cyrilzakka/clinical-trials huggingface dataset:
Yoga and Occupational Therapy to Improve Pain

This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Self-management education session occurred monthly within the community. Group yoga intervention was delivered two times a week with a specifically designed program that was progressively more difficult. Assessments were then administered pre and post intervention, and a semi-structured interview was completed following the intervention. Quantitative and qualitative data were then compared between groups.

This was a randomized control trial completed with two specific aims.

Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with an ongoing self-management education for people with chronic pain.

Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with chronic pain. The key variables of interest were pain interference, functional performance, balance, strength, mobility, and quality of life (QoL)

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* Individual with self-reported pain for over six months
* attending outpatient pain clinic
* ability to attend yoga classes
* ability to complete assessments
* ability to provide informed consent

Exclusion Criteria:

* consistent yoga practice over the past year
* self-reported exercise restrictions
* serious and recent medical procedures or conditions without doctor's note
* high risk pregnancy
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.

Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that lead progressively to thyroiditis. There is no effective therapy available that can change the natural history of CAT, which presents a high incidence of hypothyroidism and requires continuous treatment with levothyroxine (LT4).

Laser light can be valuable since the local and systemic actions of low-level laser therapy (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate regeneration of various tissues and, in animal thyroids, can lead to improvement in microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels. Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function, their concentration of thyroid autoantibodies, and the parameters of their ultrasonography study.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.
* Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies
* Ultrasonography results consistent with CAT
* Patients undergoing LT4 treatment
* Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH)

Exclusion Criteria:

* Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones
* CAT with normal thyroid function
* CAT with subclinical hypothyroidism
* Thyroid nodules
* Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation)
* History of Graves' disease
* Thyrotropin receptor antibody (TRAb) detectable
* Prior treatment with radioiodine
* Tracheal stenosis
* Pregnancy
* History of ionizing irradiation and/or neoplasia in the cervical area
* Previous surgical intervention in the thyroid
* Thyroid hypoplasia
* Ectopic thyroid
* Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver failure, etc.)
Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including :

* patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency),
* patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

The patients eligible for this study will already be hospitalized with repeated monitoring of clinical and biological parameters.

Participation in the study will result in an additional sampling of blood (estimated volume 6 mL for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks.

vials will be added to the routine sampling of these patients (ie, at the time of routine sampling for galactomannan antigemia), and no new sampling procedure will be required.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of invasive mould infection

  * in a patient at high risk according to the EORTC/MSG criteria updated in 2008 (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressor, recipients of allogeneic HSCT, or inherited severe immunodeficiency)
  * or in a patient with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns).
* Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions, including patients referred from other centers.
* Only adult patients (18 years or older) will be included

Exclusion Criteria:

* Age : under 18 years
* Patients previously included in the trial with a diagnosis of mucormycosis. However patients previously entered in the trial with a diagnosis other than mucormycosis will be eligible for re- new inclusion.
* Presence of any medical condition that would not allow collection of blood samples for the qPCR test.
* History of documented, successfully treated, prior mucormycosis.
* protected people (pregnant women, minor, guardianship...)
Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

Nerve blocks for arm and hand surgery provide many advantages for patients including excellent pain control and reduction in general anesthesia-related adverse effects. Infraclavicular block is possibly the best method for performing regional anesthesia of the arm because of the consistent anesthesia of the whole arm and low incidence of serious adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying the forearm and hand. Recent research has indicated that to improve success from 60% to 79% two types of muscle stimulation must be sought before injection of local anesthetic. This can be time consuming, requires a significant learning process, increases complications and leaves 21% of patients with inadequate anesthesia requiring supplementation or general anesthesia. More recently practitioners have been using ultrasound imaging to direct the needle and watch local anesthetic spread around the nerves. Preliminary reports have documented that this technique is associated with much greater success than the nerve stimulation method. However a good quality study comparing the dual-endpoint infraclavicular technique with an ultrasound-guided technique has not been performed. This randomized study aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has a significantly greater success than the current standard, dual end-endpoint nerve stimulation technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective upper limb surgery at or below the elbow.
* Patients aged \> 18 and \< 80 years.
* ASA I-III.
* BMI \< 35.

Exclusion Criteria:

* Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. it is not feasible to have an interpreter present in the block room during performance of these procedures).
* Contraindication to brachial plexus block.
* Existing neurological deficit in the area to be blocked.
* Known loco-regional malignancy or infection.
* Coagulopathy.
* Allergy to local anesthetic agents.
* Chest or shoulder deformities.
* Severe respiratory disease.
* Healed but dislocated clavicle fracture.
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine

Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.

PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response.


Eligibility Criteria:
Inclusion Criteria:

* Female age 18 to 45 years
* Written informed consent in accordance with institutional guidelines
* Negative pregnancy test
* LSIL or HSIL on Papanicolaou (PAP) smear within the prior 6-8 weeks
* Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged by Grade 0-1 as per National Cancer Institute Common Toxicity Criteria (NCI-CTC) performed up to 30 days prior to administration of study treatment.
* Body mass index (BMI) ≤32 kg/m2
* Women of child-bearing potential (WOCBP) agree to use two forms of medically effective contraception (e.g. hormonal contraception, intrauterine device, barrier method, spermicide, etc...) during the study and for at least 12 weeks following the completion of treatment. Patients agree to inform the investigator immediately if they become pregnant during the study or within 12 weeks following completion of treatment and to provide information about the pregnancy, delivery and health of the infant until the age of one month.
* Able and willing to comply with all study procedures

Exclusion Criteria:

* Active infection with herpes simplex virus (HSV)
* Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or Hepatitis B surface antigen (HBsa)
* Pregnant or breast-feeding
* History of any prior cervical surgical treatment
* History of any active autoimmune disease or current medical condition requiring the use of systemic or topical corticosteroids (excluding steroid containing eye drops or inhaled steroids) or other immunosuppressive agents within 4 weeks prior to enrollment
* History of cancer (excluding basal cell carcinoma of the skin)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Administration of any blood product within 3 months of enrollment
* Administration of any vaccine within 6 weeks of enrollment
* Active infection requiring antimicrobial treatment
* Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
* Any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants or platelet inhibitors
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
* Any condition which, in the opinion of the investigator, would limit the evaluation of the patient.
Cardiac Rehabilitation for Young People

Heart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life.

While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes).

Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP.

The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.


Eligibility Criteria:
All participants meeting the following inclusion criteria and aged between 11-16 years old will be eligible:

Inclusion Criteria:

1. Fluent in English
2. Consent to participate
3. Diagnosed with at least one of the following:

   * Congenital heart disease (all subtypes)
   * Cardiomyopathy
   * Cardiac arrhythmia
   * Heart failure
   * Post-cerebrovascular event
   * Post-heart valve repair/replacement

Exclusion Criteria:

1. Significant risk or safeguarding concerns (i.e., suicidal ideation)
2. Head injury/organic impairment
3. Significant social and/or communication difficulties

Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography

This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.

Shivering is a physiologic reaction aimed at raising body temperature that is very common amongst patients undergoing cerebral angiographies. The use of pre-warmed solutions during the procedure may reduce the incidence of shivering amongst these patients. In this triple-blind randomised trial, a consecutive sample of participants receiving total intravenous anaesthesia (TIVA) and undergoing cerebral angiography will be allocated to receive a warmed (39ºC) solution of up to 500cc of isotonic saline or the same solution, but at room temperature. Patients requiring sedation, those expected to require mechanical ventilation after the procedure, those with diminished consciousness (Glasgow Coma Scale \<15 pts) and patients not wishing to participate will be excluded from the study. The primary endpoint for this study is the incidence of shivering up to 60 minutes after the procedure is completed. Shivering will be assessed using a validated scale by operators unaware of treament allocation. All analyses will be undertaken by a statistician that will not participate of the clinical assessment of included patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving TIVA
* Patients undergoing cerebral angiography

Exclusion Criteria:

* Glasgow Coma Scale \<15 points prior to procedure
* Expected need of mechanical ventilation after procedure completion
* Use of sedatives
* Refusal to participate
Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia

Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria)
* Stabilized out-patients
* Under treatment with an oral antipsychotic drug

Exclusion Criteria:

* Administration of a depot antipsychotic drug
* Participation in another clinical trial within 4 weeks prior to enrolment into this study
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Severe symptomatic calcific aortic valve stenosis with:

   1. High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients),
   2. High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150).
   3. Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score \> 4 or EuroSCORE ≥ 10).
2. Age ≥ 75 years
3. NYHA ≥ II
4. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion Criteria:

1. Non-calcified aortic valve
2. Acute myocardial infarction ≤ 30 days before the intended treatment
3. Untreated clinically significant coronary artery disease requiring revascularization.
4. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
5. Mixed aortic valve disease (with predominant aortic regurgitation)
6. Preexisting bioprosthetic valve or ring in any position
7. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures

The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).

The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.

The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 18 years of age.
* Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
* Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
* Patients with an international normalized ratio (INR) of 2.0 or above.
* Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
* Patients able and willing to comply with the procedures laid out in the study protocol. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol.

Exclusion Criteria:

* Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
* Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
* Patients with a known congenital coagulation disorder.
* Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
* Patients with present or past specific factor inhibitor activity.
* Patients with thrombocytopenia of \< 80,000 or a history of heparin induced thrombocytopenia (HIT).
* Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion.
* Patients who have received vitamin K more than 3 hours prior to the infusion of study drug.
* Patients with a history of hypersensitivity to plasma-derived products.
* Pregnant or nursing women.
* Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
* Patients previously enrolled in this study.
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia

Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.

A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously).

During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo.

Assessments include:

* Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
* Body weight measurements
* Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
* Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
* Meets any of the following criteria at Randomization:

  * Not currently receiving antineoplastic therapy
  * On standard of care systemic antineoplastic therapy or treatment without curative intent
* Signed informed consent.

Key Exclusion Criteria:

* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
* Current active reversible causes of decreased food intake.
* Current, severe gastrointestinal disease
* Participants with known symptomatic brain metastases requiring steroids.
* Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
* inadequate renal or liver function.
* Women who are pregnant or breast-feeding