louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00816465: Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Hoodia gordoni
NASH
NAFLD
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease.

Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.

Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.


Eligibility criteria: Inclusion Criteria:

* Subjects who have completed the informed consent process culminating with written informed consent by the subject
* Men and women age 18 to 65 years inclusive.
* Patients with biopsy proven NASH with a score of 4 or above.
* Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
* HBA1C between 5.5 and 14%.

Exclusion Criteria:

-

Primary outcomes:
measure: decreased insulin resistance
timeFrame: 30 days
measure: safety
timeFrame: 60 days
Secondary outcomes:
measure: reduced hepatic injury
timeFrame: 30 days
measure: reduced weight/BMI/abdominal circumference
timeFrame: 30 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT04215965: Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy
Official title: Efficacy and Safety of a Low-citrate-based Anticoagulation With Calcium-free Phosphate-containing Replacement Fluid Compared to Standard Citrate-based Anticoagulation Protocol in Patients Requiring Continuous Renal Replacement Therapy; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Critical Care
Keywords: CRRT
Renal failure
Citrate
Phosphore
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 100
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: In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion


Eligibility criteria: Inclusion Criteria:

1. Acute renal failure requiring CRRT
2. Suitability for regional anticoagulation of the CRRT circuit
3. Clinical equipoise regarding the method of circuit anticoagulation
4. Subject is affiliated with a social security system (if required by individual country regulations).
5. Subject meets national regulatory criteria for clinical trial participation.
6. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form

Exclusion Criteria:

1. Age less than 18 years
2. Expected stay in ICU less than 24 hours
3. Pregnant or breastfeeding
4. Suspected ischemic hepatitis or liver failure
5. Chronic kidney disease requiring dialysis prior to ICU admission
6. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
7. Metformin and acethaminophen intoxication

Primary outcomes:
measure: Circuit lifetime
timeFrame: First 3 days of continous renal replacempent therapy
Secondary outcomes:
measure: Efficacy of the new RCA solution
timeFrame: first 3 days of CRRT
measure: Efficacy of the new RCA solution
timeFrame: first 3 days of CRRT
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Emilie GARRIDO
role: STUDY_DIRECTOR
References:
Clinical trial NCT05163665: Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Official title: Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Neoplasms
Keywords: Closure of GI defects
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 82
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 is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.

Detailed description: Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.

Eligibility criteria: Inclusion Criteria:

* Patient is greater than or equal to 18 years of age.
* Patient can provide informed consent.
* Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
* Post resection defect \> 3cm.
* Lesion 2cm or greater from the dentate line.

Exclusion Criteria:

* Patient is \< 18 years of age.
* Patient refused and/or unable to provide consent.
* Patient is pregnant.
* Patient is currently incarcerated

Primary outcomes:
measure: Cost of each closure
timeFrame: Day 1
Secondary outcomes:
measure: Rate of complete closure of GI defect
timeFrame: Day 1 (end of procedure)
measure: Successful Tissue approximation
timeFrame: Day 1 (End of procedure)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT03256565: Q-tip Test and Urodynamic Study
Official title: Correlation Between Q-tip Test and Urodynamic Study in Women With Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 176
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with stress urinary incontinence

Brief summary: Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be partly responsible for pathogenesis of women with stress urinary incontinence (SUI). Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this study was to search a surrogate for assessment of urethral hypermobility by correlating the Q-tip angle and the urodynamic variables in women with SUI.

Detailed description: All women with SUI and underwent Q-tip testing were reviewed. Patient characteristics, degree of prolapse determined by Pelvic Organ Prolapse Quantification system, Q-tip angle, the results of urodynamic studies, the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire were reviewed from their medical records. Spearman correlation test, and univariate and multivariate backward stepwise linear regression analysis were performed as appropriate.

Eligibility criteria: Inclusion Criteria:

* all women with stress urinary incontinence, who underwent both Q-tip testing and urodynamic study, and completed the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire

Exclusion Criteria:

* women who had incomplete exam or questionnaires

Primary outcomes:
measure: Correlations of Q-tip angle with pressure transmission ratio
timeFrame: Between 2014 and 2020
Secondary outcomes:
measure: Correlations of Q-tip angle with the other parameters of urodynamic studies
timeFrame: Between 2014 and 2020
measure: Correlations of Q-tip angle with pad weight
timeFrame: Between 2014 and 2020
measure: Correlations of Q-tip angle with symptoms
timeFrame: Between 2014 and 2020
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT05103865: Animal-Assisted Therapy in the Residential Treatment of Schizophrenia and Addictions
Official title: Animal-Assisted Therapy in the Residential Treatment of Schizophrenia and Addictions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnosis, Dual (Psychiatry)
Keywords: Animal-assisted therapy
everyday life skills
schizophrenia
residential treatment
dual pathology
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Animal-assisted therapy (AAT) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies. This study assesses the viability of the implementation and the efectiveness of an AAT program in patients diagnosed with substance abuse disorder and associated mental disorders (dual pathology).

Detailed description: Animal assisted therapy (AAT) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies. The study assesses the implementation and effectiveness of a TAA program in patients diagnosed with substance use disorder and schizophrenia spectrum disorder.

Eligibility criteria: Inclusion Criteria:

* Meeting DSM-5 criteria for substance abuse disorder and the presence of schizophrenia
* Voluntary participant in the study and having signed the informed consent

Exclusion Criteria:

* Patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier)
* Animal-specific phobia

Primary outcomes:
measure: The Life Skills Profile questionnaire (LSP)
timeFrame: Change from Life Skills at 3-6-9 months (12 minutes)
measure: Barrat impulsiveness scale (BIS-11)
timeFrame: Change from impulsiveness at 3-6-9 months (12 minutes)
measure: Calgary Depresión Scale for Schizophrenia (CDSS)
timeFrame: Change from Depresión at 3-6-9 months (12 minutes)
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from self.-esteem at 3-6-9 months (12 minutes)
measure: Positive and negative symptom scale (PANSS)
timeFrame: Change from Positive and negative symptom at 3-6-9 months (12 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05608265: Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Official title: Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Retinal Imaging
Lead sponsor: PulseMedica
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 70 years of age
* Male or female
* Diagnosed diabetic retinopathy
* Two eyes with clear ocular media

Exclusion Criteria:

* Patients younger than 18 years and over 70 years of age
* Patients without diabetic retinopathy
* Opacification of cornea, lens, or vitreous

Primary outcomes:
measure: Successful performance of the real-time eye tracking function by post-image processing
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Device usability as assessed by a survey
timeFrame: Through study completion, an average of 6 months
measure: Image Quality as assessed by user assessment of image quality parameters
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Retina Consultants
Study officials:
References:
Clinical trial NCT01134965: to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
Official title: An Open Two-way Cross-over Study to Evaluate the Effect of Multiple Doses of Flibanserin 100 mg Film-coated Tablets Given Once Daily on the Single Dose Pharmacokinetics of Digoxin 0.5 mg in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. Flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.


Eligibility criteria: Inclusion criteria:

healthy male and female subjects

Primary outcomes:
measure: Maximum concentration of digoxin in plasma after single dose (Cmax)
timeFrame: 72 hours
measure: Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf)
timeFrame: 72 hours
Secondary outcomes:
measure: Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 511.158.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03624465: Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
Official title: Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatectomy
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.

Detailed description: Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is scheduled to undergo elective prostatectomy surgery

Exclusion Criteria:

* Significant comorbidities
* Subjects with pacemakers, defibrillators, or other electromedical implants
* Subjects with ferromagnetic implants
* Clinical history of impaired coagulation
* Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
* Subject is not likely to comply with the follow-up evaluation schedule
* Subject is participating in another clinical trial

Primary outcomes:
measure: Number of Tools Required to Retract the Prostate During Procedure
timeFrame: During planned prostatectomy procudure
measure: Incidence of Device Related Adverse Events (Safety)
timeFrame: Through 30 days post prostatectomy procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez (FALP)
Study officials:
affiliation: Mayo Clinic
name: Matthew Gettman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527565: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Official title: A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical
* examination, as judged by the investigator
* Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive)
* Minimum body weight of 65 kg
* Fasting blood glucose between 3.8-6.0 mmol/L
* Glycohemoglobin (HbA1c) below 6.4 %
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
* Hepatitis B or C
* Subjects with a first-degree relative with diabetes mellitus
* Known or suspected allergy to trial product or related products
* Smoking during the past three months

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: tmax, the time to maximum insulin aspart concentration
measure: Area under the insulin aspart curve
measure: Mean residence time (MRT)
measure: The area under the glucose infusion rate curve
measure: GIRmax, maximum glucose infusion rate value
measure: tGIRmax, time to maximum glucose infusion rate value
measure: Adverse events
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01761565: Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Official title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plasma Concentrations
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs


Eligibility criteria: Inclusion Criteria:

* Non smoking
* Ages 18 to 45 year, inclusive
* BMI between 18 and 30

Exclusion Criteria:

* Subjects taking any prescription or OTC medications or vitamins or supplements
* Pregnant females
* Subjects with pulmonary disease or sleep apnea

Primary outcomes:
measure: Cmax
timeFrame: 24 hours in Treatment A, 37 hours in Treatment B
measure: Time to Steady State
timeFrame: 24 hours
measure: CST½
timeFrame: 24
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA
state: Kansas
Study officials:
affiliation: PRA
name: Sandra K. Willsie, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.