louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01993056: The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury
Keywords: injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
First posted: 2013-11-25
Enrollment: 265
Sex: MALE
Minimum age (years): 32
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.


Eligibility criteria: Inclusion Criteria:

* male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis

Exclusion Criteria:

* major time-loss injury, chronic inflammatory joint disease

Primary outcomes:
measure: injury incidence
timeFrame: August 2011 - June 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Saarland University
state: Saarland
Study officials:
affiliation: Saarland University, Institute for Sports and Preventive Medicine
name: Daniel Hammes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00574756: Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Official title: The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ranolazine
Diastolic Heart Failure
Tissue Doppler Ultrasound
Echocardiography
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.


Eligibility criteria: Inclusion Criteria:

* Moderate of severe diastolic dysfunction, E/Ea\>12
* Preserved systolic function
* NYHA Class I-II

Exclusion Criteria:

* QTc \>450 msec at enrollment
* Taking medications that prolong QT interval or are potent inhibitors of CYP3A
* Significant coronary artery disease
* Severe valvular disease
* Hepatic disease
* Severe kidney disease
* Women of childbearing age
* Prior serious ventricular arrhythmia

Primary outcomes:
measure: Change in E/Ea
timeFrame: 2 weeks
Secondary outcomes:
measure: changes in mitral inflow parameters (E, A, IVRT, DT)
timeFrame: 2 weeks
measure: Changes in tissue doppler parameters (Ea, Aa)
timeFrame: 2 weeks
measure: Changes in pulmonary venous inflow (S, D, a reversal)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: UCSD Medical Center
name: Anthony DeMaria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100956: Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Official title: Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: chronic pain
neuropathic pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Detailed description: Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Eligibility criteria: Inclusion Criteria:

* Weight \< or equal to 240 pounds
* Neuropathic pain for \> 6 months: with primary pain area below the umbilicus

Exclusion Criteria:

* Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
* Pregnancy
* spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.

Primary outcomes:
measure: Spontaneous Pain From Their Neuropathic Pain Disease
timeFrame: 240 minutes post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C. Eisenach, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188156: Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II
Official title: Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Radical Mastectomy
Keywords: thoracic epidural blockage
Ultrasound Guided Serratus Anterior Plane Block
Pectoral Nerve Block II
Radical Mastectomy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 99
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)

Detailed description: There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .

Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .

Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.

In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries

Eligibility criteria: Inclusion Criteria:

* Women aged 35-65 years.
* BMI 18.5 - 25 kg/m2.
* American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria:

* Patient refusal.
* Coagulopathy.
* Mental and psychiatric disorders.
* History of chronic pain.
* Hypersensitivity or contraindication to any of study drugs
* Previous chemotherapy.

Primary outcomes:
measure: Measurement of Post-operative Pain
timeFrame: First 24-hour analgesic after Mastectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University hospitals
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: Alaa Aldine Mahmoud Said, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01740856: Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization
Official title: Randomized Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest Within Five to Three Hours After Diagnostic Cardiac Catheterization With a 6F Sheath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease With Myocardial Infarction
Keywords: cardiac catheterization
safety
nursing care
rest
Patients
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.

Detailed description: Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.

Eligibility criteria: Inclusion Criteria:

* age equal too or above 18 years
* patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and
* who agree to participate by reading and signing the informed consent form.

Exclusion Criteria:

* patients with restriction ambulation;
* users of coumarin anticoagulants;
* IMC greater than 35 kg/m2;
* patients with hypertension (systolic PA \> 180 mmHg and diastolic PA \> 110 mmHg) at the end of the procedure

Primary outcomes:
measure: Safety
timeFrame: until three days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul
name: Eneida R Rabelo da Silva, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas de Porto Alegre
name: Roselene Matte, RN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01895556: Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision
Official title: A Study of the Effect of Information About the Relationship Between HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision Among Circumcised and Uncircumcised Men in Malawi, Africa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Dis-inhibition
Keywords: Malawi
Risk Compensation
Male Circumcision
Demand
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.


Eligibility criteria: Inclusion Criteria:

* The study will involve men between the ages of 25 and 40

Exclusion Criteria:

* None

Primary outcomes:
measure: Condom use
timeFrame: One year after baseline survey
Secondary outcomes:
measure: Male circumcision
timeFrame: One year after baseline survey
measure: Condom purchases
timeFrame: one year after baseline survey
measure: number of sexual partners
timeFrame: one year after baseline survey
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Rebecca Thornton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Susan Godlonton, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00297856: Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
Official title: Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Tetanus
Acellular Pertussis
Keywords: Boostrix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan

Brief summary: Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.

Eligibility criteria: Inclusion Criteria:

* Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available

Primary outcomes:
measure: Occurrence of medically-attended neurological events.
timeFrame: 30 days following vaccination with Boostrix.
Secondary outcomes:
measure: Occurrence of medically-attended hematologic events
timeFrame: 30 days following vaccination with Boostrix
measure: Occurrence of allergic reactions.
timeFrame: 30 days following vaccination with Boostrix
measure: Occurrence of new onset chronic illnesses
timeFrame: 6-month period following vaccination with Boostrix
measure: Occurrence of neurological and hematological events and allergic reactions
timeFrame: Within the second 30-day period following vaccination with Boostrix
measure: Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine
Other outcomes:
Locations:
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9.
Clinical trial NCT02015156: A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
Official title: Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Trastuzumab
Healthy Male Volunteers
Single-Dose
Phase 1
Biosimilarity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 162
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

Detailed description: Safety evaluation.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg\^m2; and a total body weight \>50 kg (110 lbs).
* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
* Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Previous exposure to an anti-HER2 antibody.
* History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.

Primary outcomes:
measure: Incidence of body temperature greater than or equal to 38.0 degrees Celsius
timeFrame: within 24 hours
Secondary outcomes:
measure: Incidence of pyrexia
timeFrame: within 24 hours
measure: Severity of pyrexia
timeFrame: within 24 hours
measure: Timing of pyrexia
timeFrame: within 24 hours
measure: Seriousness of pyrexia
timeFrame: within 24 hours
measure: Relationship of study therapy to pyrexia
timeFrame: within 24 hours
measure: Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06667856: Foot Core Exercise Training with Telerehabilitation
Official title: Investigation of the Effectiveness of Foot Core Exercise Training with Telerehabilitation in Individuals with Rheumatoid Arthritis: a Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rheumatoid Arthritis
Foot Core
Exercise
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of lower extremity exercises combined with foot core exercise training on lower extremity pain, foot functionality, static and dynamic parameters of gait, and postural stability in individuals with rheumatoid arthritis using synchronous and asynchronous telerehabilitation methods.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with rheumatoid arthritis
* Being between the ages of 18-65
* Being willing to participate in the study

Exclusion Criteria:

* Having a neurological disease
* Having a pulmonary or cardiovascular problem that may affect daily life activities
* Sensory system disorders
* Having a history of surgery on the lower extremities or trunk
* Experiencing dizziness
* Having a cognitive disorder
* Having an additional rheumatic disease

Primary outcomes:
measure: Foot Posture Index
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Static Gait Analysis Evaluation
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Dynamic Gait Analysis Evaluation
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Postural Stability Assessment
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes:
measure: Visual Analog Scale-Pain
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Foot Function Index
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: