louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06754774: Shoulder Endurance Test: Normative Values in a Population of Female Handball Players Aged 14 to 18 in Intensive Training Structures.
Official title: Shoulder Endurance Test : Valeurs Normatives Chez Une Population De Handballeuses De 14 À 18 Ans En Structures Intensives D'entrainement. SET-HANDBALL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Subjects 14 to 18 Years Old
Keywords: Shoulder Endurance Test
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: shoulder endurance
Primary purpose: PREVENTION

Brief summary: 57% of young female handball players experience shoulder pain. This pain is likely to affect training and performance, but most players continue to play despite it. Endurance of the shoulder lateral rotators is a risk factor for sports such as handball. A protocol for applying the Shoulder Endurance Test (SET) to assess the endurance of the lateral rotators of the shoulder has been proposed, but the authors stress the need for further research to validate this test in different sports and for different populations.

The purpose of the study was to determine normative values for the Shoulder Endurance Test in female handball players aged 14 to 18 in intensive training facilities.


Eligibility criteria: Inclusion Criteria:

Girls aged 14 to 18 playing handball Handballers training at the Pôle Espoirs or the Centre Labellisé d'Entrainement 29 Players of legal age who have given their consent Signature of consent by parents for underage players

Exclusion Criteria:

Refusal of the minor to take part, even if the legal representatives want the player to take part in the study Refusal to perform the test

Pain preventing the test from being performed

All musculoskeletal conditions affecting the upper limb less than 6 months old.

Shoulder and cervical spine surgery less than 6 months old.

All musculoskeletal conditions affecting the cervical spine less than 6 months old.

Player under legal protection (guardianship/trusteeship) or deprived of liberty

Primary outcomes:
measure: To determine normative values for the Shoulder Endurance Test in female handball players aged 14 to 18.
timeFrame: Day 1
Secondary outcomes:
measure: Assessing intra-examiner reliability
timeFrame: two months after the test
measure: Assessing inter-examiner reliability
timeFrame: two months after the test
measure: Determine the SET score on the non-dominant arm
timeFrame: Day 1
measure: Evaluate the effort perceived during the test
timeFrame: Day 1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT06460974: The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer
Official title: The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients With Breast Cancer
Keywords: Anxiety
Comfort
Breast Cancer
Stress
Stress Ball
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

Detailed description: The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).

Eligibility criteria: Inclusion Criteria:

* who is literate in Turkish,
* who was diagnosed with stage 1, 2 and 3 breast cancer
* who had the second cure or above chemotherapy receiving treatment
* over 18 years of age
* female
* platelet level \>50,000 mm3
* not having any physical problems squeezing a stress ball

Exclusion Criteria:

* those who did not agree to participate in the study
* those who received chemotherapy for the first time,
* those who had any physical disability to squeeze a stress ball
* Any receiving intravenous treatment from both arms,
* having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
* having any psychiatric disease,

Primary outcomes:
measure: Distress Thermometer
timeFrame: 6 months
measure: State-Trait Anxiety Inventory
timeFrame: 6 months
measure: General Comfort Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Mersin University
name: Birgül VURAL DOĞRU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033174: Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
Official title: Effects of Acute and Chronic Red Wine Intake in the Expression of Pro-inflammatory and Prothrombotic Factors in Circulating Monocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: alcohol, inflammation, oxidation.
Lead sponsor: Instituto de Investigación Sanitaria Gregorio Marañón
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in healthy people after a five days period.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Individuals with a plasma cholesterol level \> 220 mg/dl
* Smokers

Primary outcomes:
measure: Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake
timeFrame: Baseline and 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IiSGM
Study officials:
affiliation: Head of section. Dep. of Internal Medicine
name: Luis A Alvarez-Sala, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255574: Correlation Between Cervical Spine Sagittal Alignment and Functional Disability in Preparatory School Students With Mechanical Cervical Pain
Official title: Correlation Between Cervical Spine Sagittal Alignment and Functional Disability in Preparatory School Students With Mechanical Cervical Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children, Only
Keywords: cervical spine
sagittal alignment
functional disability
preparatory school children
mechanical cervical pain
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preparatory school age students

Brief summary: Neck pain is a major public health concern that has been extensively studied in adults but not in children and adolescents. Mechanical neck pain became prevalent among children and adolescents, and has its impacts on functional ability.

This study is aiming to investigate the correlation between Cervical spine sagittal alignment parameter (cranio-cervical angle) and functional disability in preparatory school students with mechanical cervical pain.

Detailed description: * Correlational study between cranio-cervical angles and functional disability in students with mechanical cervical pain.
* Inclusion Criteria Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.
* exclusion criteria Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain

Eligibility criteria: Inclusion Criteria:

* Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.

Exclusion Criteria:

* Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain

Primary outcomes:
measure: ● cervico cranial angle by X-ray device
timeFrame: one hour
measure: Functional neck status
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00894374: Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Official title: A Single-Dose Bioequivalence Study Comparing Artesunate Tablet (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Falciparum Malaria
Keywords: Bio-equivalence, Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* BMI of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* A positive urine drug screen, history of regular alcohol consumption.

Primary outcomes:
measure: AUC and Cmax of active metabolite of artesunate
timeFrame: 30-Aug-2009
Secondary outcomes:
measure: Tolerability
timeFrame: 30-Aug-2009
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04341974: Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury
Official title: Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Malignancy
Acute Kidney Injury
Cronich Kidney Disease
Keywords: serum creatinine
kidney dysfunction
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 423
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: All patients were older than 18 years, underwent surgery under general anesthesia for oncological disease who underwent major elective general abdominal surgery from November 2016 to February 2017 at the Department of Anaesthesia of Careggi Hospital

Brief summary: The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Scheduled for elective surgery
* Surgery for oncological disease

Exclusion Criteria:

* Patients undergoing postoperative chemotherapy
* Patients who died within 12 month after surgery

Primary outcomes:
measure: Adoption of serum creatinine as marker of acute kidney injury postoperively
timeFrame: 3rd postoperative day
Secondary outcomes:
measure: Incidence of acute kidney injury
timeFrame: 3rd postoperative day
measure: Adoption of serum creatinine as marker of long term kidney dysfunction
timeFrame: 12 month after surgery
measure: Incidence of long term kidney dysfunction
timeFrame: 12 month after surgery
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
References:
citation: Villa G, De Rosa S, Scire Calabrisotto C, Nerini A, Saitta T, Degl'Innocenti D, Paparella L, Bocciero V, Allinovi M, De Gaudio AR, Ostermann M, Romagnoli S. Perioperative use of serum creatinine and postoperative acute kidney injury: a single-centre, observational retrospective study to explore physicians' perception and practice. Perioper Med (Lond). 2021 May 25;10(1):13. doi: 10.1186/s13741-021-00184-6.
Clinical trial NCT05874674: The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Undergoing Hemodialysis: A Pilot Study
Official title: The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Diathesis Undergoing Hemodialysis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dialysis; Complications
Bleeding
Keywords: dialysis
bleeding
nafamostat
heaprin
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison nafamostat and low molecular weight heparin among dialysis patients


Eligibility criteria: Inclusion Criteria:

* platelet below 10k PTT above 60 second INR above 20 patient with bleeding (epistaxis, orbital bleeding, hematuria) recent brain hemorrhage (within 6 months) receiving anticoagulant therapy (coumadin or NOAC) dual antiplatelet agent users received major surgery within one month

Exclusion Criteria:

* cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

Primary outcomes:
measure: Number of patients with severe bleeding
timeFrame: 6 month
Secondary outcomes:
measure: Number of patients with dialysis circuit clot
timeFrame: 6 month
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei Unviersity Wonju College of Medicin
state: Kangwondo
Study officials:
References:
Clinical trial NCT04042974: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
Official title: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed description: hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Eligibility criteria: Inclusion Criteria:

* nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

* • women with suspected pregnancy

  * heavy vaginal bleeding
  * recent pelvic infection
  * those known to have hypersensitivity or contraindication to dinoprostone
  * those who received analgesics prior to OH
  * a concomitant neurologic disease that could affect the correct evaluation of pain

Primary outcomes:
measure: Intensity of pain
timeFrame: an expected average of 10 minutes
Secondary outcomes:
measure: Intensity of pain
timeFrame: 30 minutes after the procedure
measure: Operative time
timeFrame: an expected average 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04354974: Evaluation of a Cognitive Remediation Program for Mood Disorders
Official title: Evaluation of a Cognitive Remediation Program for Mood Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Taking Charge of Cognitive Impairment in Patients With Mood Disorders
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of the specific therapeutic efficacy of Cognitive Training Therapy for Bipolar Patients on cognitive deficits in patients with bipolar disorder, treated over three months and followed up over nine months. Randomized, double-blind study.
Primary purpose: OTHER

Brief summary: Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years old
2. The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.
3. Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 ≤ 18))
4. Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS ≤ 8))
5. Stable and effective treatment at minimum dose for at least 2 months
6. Cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist
7. Free and Informed Consent Form read, initialled and signed
8. Patient affiliated to a social protection scheme or beneficiary of State Medical Aid
9. Patient knowing how to speak French -

Exclusion Criteria:

1. Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder
2. Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months
3. Manic, hypomanic or major depressive episode in the last 2 months
4. Somatic or neurological disorder which may lead to cognitive impairment
5. Current or less than one month's commitment to another research protocol
6. A neuropsychological assessment prior to 6 months.
7. Patient under protective custody, guardianship or reinforced guardianship

Primary outcomes:
measure: the Perceptual Reasoning Index (PRI) the Wechsler Intelligence Scale.
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly sur Marne
country: France
facility: Youcef Bencherif
Study officials:
References:
Clinical trial NCT01713374: Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System
Official title: Studies on the Physiological Meaning of Flow-mediated Constriction, Flow-mediated Dilatation and Vasomotion/Flowmotion: Circadian Variability and Role of the Sympathetic Nervous System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Keywords: endothelial function
sympathetic nervous system
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the three interventions under study will increase FMC while causing a blunting in FMD.

Further, the investigators plan to study the circadian variability of FMC and FMD. The investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the early hours.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.

Exclusion Criteria:

* any active disease

Primary outcomes:
measure: Change in FMD in response to sympathetic activation
timeFrame: Change in FMD before versus 1 Minute after begin of intervention
Secondary outcomes:
measure: Change in FMC during sympathetic activation
timeFrame: Change in FMC before versus 1 minute after begin of each intervention
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz
state: Rheinland Pfalz
Study officials:
affiliation: University Medical Center Mainz
name: Tommaso Gori, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: