louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03306511: Sprint Performance in Football Players With a Previous Hamstring Injury
Official title: Sprint Performance in Football Players With a Previous Hamstring Injury Compared to Healthy Controls: An Exploratory Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sprint Performance
Hamstring Injury
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish competitive football players

Brief summary: Few studies indicate that sprint performance may be impaired in football players with a previous hamstring strain injury. This exploratory cross-sectional study aim to compare sprint performance between football players with and without a previous hamstring strain injury. The findings may elucidate potential indications of insufficient rehabilitation following a hamstring strain injury.

Sprint performance data will be collected using the MySprint Iphone Application.

Due to pragmatic reasons and the exploratory nature of this study the aim is to include players on a team level.

Based on the prevalence of hamstring strain injuries the expected number of cases to be included are 10-20 football players with a previous hamstring strain injury, and a corresponding 80-90 number of healthy controls.

No outcomes will be weighted (flat outcome structure).


Eligibility criteria: Inclusion Criteria Controls:

* Able to participate fully in regular football training and matches

Exclusion Criteria Controls:

* Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.
* Longstanding injury (\>6 weeks) in the lower extremities or trunk in the preceding 12 months.
* Any pain in the lower extremity, pelvis, or spine during testing

Inclusion Criteria Cases:

* Able to participate fully in regular football training and matches
* Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.

Exclusion Criteria Cases:

* Longstanding injury (\>6 weeks) in the lower extremities (except hamstring strain injury) or trunk in the preceding 12 months.
* Any pain in the lower extremity, pelvis, or spine during testing

Primary outcomes:
measure: Theoretical maximal force
timeFrame: Baseline
measure: Theoretical maximal velocity
timeFrame: Baseline
measure: Theoritical maximal power output
timeFrame: Baseline
measure: Slope of the linear decrease on ratio of force as sprint velocity increases
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Testing will be conducted in the facilities of the included football clubs in Copenhagen
state: Danmark
Study officials:
affiliation: Hvidovre University Hospital
name: Lasse Ishøi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915611: Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
Official title: Evaluating the Effectiveness of a Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Pain, Chronic
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of a combined physical and psychological intervention in reducing pain and improving function in carpal tunnel syndrome patients with nociplastic pain.


Eligibility criteria: Inclusion Criteria:

* Adults aged 25-65 years
* Both sexes
* Diagnosis of carpal tunnel syndrome based on clinical examination and nerve conduction studies
* Presence of nociplastic pain as determined by the Central Sensitization Inventory (CSI) with a score ≥40
* Positive tinel and phalen sign.

Exclusion Criteria:

* Previous carpal tunnel release surgery
* Other musculoskeletal or neurological disorders affecting the upper extremity

Primary outcomes:
measure: Pain intensity using the Numeric Pain Rating Scale (NPRS)
timeFrame: Changes in pain intensity at baseline, 6 weeks, 12 weeks.
measure: Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Changes in Functional ability at baseline, 6 weeks, 12 weeks.
measure: Median nerve motor distal latency
timeFrame: Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks.
measure: Median nerve sensory distal latency
timeFrame: Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks.
Secondary outcomes:
measure: Pain catastrophizing using the Pain Catastrophizing Scale (PCS)
timeFrame: Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks.
measure: Fear of movement using the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks.
measure: Grip strength measured using a hand dynamometer
timeFrame: Changes in Grip strength at baseline, 6 weeks, 12 weeks.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT01184911: Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
Official title: Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Intermittent Preventive Treatment
Placental Malaria
Keywords: Malaria
Pregnancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Uganda Malaria Surveillance Project
First posted: 2010-08-19
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.


Eligibility criteria: Inclusion Criteria:

* 16-26 weeks gestation based on LMP or ultrasound or fundal height
* Axillary temperature \<37.5 degrees C
* Informed consent
* HIV status known and negative
* Blood smear positive for falciparum malaria

Exclusion Criteria:

* History of hypersensitivity reaction to SP or components of SP
* Axillary temperature ≥37.5 degrees C
* History of receipt of antimalarials or antibiotics with antimalarial activity\* in the past month
* Residence \> 30 km from the ANC clinic or unwillingness to return for follow-up visits
* Hemoglobin level \< 5 gm/dL

  * These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.

Primary outcomes:
measure: Parasite clearance
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tororo
country: Uganda
facility: Infectious Disease Research Center
Study officials:
affiliation: University of California, San Francisco
name: Veronica Ades, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Scott Filler, MD, DTM&H
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Malaria Surveillance Project
name: Moses Kamya, MBChB, MMed, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02639611: Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
Official title: Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Expanders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate changes in shoulder tightness, chest tightness, and general pain related to post-mastectomy reconstructive surgery with tissue expansion in women who are randomized to receive acupuncture treatment immediately after surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.


Eligibility criteria: Inclusion Criteria:

* Women who are newly diagnosed with breast cancer, enrolled in the The Breast Cancer Database of NYU Cancer Center (BCD) and who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes
* Women who are newly diagnosed with breast cancer
* Women who are enrolled in the Breast Cancer Database (BCD)
* Women who are having breast cancer surgery involving a mastectomy procedure with insertion of a tissue expander for reconstructive purposes

Exclusion Criteria:

* Women who had neoadjuvant chemotherapy and/or radiation therapy, women who are currently on anticoagulant therapy, women who are having breast reconstruction with Alloderm, women who have chronic pre-operative pain, and/or women who have had a history of previous implants or prior augmentations
* Women who had neoadjuvant chemotherapy and/or radiation therapy
* Women who are currently on anticoagulant therapy
* Women who are having breast reconstruction with Alloderm
* Women who have chronic pre-operative pain
* Women who have had a history of previous implants or prior augmentations
* Women who are currently on anticoagulant therapy
* Women who are having breast reconstruction with Alloderm
* Women who have chronic pre-operative pain
* Women who have had a history of previous implants or prior augmentations

Primary outcomes:
measure: Shoulder Tightness Score on Pain and Discomfort Assessment Questionnaire
timeFrame: 6 Weeks
measure: Chest Tightness Score on Pain and Discomfort Assessment Questionnaire
timeFrame: 6 Weeks
measure: General Pain Score on Pain and Discomfort Assessment Questionnaire
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Freya Schnabel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447811: Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance
Official title: Two Ascending Single Doses Crossover, Placebo Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MOA-728 Administered Orally to Subjects on Stable Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methadone-maintenance Subjects
Keywords: Methadone
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.


Eligibility criteria: Inclusion Criteria:

* History of methadone treatment for at least 1 month before day -1 at a dose of ≥ 30 mg/day, and a positive drug test result for methadone.
* Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria:

* Allergy to opioids (eg, codeine, morphine, or oxymorphone) or opioid antagonists (eg, naloxone or naltrexone).
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Pharmacokinetics
Secondary outcomes:
measure: Safety, tolerability, and pharmacodynamics
Other outcomes:
Locations:
city: Willingboro
country: United States
state: New Jersey
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT01831011: Mildronate for Acute Ischemic Stroke
Official title: Efficacy and Safety of Mildronate for Acute Ischemic Stroke: a Randomized, Double-blind, Active-controlled Phase II Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: randomized trial
acute ischemic stroke
mildronate
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

Detailed description: A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Eligibility criteria: Inclusion Criteria:

* (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients \>= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value.

Exclusion Criteria:

* (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.

Primary outcomes:
measure: the modified Rankin scale
timeFrame: 3 months
Secondary outcomes:
measure: NIHSS scores
timeFrame: 15 days
measure: the Barthel index
timeFrame: 15 days
Other outcomes:
Locations:
city: Xi an
country: China
facility: the Department of Neurology
state: Shanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
affiliation: the Department of Neurology , Xijing Hospital
name: Guang Yun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: the Department of Neurology , Xijing Hospital
name: Yi Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091311: Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases
Official title: Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelid Diseases
Keywords: Meibomian Gland Dysfunction
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility criteria: * Signed and dated informed consent.
* Male or female up to 4 years old.
* Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month.
* Without any active pathology requiring a change in ocular treatments within the last month before inclusion.
* Best corrected far visual acuity (VA) \> 1/10

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: HÃ´pital Gabriel Montpied
city: Paris
country: France
facility: C.H.N.O des XV-XX
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Christophe Baudouin, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Chiambaretta, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Bichat
name: Serge Doan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02817711: Lyon BJI Cohort Study
Official title: Lyon BJI Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone and Joint Infection
Keywords: infection
bone and joint infection
relapse
adverse event
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes all patients who have a bone and joint infection, with or without implant, and treated in the department of infectious disease at the HCL.

Brief summary: The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.

Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.

Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.

This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.


Eligibility criteria: Inclusion Criteria:

* patients with bone or joint infection, with or without implant

Primary outcomes:
measure: Treatment Failure in patients with bone or joint infection
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of serious adverse events in patients with bone or joint infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse
Study officials:
affiliation: Centre de reference des infections ostéo-articulaires
name: Tristan Ferry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04615611: Physiologic Performance Response to Salbutamol
Official title: Individual beta2-adrenergic Performance Response to Salbutamol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years of age
* Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women
* Body mass index lower than 26

Exclusion Criteria:

* Allergy towards study drug
* Unacceptable side effects of the study drug
* Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes
* Current smokers
* Use of prescription medicine
* Pregnancy

Primary outcomes:
measure: Sprint performance
timeFrame: Measured ½ hour after drug administration
Secondary outcomes:
measure: Muscle strength
timeFrame: Measured ½ hour after drug administration
measure: Sprint fatigue tolerance
timeFrame: Measured ½ hour after drug administration
measure: Cycling endurance performance
timeFrame: Measured ½ hour after drug administration
Other outcomes:
Locations:
Study officials:
References: