cyrilzakka/clinical-trials huggingface dataset:
Acute Exposure to High Altitude on Symptoms

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) in altitude related symptoms

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested at Low Altitude (Zurich, 470m) and High Altitude (2500m).

Regularly during the exposure of approximately 5 hours, the participants will be asked to complete altitude related symptom questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement

The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery

Knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. The period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. Peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. After the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. The level of pain greatly affects the success rate of the patient's rehabilitation. Thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients between the ages of 18 and 80 who have signed an informed consent form.
* ASA is less than 3
* Spinal anesthesia

Exclusion Criteria:

* Patients with sensitivity to the anesthetic.
Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour

In integrative medicine wraps are applied for different indications. In this study the effects of thorax with ginger and mustard flour are investigated under standardized conditions. Heart rate variability, well being, warmth distribution and respiratory activity of healthy subjects will be measured.

The purpose of this study is to investigate the effects of different thorax wraps in healthy subjects. Subjects undergo three different interventions (wraps with ginger flour, mustard flour or warm water (placebo)) on three different days. Heart rate variability and respiratory activity is measured for ten minutes before, during (up to 20 minutes) and for ten minutes after each thorax wrap. To investigate the effects on heat development and regulation, photos are taken with a thermographic infrared camera at various moments in time. Participants are asked to fill in questionnaires referring to their subjective perceptions of warmth, bodily warmth distribution and wellbeing. The order of the thorax wrap interventions is randomized.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.

Exclusion Criteria:

Inflectional disease with body temperature \> 38 °C. Skin damage on the thorax area Known intolerance or hypersensitivity to mustard or ginger products. Heart failure. Asthma bronchiale. Taking medication with influence on heart rate variability ( mainly tricyclic antidepressants and beta blocker).

Consumption of coffee or nicotine less than three hours before the intervention.

Pregnancy. Deficient knowledge of the German language.
Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

This program allows physicians to request permission from Amicus Therapeutics (Amicus) for treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry disease. Treatment is open label for 6 months with renewal every 6 months.

This Physician Initiated Request program allows physicians to request permission from Amicus to receive migalastat HCl for specific patients with Fabry disease who have a mutation amenable to this treatment, who do not have access to available treatment alternatives, or do not meet requirements for participation in an existing migalastat clinical study. Up to 20 patients worldwide may be treated. Patients must meet specific criteria to receive Amicus permission for participation. Key criteria for participation include: 16-74 years old; Confirmed GLA gene mutation shown to be responsive to migalastat; Have no treatment option because either unsuitable for enzyme replacement therapy (ERT) or unable to access ERT. Requirements for sufficient kidney function. If permission is granted, initial approval is for a 6 month supply of migalastat HCl with renewal every 6 months available upon meeting continued eligibility.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed GLA mutation predicted to be responsive migalastat in the human embryonic kidney (HEK-293) cell-based assay
* 16-74 years of age
* Strong clinical indication for treatment of Fabry disease
* No other treatment option including either unsuitable for ERT or unable to access ERT
* Appropriate female and male contraception
* Willing to receive treatment with migalastat HCl via this program including having signed an authorization for sharing clinical data

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) or GFR \<30 mL/minute
* Scheduled for renal or other organ transplant or replacement therapy
* Receiving GLYSET® (miglitol), ZAVESCA® (miglustat) or enzyme replacement therapy FABRAZYME® (agalsidase beta) or REPLAGAL™ (agalsidase alpha)
* Contraindication to migalastat, i.e., sensitivity to other iminosugar such as miglustat, miglitol
* Treated with another investigational drug within 30 days of start of migalastat HCl treatment
* Unable to comply with study requirements or deemed otherwise unsuitable for study entry in the opinion of the investigator.
Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioural disorder often diagnosed in childhood years. Complementary/alternative treatments including natural health products (NHPs) are used by children with ADHD despite limited information on their safety or usefulness. Some evidence suggests children with ADHD have a greater need for zinc, magnesium, vitamin B6 and vitamin C. This study will supplement a small number of children diagnosed with ADHD with therapeutic levels of these nutrients over 10 weeks to get a better understanding of the safety and possible benefit of using these nutrients to treat symptoms associated with ADHD.

The is an open-label study. Children diagnosed with ADHD will be provided with a weight-based dose of a chewable natural health product containing zinc, magnesium, vitamin B6 and vitamin C for 10 weeks with an additional follow-up post intervention at 20 weeks. Severity of ADHD symptoms will be measured at baseline, week 5 and week 10 using the Connor-3 Parent and SNAP-IV validated questionnaires. Nutritional status will be monitored at baseline and week 10 for changes in serum zinc and erythrocyte magnesium. Children will be monitored for any adverse reactions that may occur using the investigational product.Following the informed consent process, participants will undergo a structured psychiatric interview prior to enrollment and will have 4 30 minute study visits and 2 10 minute telephone calls throughout the study. Blood samples will be taken 2 times with the use of a topical anesthetic to decrease sensation during the blood draw. Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children age 6-12 diagnosed with ADHD of any subtype according to DSM-IV criteria. A structured diagnostic interview (Kiddie Sads Present and Lifetime Version) will be conducted to confirm diagnosis of ADHD and assess for comorbid mental health disorders.
* Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

Exclusion Criteria:

* Changes to participants' ADHD medication within 6 weeks of study onset.
* Diagnosis of additional mental health disorder using the Kiddie Sads.
* Diagnosis of cancer.
* Antibiotic use for periods greater than 2 weeks within the 10 weeks prior to the study
* Diagnosis of Type 1 diabetes and insulin use
* Low serum ferritin/iron deficiency (\<30 ng/ml)
Investigation of the Validity, Reliability, and Responsiveness of the BETY-BQ in Myositis

Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Increased anxiety-depression-anxiety problems are observed in individuals, and many factors contributing to these conditions are reported. Therefore, while holistic evaluation of individuals, including these factors, gains importance, more information on how the quality of life changes during the disease is required. There is a need for tools to evaluate these characteristics in individuals disease management and treatment process.

The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed in patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of the improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain, coping skills, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that holistically evaluate the symptoms mentioned in myositis disease. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic disease, it aimed to examine its validation in this disease group.

This study, which the investigators planned to contribute to this field, aims to investigate BETY-BQ\^s validity, reliability, and responsiveness in individuals diagnosed with myositis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myositis
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Uncontrolled/other clinically significant disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) individuals with a diagnosis,
* Pregnant individuals,
* Individuals with malignancy
The VIDYA Study-designed to Determine if Patients With a History of Basal Cell Carcinoma Are More Inclined to Return for Follow-up if Their Risk of a Subsequent Basal Cell Carcinoma is Quantitated.

While current guidelines call for annual follow-up for patients with a history of basal cell carcinoma, compliance with these guidelines is imperfect. It is hypothesized that if patients are informed of the quantitative risk of a subsequent basal cell carcinoma based on individualized risk factors, the compliance rate for follow-up will improve.

The primary objective of this study is to assess one-year compliance with requested follow-up for patients with recent history of basal cell carcinoma, among those who receive standard sun avoidance counseling and request for follow-up compared to those who receive, in addition, an estimate of their mathematical risk of a subsequent basal cell carcinoma based on individualized risk factors.

This is an open-label, single-blind study to evaluate the effect of informing subjects of their individualized risk of a subsequent basal cell carcinoma on proportion of subjects who achieve compliance with requested follow-up with a dermatology healthcare provider, defined as in-person follow-up within 365 days following diagnosis of initial basal cell carcinoma.

Subjects will be randomized 1:1 to "intervention" (knowledge of individualized risk) or "control" (lack of awareness of individualized risk). Investigators will be aware of the modelled risk of a subsequent basal cell carcinoma for all subjects, but only subjects randomized to the "intervention" arm will be informed of their modelled risk. All subjects will receive standard sun avoidance counseling and will be requested to follow-up no later than 365 days from initial basal cell carcinoma diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosed with at least one Basal Cell Carcinoma within 30 days prior to enrollment
* Able and willing to answer all questions accurately in the Individualized Risk Assessment

Exclusion Criteria:

* History of Basal Cell Carcinoma 31 or more days prior to enrollment
* Solid Organ Transplant Recipient
* History of Immunodeficiency (e.g., HIV infection, AIDS, genetic immunodeficiency
* Prisoner
* Psychiatric inpatients or people who are institutionalized
Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.

A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.

A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early and intensive OT plus ASDM.

The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years.
* Need for hospitalization in ICU.
* At least 12 h of invasive mechanical ventilation
* Informed consent signed by legal representative and / or patient.

Exclusion Criteria:

* Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores\> 3.3 were excluded.
* Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as \> 6 points.
* Severe communication disorder and cultural limitation of language (language different from Spanish)
* Patient with limited therapeutic proportionality.
* Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
* Spinal injury or unstable fractures that limit mobilization
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer

To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥18 years old;
* Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions;
* Have at least one measurable lesion according to RECIST 1.1 standards;
* ECOG PS score: 0-2;
* Expected survival greater than 3 months;
* Routine blood routine, liver and kidney function, electrocardiogram and other routine tests were basically normal, no contraindications of chemotherapy;
* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits;
* Researchers believe treatment can benefit.

Exclusion Criteria:

* A proven allergy to the test drug and/or its excipients;
* Pregnant or lactating women;
* Patients judged by the investigator to be unsuitable for inclusion in this study;
Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement has been applied to leg pressure measurement and determination of the ankle-brachial index with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity.

In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived from the lower extremities as compared to Doppler-based measurements of blood pressure. We used signal processing analysis and regression techniques to develop a two-step algorithm which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure across the spectrum of peripheral artery disease severity.

This proposed project will validate this novel oscillometric ABI algorithm in a population of patients who have been identified as at risk for PAD and for whom screening ABI has been recommended by multiple professional organizations (AHA/ACC and American Diabetes Association). Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial index and toe-brachial index will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* At least 70 years of age
* At least 50 years of age with a history of diabetes mellitus or tobacco smoking (\>100 cigarettes in their lifetime)
* Ambulatory Outpatient

Exclusion Criteria:

* Unable to give informed consent
* Unable to lie supine for at least 15 minutes
* Known non-compressible vessels on prior laboratory studies (ABI\>1.3 on either side)
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.


Eligibility Criteria:
Inclusion Criteria:

* Women, 25 to 50 years old.
* Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
* Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
* Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

Exclusion Criteria:

* Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
* History of cancer, except basal cell or squamous cell carcinoma of the skin.
* History of genital herpes with \> 3 outbreaks per year, or active non-HPV vaginal infection.
* Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
* History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

This study integrates traditional Chinese medicine syndromes and pulse diagnosis, and uses laser vibration overlay and functional cerebral angiography to understand the efficacy of scalp acupuncture against Parkinson's Disease.

Traditional Chinese medicine does not have the term " Parkinson's disease". According to the symptoms of the disease, it is closer to the "Liver wind", "Vibration" and "Chatter" in Chinese medicine. Scalp needle stimulation can increase the content of dopamine in the brain and improve mitochondrial function and reduce the death of substantia nigra.

This study integrates TCM syndromes and pulse diagnosis, and uses laser vibration overlay and functional brain image to understand the effect of scalp acupuncture on Parkinson's disease. The project will be carried out in two phases: the first phase is the pilot study, and 200 patients with limb shakes were collected from the neurology clinic. After the laser vibration overlay test, 20 patients with mild tremors and diagnosed as Parkinson's disease were selected. , treated by Wen's scalp acupuncture. In the second phase, 80 Parkinson patients were enrolled, randomized to the treatment group and the control group, and the changes in TCM syndrome, pulse diagnosis and Parkinson scale were compared before and after treatment, and the fMRI and vibration overlay ratios were evaluated after scalp acupuncture.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as Idiopathic Parkinsonism by Neurologist
2. Have taken first line drugs more than three months
3. Did not take any acupuncture or rehabilitation
4. Voluntary

Exclusion Criteria:

1. Taking anticancer drug now or diagnosed as depression, psychosis or other mental illnesses
2. Medical history of stroke or dementia
3. Taking anticoagulant now or having coagulation disorders
4. Scalp infection
5. Pregnant women
6. Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted cardioverter-defibrillator
7. Belonephobia