cyrilzakka/clinical-trials huggingface dataset:
Floatation-REST and Anorexia Nervosa

The study proposed in this protocol aims to document the effect of Floatation-REST (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.

Flotation-REST (reduced environmental stimulation therapy) alters the balance of sensory input by systematically attenuating signals from the visual, auditory, thermal, tactile, vestibular, and proprioceptive systems. Previous research has shown that this heightens interoceptive awareness and reduces anxiety in clinically anxious populations. Anorexia nervosa (AN) is characterized by elevated anxiety, distorted body image, and disrupted interoception, raising the question of whether floatation therapy might positively impact these symptoms. A recent safety study found that Floatation-REST was well tolerated by individuals weight-restored outpatients with current or prior AN. Additionally, participants reported improvements in affective state and body image disturbance following floating, raising the possibility that this intervention might be investigated for clinical benefit in more acutely ill cases.

The primary aim of this study is to begin to examine the effect of Floatation-REST on body image disturbance in inpatients with AN. Secondary aims including determining whether Floatation-REST has an impact on anxiety, emotional distress, eating disorder severity, functional ability, and interoception.

Eligibility Criteria:
Inclusion Criteria:

* Primary clinical diagnosis of anorexia nervosa
* Receiving inpatient treatment for eating disorder
* Body mass index greater than or equal to 16
* No new medication prescription in the week prior to study randomization
* Independently ambulatory
* No current evidence of orthostatic hypotension
* Ability to lay flat comfortably
* Possession of a smartphone with data plan
* English proficiency

Exclusion Criteria:

* Active suicidal ideation
* Active cutting or skin lacerating behaviors
* Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
* Comorbid schizophrenia spectrum or other psychotic disorder
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation

Atrial fibrillation (AF) is progressively common, and increases the risk of stroke five-fold. Oral anticoagulation is the mainstay therapy; however, it increases the risk of bleeding. Moreover, 30% with AF and at risk of stroke are not in relevant anticoagulation. The randomized PROTECT-AF trial has demonstrated the superiority of left atrial appendage occlusion (LAAO) as compared to warfarin for prevention of the combined endpoint of stroke, major bleeding and cardiovascular mortality. However, studies comparing LAAO to therapy with novel oral anticoagulants (NOAC) have not been carried out.

This study aims to assess the effect of left atrial appendage occlusion (LAAO) to reduce the incidence of stroke, systemic embolism, major bleeding and all-cause mortality in patients with atrial fibrillation (AF) and a prior ischemic stroke or transient ischemic attack (TIA).

An investigator-initiated multicenter, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). The active comparison LAAO is tested against NOAC therapy in a 1:1 stratified randomization. Patients should have AF, and an ischemic stroke or TIA within 6 months prior to enrollment. In total 750 patients will be included. Follow-up will be based on in-office and telephone follow-up during the first 3 years after randomization, along with up to 10 years long-term follow-up through the National Patient Registries.

The main study outcomes: The primary outcome is a composite of stroke (hemorrhagic or ischemic), systemic embolism, major bleeding or all-cause mortality assessed after at least two years follow-up for the last enrolled patient. Secondary outcomes will examine early and late safety outcome measures. The long-term outcome will be assessed up to 10-years after randomization through the National Patient Registries.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
* Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy
* Ischemic stroke within the recent 6 months verified by neuroimaging, or
* Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI)

Exclusion Criteria:

* Modified rankin scale \> 3 at time of enrollment
* Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2
* Contraindication towards long-term aspirin therapy
* Planned combined cardiovascular interventional procedures at the time of enrollment
* Terminal illness or cancer with life expectancy less than 2 years.
Coronary Artery Ectasia Database - Poland

The goal of this observational study is to comprehensively investigate the current prevalence, morphological characteristics, risk factors for the development, complications as well as long-term prognosis of coronary artery aneurysm and ectasia (CAAE) in the Polish population.

Data obtained from the CARED-POL Registry will enable the selection of morphological risk factors for the unfavorable course of CAAE, including the progression and development of giant aneurysms, aneurysm clotting with vessel occlusion, and thromboembolic complications. Comparing the safety and effectiveness of available CAAE treatment methods in individual patient subgroups will allow individualization of treatment, including anticoagulant therapy.

Coronary artery aneurysm or ectasia (CAAE) is a rare vascular pathology diagnosed in 0.15-5.3% of patients undergoing coronary angiography. CAAEs are often diagnosed incidentally, while symptomatic patients experience various complications, including unstable angina, acute myocardial infarction, arrhythmias, or sudden cardiac death. The most common etiology of CAAE is atherosclerosis, Kawasaki disease, or other vasculitis. Detailed pathomechanisms and risk factors of unfavorable courses of CAAE have not yet been known. In addition, the data on Polish patients are limited to case reports, case series, and small groups from major academic centers.

CARED-POL is a multicenter, observational nationwide registry of CAAE. Patients will be included ambispectively based on the angiographic diagnosis of coronary artery aneurysm (CAA) or coronary artery ectasia (CAE).

All participating centers will enroll patients retrospectively based on their internal databases after evaluation of coronary angiography by an experienced interventional cardiologist and prospectively for six months from the CARED-POL joining. Angiographic assessment will be based on quantitative coronary angiography (QCA). The patient data will be collected from standardized and anonymous forms via the Scientific Platform of the Polish Society of Cardiology. In accordance with initial assumptions, 2,000 patients in all participating centers will be included.

Patients included in the registry will undergo a minimum of 6 months of follow-up with assessment of the following endpoints: all-cause death, re-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events, and any cause for repeat coronary angiography.

Data will be obtained from outpatient visits, medical records, or telephone interviews. In patients who undergo repeated coronary angiography, the formation of a new aneurysm or progression of an existing one will be detected. Aneurysm progression is diagnosed as an increase in size demonstrated on at least two orthogonal angiographic views.

Eligibility Criteria:
Inclusion Criteria:

* CAA or CAE defined as a focal dilatation with a diameter of more than or equal to 1.5 times the adjacent normal coronary segment

Exclusion Criteria:

* the lack of informed consent for prospectively enrolled patients
Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty

Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.


Eligibility Criteria:
Inclusion Criteria:

* Candidates of rhinoplasty
* Willingness to participate

Exclusion Criteria:

* Having structural problems such as nasal obstruction
* History of the deformity requiring rhinoplasty of the deviated septum
* Hardening surgery
* New clinical conditions or a change in therapeutic technique
* Unwillingness to continue participating in the study
* Having no access to subjects after the operation
Associated Pathologies Following Luxatio Erecta Humeri: A Retrospective Analysis of 31 Cases and Diagnostic Algorithm

The aim of this study was to evaluate the clinical outcome of this rare injury with special emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the diagnosis of associated pathologies following LEH.


Eligibility Criteria:
Inclusion Criteria:

* Included for analysis were all patients over 18 years of age who have been treated for LEH between at our department.

Exclusion Criteria:

* Only injuries of the affected shoulder were taken into account, non-shoulder related pathologies were not addressed.
* Other types of shoulder dislocation except Luxatio erecta
A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin

Juvelook® (VAIM, Korea) is made by dissolving irregular PDLLA particles in a solvent mixture of DMSO (Dimethylsulfoxide) and EC (Ethylene Carbonate) and then injecting them through microneedling to create reticulated foamy microspheres, which are hollow spherical particles. It received CE approval in Europe in 2020 and is widely used domestically as a material for tissue restoration, including skin fillers and collagen stimulators. The spherical shape with internal foam structure of PDLLA exhibits excellent biocompatibility, biodegradability, porosity, and mechanical strength. It allows for the control of particle size and acts as a collagen stimulator while gradually dissolving over time. This stimulates fibroblast cells and promotes skin rejuvenation. In clinical practice, Juvelook® particles are injected to address various concerns such as facial wrinkles, increased elasticity, depressed scars, acne scars, accident scars, under-eye hollows, freckles, whitening effects, and neck wrinkles. Therefore, this study aims to investigate the efficacy of Juvelook® not only in volume augmentation but also in improving photoaged skin.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult women over 30 years old with photoaged skin.
2. Individuals who have a clear understanding of the purpose and content of the study, as well as the potential risks and side effects, and voluntarily sign the informed consent form to participate in the clinical trial.
3. Individuals who are physically healthy and can be tracked and observed throughout the entire study period.

Exclusion Criteria:

1. Individuals who have received anti-aging/whitening treatments (such as laser or chemical peels) on their face within 3 months prior to the start of the study.
2. Individuals who have applied anti-aging/whitening agents to their face within 3 months prior to the start of the study.
3. Pregnant or breastfeeding women.
4. Individuals who are participating in other clinical trials.
5. Individuals who, in the judgment of the researchers, are deemed ineligible to participate in the study.
A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)

The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).


Eligibility Criteria:
Inclusion Criteria:

* Must have received at least one prior therapy that includes either

fludarabine or equivalent nucleoside analogue or an alternative regimen

* Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic

lymphoma (SLL)

* Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
* Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment.
* Women of child-bearing potential who are not currently sexually active must

agree to use a medically accepted method of contraception should they become

sexually active while participating in the study.

* Life expectancy ≥12 weeks

Exclusion Criteria:

* Symptomatic brain metastases or primary central nervous system malignancy
* Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
* Non-hematological toxicities from prior therapy
* Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
* Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

* Clinically active hepatitis B or C defined as disease that requires

therapy

* Women who are breast-feeding, pregnant, or intend to become pregnant
* Prior allogeneic bone marrow transplant (auto hematopoietic stem cell

transplantation \[HSCT\] is allowed if fully recovered)

* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is

considered by his or her physician to have a 2 year survival expectation

* Any investigational drugs within 4 weeks prior to the start of treatment
* Concurrently receiving treatment in any other clinical study
* Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib or flavopiridol)
* Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless

stable, defined as being responsive to corticosteroids or other standard therapy
The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women

Intramuscular (IM) vaccination administered using the right injection technique is known to cause less pain and injury. Nurses employ different approaches like applying pressure, tapping the skin, cold and hot applications for reducing the pain caused by the IM vaccine administration. Helfer skin tap is among the techniques that relax muscles.

The aim of the study was to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was conducted on pregnant women who applied to the Family Health Center to get a tetanus vaccine. The Helfer skin tap and standard application groups each included 33 and 32 pregnant women, respectively.

In 1988, Joanne Helfer developed the "Helfer Skin Tap Technique" which is applied by touching the skin over the injection site and attempted to reduce the intramuscular injection-related pain. In this technique, after determining the injection site, nearly 15 strokes are made on the skin for almost five seconds using the fingertips of the dominant hand in order to soften the muscles. Later, the skin is cleaned with alcohol, the non-dominant hand is put in V shape and the skin is hit three times. During the third stroke, the syringe is pricked into the muscle with a 90-degree angle at the same time. Making a few taps relaxes the muscles and counting to three helps synchronizing the muscle tap and injection and standardizes the technique. Mechanical stimulation of muscle fibers of larger diameters decreases the effect of smaller, pain generating fibers. According to the gate control theory suggested by Roger Metzack and Past Wall (1965), in addition to a mechanical stimulation during an IM injection, this technique also causes distraction, which, in turn, helps reducing pain.

The study aimed to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was a randomized clinical trial conducted in Manisa Soma Family Health Center in Turkey. The study was conducted with 65 pregnant women who got tetanus vaccine. Tetanus vaccine was administered using the Helfer skin tap techniques to 33 of the pregnant women and standard IM injection technique to 32 women. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and immediately after the vaccine.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* being pregnant,
* having no infection, scar tissue, or incision, and receiving parenteral treatment in their injection area
* having no history of pain in their injection are
* applying for tetanus vaccine
* speaking Turkish
* voluntariness.

Exclusion Criteria:

* under the age of 18
* not being pregnant
* having a vaccination other than tetanus,
* having pain or a local infection prior to vaccination,
* having a circulatory disorder, peripheral vascular disease,
* cognitive and psychological problems,
* using painkillers at least 6 hours before the procedure,
* refusing to participate
Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World

Because of high cost, persons with hemophilia in many developing countries cannot afford adequate treatment. For example, many persons with hemophilia in India and China are only rarely treated with factor replacement in response to bleeds, and as a result many have developed significant arthropathy and disability. A pilot study in China estimated the mean Hemophilia Joint Health Score (HJHS) at 13.1 (SD 9.03) suggesting that these children had highly prevalent, severe joint disease. The lack of relationship between the HJHS and treatment history suggests overall inadequate therapy.

The proposed study will quantify the burden of arthropathy, physical disability, and quality of life (QoL) in boys with hemophilia in Brazil - where comprehensive treatment is just beginning to be widely available. This study will also provide an opportunity to compare these outcomes to those observed in Canada, where the dominant therapy has become life-long prophylaxis.

In order to quantify the burden of illness in hemophilia, and to study the response to different treatments, it is necessary to have quantitative outcome measures of high validity and reliability. The International Prophylaxis Study Group (IPSG - chair Dr. Victor Blanchette) was established in 2001 with the stated purpose of developing and testing outcome tools for this purpose. The group has developed a magnetic resonance imaging (MRI) score for quantifying arthropathy (representing the domain of structure and function domain in the ICF framework), a quantitative physical examination score, and the Hemophilia Joint Health Score or HJHS, to replace the older and less sensitive World Federation of Hemophilia (WFH) score (representing the domain of structure and function in the ICF). In addition Canadian investigators have also developed a quality of life measure for boys with hemophilia, the Canadian Hemophilia Outcomes Kids' Life Assessment Tool or CHO-KLAT (representing the domain of participation in the ICF).

We will use these tools, and other validated measures, to begin to determine the burden of hemophilia in Brazil and compare it to the burden of disease in Canada. Additionally, we will use this study to demonstrate the validity of these tools in the Brazilian population.

Eligibility Criteria:
Inclusion criteria

* Hemophilia A or B moderate or severe as determined by serum factor activity ≤ 5%
* Age 7 - 18 yrs. inclusive
* At least one parent or guardian fluent in written Portuguese or English and able to complete the study outcome questionnaires.

Exclusion criteria

* None (Children with inhibitors will be allowed into the study for 2 reasons: i) our study aims to document the health of persons with hemophilia in a generalizable way, ii) not all children will have had inhibitor testing done.)
CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients

The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.

Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients with an increased risk of severe COVID-19 belonging to one or more of the following groups :

  * Age ≥ 50 years
  * Body Mass Index ≥ 30 kg/m²
  * Diabetes
  * Hypertension
  * Chronic renal failure (eGFR \<60 mL/min)
  * Chronic heart disease
  * Asthma/Chronic Obstructive Pumonary Disease/Cystic fibrosis
  * Chronic liver disease
  * Chronic neurological disease
  * Solid organ transplant
  * Bone marrow transplant
  * Sickle cell anemia/ Major thalassemias
  * Active or currently treated or \<1 year diagnosed cancer
  * Active or currently treated or \<1 year diagnosed malignant blood disease
  * Immunosuppressive treatment observed for more than 1 month
* Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:

  * Positive SARS-CoV-2 RT-PCR nasal swab samples AND
  * Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgueusia...(1)
* Informed consent to participate to the trial
* Patients must be able and willing to comply with study visits and procedures

Exclusion Criteria:

* Initial need for hospitalization for COVID-19 management
* Pregnancy and breastfeeding
* Participation to another interventional drug trial
* Subject protected by law under guardianship or curatorship
* Absence of health insurance
* Known hypersensitivity to camostat mesylate
* Known person sharing the same household already included in the study
* Participation to another COVID-19 ambulatory interventional study
* Patients having completed a full SARS-CoV2 vaccine immunization procedure less than 4 weeks prior to COVID-19 diagnosis (last vaccine injection performed less than 4 weeks prior to COVID-19 diagnosis)