cyrilzakka/clinical-trials huggingface dataset:
Ethics and Research in Anaesthesia

Under the impetus of governing bodies, learned societies, hospital management, CPPs, etc., clinical research has developed and structured considerably, in order to provide the medical community and patients with the most appropriate care, and to formulate recommendations.

In anesthesia, clinical research evaluates drugs, medical devices or care pathways. However, the general public's perception of this research in our specialty remains confidential. Several studies carried out in oncology have shown limited interest in research on the part of the general public and patients, and more often than not a lack of awareness of ethical laws and the role of french ethics committee (CPP).

By means of an anonymous questionnaire handed out at the anesthesia consultation, the investigators would like to assess patients' level of knowledge of clinical research in anesthesia, and find out how they feel about the possibility of being included in a trial.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* patient undergoing surgery

Exclusion Criteria

* Refusal to participate
* Patient unable to read or answer questionnaire
Impact of Personalized Interventions to Raise Teleconsultation Awareness in EHPAD

The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.


Eligibility Criteria:
Inclusion criteria:

- Be a resident in Lozère's EHPAD

Exclusion Criteria:

- Patient who reject the study protocol
Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible

The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.

Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \& distal side on standardized IOPA x-rays.

Eligibility Criteria:
Inclusion Criteria:

* patients who have 1 or 2 missing teeth in both side of posterior mandible

  * adequate bone quantity and quality at the implant site
  * the implant sites with at least 3 months of healing after extraction,
  * patients well motivated for implant therapy and maintaining good oral hygiene
  * the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.
  * Patients who gave written informed consent

Exclusion Criteria:

* • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome

  * infection around the implant site
  * history of bruxism/parafunctional habits
  * patients with history of any bleeding disorder or on anti-coagulant therapy.
  * pregnant patients
BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease

Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease

Background:

Statin therapy is known to improve clinical outcomes in patients with coronary artery disease (CAD), while being highly cost-effective. However, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary CAD disease prevention. Previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. However, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. Urine analysis with liquid chromatography/mass spectrometry (LC-MS) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in CAD patients in Germany.

Objectives: In this pilot study (i) a feasibility testing of objective (LC-MS urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients.

Methods:

Outpatients with CAD treated in University Hospital Düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. Based on sample size calculation about 130 patients will be recruited. A biochemical method of objective urine measurement of statin intake by LC-MS will be combined with a preselected set of questionnaires on adherence behavior and associated factors. Clinical characteristics will be obtained from patient records. A sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey.

Outlook:

Based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. The results will be used for the development of a complex tailored intervention for non-adherent patients in Germany.

Eligibility Criteria:
Inclusion Criteria:

* patients with coronary artery disease
* prescription of atorvastatin or rosuvastatin

Exclusion Criteria:

* \< 18 years
* impairment (e.g. dementia)
* language barrier (German)
* end-stage kidney disease with hemodialysis
Neuromuscular Warm-Up Program for Badminton Players

This study aims to develop and evaluate a new warm-up program specifically designed for recreational badminton players. The program focuses on exercises that enhance balance and reduce the risk of ankle injury. Participants will be asked to follow this warm-up routine, and their performance will be assessed before and after to see if the exercises improve their balance and overall movement. The goal is to create a practical, effective warm-up routine that can be easily incorporated into badminton practice.

This study investigates the effectiveness of a novel neuromuscular warm-up program tailored for recreational badminton players. The program is designed to improve balance, enhance movement efficiency and reduce the risk of injuries commonly associated with badminton.

Participants will be recruited from recreational badminton clubs and will undergo baseline assessments of balance performance and lunge movement using motion capture (Mocap), EMG. and inertia measurement unit (IMU). The warm-up program includes a series of targeted exercises selected based on expert consensus from a previous Delphi study. These exercises focus on key areas such as dynamic stability, and proprioception.

Participants perform pre and post test with Star Excursion Balance Test (SEBT) and forward lunge movement with (IMU, MOcap and MEG) attached on the lower limb. The intervention will be: 1) novel neuromuscular warmup and 2) traditional warmup. Participants will perform both the warmup but on different days with one day rest in between the interventions.

The study\&#39;s findings aim to inform best practices for warm-up routines in badminton, potentially offering a standardized program that can be widely adopted by recreational players to enhance their performance and safety on the court.

Eligibility Criteria:
Inclusion Criteria:

* Injury free for \&gt;1 year, plays badminton minimum of once a week, have experience of playing at least 3 years

Exclusion Criteria:

* Badminton players that participate in competition in any level (novice, intermediate or elite tier), involve in any regimented training, participants with any joint disorder, non-communicable diseases (NCD), neurologically unstable, consumption of any medication that can interfere with performance.
Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris

The objective of the study was to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris (MAV); and to determine the expression of HIF-1 alpha by examining the immunohistochemistry and ELISA as a sign of hypoxia/anoxia in MAV lesion. This was a randomized, placebo-controlled clinical trial that was performed in 2015 at three different dermatology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta, Gatot Soebroto Army Hospital Jakarta, and PT. Mattel Indonesia, Cikarang. One hundred and twenty eight subjects with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline or comedone extraction for six weeks. Subjects who had acne lesion and the back area were offered skin lesion biopsy to evaluate immunohistochemistry and ELISA before administration of medication. The main outcome was total reduction of inflammatory and non inflammatory lesions, evaluated every two weeks.

Acne vulgaris (AV) is a polymorphic disease, characterized by inflammatory and noninflammatory lesions. Systemic antibiotics play a role as the first line therapy of moderate acne vulgaris treatment. Since bacterial resistance tends to increase, alternative therapy for moderate acne vulgaris is needed.

This study aims to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris; and to etermine the expression of HIF-1 alpha by examining the immunohistochemistry and ELISA as a sign of hypoxia/anoxia in MAV lesion.

This was a randomized, placebo-controlled clinical trial that was performed in 2015 at three different dermatology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta, Gatot Soebroto Army Hospital Jakarta, and PT. Mattel Indonesia, Cikarang.

One hundred and twenty eight subjects, aged between 15 and 50 years, with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline (100 mg) or comedone extraction for six weeks. Subjects who had acne lesion and the back area were offered skin lesion biopsy to evaluate immunohistochemistry and ELISA before administration of medication.

At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction of inflammatory and noninflammatory lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate acne vulgaris based on clinical manifestation of face (20-100 comedones, 15-50 inflammatory lesions, and/or 30-125 total lesions)
* Age range of 15 to 50 years old

Exclusion Criteria:

* History of oral antibiotics consumption within 2 weeks preceding this study
* Usage of topical retinoid in less than previous 2 weeks
* History of systemic retinoid consumption within 3 months preceding this study
* Pregnant of breastfeeding women
* Consuming oral contraception during examination
* Drug allergy or skin manifestation due to side effect of moderate acne vulgaris first line therapy
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type a As a Treatment for Lower Limb Post-stroke Spasticity

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

The primary hypothesis is that the effects of DN on post-stroke spasticity in the lower limbs at the spinal level is comparable to BTX-A in reducing spasticity by decreasing stretch reflex excitability.

Sample size: Spain, Canada and Belgium will recruit 90 participants (30 per country)

The platform used for randomization and electronic data collection will be Research Electronic Data Capture (REDcap): https://www.project-redcap.org/. A shared license will be used among the countries involved in the study.

Data dictionary:

* DN: Dry Needling
* BTX-A: Botulinum toxin type A
* TSRT: Tonic Stretch Reflex Threshold
* MAS: Modified Ashworth Scale
* 10MWT: 10 Metre Walk Test
* TUG: Timed Up \& Go
* PPI: Public and Patient Involvement
* SOP: Standard Operating Procedure

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
7. independent ambulation with or without aids.

Exclusion Criteria:

1. medical conditions interfering with data interpretation.
2. contraindications for BTX-A or DN treatment.
3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
4. pregnant or breastfeeding.
A Long-term Follow up Study of EXG102-031 in Participants With wAMD

This is a long-term, safety and efficacy follow-up study of patients in the EXG102-031-111 gene therapy clinical trial for wAMD. Patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.

This study will enroll patients with wet age-related macular degeneration (wAMD) who have previously be treated with EXG102-031 injection, those patients will Voluntary join this long-term follow-up study to be evaluated the long-term safety and efficacy.

The first two years of long-term follow-up will be conducted every 2 months; From 3 years to 5 years after administration,follow-up visits will be conducted every six months.

Eligibility Criteria:
Inclusion Criteria:

1. Previously received treatment with EXG102-031 in the study (EXG102-031-111);
2. Paticipantes are informed consent and willingness to follow protocol procedures.

Exclusion Criteria:

1. Paticipantes are unwilling or unable to participate in long-term follow-up
JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia( B-ALL )


Eligibility Criteria:
Inclusion Criteria:

1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE)；
2. Histologically confirmed as B cell ALL ;
3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);
4. According to the researcher's assessment, the expected survival period is greater than 3 months;
5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \< 34 μ Mol/L; Creatinine clearance rate\>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;
7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)\>30 × 109/L, Hb\>80 g/L, with a single venous access and no other contraindications for blood cell separation;
8. MRI examination showed no central involvement of lymphoma; No central nervous system leukemia;
9. Individuals with fertility must agree to the use of efficient contraceptive methods;
10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women, as well as women with pregnancy plans within six months;
2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
4. Previously received treatment targeting CD19;
5. Received autologous hematopoietic stem cell transplantation within 6 weeks;
6. The presence of uncontrollable active bacterial or fungal infections;
7. Allergies to research related drugs or cellular components;
8. Active autoimmune diseases exist;
9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
11. Received other experimental drug treatments within the past 3 months;
12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;
13. Researchers believe that other reasons are not suitable for clinical trial participants.
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).

To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
3. Presence of any two of the following risk factors:

   * SLE duration of \>= 5 years
   * Postmenopausal
   * Age \>= 40 years
   * Diabetes mellitus
   * Hypertension (140/90 mmHg)
   * Serum low density lipoprotein (LDL) level \>= 2.6 mmol/L or total cholesterol \>= 5.5 mmol/L
   * Obesity (body mass index \>= 27 kg/m2)
   * Chronic current smoker
   * Positive antiphospholipid antibodies
   * Renal function impairment
   * Persistent proteinuria \>= 1 gm/day for \>= 6 months
4. Informed consent obtained

Exclusion Criteria:

1. Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
2. Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
3. Patients with history of arterial or venous thromboembolism
4. Patients receiving aspirin or other anti-platelet agents
5. Patients receiving long-term non-aspirin NSAIDs
6. Patients receiving anticoagulation therapy (e.g., warfarin)
7. Patients with history of intolerance or allergy to the statins
8. Pregnant or lactating women
Self-acupuncture for Migraines Feasibility Study

Patients who have had a course of acupuncture at the Royal London Hospital for Integrated Medicine to manage their migraines, and found it effective, will be taught to do self-acupuncture. This is a feasibility study so the main aim is to test the trial design but the researchers will also explore self-acupuncture's effectiveness, acceptability and safety.

Aim: The proposed study will evaluate the feasibility of teaching SA to patients with migraines in the United Kingdom National Health Service setting.

Methodology: The study will employ a pragmatic, mixed-methods, randomised, parallel-group, exploratory design. The study will compare SA plus standard care versus standard care alone. Participants will complete outcome measures at various time points and be invited to take part in a qualitative telephone interview to explore their views on the design of the study and acceptability of the intervention. The researcher will take field notes of the observation of the SA teaching session to explore the acceptability of the SA teaching method. Data will be analysed to test the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years old and over.
* Patients with migraines (when topiramate and propranolol are unsuitable).
* Patients who have been referred to the Royal London Hospital for Integrated Medicine (RLHIM) for a course of at least 6 acupuncture sessions to manage their migraines.
* Patients who have completed a course of acupuncture for the management of their migraines at RLHIM and self-declare that they benefitted from it.
* Patients must have completed the course of acupuncture within the last 3 to 24 months.

Exclusion Criteria:

* Patients unwilling to participate (for instance due to needle phobia).
* Patients currently receiving acupuncture.
* Patients with severe clotting dysfunction or who bruise spontaneously.
* Patients unable to complete the questionnaires as judged by the researchers.
* Patients who have previously been taught or have practiced SA.
* Patients who are assessed as being unable to do SA (such as if they have poor hand function).
A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens

This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 20 to 65.
2. Subject with -1.00 to -10.00 D myopia, less than 1.00 D astigmatism.
3. Subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 Log MAR (distance) or better in each eye.
4. Willing to comply with all study procedures and be available for the study duration.
5. Provide signed and dated informed consent form.

Exclusion Criteria:

1. Subjects have a history of allergies that contraindicate contact lens wear.
2. Subjects have other active ocular or systemic diseases such as, but not limited to anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or diabetes.
3. Subjects have medications that would contraindicate contact lens wear.
4. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
6. Any active participation in any contact lens or lens care product clinical trial within seven days prior to this study.
7. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
8. Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
9. Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
10. Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
11. Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or unusual response to your contact lens wear.
12. The subject has over grade II corneal and conjunctival staining (Oxford scheme) if who has a history of dry eye.
13. Subject had any corneal surgery (e.g., refractive surgery).