cyrilzakka/clinical-trials huggingface dataset:
Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment

Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design.

Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition.

The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets.


Eligibility Criteria:
Inclusion Criteria:

* planned inpatient or outpatient radiotherapy
* ≥ 18 years of age
* diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months)

Exclusion Criteria:

* metastatic disease
* severe neurological problems or other contraindications for resistance training
Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance

The purpose of this study was to examine the effectiveness of the Mole's Veggie Adventures mobile application in increasing fruit and vegetable acceptance among 3-6-year-olds.

After the parents of the participating children had signed an informed consent and filled in the baseline questionnaires, the participating early childhood education and care (ECEC) centers (in Finland) or groups within the ECEC centers (in Poland) were randomly allocated into intervention and control arms. Researchers visited the intervention arm groups and introduced the application to the ECEC professionals. The ECEC professionals were instructed to use the application with a tablet computer at least one to two times a week during the intervention period (3-4 weeks) and to record the number of tasks completed by their group in a logbook. In addition, the research team recommended that each group focuses on at least six vegetables or fruits during the intervention period. The control arm groups were instructed to continue their normal routines during the intervention period and to refrain from introducing any novel food education methods during the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* All children in the participating early childhood education and care (ECEC) groups

Exclusion Criteria:

* None
Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.

This Biobank is comprised of: 1) medical, social, obstetrical and ultrasonographic data, 2) human biological samples (maternal plasma, serum and buffy coat, maternal urine, cord blood) and 3) the results derived from these (biochemical or ultrasonographic markers, genetics, risk calculations ...)

Eligibility Criteria:
Inclusion Criteria:

* (specific to each study)

Exclusion Criteria:

* pregnant women \<18 years old at recruitment
* negative fetal heart at recruitment
* women not able to provide an informed consent to the study
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

The purpose of this study is to determine the feasibility of a 10-week tai chi chuan intervention as a treatment for anxiety and sleep quality in young adults.


Eligibility Criteria:
Inclusion Criteria:

* mild to severe symptoms of anxiety
* interest in participating in an exercise intervention
* willingness to accept randomization
* provides informed consent
* low or moderate risk for acute cardiovascular event

Exclusion Criteria:

* currently receiving psychotherapy or medication for psychological problems
* current suicide or homicide risk
* current or history of psychosis
* current alcohol or substance dependence
* high risk for an acute cardiovascular event
* current use of prescription drugs with potential to influence the parasympathetic or sympathetic nervous system
* current or previous extensive involvement in mind-body exercise
* symptoms of severe depression
The Support, Educate, Empower (SEE) Program

This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group.

The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.


Eligibility Criteria:
Inclusion Criteria:

* Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
* Did not opt-out from recruitment letter

Exclusion Criteria:

* Do not speak English
* Have a diagnosed serious mental illness (for example, Schizophrenia)
* Diagnosed cognitive impairment
* Do not instill their own eye drops
* Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period
* Unable to attend all study visits
* Active ocular infection or uveitis
Correlation Between Functional Capacity and Functional Capability in Duchenne Muscular Dystrophy

This study investigates the correlation between assessments measuring functional capacity and functional capability in patients with Duchenne muscular dystrophy.

This study is a prospective single-arm observational study, with a total of two visits for one year follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 5 to 18 years diagnosed with Duchenne muscular dystrophy through genetic testing
2. Children who understand the contents of this research and can properly conduct the research

Exclusion Criteria:

1. Requiring daytime ventilator assistance or using invasive mechanical ventilation through tracheostomy (Non-invasive mechanical ventilation such as positive pressure ventilation at night is allowed)
2. History of peripheral nerve damage
3. History of major surgery within 12 weeks or if major surgery is expected during the test period
4. History of central nervous system disorders (eg, cerebral infarction, spinal cord injury)
5. Having difficulties in conducting this study due to cognitive decline.
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance

The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.

An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (body mass index \[BMI\] between 25 and 40kg/m2)
* fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
* fasting plasma insulin above 90pmol/L

Exclusion Criteria:

* Diabetes, chronic, metabolic or acute disease
* Major surgery within the last 3 months
* Significant weight loss (±10%) within the last 6 months
* Any medication-taking known to affect lipid of glucose metabolism
* Allergy, intolerance or dislike of fish
* Smokers
The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes

Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 41-70 years old
2. Body mass index 27-40 mg/m²
3. Type 2 diagnosis for more than 1 year
4. HbA1c \>6%

Exclusion Criteria:

1. Currently following ketogenic diet
2. Use of insulin
3. HbA1c \>10%
4. Recent weight loss (\>5kg in 6 months)
5. Recent eGFR \<30mL/min
6. Heart failure
7. Substance abuse
8. Cancer
9. Myocardial infarction within 6 months
10. Pregnancy or consideration of
11. Use of antipsychotic drugs
How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?

The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.

Knee osteoarthritis (OA) is a chronic progressive disease affecting more than 20% of people older than 45 years. A myriad of different treatments have been proposed in the scientific literature, and current treatment options include conservative and surgical procedures in which the main objective is to relieve pain and improve function.

Conservative nonsurgical interventions include weight management, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroid and hyaluronic acid injections. Although these agents have been beneficial in the short term, there is a lack of evidence that such interventions alter the progression of OA. More recently, platelet-rich plasma (PRP), a biological therapy, has become an emerging treatment option to improve the status of the joint for patients with OA.

PRP is an autologous blood product that is injected into the knee joint, which contains an elevated concentration of platelets above that of whole blood. However, the optimal PRP preparation is still unknown. Studies are needed that investigate optimal platelet count and how that is related to clinical outcome.

This study is designed as a double-blind randomized controlled study, where enrolled subjects are randomized to one of five treatment groups (in blocks of 10):

1. a total PRP injection dose of less than 5 billion platelets;
2. a total PRP injection dose between 5 and \<10 billion platelets;
3. a total PRP injection dose between 10 and \<20 billion platelets;
4. a total PRP injection dose of \>20 billion platelets; and
5. a saline injection control

Each patient will be asked to complete a questionnaire at baseline, 6, 12, and 26 weeks.

After patients have completed all the study questionnaires, the Investigators will pull the results from the blood analysis, so that blood composition levels can be correlated with any pain improvements that are felt. The purpose of the study is to establish if there is a relationship between the injection dosage a patient receives and knee pain level (based on the pain scores from the self-reported questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years of age
* Previous diagnosis of unilateral, primary osteoarthritis of the knee
* Knee pain; duration of symptoms \> 4 weeks
* K-L grade 0-4

Exclusion Criteria:

* Under 40 years of age; over 80 years of age
* Bilateral knee pain
* Duration of symptoms \< 4 weeks
* NSAID or clopidogrel use in the last 7 days
* High risk of a thrombotic event if discontinuing NSAID or clopidogrel for four weeks.
* Steroid use in the last 6 weeks
* Active diagnosis of leukopenia/anemia/thrombocytopenia
Liquid Biopsy for Detection of Driver Mutation in NSCLC

The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .

Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.

Eligibility Criteria:
cohort 1

Inclusion Criteria:

* patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
* Age ≥ 18 years
* newly diagnosed patients have not received TKI and chemotherapy
* patients who are drug-resistant have not received next-generation TKI

Exclusion Criteria:

* patients who have more than one type of carcinoma
* patients who reject to sign the informed consent from

cohort 2

Inclusion Criteria:

* patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
* patients will have regular follow-up in Chinese people liberation army general hospital every month.

Exclusion Criteria:

* patients who are refused to provide the informed consent from
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass

Ticagrelor, a direct-acting oral P2Y12-receptor antagonist, provides greater and more consistent platelet inhibition than clopidogrel. This study aimed to compare outcomes of ticagrelor plus aspirin versus clopidogrel plus aspirin 1 year after off-pump coronary artery bypass grafting (OPCAB) in patients with clopidogrel resistance.

Between November 2014 and November 2020, 1739 patients underwent OPCAB. Aspirin (100mg daily) and clopidogrel (75mg daily) were administered beginning at aday 1 after surgery. On the 7th postoperative day, the clopidogrel resistance was evaluated by point-of-care assay. Among them, the patients had clopidogrel resistance were enrolled in this study. Investigators divide them into two groups \[A: ticagrelor, B; clopidogrel\]. Primary endpoint was all-cause of mortality 1 year after OPCAB. Secondary endpoint included major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or stroke). Multivariate Cox regression was used to evaluate predictors of end points.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged 19 years or older
2. undergoing elective OPCAB surgery with multi-vessel coronary artery disease.

Exclusion Criteria:

1) patient had aspirin resistance
Golden Black Seed: Support of Metabolic Health and General Wellness.

To document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic health and wellness in human subjects.

Golden Black Seed contains extracts from the turmeric root (Curcuma longa) and black cumin seeds (Nigella sativa). Both botanicals have been used traditionally in Asian cooking, and also in herbal medicine for reducing inflammation.

For this clinical study, human participants will be tested over a period of 8 weeks. Below is a simplified diagram illustrating the involvement of each human subject, where all study participants will be tested on three different clinic days.

Eligibility Criteria:
Inclusion Criteria:

1. Adult people of either gender;
2. Age 40-75 years (inclusive);
3. BMI 25-34.9 (inclusive);

Exclusion Criteria:

1. Cancer during past 12 months;
2. Chemotherapy during past 12 months;
3. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder);
4. Currently consuming large doses of anti-inflammatory nutritional supplements, and unwilling to stop taking these supplements for 2 weeks prior to and during the study;
5. Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
6. Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);
7. Currently experiencing intense stressful events or life changes;
8. Currently in intensive athletic training (such as marathon runners);
9. Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant;
10. Known food allergies or sensitivities related to the test products or placebo;
11. History of drug abuse during past two years;
12. Participation in another clinical trial involving a consumable test product.
Trop-Shock DFT-testing Versus None

Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.

The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.


Eligibility Criteria:
Inclusion Criteria:

* ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy

Exclusion Criteria:

* Atrial fibrillation with inappropriate anticoagulation
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
* Ask an immediate breast reconstruction during the surgery
* World Heath Organization score \<3
* Glandular volume : french bra cup size A, B ou C
* Glandular ptosis \<=2 (Classification and Algorithm for Treatment of Breast Ptosis)
* Contraception for woman of childbearing age and no pregnancy
* Valid Social Security
* Wrote consent

Exclusion Criteria:

* History of breast cancer surgery
* Breast cancer not operated on the side concerned by the prophylactic mastectomy
* Patient having had irradiant treatment
* Breast hypertrophy
* Smoking \> 10 cigarette/day
* Body Mass Index \> 30
* Large breast volume requiring prostheses \> 500ml
* Chronic pulmonary obstructive gold 4
* ASA (Physical Status score of American Society of Anesthesiologists) \> 3
* Chronic shoulder pain on the side to operate, or both shoulders
* History of abarticular pathology of the shoulder on the operating side
* Patient involvment in another clinical research
* Protected patient or unable to give consent
* Pregnant or breastfeeding woman
* Vulnerable person (Article L1121-6 of the Public Health Code)