cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Registry to Study the Characteristics and Outcomes of Jordanian Heart Failure Patients.

Heart Failure research registry is a collection of computerized information about individuals with heart failure. The database in this registry is obtained from several Jordanian medical centers which will represent an extremely valuable resource for epidemiological research on heart failure patients.

Understanding the cause of Heart Failure (HF) and how the body will respond to it, is critical for an effective treatment. HF is a global problem with significant morbidity and mortality, despite improved understanding of the pathophysiology and a growing range of therapeutic options. Jordanian Heart Failure Registry (JoHFR) will be the first research project of heart failure prevalence in Jordan. It is undertaken by primary healthcare professionals with main aim to improve knowledge about the care of patients with HF. The investigators responsible for conducting this research are physicians and their teams who deal with heart failure patients in their outpatient and inpatient clinic centers including the public and private medical sectors in Jordan's medical community. Standards in the Hashemite kingdom of Jordan complies with the recognized good guideline directed medical practices internationally

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years or older with Heart Failure diagnosis as defined by internationally recognized guidelines.
2. Current residents of the Hashemite Kingdom of Jordan

Exclusion Criteria:

1. Patients who refuse or unable to sign a consent form.
2. Patient inability to follow up with provider
Scalp Cooling to Prevent Chemo-induced Hair Loss

Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of breast cancer stage 1-2
* Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
* Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,
* Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
* Concurrent traztuzumab at standard doses is allowed
* Concurrent pertuzumab at standard doses is allowed
* Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
* Subjects must have TSH collected within 1 year prior to treatment and found within normal range.
* If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.
* CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.

Exclusion Criteria:

* Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
* Baseline alopecia (defined CTCAE v4.0 grade \> 0, see appendix B for CTCAE v4.0 scale)
* Subjects with cold agglutinin disease or cold urticaria
* Subjects who are scheduled for bone marrow ablation chemotherapy
* Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
* Male gender
* Age \>= 70 years
The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France.

Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.


Eligibility Criteria:
Inclusion Criteria:

* students in a primary school in Reunion Island, drawn by lot for the study and whose school director agrees to participate in the program
* in a primary school with more than 10 classes
* within a class from the second and the third cycle: CE (elementary course) 1, CE2, CM (average course) 1 or CM2
* whose 2 parents have given their consent

Exclusion Criteria:

* in a school that has already benefited from the awareness program by the MiSolRé association in 2016/2017, 2017/2018, 2019/2020, 2020/2021
* in CP (preparatory course) class
* in a multi-level class
The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® \& Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 inclusive
2. Written informed consent provided, prior to any study related assessments/procedure being conducted.
3. Men \& Women with a BMI between 18-30kg/m2
4. Addison's disease or Bilateral Adrenalectomised patients with pre-hydrocortisone cortisol level below 100nmol/L and ACTH greater than 50ng/L on screening visit
5. All patients must be stabilised on hydrocortisone with no change in dosage for 6 months, other than transient increases for concurrent illness.
6. Able to self-inject into deltoid and thigh muscles following teaching at recruitment.
7. Female patients of child-bearing potential must be willing to use an acceptable method of birth control/abstinence from the time consent is signed until 6 weeks after treatment is discontinued. Acceptable methods include: physical barrier (male or female condom, contraceptive sponges, diaphragms and cervical caps),-contraceptive pill or patch, spermicidal method alongside a physical barrier or an intrauterine device (IUD). Abstinence is also acceptable if it falls in line with the patient's usual lifestyle however it must be complete abstinence and not either; periodic, ovulation timed, symptothermal or withdrawal based. Those patients that utilise hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above). Patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.

Exclusion Criteria:

1. Patient on oestrogen based or mixed oral contraceptives unless willing to use alternate effective method of contraception
2. Patient on any forms of oral steroids other than hydrocortisone.
3. Any patient with secondary adrenal failure
4. Patients with a diagnosis of any disease or condition listed in Hydrocortisone 100mg/ml and Solu-Cortef®'s SmPC as being contraindicated or precautionary for use
5. Patient with concurrent illness in the week preceding screening/study visit.
6. Patient must not have had an adrenal crisis in the week before screening
7. Patient with Nelson's syndrome.
8. Participating in another IMP investigation
9. Patient who is unable or unwilling to comply with the protocol.
10. Patient taking any medications/substances that are known to interact with hydrocortisone e.g. CYP3A4 inhibitors
11. Pregnant or breastfeeding patients
12. Patient has any other disease or condition that, in the opinion of the investigator, might compromise patient safety or interfere with the results of the trial
Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19

The purpose of this study is to prove the efficacy and safety Surfactant-BL, administered by inhalation in adult hospitalized patients with ARDS due to COVID-19.

The efficacy and safety of Surfactant-BL will be evaluated in terms of mean duration of oxygen therapy (days) after hospitalization, in adult patients with ARDS due to SARS-COV-19 infection.

Adult patients with COVID-19 induced respiratory failure will be receive either standard treatment or standard treatment plus Surfactant-BL.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent for participation in the study.
2. Male of female ≥18 and ≤ 75 years of age.
3. Body-mass index (BMI) ≤ 40 kg/m2.
4. Probable (the presence of a characteristic clinical findings of COVID-19 in combination with characteristic changes in the lungs according to computer tomography (CT) data) or confirmed (according to the results of laboratory tests for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods) diagnosis of COVID-19.
5. ARDS diagnosed within 24 hours prior to screening and confirmed at screening according to the following criteria (adapted Berlin criteria):

   * bilateral darkening of the pulmonary fields (infiltration, pulmonary edema) on the chest CT, which cannot be fully explained by pleural effusion, lung tissue atelectasis, tumor or other neoplasms;
   * nature of pulmonary infiltrates: respiratory failure not associated with heart failure or fluid overload;
   * oxygenation index (РаО2/FiO2 ratio): 150 mm hg \< РаО2/FiO2 ≤ 300 mm hg at the positive end-expiratory pressure (PEEP) or the continuous positive air pressure (CPAP) ≥ 5 cm H2O.
6. Oxygen saturation of the blood according to pulseoximetry (SpO2) ≤ 93 % in ambient air.
7. No indications for immediate tracheal intubation and artificial lung ventilation (ALV).
8. Negative pregnancy test result (applicable to female patients with preserved breeding potential).

Exclusion Criteria:

1. ARDS due to the other viral infections.
2. Non-pulmonary ARDS.
3. Comorbidities continuing at the time of the screening or a history of comorbidities that increase the risk of patient transfer to ALV or may be fatal within 3 months, including but not limited to the following:

   * Any autoimmune diseases.
   * Resistant hypertension.
   * A history of stable ischemic heart disease, chronic heart failure (NYHA class III / IV) or unstable angina.
   * Congenital / acquired QT interval prolongation and / or history of the risk factors for QT interval prolongation.
   * Tuberculosis.
   * Suspected active uncontrolled bacterial, fungal, viral, or other infections (other than COVID-19).
   * Chronic kidney disease stage 4 or the need for hemodialysis / peritoneal dialysis.
   * Multiple organ dysfunction syndrome.
   * Cancer.
4. Patients with HIV infection, viral hepatitis B and C.
5. History of organ transplantation.
6. History of conditions requiring ALV.
7. Idiosyncrasy of study drug components.
8. Pregnancy, lactation.
9. Participation in any interventional clinical trial of any drug product at the time of the screening.
Hatha Yoga in Breast Cancer Survivors

This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).

PRIMARY OBJECTIVES:

I. To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema.

II. To identify and document required modifications for a safe and feasible practice.

III. To obtain recruitment estimates and determine barriers to recruitment (acceptability).

IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.

V. To establish safety. VI. To assess satisfaction. VII. To determine the preliminary efficacy of a modified yoga program for lymphedema in BCS, and associated physical and psychological symptoms/symptom burden, and overall health status.

OUTLINE:

Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes.

3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

Lymphedema Group:

* Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit,
* \> 3 months (mths) post-breast cancer treatment
* No active cancer
* Has compression sleeve
* Ability to understand English in order to complete questionnaires
* Willing to do guided and home yoga practice
* Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
* Medical clearance
* Reliable transportation to the study site

No Lymphedema Group:

* No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex ≥ 7)
* \>3 months post- breast cancer treatment
* No active cancer
* Ability to understand English in order to complete questionnaires
* Willing to do guided and home Yoga practice
* Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
* Medical clearance
* Reliable transportation to the study site.

Exclusion Criteria (Both Groups):

* Active cancer
* Undergoing radiation therapy or chemotherapy
* Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
* Active yoga practice \< 3 months
* Currently undergoing phase I complete decongestive therapy (CDT)
* Inability to complete study forms
Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke

Assessment of a custom made grasp device in the rehabilitation of stroke victims.


Eligibility Criteria:
Inclusion Criteria:

1. Damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by CT scan: parietal, cerebellar, internal capsule and basal ganglia,
2. A score of 6 or more on the arm section of the Rivermead Motor Assessment (able to reach and pick up a tennis ball and release on thigh),
3. Time between start of hand opening and start of hand transport \> 60 ms (measured with GRASP).

Exclusion Criteria:

1. Cognitive dysfunction which prevents understanding of the task,
2. Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain),
3. A diagnosis of Parkinson's disease, or
4. Lack of informed consent.
The Metabolic Effects of Intermittent Fasting

Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, ages 25-45 years
2. BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
3. Normal thyroid function
4. Regular menses (women)
5. At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes

Exclusion Criteria:

1. Any chronic diseases including hypertension and Type 2 diabetes mellitus
2. Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL\>190 or an estimated 10-year ASCVD risk of \>7.5%)
3. Chronic medications, including oral contraceptive pills
4. Pregnant and/or breastfeeding
5. History of an eating disorder
6. 25-OH vitamin D level \< 20 ng/mL
7. Active substance abuse, including alcohol
8. Subjects with a prior history of intermittent fasting
9. The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol
Contrast Specific Echocardiogram Versus Left Ventricular Opacification (LVO) Imaging Settings

This study compares "contrast specific imaging setting" images with "left ventricular opacification (LVO)" images taken on the same group of patients at different points in time, to see if one is more effective at assessing the function of the heart.

Ultrasound testing of the heart using a "dye" or contrast is often used to get clear pictures of the heart in many heart conditions. When this test is done when the heart is working hard, such as when exercising, this is called contrast stress echocardiography.

Current guidelines recommend the method called "contrast specific imaging setting," as the best way of looking at the main pumping part of the heart. However, it is not known if it provides better pictures when compared to a different method called "left ventricular opacification (LVO)."

This study will compare pictures in patients who have had tests done using both ways of looking at the heart and will compare; LVO; enhanced and unenhanced LVEBD; LVO imaging with contrast specific imaging Wall Motion Classification and LVO to contrast specific imaging Left Ventricular Ejection Fraction (LVEF). The comparison will be done by a group of experts in cardiac ultrasound.

Eligibility Criteria:
Inclusion Criteria:

1. Participants enrolled in the Luminity 422 study that also have complete data with contrast specific imaging obtained within a 60 day window.
2. Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

1. Unwilling / unable to give informed consent
Investigation of Biopsychosocial Characteristics of Individuals with Knee Osteoarthritis

Since pain and depression are observed together in rheumatic diseases, the concept of limitation caused by the disease and health-related quality of life becomes more determinant than radiological joint damage. Sleep problems observed in OA also increase the level of depression findings and difficulty in movement. The chronic nature of the disease includes issues such as pain, fatigue, sleep problems, loss of function, anxiety, depression, and social isolation, together as in other chronic diseases. This complex structure accompanies a picture in which inflammatory processes are triggered.

When the literature is examined, the necessity of evaluation and methods including all these biopsychosocial characteristics of chronic diseases with multifaceted symptoms is emphasized. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasized that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide a holistic assessment of chronic diseases. When the literature, including individuals diagnosed with osteoarthritis, is analyzed, the inadequacy of the studies providing biopsychosocial evaluation draws attention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria
* Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria
* To be 18 years of age or older
* Being a reader-writer
* Having read and signed the informed consent

Exclusion Criteria:

* History of major psychiatric illness
* Having malignant disease
* Having chronic infectious or other rheumatologic diseases
* Serious knee trauma or surgical operation in the last 6 months
* Having collagen tissue disease
* History of peripheral vascular disease or neuropathy
* Being in stage 4 according to Kellgren Lawrence radiologic staging criteria
* To have received a physiotherapy program for the relevant knee in the last 3 months