louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06619093: Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
Official title: Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sickle Cell Disease (SCD)
Keywords: Hemolysis
Coagulation
Red blood cell
Sickle cell disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424
First posted: 2024-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).

Brief summary: Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \&gt; 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.


Eligibility criteria: Inclusion Criteria:

* Aged 8 years or older
* Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
* Patient covered by a social security or equivalent health insurance plan
* Collection of the non-opposition for adults
* Information of the minor and collection of the non-opposition from both parents

Exclusion Criteria:

* Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
* Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\&#39;s discretion)
* Patient under guardianship, curatorship, or legal protection
* Patient subject to a legal protection measure
* Person admitted to a health or social care institution for purposes other than research

Primary outcomes:
measure: Overall coagulation activity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Insitut Hématologique et Oncologique Pédiatrique (IHOPe)
city: Lyon
country: France
facility: Service de Médecine Interne - Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT06648993: Body Awareness and Physical Activity Levels of Pregnant Women and Age, Number of Pregnancies and Gestational Week
Official title: Investigation of the Relationship Between Body Awareness and Physical Activity Levels of Pregnant Women and Age, Number of Pregnancies and Gestational Week
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The aim of this study was to investigate the relationship between body awareness and physical activity levels of pregnant women according to variables such as age, number of pregnancies and gestational week. The main question it aims to answer is: do physical activity levels of pregnant women and age, number of pregnancies and gestational week have an impact on body awareness in pregnant women


Eligibility criteria: Inclusion Criteria:

* being in the 2-3rd trimester of pregnancy and
* volunteering to participate in the study

Exclusion Criteria:

* having a risky pregnancy,
* being prohibited from physical activity by a physician,
* having any limb deficiency,
* neurological disease,
* mental deficiency

Primary outcomes:
measure: Body Awareness
timeFrame: Baseline
Secondary outcomes:
measure: Physical Activity Levels
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Number of births
timeFrame: Baseline
measure: weeks of gestation
timeFrame: Baselin
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT02620293: A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With Dry/Atopic Skin
Official title: A 47 Hour, Single Application, Occlusive Forearm Skin Patch Test to Assess, Under Dermatological Control, the Acute Cutaneous Tolerance of Project Storm on the Forearm of Adult Subjects With Dry/Atopic and Very Dry/Atopic Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eczema
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: Skin Investigation Technology
First posted: 2015-12-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is an open label, non-comparative investigation to determine the tolerance of Eczema Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.

The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.

Detailed description: At immediate, 1, 24, 48, and 72 hours post-test patch removal (date \& time of each assessment will be recorded), each test site will be scored for erythema and oedema by the trained investigator using the ISO 10993 scoring system.

Primary Endpoint The irritation of the test product according to the Cutaneous Irritancy Index value. The test product should be graded as 'non-irritant' and confirmed by the study dermatologist.

Eligibility criteria: Inclusion Criteria:

* Subjects who are able to give written informed consent and from whom written informed consent has been obtained
* Generally healthy male and female subjects between the ages of 18 and 65 years inclusive
* Subjects assessed by the dermatologist as having dry/atopic and very dry/ atopic skin
* Subjects who are able to understand the study, co-operate with the study procedures and are able to attend for all study assessments

Exclusion Criteria:

* Subjects with active Psoriasis or other active skin disorders or with present skin tumours or malignant disease or a history of those
* Subjects taking antihistamine or corticoids, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of the dermatologist may affect the test results.
* Subjects with active skin disorders or a history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the trainee dermatologist or SIT personnel may affect the test results

Primary outcomes:
measure: Skin tolerance assessment using the ISO 10993 scoring system through visual assessment
timeFrame: 47 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Skin Investigation Technology
Study officials:
affiliation: Skin Investigational Technology
name: Dörte Segger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339793: Exploring the Relationships Among Hospital's Corporate Social Responsibility, Job Attitudes and Job Performance
Official title: Exploring the Relationships Among Hospital's Corporate Social Responsibility, Job Attitudes and Job Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corporate Social Responsibility(CSR)
Keywords: corporate social responsibility
social identity theory
stakeholder theory
organizational commitment
organizational performance
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: employees in the hospitals

Brief summary: In recent years, many hospitals have progressively perceived the importance of corporate social responsibility (CSR). More and more hospital superintendents thus have realized that they should have a CSR strategy to deal with various stakeholders. Hospital, as a health care sector, is a labor-intensive industry. The management of hospitals should view its employees as salient stakeholders as well as a sort of precious asset by which hospital can possess a unique competition advantage in the operation. It is therefore important for superintendent to understand an employee's perspective on CSR and its impact on employees' work attitudes and organizational performance.

Detailed description: Based on the stakeholder theory and social identity theory, this study attempts to employ a survey approach to understand the superintendents and employees' perceptions of CSR, and to explore the effects of CSR on organizational commitment of employees and organizational performance. The samples are taken from the senior managers (such as the superintendent and vice superintendent) and employees in the hospitals of which the number of beds are more than 200. The structural equation modeling (SEM) is applied to confirm the research framework and to test the hypotheses. The results will provide a reference for the management and regulators of hospitals to set up the CSR policies, and contribute to senior managers on the CSR strategy and human resource development with regard to hospitals.

Eligibility criteria: Inclusion Criteria:

* senior managers (such as the superintendent and vice superintendent) and employees in the hospitals

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Neipu
country: Taiwan
facility: Meiho University
state: Pingtung
Study officials:
affiliation: Meiho University
name: Huei-Yin Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01680393: Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position
Official title: Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 60
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: This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

Detailed description: This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing elective shoulder surgery

Exclusion Criteria:

* untreated hypertension
* no pulse in a. dorsalis pedis or a.tibialis posterior
* leg ulcers
* failed scalenous blockade

Primary outcomes:
measure: cerebral oxygenation
timeFrame: per minute
Secondary outcomes:
measure: ephedrine
timeFrame: throughout duration of anaesthesia, approximately 60 minutes
measure: cardiac output
timeFrame: per minute
measure: Stroke volume
timeFrame: per minute
measure: mean arterial pressure
timeFrame: per minute
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen N
Study officials:
affiliation: Department of Anesthesiology, Bispebjerg Hospital
name: Frank Pott, MD,DMsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270593: ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis (Accreta, Increta, Percreta).
Official title: ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Previa
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary health institutions

Brief summary: Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels.

Detailed description: Placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the ADAMTS and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.

Eligibility criteria: Inclusion Criteria:

* pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler

Exclusion Criteria:

* Pregnant women with comorbid diseases other than previa totalis .

Primary outcomes:
measure: ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
timeFrame: Up to 6 months
Secondary outcomes:
measure: ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of myometrial samples in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
timeFrame: Up to 6 months
measure: ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Fetal Membranes in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
timeFrame: Up to 6 months
measure: placenta previa totalis in the development, progression and in exacerbating; ADAMTS and proteoglycans, to determine the relationship of changes in expression.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Women's Health Education and Research Hospital
Study officials:
affiliation: zekai tahir burak women's health education and research hospital
name: ahmet nuri danısman, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT04895293: RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Official title: Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age Related Macular Degeneration
Lead sponsor: Maturi, Raj K., M.D., P.C.
Sponsor class: INDIV
First posted: 2021-05-20
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects receive the study treatment
Primary purpose: TREATMENT

Brief summary: This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.


Eligibility criteria: Inclusion Criteria:

• General Inclusion Criteria:

1. Male or female patients, 50 years of age or older at baseline
2. Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.

   • Ocular Inclusion Criteria:
3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
4. Presence of choroidal neovascularization secondary to AMD
5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.

Exclusion Criteria:

• General Exclusion Criteria:

1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
2. History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
3. Participation in any investigational drug or device study within 30 days prior to baseline
4. History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.

   • Ocular Exclusion Criteria:
5. Active ocular or periocular infections, malignancy
6. Aphakia
7. History of pars plana vitrectomy in the study eye
8. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
9. History of significant ocular disease other than exudative AMD that may confound results
10. Uncontrolled glaucoma (defined as intraocular pressure \>21mm Hg despite treatment with ocular hypotensive medications at baseline).

Primary outcomes:
measure: Macular Edema
timeFrame: 3 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 3 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
Study officials:
affiliation: Midwest Eye Institute
name: Raj K. Maturi, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03419793: Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
Official title: Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with stroke.

Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3 sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of stroke

Exclusion Criteria:

* if they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).

Primary outcomes:
measure: goniometry
timeFrame: Change from Baseline Range of Motion at 8 weeks
Secondary outcomes:
measure: Barthel Index (BI)
timeFrame: Change from Baseline Functional level at 8 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: Change from Baseline Muscle power at 8 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline muscle tone at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: department of medicine systems
name: Giuseppe Annino, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03703193: Dry Needling for Shoulder Pain in Stroke Patients
Official title: Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.


Eligibility criteria: Inclusion Criteria:

* first-ever unilateral stroke;
* hemiplegia resulting from stroke;
* age between 30 and 60 years old;
* presence of hypertonicity in the upper extremity;
* pain symptoms in the shoulder
* active trigger points in the shoulder muscles reproducing the shoulder pain symptoms

Exclusion Criteria:

* recurrent stroke;
* absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
* previous treatment with botulinum toxin-A in the 6 months prior the study;
* severe cognitive deficits;
* other neurologic diseases,
* underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture
* fear to needles;
* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Primary outcomes:
measure: Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention
timeFrame: Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention
Secondary outcomes:
measure: Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention
timeFrame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
measure: Presence of active trigger points in the shoulder musculature
timeFrame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: César Fernández-de-las-Peñas
state: Madrid
Study officials:
References: