cyrilzakka/clinical-trials huggingface dataset:
Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients

The goal of this randomized controlled trial is to investigate the effects of Tai-Chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. Participants will be randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity.

Late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity. To evaluate the effectiveness of Tai-Chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). A linear mixed-effects model will be used to study the between-group differences in outcomes. In addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. Qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with stage IIIB or IV non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year;
* a current Eastern Cooperative Oncology Group Performance Status of 0-2;
* experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0-10 numeric rating scale \[NRS\] for each symptom);
* able to communicate in Cantonese, Mandarin, or English;
* conscious and alert

Exclusion Criteria:

* suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack);
* currently participating in any other exercise or mind-body classes; or 3) performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly
Low-level Laser Therapy in Distal Radius Fractures

Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks. After removing the cast, it is common to still have pain, swelling and reduced mobility in the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.

Patient with distal radius fractures are after removal of the cast are recruited form Bergen Emergency Department, where the are randomly divided into two groups with concealed allocation. Patient will be treated 3 times a week, for 3 week. After removal of the cast, the patients pain threshold, swelling, AROM, strength and function is measured. The patients will meet for following-up controls until 26 weeks after injury.

Changes in outcome measures during the study:

Due to covid 19 virus restrictions, we had to abandon the objective physical measurements as planned. Primary outcome measures were retrieved allowing no physical contact with the participants (Ipad, telephone or e-mail).

Eligibility Criteria:
Inclusion Criteria:

* Patients with distal radius fracture, with or without ulna fracture (Colles' fracture
* The breach must be closed
* after reduction: 0 degrees dorsal displacement of radius
* Under 5 degrees shortening of the radius
* Under 3 mm step in the joint
* 18+ years

Exclusion Criteria:

* People who do not speak Norwegian or English
* If the patient is pregnant
* Patient with Smith fracture
* Wounds over fracture area
* If the patient hav a peripheral neve injury
* If the patient had (previously) operated the wrist
* Persons with verified osteoporosis at the time of injury, systemic inflammatory disease (rheumatism), mental illness, stroke, Parkinson's disease, multiple sclerosis, cancer or congenital malformations in wrist
* If the laser treatment can not be started within 3 days after removal of the cast
Premenstrual Syndrome and Interpersonal Counseling

This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms.

People diagnosed with Premestrual Syndrome were identified through an online questionnaire. 80 people who were identified and accepted to study were divided into two groups as experiment and control. Initially, pre-menstrual screening tool, interpersonal relationship dimensions scale and perceived stress scale were applied to all groups. Then, 8 sessions of interpersonal counseling, each lasting 40 minutes, were applied to the experimental group for 2 months. Scales were repeated for both groups after the application was completed. Repeated measurements were made 3 months later.

Eligibility Criteria:
Inclusion Criteria:

1. According to the Pre-menstrual Symptom Screening Instrument, which is located in the group living with AES (Pre-Mental Syndrome)
2. between the ages of 18-30
3. Menstruating at regular intervals for at least 2 years (21-35 days)
4. Those who have never given birth
5. Speak and understand Turkish
6. It will consist of people who have not received antidepressant, oral contraceptive or hormone therapy for any reason.

Exclusion Criteria:

1. Having a known gynecological disease (endometriosis, polycystic ovary, ...)
2. A known, ongoing physical health problem (diabetes, rheumatic disease, ...)
3. Any psychiatric disease diagnosed (psychotic disorder, mood disorder, anxiety disorder ...)
4. People who use cigarettes, alcohol or substances
Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment

This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:

Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?

Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Adult males from 18 to 75 years age.
3. History of histologically or cytologically confirmed adenocarcinoma
4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC.
5. Evidence of target lesion in imaging studies.
6. ECOG performance status 0-1
7. Estimated survival≥12 weeks

Exclusion Criteria:

1. Do not meet the inclusion criteria.
2. Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
3. Receiving organ transplantation in the last 3 months.
4. Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
5. Participants with pneumonia.
6. Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
7. Unwilling and unable to provide informed consent.
8. Patients who are judged unsuitable for clinical trial participation by the investigators.
Abu Dhabi Sleep Apnea (ADSA) Study

Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight \[1\]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance \[2\]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity \[3\]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.


Eligibility Criteria:
Inclusion Criteria:

Participants aged between 18-64 years old. Both Gender male and female.

Exclusion Criteria:

Paediatrics below the age of 18. Any participant who is unable to take part
Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females

The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.

both groups (A\&B) will take their medical treatment in the form of (NSAIDs) and the study group B will under go a siet plan which will fits the participants. Diet plan extends for 12 weeks in the form of caloric restriction program and each woman in group B will perform aerobic exercise program, in the form of treadmill 3 times/week for 8 weeks for 12 weeks. Each session will take about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill by low speed as in warming up.

Eligibility Criteria:
Inclusion Criteria:

* Age will range between 20- 30 years old.
* only females will participate in the study.
* All patients who will be enrolled to the study will have their informed consent.

Exclusion Criteria:

* Diabetes mellitus.
* Individuals with cardiopulmonary conditions.
* Individuals with any pelvic disease.
* Individuals undergoing radiation therapy or chemotherapy.
* Hepatic or pancreatic diseases.
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in different Mycobacteria strains. The investigators observed increased LIN serum levels in three cases after combining LIN and CLA of which the investigators described one in a case report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and CLA.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Signed informed consent
* Diagnosis of MDR/XDR-TB confirmed with standard microbiological criteria (culture-based, molecular or both)
* Treatment with linezolid 300mg twice daily per os.

Exclusion Criteria:

* Hypersensitivity to: linezolid, clarithromycin, erythromycin, or any macrolide antibiotics, or any of the excipients of linezolid or clarithromycin.
* Concomitant use with astemizole, cisapride, ergotamine derivatives (dihydroergotamine, ergotamine), monoamine oxidase inhibitors (phenelzine, isocarboxazid, selegiline, or moclobemide), pimozide, or terfenadine.
* Pregnancy or breast-feeding.
* Hypokalemia
* Concomitant use of other P-gp inhibitors/inducers, e.g. amiodarone, verapamil, digoxin, tipranavir/ritonavir, lovastatin, tariquidar, itraconazole, dipyridamol, erythromycin, ritonavir, quinidine.
EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY

Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. The effects of US are due to alteration of cell membrane activity, vascular wall permeability and facilitation of tissue healing. The aim of this study is to investigate the effect of pulsed US treatment in patients with Bell's palsy when added to superficial heating, massage and exercise therapies.

In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years) diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological examinations were performed by an experienced electromyographer who was blind to the patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.

Exclusion Criteria:

* Central nervous system pathology
* Recurrent Bell's palsy
* Diabetes mellitus
* Contraindications of ultrasound treatment

  * Active infection
  * Cancer
  * Pregnancy
  * Lactation
  * Open wound around application area
China Intensive Lipid Lowering With Statins in Acute Coronary Syndrome

In summary, the CHILLAS study will be the first multicenter study performed in a Chinese population using a patient-level analysis to compare the effects and safety of intensive statin therapy with that of moderate statin therapy. Therefore, it will determine whether "lower is better", that is, whether LDL cholesterol lowering to a level of approximately 100mg/dl provides a benefit inferior to that of LDL cholesterol lowering to a much lower level; examine the role of inflammatory markers in predicting cardiac events and response to statin therapy; and evaluate the effects of statin therapy on regression of coronary atherosclerosis using IVUS.

The CHILLAS study is planned to evaluate whether intensive treatment with statins for 2 years results in a reduction of cardiovascular events in patients with ACS. A total of 1,600 patients will be randomly assigned to receive intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins) or moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins). Both groups receive dietary counseling. Over a 2-year follow-up period, the primary outcome measure is the time to occurrence of cardiac death, nonfatal acute myocardial infarction, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, documented unstable angina or severe heart failure requiring emergency hospitalization, and stroke. The planned duration is between December 2006 and December 2009.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute coronary syndrome
* Clinically stable for 24 hours

Exclusion Criteria:

* Hypersensitive to statins
* Receiving therapy with atorvastatin at a dose greater than 20 mg per day before enrollment or lipid-lowering therapy with fibric acid derivatives or niacin that can not be discontinued
* Having a coexisting condition that shortened expected survival to less than two years
* Having obstructive hepatobiliary disease or other serious hepatic or kidney disease
* Having an unexplained elevation in the creatine kinase level that was more than three times the upper limit of normal and that was not related to myocardial infarction
* Having undergone surgery or serious trauma within the preceding two months
* Having been in the final stage of chronic congestive heart failure
* Having a baseline level of LDL cholesterol less than 50mg/dl
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
* (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
* Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was \> 12 months prior to enrollment,
* Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.

Exclusion Criteria:

* Prior system therapy for advanced CRC (Ph 2 portion only)
* Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
* Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
* Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed \> 2 weeks of enrollment and be fully recovered from any procedure.
Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound in the Hands of Internists

The study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \\ sonographer ).

Up to 1000 subjects; Study population will be distributed according to the following schema:

Group 1 -up to 800 patients hospitalized in the Internal Medicine division Group 2 - up to 200 patients hospitalized in the acute Geriatric division


Eligibility Criteria:
Inclusion Criteria:

1. Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication
2. Willing and able to provide consent for a short partial transthoracic POCCUS examinations
3. No urgent or other compelling need for a comprehensive echo exam by the echo lab.

Exclusion Criteria:

1. Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS
2. Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination
3. Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations.
4. Patients after lung resection
5. Patients unable lie in bed and undergo a standard echo study
6. Participation in an interventional study
Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years
* has recurrent Bacterial Vaginosis

Exclusion Criteria:

* pregnancy
* use of other antmicrobial
* not provide informed consent
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.

This study will evaluate the benefit of augmenting a compliant College of Gastroenterology colorectal cancer screening program with the addition of yearly FIT testing at two critical points in the current recommended follow up: 1. In patients found to have adenomatous polyps for the first time after colonoscopy, the addition of FIT in yearly intervals following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10 or subsequent colonoscopy. Current screening guidelines do not recommend the combination of colonoscopy and FOBT.

Two factors plague an effective colon cancer screening program: 1) a less than 100% sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient acceptance and adherence.

FIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved specificity and better patient compliance. The addition of FIT after initial colonoscopy could be applied to a screening program and thereby salvage "missed" lesions by increased detection rates

Eligibility Criteria:
Inclusion Criteria:

Group I (positive colonoscopy)

* 18 to 75 years of age
* male or female
* willing to provide written informed consent
* In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.

Group II (negative colonoscopy)

* 50 to 69 years of age
* Male or female
* Willing to provide written informed consent
* In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.

Exclusion Criteria:

Group I (positive colonoscopy)

* chronic use of coumadin
* history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
* age or health status contraindicates repeat colonoscopy
* history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
* The index colonoscopy resulted in a perforation requiring surgical repair
* An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.

Group II (negative colonoscopy)

* chronic use of coumadin
* history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
* age or health status contraindicates repeat colonoscopy
* history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
* The index colonoscopy resulted in a perforation requiring surgical repair
* Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less