathology in the waist, hip and ankle joint, patients with active tumors
* Patients with febrile infectious disease
* Having had serious surgical operations in the last 6 months
* Patients who have undergone and/or have been injected with intraarticular steroid and hyaluronic acid into the knee joint
* Patients who have received balneotherapy and peloidotherapy in the last one year
* Patients with decompensated organ failure, those with inflammatory disease, those with pregnancy and breastfeeding
* People with neurological diseases such as epilepsy, inner ear hearing aids, pacemakers and other individuals with a small metallic implant

Primary outcomes:
measure: Western Ontario and McMaster University (WOMAC) osteoarthritis index
timeFrame: two weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: two weeks
measure: Timed Up and Go (TUG)
timeFrame: two weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baylsa University
name: Mustafa Fatih Yaşar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630169: Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Official title: APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Corneal Edema
Lead sponsor: Aurion Biotech
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
* BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).

Exclusion Criteria:

* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
* Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

Primary outcomes:
measure: BCVA - 15-letter improvement (3-line gain)
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Aurion Biotech site
Study officials:
affiliation: Aurion Biotech
name: Study Manager, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06162169: A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
Official title: A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent
2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values.
3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator

Exclusion Criteria:

1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;
2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;
3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose;
4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial

Primary outcomes:
measure: Observed maximum concentrations (Cmax )of JAB-21822
timeFrame: approximately 10 days
measure: Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822
timeFrame: approximately 10 days
measure: Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822
timeFrame: approximately 10 days
measure: Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin
timeFrame: approximately 10 days
measure: Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin
timeFrame: approximately 10 days
measure: Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin
timeFrame: approximately 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Hospital
state: Beijing
Study officials:
affiliation: Beijing Gaobo Hospital
name: He Qing B.Pharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06075069: Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
Official title: Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function


Eligibility criteria: Inclusion Criteria:

* Infants with bilateral cleft lip and palate.
* Centralized pre-maxilla that does not need active appliance.
* Normal inner ear and auditory nerve function.

Exclusion Criteria:

* Infant with unilateral cleft lip and palate or cleft palate only.
* Deviated pre-maxilla that needs active appliance.
* Congenital hearing problems or sensorineural hearing loss/

Primary outcomes:
measure: Assessment of middle ear pressure
timeFrame: up to one year of age
measure: Assessment of middle ear compliance
timeFrame: up to one year of age
measure: Assessment of hearing quality
timeFrame: up to one year of age
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References: