cyrilzakka/clinical-trials huggingface dataset:
Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation

The purpose of this study is to evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed.

The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compare three different point locations (one acupuncture point and two non-acupuncture points) stimulated with acupuncture needles. Two measurements each with 20 subjects are planned.

* With the EEG measurements the impact of the stimulation's location on background rhythm especially in the somatosensoric cortex is evaluated.
* With the fMRI (functional magnetic resonance imaging) measurements the impact of the stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional connectivity is evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. healthy subjects of age from 18 to 40 years (inclusive)
2. right-handed (evaluated by "The Edinburgh Inventory")
3. with informed consent signed
4. no acupuncture treatment in the last 12 months
5. no medical knowledge about acupuncture
6. free time to take part in the measurements

Exclusion Criteria:

1. history of neurological and/or psychiatric diseases
2. history of brain injury
3. cognitive handicap, severe speech disorder, alcohol or drug abuse
4. history of neurosurgical intervention
5. chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
6. pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
7. any contraindication for acupuncture (e.g., anti-coagulation therapy)

   Additional exclusion criteria for fMRI measurement:
8. any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )
Effect of Helmet Type, Home-use Low-level Light Therapy Device for Chemotherapy-induced Alopecia

As far as breast cancer is concerned, chemotherapy (CT) is an important treatment. However, there are many adverse effects impairing the patient's quality of life (QOL), in which chemotherapy-induced alopecia (CIA) affects up to 65% of the patients. This condition is reversible. Nevertheless, it takes several months after CT for visible hair regrowth. Different characteristics of the new hair are common; for example, 65 percent of the patients have experienced a graying, curling, or straightening effect. Besides, the emotional trauma due to alopecia can not be neglected.

Currently, scalp cooling is the only available and verified management for prevention. Unfortunately, the success rate of scalp cooling is variable, especially among the patients receiving anthracycline-based combinations.

Low-level light therapy (LLLT) has been proven as a therapeutic technique for adrenergic alopecia. Recently, investigators have checked the validity of LLLT for the CIA. Although the preliminary outcome showed failure at accelerating hair recovery, technical progress of LLLT may improve the end result. Specifically, LLLT is a technique that utilizes laser diodes (LD) or light-emitting diodes (LED) to promote tissue repair. The light source from LD is coherent while LED is an incoherent light source. Therefore, LDs can deliver energy to tissues more efficiently than LEDs. To comprehensively evaluate the beneficial effect of LLLT in treating CIA, we conduct a clinical trial with a more advanced device equipped with 69 LDs.

The project aims to explore the effect of low-level light therapy in chemotherapy-induced alopecia. We expect the therapy will lead to an improvement in the patient's hair count, hair width, and quality of life after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 to 75 years
* Informed Consent as documented by signature.
* Able to read and converse in chinese
* Female
* Diagnosis of breast cancer
* They completed chemotherapy no more than 2 weeks
* Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen.
* life expectancy was at least 6 months.
* Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)

Exclusion Criteria:

* scalp tumor or melanoma
* having any serious mental illness or history, or taking psychotropic drugs
* a medical history of dermatosis
* severe liver and kidney damage
* Pregnancy
* Take any of the following medications for 6 months prior to initiation of the study: topical minoxidil, and spironolactone, and topical calcitriol
* Receiving scalp cooling during chemotherapy
Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant

İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.

Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria: American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* Inclusion Criteria:
* 18-65 years of age
* American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* local anesthetic allergy
* Infection at the procedure site Body Mass Index \>35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease
Efficacy of Indigenously Adapted Cognitive Behavioral Therapy for Reducing Gaming Addiction Among Adolescents

Research evidence identified internet gaming as an emerging problem in youth across the globe and a lot of interventions are being used for managing gaming and associated psychological problems considering cultural aspects. Therefore, the present study aims at investigating the efficacy of Indigenously adapted cognitive behavior therapy for internet gaming addiction among Pakistani Youth. For this purpose, adolescents enrolled in 8th-12th grades in elementary and higher secondary schools in twin cities of Pakistan. Adolescents who scored high on Internet gaming disorder in screening will be included in the study and further detailed investigation will be completed by administering semi-structured Clinical Interviews, Coping inventory, self-control, and social connectedness. Participants will be divided into 2 groups i.e. experimental and control groups.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescents ranging from 13 - 19 years (WHO, 2013) enrolled in an educational institute in the vicinity of the Federal capital area
2. Playing Internet offline/online games.
3. Excessive users who play more than 5-8 hours per day,40 hours per week will be included.
4. Playing games for at least the past year.
5. No history of major illness or any other psychological disorder.

Exclusion Criteria:

1. Diagnosed prior for any mental or psychological disorder.
2. Receiving any psychotherapy or medication for any particular disorder
Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD

Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.

Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18-80 years old
* 2. End-stage liver disease
* 3. Signed informed consent

Exclusion Criteria:

* 1. Tumours of the liver or other organs
* 2. Liver transplantation recipients
* 3. Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
* 4. Other diseases that may seriously affect the survival
* 5. Human immunodeficiency syndrome
* 6. Interferon or glucocorticoid therapy within 1 year
* 7. Treated for mental illness
* 8. Participation in other clinical trials within 30 days
* 9. Pregnant or breastfeeding subjects
* 10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
* 11. Other circumstances that are unsuitable for participation in this study
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent (either from patient or patient's legally acceptable representative)
2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
3. Patients with alcoholic hepatitis defined as:

   1. History of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, AND
   2. Consumed alcohol within 12 weeks of entry into the study, AND
   3. Serum bilirubin \> 3 mg/dL AND AST \> ALT, but less than 300 U/L AND
   4. MELD score between 11-30, inclusive
4. No evidence of active infection as determined by the investigator.
5. Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
6. Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration

Exclusion Criteria:

1. Other or concomitant cause(s) of liver disease as a result of:

   1. Autoimmune liver disease
   2. Wilson disease
   3. Vascular liver disease
   4. Drug induced liver disease
2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
3. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
4. If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
5. Serum creatinine \> 2.5 mg/dL
6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
7. Stage 3 or greater encephalopathy by West Haven criteria
Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation

1. Diagnosis MF(includ Post-ET,Post-PV,PMF,MDS/MPN with MF)
2. With at least two month Ruxolitinib treatment prior to transplantation
3. DAC+BF as myeloablative conditioning regimen
4. CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor
5. received Rux at +6d in ASCT and continued to +60d


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years old, gender is not limited;
2. Diagnosis MF(includ Post-ET,Post-PV,PMF) according to 2016 WHO
3. With at least two month Ruxolitinib treatment before transplantation
4. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. HCT-CI score≥2
2. Woman who is pregnant or nursing
3. MPN Patients who have received allogeneic hematopoietic stem cell transplantation
Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients

This study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Intensive care unit patients who need mechanical ventilation
* Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products
* Acute physiology and chronic health evaluation II score more than 10
* Aged between 60 to 80 years old
* Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion Criteria:

* Trauma and burn patients
* Any kind of dialysis
* Suspected or confirmed difficult airway
* Use of neuromuscular blocking drugs(Except using for intubation )
* Neuromuscular disease
* Epidural or subarachnoid anesthesia
* Plan to give general anesthesia before 24 hours drugs intervention or after giving investigational drugs
* Serious central nervous system disease
* Mental disability or mental disease
* Acute hepatitis and serious liver disease(Child-Pugh C)
* Unstable angina and acute myocardium infarction
* Left ventricular ejection volume less than 30%,heart rate less than 50 beats per minute
* II and III degree atrioventricular block
* Systolic pressure less than 90 mmHg after giving vasopressors twice before beginning of this study
* Consciousness disturbance patients whose blood pressure less than 70mmHg and blood lactate more than 4.0mmol/L
* Suspected or confirmed long term use of narcotic analgesics
* Subjects who are breastfeeding or pregnant
* Allergic to investigational products or with other contraindication
* Participated in other study within 30 days
Home Based Exercise in Preventing Fall and Improving Balance in Older People

Prior studies have shown multifaceted falls prevention program with home-based exercise reduced falls significantly in the community setting. The Otago exercise program has been tested in four separated controlled trials of community living people in New Zealand. Falls were the main outcome in each trail and were defined as "unintentionally coming to rest on the ground, floor or other lower level". Not only this combination strengthening and balance training exercise could reduce fall but also could benefit in cost-effectiveness for fall prevention and decrease mortality in those 80 and older. However the limitation of Otago exercise program is that the program was needed to be trained by skill nurses or physical therapists. There are 17 steps levels to adhere the program. As some studies have shown that fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical staffs are continued the problem in the community. Therefore to establish fall prevention guideline that will be suitable and translated into the real setting, this study is aimed to test the effectiveness of simple program home-based exercise comparing to non-simple program home based exercise in preventing fall and improve muscle strength and balance dysfunction in older people with mild to moderate balance dysfunction. The method is the randomized controlled trails.


Eligibility Criteria:
Inclusion Criteria:

1. Thai elderly aged 65 years or older
2. able to communicate and follow the home-based exercise programme
3. mild to moderate balance dysfunctions as followings:

   * functional reach test score less than 26 cm.
   * five time sit to stand test more than 17.9 seconds
   * able to walk independently or walk with only single cane
4. non diagnosed with moderate to severe dementia or depression
5. non diagnosed with parkinson disease
6. non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.
7. non diagnosed with acute arthritis or recent diagnosed within 6 months.
8. informed and consent to participate in the study
9. not participate in regular Tai-chi or Yoga exercise training.

Exclusion criteria:

1. Participants would like to withdraw from the study.
2. severe injury occured after following simple designed exercise program eg. tendon injuries.
Mobile Phone Personalized Intervention for Diabetes

With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile phone intervention was a kind of high cost efficiency and high quality health care. Our study evaluated a diabetes coaching system, using mobile phones and patient/provider portals for patient-specific treatment and communication.


Eligibility Criteria:
Inclusion Criteria:

1. Physician diagnosis of type 2 diabetes
2. Age 20 years and more
3. The local resident

Exclusion Criteria:

1. Not currently managed by study physicians
2. Pregnant
3. Active substance, alcohol, or drug abuser
4. Psychotic or schizophrenic under activecare
5. Severe hearing or visual impairment
6. No telephone or mobile phone
Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise

Randomised cross-over study seeking to explore the acute physiological and perceptual responses to three novel forms of high-intensity interval training (HIT).

Randomised cross-over study seeking to explore the acute physiological (heart rate and blood pressure) and perceptual responses (rating of perceived exertion, mood and enjoyment) to three novel forms (non-contact boxing, stair stepping and stair climbing) of high-intensity interval training (HIT).

Eligibility Criteria:
Inclusion Criteria:

* adult (≥18 years) employees
* no health conditions that preclude them from exercise and on no medication, information obtained via their self-report.
* able to understand written and spoken English.
* participants reporting that they are asthmatic will allowed to participate with medical clearance and instructed to bring their bronchodilator medication and use it when required.

Exclusion Criteria:

* symptoms of or known presence of heart disease
* condition or injury or co-morbidity affecting the ability to undertake exercise
* diabetes mellitus
* early family history of sudden cardiac death
* pregnancy or likelihood of pregnancy.
Opiate Sleep Disordered Breathing Study

Lay title: A study of breathing pauses during sleep in patients on long term opiates.

Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central sleep apnoea). Clinical observation has noticed that patients on opiates have an increase in sleep apnoea.

Hypothesis: This study looks at the relationship of opiates (when used for patients chronic pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in sleep apnoea (particularly of the central variant) particularly in patients on long term opiates.

The purpose for this study is to test the hypothesis that sleep disordered breathing is more prevalent amongst a group of patients on high dose opiates for chronic pain.

Aims

1. To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain.
2. To determine the prevalence of respiratory failure in this cohort of patients. Patients on long term opiates (\>6 months) from an outpatient pain clinic population on long acting morphine formulations \> 40 mg/day, Oxycontin 30 mg/day, and Methadone \> 20 mg/day were prospectively recruited. Home polysomnograms were done on them. During their clinical review they have spirometry, arterial blood gases, psychomotor vigilance tests done on them.

Eligibility Criteria:
Inclusion Criteria:

* Patients on long acting Morphine \>40mg/day, Oxycontin \>30mg/day, and Methadone \>20mg/day were contacted.
* Stable opiate dose for 2 weeks
* Lives within 80KM of FMC

Exclusion Criteria:

* Significant CCF/CVA
* Severe COPD
* Major Psychiatric illness
* History of substance abuse in the last 3 months
Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* First-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
Micro-Health Insurance in Cambodia

People who buy insurance are sicker and/or more risk averse than those who don't. Also, Micro-health insurance increases utilization of public health care facilities and protects against asset sales.

Randomly assign coupons giving a discounted price for insurance. Since coupon receipt is exogenous, use these coupons as an instrument for take-up of insurance.

Eligibility Criteria:
Inclusion Criteria:

* Must be in a village where the health insurance program is being offered.