louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04127149: Evaluation of Ultra-portable Ultrasound in General Practice
Official title: Pragmatic Evaluation of Ultra-portable Ultrasound for a List of Indications in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Pleural Effusion
Renal Colic
Hepatic Colic or Cholecystitis
Subcutaneous Abscess or Cyst
Fracture of Long Bones
Intra-uterine Pregnancy or Extra-uterine Pregnancy or Miscarriage
Phlebitis
Keywords: ultrasound scanner
sonogram
general practice
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is an interventional multi-centre study comparing two groups of general practitioners with or without an ultrasound scanner over a period of 6 months. The evaluation focuses on the management of patients for 8 pathologies:

* Pneumonia
* Pleural effusion
* Renal colic
* Hepatic colic or cholecystitis
* Subcutaneous abscess or cyst
* Fracture of long bones
* Intra-uterine pregnancy or extra-uterine pregnancy or miscarriage
* Phlebitis The principal hypothesis is that there are fewer complementary exams in the group of doctors using ultrasound scanners.

The secondary hypotheses are:

* There is better patient orientation (emergency care, specialist consultation, return home) in the group of doctors using the ultrasound scanners.
* The global cost of the care is lower in the group of doctors using the ultrasound.
* Using ultrasound during the consultation decreases the anxiety of the patient.
* Using ultrasound increases the duration of the consultation.
* There is no difference between the predicted and the real orientation of the patients.


Eligibility criteria: Inclusion Criteria:

* patients age 18 and over
* consulting their general practitioner for one of the 8 conditions below

Exclusion Criteria:

* patients who have already received an imagery exam for the acute episode justifying the consult
* opposition to participate

Primary outcomes:
measure: Number of complementary exams
timeFrame: Two weeks after inclusion
Secondary outcomes:
measure: Number of hospitalisations, specialist orientation or return home
timeFrame: Two weeks after inclusion
measure: Cost of care
timeFrame: Four weeks after inclusion in the study
measure: Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale
timeFrame: Two weeks after inclusion in the study
measure: Consultation duration
timeFrame: Two weeks after inclusion in the study
Other outcomes:
Locations:
city: Les Vans
country: France
facility: Maison de santé pluridisciplinaire Léopold Ollier
Study officials:
affiliation: Maison de sante pluridisciplinaire Leopold Ollier Les Vans
name: Francis PELLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02386449: A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
Official title: A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-03-12
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 18 to 60 years
* Subjects scheduled for an elective colonoscopy
* Women of child-bearing potential using at least one highly effective contraceptive method
* Subjects able to understand all instructions
* Informed consent signed

Exclusion Criteria:

* Hypersensitivity to active ingredients
* Female participants pregnant or with a positive blood pregnancy test
* Acute surgical abdomen
* Previous colorectal surgery
* Gastrointestinal (GI) surgery
* GI diseases, active inflammatory bowel disease, colon disease
* Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
* Use of laxatives or antidiarrheal agents 72 hours prior to screening
* Significant alterations in laboratory values or other diseases that could interfere with the results

Primary outcomes:
measure: Percentage of subjects classified as success (Aronchick scale)
timeFrame: At visit 2 (day 1 of colonoscopy)
Secondary outcomes:
measure: Percentage of subjects classified as success (Ottawa scale)
timeFrame: At visit 2 (day 1 of colonoscopy)
measure: Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)
timeFrame: At visit 2 (day 1 of colonoscopy)
measure: Subject satisfaction (Likert scale)
timeFrame: At visit 2 (day 1 of colonoscopy)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00501449: Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes
Official title: Psychosocial Aspects of Multiple Endocrine Neoplasia (MEN) Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Endocrine Neoplasia
Keywords: Multiple Endocrine Neoplasia
Questionnaire
Psychosocial
Surveillance Behaviors
MEN Syndromes
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-16
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of MEN1 or MEN2.

Brief summary: The specific aims of the study include:

1. Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2.
2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among adults with MEN1 or MEN2, and identify associated with those outcomes.

Detailed description: The proposed cross-sectional study is intended to obtain information regarding current surveillance behaviors and other psychosocial outcomes among persons affected by the multiple endocrine neoplasia (MEN) 1 or MEN2, which are inherited conditions.

Study participants will include patients who have been seen previously at MDACC for evaluation of MEN1 or MEN2. Because this is the first time investigators are contacting these patients to invite them to participate in psychosocial research, the proposed study also will help determine the feasibility of conducting similar studies in the future.

Investigators anticipate that data gathered from this study will enhance existing knowledge about the psychological and behavioral aspects of the MEN syndromes, and will inform future research efforts directed toward this understudied population.

Eligibility criteria: Inclusion Criteria:

1. Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2
2. Spouse, Significant Other, or Family Member who is at least 18 years of age and who is related to an individual who is a patient at MDACC and who has been diagnosed with MEN1.
3. Ability to read and write English

Exclusion Criteria:

1) Inability to be contacted via mail (i.e., no contact information on record, incorrect address)

Primary outcomes:
measure: Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2.
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995449: Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
Official title: A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Biologics-Inadequate
KB003
GM-CSF
Lead sponsor: Humanigen, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 9
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 purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.


Eligibility criteria: Inclusion Criteria:

* At least 6 swollen and at least 6 tender joints
* C-reactive Protein (CRP) \> Upper Limit Normal (ULN)
* Prior inadequate response from biologic therapy
* Stable regimens of concomitant RA therapies

Exclusion Criteria:

* Unstable medical conditions

Primary outcomes:
measure: This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.
timeFrame: Weeks 14 & 30
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Frederick
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Wilmington
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Oak Creek
country: United States
state: Wisconsin
Study officials:
affiliation: Humanigen, Inc.
name: Nestor A. Molfino, MD, MSC
role: STUDY_CHAIR
References:
Clinical trial NCT05312749: The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students
Official title: The Effect of Web-Based Progressive Muscle Relaxation Exercise on the Perceived Stress and Anxiety Level of Nursing Students Found in Clinical Practice for the First Time: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Nursing Students
Relaxation Program
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time.

Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)".


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Studying in the 2021-2022 academic year
* Being in 2nd grade
* Not going into clinical practice before

Exclusion Criteria:

* Being under the age of 18
* Not studying in the 2021-2022 academic year
* Being in 1st, 3rd or 4th grade
* Prior clinical practice

Primary outcomes:
measure: The State-Trait Anxiety Inventory
timeFrame: 12 week
measure: Perceived Stress Scale
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk university nursing faculty
state: Center
city: Elazığ
country: Turkey
facility: Fırat Üniversitesi
Study officials:
affiliation: Firat University
name: Gülcan B.TURAN, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03850249: Radioscapholunate Fusions After Wrist Trauma
Official title: Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posttraumatic Radiocarpal Osteoarthritis
Keywords: Radioscapholunate
Fusion
Arthrodesis
Radiocarpal osteoarthritis
Partial radiocarpal fusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Central Hospital, Nancy, France
First posted: 2019-02-21
Enrollment: 85
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 who had posttraumatic radiocarpal osteoarthritis and underwent RSL fusion

Brief summary: The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

Detailed description: The investigators compared three populations: patients with radioscapholunate (RSL) fusion alone, patients with RSLfusion and distal scaphoid excision and patient with RSL fusion, distal scaphoid excision and excision of the triquetrum.

The investigators performed clinical (pain, grasp strength, wrist motion), functional and radiographic (midcarpal osteoarthritis and radiocarpal nonunions) evaluation

Eligibility criteria: Inclusion criteria:

* posttraumatic radiocarpal osteoarthritis
* Patients who underwent radioscapholunate fusion

Exclusion criteria:

* Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease
* Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery

Primary outcomes:
measure: presence of mediocarpal osteoarthritis
timeFrame: 1 day
measure: presence of scapho-trapezoidal trapezoid
timeFrame: 1 day
measure: presence of non-consolidation of radio-scapho-lunar arthrodesis
timeFrame: 1 day
Secondary outcomes:
measure: Assess overall survival
timeFrame: 1 day
measure: the prognostic factors of good clinical
timeFrame: 1 day
measure: the prognostic factors of radiographic evolution
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Benjamin Degeorge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251349: Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications
Official title: Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications in the Context of Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heterotopic Ossification
Hip Arthropathy
Myositis Ossificans Traumatica, Thigh
Keywords: Heterotopic Ossification
Total Hip Arthroplasty
Irradiation Hip
Diclofenac
Prevention of HO
NSAID
Brooker Classification
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 512
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants of the study are patients at the Universitätsklinikum Jena or the Waldkrankenhaus Eisenberg. Irradiation was performed in Jena. Total hip arthoplasty and following inpatient stay, inclusive NSAID therapy was performed in Eisenberg

Brief summary: Aim of this study is to proof the efficacy of in Jena established prophylaxis of new bone formation aside the skeleton with irradiation and compare it with the common literature. Furthermore we want to compare irradiation treatment with the alternative prophylaxis with analgetics from the NSAID type.

Detailed description: Aim of this retrospective analysis is to compare the incidence of heterotopic ossification one year after total hip arthroplasty with the at our location established concept of irradiation 24h preoperative and incidence in common literature. Furthermore the comparison between irradiated patients and patients treated with NSAIDs.

Eligibility criteria: Inclusion Criteria:

Patients with total hip arthroplasty performed at Eisenberg Patients with preoperative irradiation (24h pre-op) or postoperative diclofenac treatment Patients with x-ray images immediately (3-5 days postoperative) postoperative and at least 365 days postoperative

Exclusion Criteria:

Patients with missing follow up image

Primary outcomes:
measure: Presence of heterotopic ossification (HO)
timeFrame: at least 365 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Radiooncology, Jena
Study officials:
affiliation: Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena
name: Matthias Mäurer, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04409249: Prognosis in Pregnant With COVID-19
Official title: Prognostic Factors in Pregnant Women With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Prognostic Factors
Pregnancy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary center data

Brief summary: COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. The secondary aim is to determine the predictive values of clinical and laboratory data for the severity of COVID-19.


Eligibility criteria: Inclusion Criteria:

* Being pregnant with a diagnosis of COVID-19 between the ages of 18-45

Exclusion Criteria:

* Suspected COVID-19 diagnosis

Primary outcomes:
measure: the factors affecting prognosis in pregnant women diagnosed with COVID-19
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Halkali
Study officials:
References:
Clinical trial NCT00602849: Bioequivalency Study of Sertraline Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* Treatment with any triptan within 30 days prior to or during the study.
* History of allergic or adverse response to sertraline or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Fly
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
affiliation: Anapharm
name: Benoit Girard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04244149: Effect of an Exercise Bout in Plasma and Fecal Profile
Official title: Exploring the Effect of Exhaustive Exercise From a Metabolomic and Metagenomic Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to study the effect of a bout of exercise on the metabolomic profile of plasma and feces as well as its influence on the intestinal microbiota.

Detailed description: The practice of physical exercise has numerous health benefits, preventing the appearance and development of cardiovascular diseases and various types of cancer. Exercise causes changes in the vascular, muscular and pulmonary systems, etc. One of the benefits that can result from exercise modification of the intestinal microbiota and its metabolic profile. In order to identify the potential changes that exercise has on the intestinal microbiota and its metabolic profile, the purpose of this study is to identify changes in the plasma and fecal metabolome and in fecal microbiota associated with a bout of exercise

Eligibility criteria: Inclusion Criteria:

* 18-45 years of age
* high physical condition (VO2 ≥ 55 ml/kg/min)
* BMI 18-25 kg/m2

Exclusion Criteria:

* antibiotics intake during 3 months prior to the study,
* smoking
* nutritional complements
* ergogenic complements
* prebiotics
* probiotics
* vegetarian or vegan diet
* chronic medication
* gastrointestinal surgery
* Any diagnosed disease

Primary outcomes:
measure: Plasma metabolome profile
timeFrame: Changes from baseline to 30 min after the exercise intervention
measure: Fecal microbiota
timeFrame: Changes from baseline to 30 min after the exercise intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Villaviciosa de Odon
country: Spain
facility: Maria del Mar Larrosa Pérez
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Mar Larrosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: