cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation for Chronic Pain Relief

In the present study, the investigators intend to investigate whether anodal transcranial direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.

tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients.

The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients.

Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.

Pain will be measured using visual analog scale (VAS) for pain and the short form McGill questionnaire (SF-MPQ). Disability will be measured using the ( Pain Disability Index (PDI) of Life-54 scale (MSQoL-54). Depressive symptoms and anxiety will also be evaluated using the Center for Epidemiological Studies-Depression Scale and the State-trait Anxiety Inventory (STAI). Cognitive function will be mesured using minimental test. Evaluations will be performed at baseline, immediately after the end of treatment, and once a week during a 3-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* chronic pain patients VAS \> 4

Exclusion Criteria:

* pregnancy
* scalp lacerations
* History of seizures
* metal implants in the head
* heart pace maker
My Health Coach App RCT

The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are:

Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life?

All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete.

Researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.

This trial involves a 2-arm randomized controlled trial. Participants will be randomized (50:50 allocation) into the (1) My Health Coach group, or the (2) Wait-list Control group. The My Health Coach app is designed to support the quality of life of adults with FASD by providing tools to help with self-management, advocacy, health literacy, use of supports, and engagement in meaningful activities.

This study is designed to: (1) evaluate the efficacy of the My Health Coach app with adults with FASD, (2) test whether changes in competence, autonomy, and/or relatedness mediate intervention outcomes on reported quality of life, and (3) identify app usage patterns that relate to greater outcome improvement. Primary outcomes include perceived well-being, the degree to which basic psychological needs of competence, autonomy, and relatedness are met, and readiness for self-management. We are also interested in participants' perceptions of app quality and patterns of app usage.

All participants will complete the study assessment battery measuring these outcomes at baseline (T1), 6 weeks (T2), and 12 weeks (T3). Wait-list participants will receive the app after T3.

Eligibility Criteria:
Inclusion Criteria:

* adult 18 years or older
* have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
* have sufficient fluency in written English
* own a smartphone

Exclusion Criteria:

* participated in the past feasibility trial of the My Health Coach app
Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)

The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.


Eligibility Criteria:
Inclusion Criteria:

* For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.
Near Infrared Spectroscopy in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position

Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. After prolonged operative time in a Trendelenburg position rare but significant complications are a cerebral oedema or a well leg compartment syndrome.

Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the perfusion pressure is decreased proportionally to the lower extremity elevation. The condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after 4 hours in a Trendelenburg position.

If not promptly diagnosed and treated, a compartment syndrome has devastating complications like permanent dysfunction, limb loss, renal failure or even death.

There are no specific guidelines for diagnosis and for the timing of surgical decompression. Fasciotomy is a clinical decision. There is no universal agreement at which compartment pressure irreversible muscle damage occurs.

The only objective diagnostic tool available is currently to measure the intramuscular pressure, however this is invasive, painful and may yield unreliable results. An intracompartment pressure of 0- 10mm Hg is the normal range.

Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and somatic tissue oxygenation below the sensors and may help detecting promptly a compartment syndrome.

Therefore, the investigators designed the present study to detect a change in the tissue oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the Trendelenburg position.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position

Exclusion Criteria:

* Preexisting moderate neurological disease
* Moderate cerebrovascular disease
* Coronary disease with angina pectoris (CCS ≥ 1)
* Peripheral arterial disease II (with intermittent claudicatio)
* Cardiac insufficiency (NYHA \>2)
* Tumour in pharynx, larynx or oesophagus, an aneurysm of the thoracic aorta
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.


Eligibility Criteria:
Inclusion Criteria:

* are healthy males or females;
* in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
* read, understand and provide signed informed consent.

Exclusion Criteria:

* are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
* are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
* are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
* have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.
IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy

Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD

Device therapy using defibrillators and cardiac resynchronization therapy (CRT) is an important advance in the care of patients with acquired heart disease and heart failure. In specific groups these devices appear to significantly reduce the risk of sudden cardiac death and progression of heart failure. However, our ability to identify ideal candidates, and those who are most likely to respond and benefit from this therapy, is poor.

Preliminary studies using specialized Magnetic Resonance Imaging (MRI) appears to be one of the more valuable ways of predicting response to device therapy and holds substantial promise for patients with cardiomyopathy.

Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

Eligibility Criteria:
Inclusion Criteria:

* .Any patient accepted for primary prevention ICD (+/-) CRT)

Exclusion Criteria:

* Known contra-indications to MRI.
* Recent myocardial infarction or revascularization procedure within the past 3 months.
* GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.
APPEND-CT Registry

The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.

An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.

Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.

As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.

Eligibility Criteria:
Inclusion Criteria:

* Watchman FLX LAAO
* A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
* A minimum of one year clinical follow-up data
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS

The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.

This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced.

Subjects will receive appropriate training in the use of real-time CGM. Subjects will have regular contact with the study team during the study.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 16 - 24 years old (inclusive)
2. Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
3. HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
4. Treated with insulin pump or MDI
5. Has a Smart phone compatible with Dexcom G5 or similar
6. Willingness to wear study devices
7. Willing to follow study specific instructions
8. Literate in English

Exclusion Criteria:

1. Non-type 1 diabetes mellitus including those secondary to chronic disease
2. Any other physical or psychological disease likely to interfere with the normal conduct of the study
3. Untreated celiac disease or hypothyroidism
4. Current or planned users of real-time or flash (Libre) glucose monitoring sensors
5. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
6. Regular use of acetaminophen
7. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
8. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
9. Lack of reliable telephone facility for contact
10. Known or suspected allergy against insulin
11. Severe visual impairment
12. Severe hearing impairment
13. Subject not proficient in English
Biomarkers of Pancreatic Cancer and New Way to Detection

Amphoteric regulatory protein (AREG), a member of epidermal growth factor (EGF) family, is expressed in many tumors.Our study confirmed that the expression of AREG in the serum of patients with pancreatic cancer is significantly higher than that of patients with benign pancreatic diseases and healthy people, which is expected to become a new early serum marker of pancreatic cancer. The serum concentration of AREG was detected by traditional ELISA and compared with CA-199, which was a conventional tumor marker of pancreatic cancer. Next, we compare the advantages of using sensor to detect AREG compared with ELISA.

Serum was collected ： pancreatic cancer : healthy control =200:200 Clinical data were collected: age, gender, diagnosis, cancer stage, CA199 level at initial diagnosis, histopathological type, etc. The informed consent of the subjects was obtained before the study, and all experimental procedures were approved by ethics.

Draw a summary table of patient characteristics. The level of AREG was detected by ELISA kit and compared with CA199.

Fabrication of a new electrochemical biosensor. Characterization of sensor performance.

Eligibility Criteria:
Inclusion Criteria:

* The healthy control group had no history of benign pancreatic diseases and other benign and malignant tumors.
* Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual.

Exclusion Criteria:

* Uncontrolled active infection.
* Acute or chronic pancreatitis.
* It is accompanied by other uncontrolled malignant tumors.
* Any other uncontrolled active disease that prevents participation in the trial.
* Having a history of mental illness that is difficult to control.
* In the opinion of the investigator, the presence of medical or psychiatric history or laboratory abnormalities may increase the risk associated with participation in the study or the administration of the study drug, or may interfere with the interpretation of the results.
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.

OBJECTIVES:

* Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
* Determine the survival rate in patients treated with this regimen.

METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:

   1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
   2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
2. Must have been excised with breast-conserving resection and no positive margins
3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
5. Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

1. Age: 18 and over
2. Sex: Female
3. Menopausal status: Not specified
4. Performance status: Not specified
5. Life expectancy: Not specified
6. Hematopoietic: Not specified
7. Hepatic: Not specified
8. Renal: Not specified
9. Other:

   1. Not pregnant
   2. Negative pregnancy test
   3. Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

1. Biologic therapy: Not specified
2. Chemotherapy: Not specified
3. Endocrine therapy: Not specified
4. Radiotherapy: No prior radiotherapy to the ipsilateral breast
5. Surgery: See Disease Characteristics
Time-course of Mitochondrial Biogenic Gene and Protein Expression in Exercised Human Skeletal Muscle

This study examines the impact of exercise intensity on the 12-hour time-course of mitochondrial biogenic gene and protein expression in human skeletal muscle. Briefly, participants will perform two experimental sessions involving an acute bout of work-matched low- or high-intensity interval cycling exercise in a randomized crossover fashion, two weeks apart. Skeletal muscle biopsies will be obtained from the vastus lateralis (3 from each leg) before and 1, 3, 6, 9, and 12 hours post-exercise. Changes in the expression of various transcription factors and mitochondrial proteins will be examined at the mRNA and protein level to determine the time-course of changes in these factors differs between exercise protocols of different intensities.


Eligibility Criteria:
Inclusion Criteria:

* recreationally active (no more than three hours of structured weekly physical activity)
* not currently involved in a systematic training program for improving cardiorespiratory fitness, muscular strength, and/or sport-specific skills
* body mass index \< 30 kg/m2

Exclusion Criteria:

* presence of cardiometabolic disease
* taking regular prescription medication for the treatment of cardiometabolic disease
* current cigarette smoker
A Rollover Protocol of Dacomitinib For Patients In Japan

The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.

The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received dacomitinib on another clinical trial in Japan
* Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

* Patients who meet one or more study withdrawal criteria on the prior study
* Participation in other studies involving other investigational drug(s) during study participation
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol

The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).

A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
* Acceptable body mass (\< 30) and the weight is \< 90 kg
* Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
* Has a sitting blood pressure systolic \< 140 mm/Hg and diastolic \< 90 mm/Hg.

Exclusion Criteria:

* Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
* Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
* Has not a uncontrolled disorder
* No women over the age 35 who smoke.