cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Medicine for Depression

This study will examine the feasibility and efficacy of lifestyle medicine for the management of depression in Chinese adult population. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, and sleep. While lifestyle medicine has been recognized for centuries as a means to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. In the existing literature, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g, physical activities and sleep) on depression. However, there is very limited research on the effectiveness of an integration of multiple lifestyle adjustments on depression.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged ≥ 18 years;
2. Cantonese language fluency;
3. Patient Health Questionnaire (PHQ-9) score ≥ 10; and
4. Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Pregnancy;
2. Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);
3. Using medication or psychotherapy for depression;
4. Having unsafe conditions and are not recommended for exercising or a change in diet by physicians; and
5. Have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification.
Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram

The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

In a first step, the team will build a multi-parametric algorithm on existing records issued from the Epilepsy Monitoring Units. Each selected record will be analyzed by EMU medical team in order to detect seizure on the EEG. The algorithm will adapt in order to obtain the best sensitivity and specificity regarding seizure detection.

in a second step,algorithm will validate on a cohort of other recordings in patients with epilepsy

Eligibility Criteria:
Inclusion Criteria:

* patients with epilepsy
* with a long-term video-EEG recording
* 1 (or more) seizure (s) recorded
* onset seizure clearly defined on the basis of the EEG

Exclusion Criteria:

* bad quality of the Electrocardiogram recording
* pace-maker
* non sinus rhythm
Topical SGX302 for Mild-to-Moderate Psoriasis

To evaluate SGX302 (topical hypericin ointment and gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
* Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
* Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

Exclusion Criteria:

* Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
* Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
* Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
* Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations

This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations.

This protocol includes a non-randomized, open-label, Phase 1/2 study (HORIZON). Approximately 30 participants will be enrolled into the dose escalation study (HORIZON). Each participant will receive the study agent by subretinal injection in one eye on a single occasion. Enrollment will begin with the lowest dose and will proceed to higher doses only after review of safety data by a Data and Safety Monitoring Committee (DSMC). There are a total of 15 visits over approximately 36 months, and long-term follow-up evaluations annually at years 4 and 5.

Eligibility Criteria:
Phase 1/2 Dose Escalation Inclusion Criteria:

* Male subjects with a documented RPGR mutation
* Clinical diagnosis of X-linked retinitis pigmentosa (XLRP)
* Best-corrected visual acuity not better than 78 ETDRS letters (20/32) in the study eye;
* Ability to perform tests of visual and retinal function and structure and ability to comply with other research procedures;
* Detectable baseline mean macular sensitivity, as measured by microperimetry.
* Have detectable Ellipsoid Zone (EZ) line during the pre-treatment period as assessed by OCT and confirmed by the CRC.

Phase 1/2 Dose Escalation Exclusion Criteria:

* Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or increase the risk of surgical complications (for example, glaucoma, corneal or lenticular opacities, diabetic retinopathy, retinal vasculitis);
* Use of anti-coagulant agents that may alter coagulation within 7 days prior to study agent administration;
* Use of systemic corticosteroids or other immunosuppressive medications within 3 months prior to enrollment;
* Any other condition that would prevent a subject from completing follow-up examinations during the course of the study;
* Any other condition or reason that, in the opinion of the investigator, makes the subject unsuitable for the study;
* Previous receipt of any AAV gene therapy product;
* Monocular or having BCVA less than 20/800 in the fellow eye
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery

This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.

PRIMARY OBJECTIVES:

I. Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of HS with local anesthesia versus (vs) opioid based general anesthesia (GA) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates.

II. Preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol).

III. Preliminarily identify changes in neurological activity as assessed through electroencephalogram (EEG) activity.

IV. Preliminarily evaluate the group differences in medical costs.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.

GROUP II: Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.

After completion of study intervention, patients are followed up at days 1, 3, 5, 7, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection
* Able to read, speak, and write English or Spanish

Exclusion Criteria:

* A significant anxiety disorder
* Significant pain during core biopsy as reported by the patient
* Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
* Plastic surgery involvement for oncoplastic reconstruction
* If surgery is likely greater than 3 hours
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects

Glaucoma, one of the most common causes of blindness, is associated with increased intraocular pressure (IOP) and optic nerve head ischemia. Nitrovasodilators are discussed in the treatment of glaucoma. Nitrates relax smooth muscle cells in the vasculature by liberating the vasodilator nitric oxide.

The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects of nitrates showed partially contradicting results. In addition the IOP lowering effect of nitrates is still unclear. However, recent studies show that long acting nitrates may preserve optic nerve deterioration and visual field loss.

Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do not affect systemic hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* History of migraine
* Blood donation during the previous 3 weeks
Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.


Eligibility Criteria:
Patient Inclusion Criteria:

* 18-89 years old
* Intensive Care Unit (ICU) length of stay (LOS) \>= 48 hours
* No anticipated ICU LOS for next 24 hours
* Unable to make healthcare decisions

Family Inclusion Criteria

* Identified by critical care team as legally authorized representative (LAR)
* Able to speak or comprehend English
* \>= 18 years old

Patient Exclusion Criteria:

* Less than 18 years or older than 89 years
* ICU LOS \< 48 hours
* Anticipated ICU discharge within next 24 hours
* Able to make healthcare decisions

Family Exclusion Criteria

* Not identified by critical care team as the LAR
* Unable to speak or comprehend English
* \< 18 years old
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.

Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.

This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.

This phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria
3. ECOG performance status of 0 or 1
4. No distant metastasis
5. The disease is either resectable or potentially resectable
6. Patients must have adequate organ function as defined by the following laboratory values at study entry:

   Hemoglobin ≥ 8 g/dL (transfusions are acceptable) ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L AST/ALT ≤ 3 x ULN Total bilirubin ≤ 2.5 mg/dL Creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
7. Women of childbearing potential definition (WOCBP) and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 3 months after the end of treatment.
8. WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.

Exclusion Criteria:

1. \> 75 years old
2. Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
3. Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
4. Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
5. Pregnant or lactating women.
6. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
7. Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%
8. Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia
9. known HIV positive
10. Baseline peripheral neuropathy/paresthesia grade ≥ 2.
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age.
* The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
* The patient has measurable disease.
* The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
* The patient's estimated life expectancy is at least 8 weeks.
* The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
* The patient has adequate bone marrow function.
* The patient must not have active central nervous system (CNS) metastases.

Exclusion Criteria:

* The patient has any serious, uncontrolled intercurrent illness or infection.
* The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
* The patient is pregnant or nursing.
Postoperative Adjuvant TACE Treatment in CK18 Positive Patients

To evaluate and analyse the clinical effect and application value of postoperative adjuvant TACE treatment in patients with different expression levels of CK18 using randomized controlled study and provide evidence for the necessity of postoperative adjuvant TACE.


Eligibility Criteria:
Inclusion Criteria:

1. Via clinical diagnosis and confirm it is primary liver cancer
2. Pathological evidence of HCC
3. Estimate tumor can gain treatment of curing operation
4. No evidence for extrahepatic metestasis
5. liver function ：Child-Pugh A/B

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer

Patients with breast cancer undergo a series of psiclofisicas alterations during cancer treatment, chemotherapy phase being one of the more aggressive ete effect. These changes reduce the quality of life and result in a loss of physical health-related condition. Studies have shown that the practice of physical exercise and rehabilitation strategies enhance or attenuate the impact of chemotherapy on quality of life of patients. At present, technological development from telerehabilitación systems is a promising strategy that enables fast and efficient communication between health professionals and patients, especially at this stage of the disease where the patient may encounter difficulties in matching measures improving their lifestyle with aggressive medical treatment.

To carry out this study a controlled study masked, parallel-group done were conducted usual care control group and an intervention based on a web system telerehabilitación to improve the physical condition associated with health and performed quality of life.

The CUIDATE group will identify impairments of participants at baseline assessment. The aims based on weekly improvements will be set to facilitate the final goal. After each training session there will be feedback between the participant and the CUIDATE group to change or improve any exercise or activity. This feedback will allow to us to select adequate exercises and levels of difficulty. As a result, a modifiable personal training will be assigned to each one focusing on cardio-respiratory, mobility, and endurance performance through online system rehabilitation (using written instructions, HD videos, and audio files).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I, II, or IIIA breast cancer
* Medical clearance of participation
* Access to the Internet
* Basic ability to use a computer or living with someone who has this ability
* In chemotherapy treatment at present moment;
* Have interest in improving lifestyle: fitness level
* Have signed informed consent

Exclusion Criteria:

* Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

This study is designed to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in people with neck pain.

The null hypothesis is that there will be no differences between the two manipulation techniques for short-term effects on neck range-of-motion, pain, and self-reported disability in people with neck pain.

Patients will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.

Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or prone thoracic spine thrust manipulation intervention.

Eligibility Criteria:
Inclusion Criteria:

* Between 22 and 50 years of age
* Primary complaint of neck pain with or without symptoms that spread down into one arm
* Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
* Neck Disability Index (NDI) score \> 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability).
* Proficient in speaking and reading English to complete outcome questionnaires

Exclusion Criteria:

* Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
* Neck pain that spreads down into both arms
* Low back pain or thoracic origin of pain
* Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
* Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
* History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
* Pending legal action related to current episode of neck pain
* Contraindications to thoracic spine thrust manipulation

  1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  2. hyperreflexia
  3. unsteadiness during gait
  4. Nystagmus
  5. Loss of visual acuity
  6. Impaired sensation of the face
  7. Altered taste
  8. The presence of pathological reflexes
  9. pregnancy or considering pregnancy
The Effect of Strength Training on the Hip Adduction Strength Measured With Hand-held Dynamometry

The purpose of this study is to investigate the effect of strength training with elastic bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that strength training with elastic bands will result in a clinical relevant increase in hip adduction strength.


Eligibility Criteria:
Inclusion Criteria:

* Sub-elite danish soccer players

Exclusion Criteria:

* Injury in the lower back or legs with a duration of more than 6 weeks within the last year before the study was initiated.
* Systematic strength training of the hip adductors more than once a week within the last 6 months before the study was initiated.
* Groin pain during soccer play with a duration of more than 1 week and witch resulted in loss of soccer training/game within the last 3 months before the study was initiated.
* Groin injuries within the last month before the study was initiated.