louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04150133: Effects and Tolerability With Clenpiq and Low Residue Diet
Official title: The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Preparation
Keywords: low residue diet
Lead sponsor: Hillmont GI
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2019-11-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
Primary purpose: OTHER

Brief summary: The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.

Detailed description: This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.

Eligibility criteria: Inclusion Criteria:

* All subjects age 18-80 requiring colonoscopy for appropriate indications

Exclusion Criteria:

* Active diarrhea (Greater than 3 unformed stools daily)
* Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.

Additional exclusion criteria would include;

* Subjects with a history of inflammatory bowel disease
* Colonic resection of any length
* Pregnant women
* American Society of Anesthesiologists (ASA) score greater than 3
* Body Mass Index (BMI) greater than 50
* Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines.
* Subjects unable to give their own informed consent.

Primary outcomes:
measure: Statistical equivalence of the clear liquid and low residue cohorts
timeFrame: During Colonoscopy Up to 24 hours
Secondary outcomes:
measure: Polyp Detection Rate
timeFrame: Post Procedure Up to 24 hours
Other outcomes:
Locations:
city: Flourtown
country: United States
facility: Hillmont GI
state: Pennsylvania
Study officials:
affiliation: Hillmont GI
name: Gerald Bertiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858533: Trial of Health At Work Workplace Health Intervention
Official title: A Pilot Controlled Feasibility Trial of Early Health At Work Workplace Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Workplace Health
Keywords: early intervention
sickness absence
return to work
primary care
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study will compare workplace health intervention delivered by advisors based in GP practices with normal GP care to assess the usefulness of the concept and its potential for wider use in a larger randomised controlled trial.

Detailed description: The aim of this pilot study is to examine the impact of H@W intervention(s) on job retention and return to work and compare outcomes with those from normal GP care. The target population for this study is people still at work but experiencing a work-related health problem as well as those off work. For the purpose of the study, short term sickness absence is defined as a period of 4 weeks or less and long term sickness absence defined as a period of 4 weeks or longer. Hypothesis

That H@W intervention in comparison to standard care:

* promotes work retention
* enables a quick and sustained return to work for those on short term sick leave (4 weeks or less)
* achieves sustained return to work for those on long term sick leave of 4 weeks or more. This could include a phased return to work.
* achieves positive outcomes which could mean leaving one job and starting another.

Eligibility criteria: Inclusion Criteria:

* People with work related health problems registered with GP practices in Liverpool Primary Care Trust.

Exclusion Criteria:

* People registered with GP practices outside Liverpool Primary Care Trust.
* Vulnerable adults and those considered by their GP to be unsuitable for the trial.

Primary outcomes:
measure: Number of days off work through sickness absence after index consultation, which will also apply to people at work with a work-relevant condition
timeFrame: 1 year
Secondary outcomes:
measure: Secondary outcome measure: time to first return to work (RTW) allowing for phased return.
timeFrame: 1 year
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Division of Primary Care, University of Liverpool.
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Mark B Gabbay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01929733: Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Official title: Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Keywords: Patent Ductus Arteriosus
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus

Brief summary: Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices.

In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device.

Aim of study:

To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.

Detailed description: The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects.

The data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.

Eligibility criteria: Inclusion Criteria:

* All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus

Exclusion Criteria:

* None

Primary outcomes:
measure: Success of implantation
timeFrame: one day, 10 days and a year after PDA closure and then last check-up exam
Secondary outcomes:
measure: residual shunt
timeFrame: one day, 10 days and a year after PDA closure and then last check-up exam
Other outcomes:
measure: Early and late Adverse effects
timeFrame: one day, 10 days and a year after PDA closure and then last check-up exam
Locations:
city: Haifa
country: Israel
facility: RAMBAM health care center
Study officials:
affiliation: Rambam Health Care Campus
name: Moshe Dotan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Omer Ephrat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695487: Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Official title: Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Anesthesia
THC
Postoperative Nausea
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how long and how effective it reduces PONV


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* elective open and laparoscopic surgery \>1hour

Exclusion Criteria:

* ambulatory surgery
* pregnancy, breast feeding
* \>ASA III
* BMI \>35
* antipsychotic, antiemetic, cytostatic therapy
* major cardiovascular, renal, hepatic, central nervous system disease
* current chronic cannabis consumption and hard drug abuse
* schizophrenia
* preoperative nausea and vomiting, vestibular disease
* not speaking german or french
* refusal to participate

Primary outcomes:
measure: Absence of postoperative Nausea and Vomiting
timeFrame: 0-24h after Operation
Secondary outcomes:
measure: Psychological and physiological data after ingestion of THC Analgetics required
timeFrame: 0-24h after operation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Anesthesia, Bern University Hospital , Switzerland
name: Robert Greif, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05439187: Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.
Official title: Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Venous Thromboembolism
Keywords: hernia repair
thromboprophylaxis
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of Saveljev University Surgery Clinic, Moscow

Brief summary: Aim of our study is to find frequency and risk factors for venous thromboembolism development in patients who underwent surgery for incisional ventral hernia. There were 240 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2018 to December 2019. Compression duplex ultrasound of lower legs veins was performed in 2-4 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* operated for incisional hernia in Saveljev University Surgery Clinic No Exclusion Criteria.

Primary outcomes:
measure: venous thromboembolism
timeFrame: was performed with median 3 days (min 1 day, max 7 days, interquartile range 2-4 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
References:
Clinical trial NCT02765087: E-Nose: Diagnostic Tool for Pleural TB
Official title: Diagnostic Utility of the E-Nose for Pleural TB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis, Pleural
Lead sponsor: Universidad Central de Venezuela
Sponsor class: OTHER
Collaborators: name: The ENose Company, Zutphen, Netherlands
name: Foundation for Research in Mycobacteria (FUNDAIM)
First posted: 2016-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the current gold standard.

Detailed description: The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form.

The patient who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in Netherlands.

During and after the use of the device, investigators determine the adverse effects of the intervention, according to the CTCEA.

Investigators use the pleural biopsy, which is the gold standard, to determine the diagnostic utility of the test. And, will compare the results with other tests currently perform as the regular diagnostic routine, such as Chest CT, adenosine deaminase value of pleural fluid and cytomorphologic \& cytochemistry of the pleural fluid.

Patient Registries will be keep in an electronic database, as well as handwriting history, with the backup copy in the records of the hospital in which the patient was admitted.

Auditories will be realised by the Ethics Committee in different time frames.

Eligibility criteria: Inclusion Criteria

1. Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
2. More than 15 years old.
3. Pleural effusion of any etiology

Exclusion Criteria:

1. Severe compromise of the general condition
2. Not capable to exhaled through the E-nose.
3. No possibility to follow-up.
4. By discretion of the research team.

Primary outcomes:
measure: Sensitivity and Specificity of the device for the diagnosis of Tuberculosis Pleural effusion
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Effects related to the use of the device, according to the CTCEA
timeFrame: 1 year
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Instituto de Biomedicina
state: DC
Study officials:
affiliation: Instituto de Biomedicina
name: Jacobuss de Waard, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366287: A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
Official title: A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Relative bioavailability
food effect
tablet
suspension
single dose
crossover
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Serum potassium \>5 mEq/L at screening.
* Impaired kidney function (estimated GFR \<60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.

Primary outcomes:
measure: PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
timeFrame: predose and post each dose (24, 48 and 96 hour timepoints)
measure: Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01427387: A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
Official title: Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP0456
Keywords: ASP0456
Pharmacokinetics
safety
tolerability
food effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.


Eligibility criteria: Inclusion Criteria:

* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
* Body weight (at screening);

  * female ≥40.0 kg,\<70.0 kg
  * male ≥50.0 kg,\<80.0 kg
* BMI(at screening): ≥17.6,\<26.4

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 10 days before dose is administered or is scheduled to receive medication
* History of drug allergies
* Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic disease
* Concurrent or previous heart disease
* Concurrent or previous renal disease

Primary outcomes:
measure: Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change
timeFrame: For 48 hours after dosing
Secondary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
timeFrame: For 48 hours after dosing
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Cental Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04813887: Skin Diseases and Pregnancy: Which Heathcare Professionals ?
Official title: Skin Diseases: Which Heathcare Professionals do Pregnant Women in Vendee Use?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Abnormalities
Pregnancy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 317
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective collection of data from a questionnaire answered by patients giving birth at the Departmental Hospital Center of Vendee during the postpartum period.

Brief summary: Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus.

The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

Detailed description: Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus. It is therefore essential to recognize them for a quick specialized treatment. They include: intrahepatic cholestasis of pregnancy, pemphigoid gestationis, polymorphic eruption during pregnancy, atopic eczema, generalized pustular psoriasis in pregnancy.

In view of the demography of dermatologists in the Vendee, 18 dermatologists in 2020 in all establishments (hospitals, clinics, practices), the general practitioner is at the center of these considerations.

The aim of this study is to assess the situation of skin disease during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

Eligibility criteria: Inclusion Criteria:

* Any woman who gives birth at Departmental Hospital Center of Vendee

Exclusion Criteria:

* Patient's refusal to participate in the study

Primary outcomes:
measure: Identify the health care provider that pregnant women consult when experiencing a skin disease
timeFrame: after delivery during the patient's stay in the maternity (2-3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: CHD Vendée
Study officials:
affiliation: Departmental Hospital Center of Vendee
name: Guillaume DUCARME
role: PRINCIPAL_INVESTIGATOR
References: