louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02162966: Safety and Efficacy Study of High Dose Colistin
Official title: Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infectious Diseases
Keywords: colistin
ICU
critical care
Lead sponsor: King Saud Medical City
Sponsor class: OTHER_GOV
First posted: 2014-06-13
Enrollment: 330
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: Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.


Eligibility criteria: * Inclusion Criteria:

  1. Patient age more than or equal 18 years old.
  2. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
  3. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
* Exclusion Criteria:

  1. Patient age less than 18 years.
  2. Pregnant patient.
  3. If received Colistin treatment for less than 72 hours.
  4. Renal Replacement Therapy.

Primary outcomes:
measure: Evaluate safety of high dose Colistin
timeFrame: 7 to 21 days after giving Colistin
Secondary outcomes:
measure: All cause mortality
timeFrame: 7 days after the end of therapy or at 28 days after enrollment
measure: Ventilation free days
timeFrame: 28 days after enrollment
measure: Length of ICU stay
timeFrame: 28 days after enrollment
measure: Microbiological response
timeFrame: A day 7 and at the end of therapy
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud Medical City
Study officials:
affiliation: King Saud Medical City
name: Ahmed F Mady, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302166: Effects of HICT and Intermittent Fasting on PCOS
Official title: Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
PCO
Keywords: PCO
Polycystic Ovary syndrome
Females
Body Image concerns
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.


Eligibility criteria: Inclusion Criteria:

* Unmarried females
* Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:

  * PCOM on US
  * Ovulatory dysfunction
  * Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)
* Not engaged in any regular lifestyle intervention for \&lt;3 Months prior to inclusion

Exclusion Criteria:

* Use of Estrogen, Progestin or combination.
* Taking medications or supplements for Insulin resistance \&lt; 3 months prior to the inclusion
* Type I or II DM
* Hypo/hyperthyroidism
* BMI ≥27 (Obese according to BMI Asia)

Primary outcomes:
measure: PCOS Morphology
timeFrame: 8th Week
Secondary outcomes:
measure: Anthropometrics
timeFrame: 8th Week
measure: Clinical Hyperandrogenism
timeFrame: 8th Week
measure: Body Image concerns
timeFrame: 8th Week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bilal Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Noor Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sarah Ehsan, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02430766: Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases(Close to Nerve)
Official title: Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymph Node Metastases
Keywords: irreversible electroporation
Unresectable Lymph Node Metastases
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Lymph Node Metastases.

Detailed description: By enrolling patients with unresectable Lymph Node Metastases adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Lymph Node Metastases.

Eligibility criteria: Inclusion Criteria:

* Lymph Node Metastases diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04278066: Hyperoxia and Pulmonary Complications After Cardiac Surgery
Official title: Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperoxia
Keywords: Hyperoxia
Cardiac surgery
pulmonary complications
Lung collapse
Post-operative
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient operated heart surgery with extra-corporal life support

Brief summary: The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Patient operated heart surgery with extra-corporal life support
* Hospitalization in Cardiology intensive and critical care unit
* Patient operated in HUS between 01/01/2015 and 31/12/2019
* Subject consent, after information, to the reuse of its data for the purposes of this study

Exclusion Criteria:

* Non-consent patient
* Hypoxemic patient
* Emergency surgery
* Patient with post-operative cardiac assist device
* Patient with guardianship

Primary outcomes:
measure: Retrospective study of the average of per and postoperative PaO2 in cardiac surgery
timeFrame: iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie - NHC
Study officials:
affiliation: University Hospital, Strasbourg, France
name: François FISCHER, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01065766: Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 4065
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Has type 2 diabetes mellitus
* Is treated with sitagliptin/metformin within local label for the first time

Exclusion Criteria:

* Has a contraindication to sitagliptin/metformin according to the local label
* Is treated with sitagliptin/metformin before contract and out of enrollment period

Primary outcomes:
measure: Percentage of Participants With Any Adverse Experience
timeFrame: Up to 26 weeks
measure: Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
timeFrame: At Week 12
measure: Change From Baseline to Treatment in HbA1c at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline to Treatment in FPG at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 2hr-PPG at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
timeFrame: At Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00548366: Sodium Restriction in the Management of Cirrhotic Ascites
Official title: Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ascites
Keywords: cirrhosis
portal hypertension
ascites
sodium restriction
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Detailed description: Secondary objectives:

1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
3. Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
* Age 18-75
* Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
* Spanish-speaking subjects will be eligible for participation

Exclusion Criteria:

* Active drug or alcohol abuse,
* Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
* Hemorrhagic ascites, malignant ascites,
* Creatinine \>2 mg/dL or CCl \< 30 mL/min,
* K \> 5.5 mmol/L,
* Diuretic refractory ascites
* Allergy to or intolerance of either spironolactone or furosemide
* Homelessness, incarceration, inability to follow up in clinic, or comply with diet.

Primary outcomes:
measure: Control of ascites
timeFrame: 3 months
Secondary outcomes:
measure: Patient acceptance and compliance
timeFrame: 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Jennifer A Cuthbert, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00388466: Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF
Official title: Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: whole body vibration
muscle function
cystic fibrosis
mechanography
chair-rising-test
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2006-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.

Detailed description: Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.

10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.

Every 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Cystic Fibrosis
* age older than 18 years

Exclusion Criteria:

* hypersplenic syndrome
* acute arthritis or osteomyelitis

Primary outcomes:
measure: muscle force at the beginning of the study and after 3 months
measure: muscle power at the beginning of the study and after 3 months
Secondary outcomes:
measure: pulmonary function testing at the beginning of the study and after 3 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: CF Center Cologne, University Children's Hospital
Study officials:
affiliation: University Children´s Hospital Cologne, Germany
name: Eckhard Schoenau, Prof.
role: STUDY_CHAIR
References:
citation: Fricke O, Weidler J, Tutlewski B, Schoenau E. Mechanography--a new device for the assessment of muscle function in pediatrics. Pediatr Res. 2006 Jan;59(1):46-9. doi: 10.1203/01.pdr.0000191580.07644.1c. Epub 2005 Dec 2.
Clinical trial NCT04829266: Mental Simulations and Early Mobilization of Patients After Cesarean Section
Official title: Effect of Mental Simulations on the Early Mobilization of Patients After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cesarean Section
Keywords: mental simulation
anxiety
verticalization
obstetrics
cesarean section
post-operative care
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations.


Eligibility criteria: Inclusion Criteria:

* must be qualified to and undergoing delivery using Cesarean section,
* must be undergoing conduction of anesthesia during Cesarean section,
* must be undergoing the analgesic therapy in the postoperative period,
* must be qualified to mobilization by the medical staff,
* must be fluent in Polish in speaking and writing.

Exclusion Criteria:

* any orthopedic dysfunction,
* any neurological dysfunction,
* any psychiatric disease.

Primary outcomes:
measure: willingness to verticalize
timeFrame: Immediately after a single mental simulation
measure: verticalization
timeFrame: Immediately after a single mental simulation
measure: duration of the first mobilization
timeFrame: Immediately after a single mental simulation
Secondary outcomes:
measure: pain level
timeFrame: 3 time points (before and immediately after a single mental simulation, and immediately after verticalization.
measure: anxiety
timeFrame: upon arrival at the recovery room, before and immediately after a single mental simulation.
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: 2nd Chair and Clinic of Gynecology and Obstetrics, Jan Mikulicz-Radecki University Teaching Hospital in Wrocław, Wrocław, Poland
Study officials:
affiliation: Department of Applied Obstetrics, Faculty of Health Sciences, Wroclaw Medical University
name: Anna Prokopowicz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prokopowicz A, Byrka K. Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial. Sci Rep. 2021 Nov 22;11(1):22634. doi: 10.1038/s41598-021-02036-1.
Clinical trial NCT02220166: Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease
Official title: Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac Disease
Gluten
Gluten free diet
Triticum monococcum
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 8
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: TREATMENT

Brief summary: Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated.

The aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.


Eligibility criteria: Inclusion Criteria:

* Adult Celiac patients on Gluten Free Diet (GFD) for at least one year
* Strict adherence to GFD
* Negative Celiac related serology
* Normal duodenal Histology defined as Marsh Class 0-II
* Willing to participate and adhere to study protocol
* Sign of the informed consent

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Histologic: 4 duodenal biopsies obtained and classified according to Marsh
timeFrame: Baseline, Day 60
Secondary outcomes:
measure: Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline, Day 30, Day 60
Other outcomes:
measure: Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial
timeFrame: Baseline, Day 30, Day 60
Locations:
city: Brescia
country: Italy
facility: AO Spedali Civili of Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Alberto Lanzini, MD, PhD
role: STUDY_CHAIR
affiliation: Università degli Studi di Brescia
name: Barbara Zanini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zanini B, Petroboni B, Not T, Di Toro N, Villanacci V, Lanzarotto F, Pogna N, Ricci C, Lanzini A. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. BMC Gastroenterol. 2013 May 24;13:92. doi: 10.1186/1471-230X-13-92.