cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Pregabalin in Migraine Prevention

The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.

The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.

Eligibility Criteria:
Inclusion Criteria:

* Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.
* Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.
* Available for follow-up at least 9 months.

Exclusion criteria:

* Patients with headache others than migraine.
* Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.
* Prophylactic drugs for migraine 12 weeks before randomization.
* Onset of migraine occurred after 50 years.
* Hypersensitivity to pregabalin or sodium valproate.
Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest

Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography (TCD) in comatose survivors after cardiac arrest.

Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit and cardiac intensive care unit in a university hospital.

Patients: all comatose patients older than 18 years successfully resuscitated from an out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic brain injury, no window for TCD measurements, or dead before neurological prognostication are excluded.

The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the right and left middle cerebral artery during the first 12 h after return of spontaneous circulation (ROSC). The highest value of DFV and the lowest of PI will use for the statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital discharge.

Data provided by early TCD after ROSC are associated with neurological outcome. The use of these data could lead to the development of therapeutics improving cerebral perfusion in patient resuscitated from an OHCA.

Eligibility Criteria:
Inclusion Criteria:

* older 18 years
* out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity

Exclusion Criteria:

* transcranial doppler not done or not interpretable
* associated cranial trauma
* died without neurological assessment
Telerehabilitation in Individuals With Chronic Disease

Telerehabilitation applications are a treatment method that uses new technologies. There are examples of doing for many diseases in our country. It is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. In our study, we will use the telerehabilitation system. In this system, which we will use in people with chronic disease, we aim to see improvement in tests performed in many areas such as physical activity level, respiratory capacity, depression, and anxiety level of patients.

In the study to be performed on 60 patients, 30 people will be control and 30 people will be the experimental group. The experimental group will be treated with a video conferencing method, tailor-made exercise program based on the international physical activity questionnaire level for 30 minutes 3 days a week for 6 weeks. The control group will only be informed with the help of a brochure with a standard exercise program.

The tests we can use in this experiment are as follows: Barthel daily life activities index, beck depression and anxiety scale, ferrans power quality of life index, Charlson comorbidity index, environmental measurements, waist/hip ratio, fatigue severity scale, international physical activity questionnaire. Tests specific to chronic diseases will be applied to patient one to one.


Eligibility Criteria:
Inclusion Criteria:

* Having a chronic disease
* To be able to communicate verbally
* Being in a stable period in terms of disease
* At least 3 months for the disease to be chronic
* Regulated hypertension
* Diabetes patients should have them blood sugar under 200 during therapy

Exclusion Criteria:

* Dementia
* Being a cancer patient receiving chemotherapy
* Epilepsy and a history of seizures
* Patient who has recently undergone surgery
* Pregnancy
* Delirium
* Bedridden
Evaluation of New Markers in Type 3 Angioedema

Angioedema is a common condition, with multiple etiologies.

Type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. In some cases, it may be associated with clotting factor 12 mutations. However, other genetic abnormalities remain to be identified.

Clinically, this angioedema type 3 is similar to types 1 and 2. The patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. Otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker.

Videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema.

The purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. Functional analysis of factor XII in patients with symptoms of angioedema may be an interesting marker for diagnosis.

Microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)

Exclusion Criteria:

* None
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about the health and the diabetes treatment. Participants will complete these during the normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
* Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Treatment with any investigational drug within 90 days prior to enrolment into the study
* Hypersensitivity to semaglutide or to any of the excipients
Vascular Fundus Changes in Patients With High Probability of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

The investigators propose that evidence of chronic cerebrospinal venous insufficiency (CCSVI) may be evident in the vasculature of the fundus. The investigators will be examining fundi of multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI can be found in these patients having high risk for CCSVI. The investigators will read the fundus photos, compared to age-matched normals in a "blind" fashion.

Chronic Cerebrospinal Venous Insufficiency (CCSVI) has been proposed as the cause of numerous neurodegenerative diseases of the brain. CCSVI is the result of poor drainage of blood (and cerebral spinal fluid to some degree) from weakened or stenosed veins usually located in the cervical area (most notably the internal jugular veins). Although current focus and treatment of CCSVI is on multiple sclerosis, CCSVI has also been implicated as a potential cause of Alzheimer's disease and Parkinson's Disease. Additionally, patients with Ehlers-Danlos Syndrome (EDS) -- a disorder of connective tissue -- are more prone to developing multiple sclerosis than the general population. Many EDS patients are known to have weakened and abnormal blood vessels and 40 - 70% of EDS patients develop autonomic dysfunction in addition to numerous other symptoms found in patients with CCSVI. In the small subset of EDS and multiple sclerosis patients seen at Total Eye Care, the investigators have noticed a vascular irregularity (using the optomap® and examining the results under high magnification) which offers credence to the theory of CCSVI. Such objective data has been elusive, excepting for fMRI, ultrasound (to a limited degree) and venous angioplasty results. Current treatment of CCSVI involves the ballooning and sometimes stenting, of abnormally stenosed veins. The treatment of CCSVI offers hope to many patients suffering from multiple sclerosis. Although CCSVI research is in its infancy, many doctors believe that CCSVI is a significant portion of the solution to patients with neurodegenerative diseases of the brain. Because CCSVI is a vascular disorder, the investigators hypothesize that the investigators are able to screen candidates for CCSVI via the optomap®.

Eligibility Criteria:
Inclusion Criteria:

* age matched normals
* patients with diagnosed or suspected Ehlers-Danlos Syndrome and/or diagnosed or suspected Multiple Sclerosis ("CIS")

Exclusion Criteria:

* diabetics and patients unable to sit in position for testing are excluded
Mindfulness on Physical and Mental Condition in Older Adults With Chronic Pain

This research corresponds to an experimental study, a randomized controlled clinical trial in people over 65 years of age, distributed into two groups: the experimental group will receive a program that will consist of an eight-week mindfulness-based intervention; and the control group that will only receive general recommendations about the benefits of physical exercise. Measurements will be carried out at the beginning of the intervention and immediately after its completion.


Eligibility Criteria:
Inclusion Criteria:

* The study participants are men and women over 65 years of age residing in the city of Jaén (Spain).
* People with pain with more than 3 months of evolution.
* Participants must have completed the informed consent.

Exclusion Criteria:

* That they do not voluntarily accept to participate in the study and that they are able to understand the instructions and follow the instructions of the intervention.
Pharmacological Modulation of Peripheral Nerve Excitability

The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.

The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).

Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room.

Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms.

In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%).

The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women age \> 18 years
* Understand and speak Danish
* No medication besides contraceptives

Exclusion Criteria:

* Pregnancy or lactating women
* Drug addiction (use of cannabis, opioids, or other drugs)
* Use of pain killers, alcohol, or nicotine within the last 24 hours before study start
* Any other medical treatment (e.g., antidepressants, anticonvulsants)
* History of peripheral or chronic pain conditions / neuropathy
* Skin diseases
* Scars and/or tattoos at the volar site of the forearm
* Previous traumatic experience of an electrical accident
* Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
* Participation in any other research projects/studies 7 days before study start
* Known allergy/intolerance to lidocaine/phenytoin/mepyramine
* Lack of ability to cooperate
Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a term that defines a chronic disease characterized by inflammation of the intestine. It includes ulcerative colitis (UC) and Crohn's disease (CD). The objective of the study was to administer a treatment based on a group adaptation of the BMGIM in patients with inflammatory bowel disease (IBD) and assess its impact on state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress.

To achieve the objectives a quasi-experimental, quantitative, qualitative, analytical, and prospective study was performed. 41 patients with IBD divided into a test group (24 patients), who received 8 sessions over 8 weeks, and a control group (17 patients). A saliva sample was taken from each patient before and after each session to determine cortisol levels (acute stress) and IgA (immunocompetence) using ELISA. A series of questionnaires were completed as follows: HADS (perceived anxiety), MOOD (state of mind), and CCVEII (quality of life). Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level (chronic stress) using ELISA.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old,
* Diagnosed IBD (EC or UC) in the remission phase,
* They did not receive treatment with corticosteroids at least in the two months prior to the start of the study,
* They did not receive any extra pharmacological treatment,
* Attend the collaborating hospital center with the study, in this case, the University General Hospital of Valencia,
* Attend the schedule and schedule established for the study,
* Accept the conditions of participation in the study indicated in the signed informed consent prior to the start of the study
* \* Do not take corticosteroids during the 8 weeks between the pre-test and the post-test,
* \* Perform the pre-test before starting session 1 (in case of experimental group) or appointment 1 (in case of control group); and then the retest at the end of session 8 (in the case of an experimental group) or appointment with nursing after 8 weeks (in the case of a control group).
* \* In the case of the patients belonging to the experimental group, who at the end of the 8 weeks of treatment would have attended at least 6 of the 8 sessions established (and that, obligatorily, 2 of them were 1 and 8, where the shots were taken) sample and completed the questionnaires).

Exclusion Criteria:

The patients who were excluded from this study were those who did not meet the requirements indicated in the inclusion criteria, or who showed aversion or rejection to this type of therapy.
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* PAOD and Rutherford classes 2 - 4 (pain-free walking distance \<500 m)
* eligible for peripheral revascularization by means of PTA
* peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
* minimum diameter stenosis of ≥70%
* treatment length at least 15 cm (lesion length at least 13 cm)
* maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion
* long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. \<50% stenosis) segments in between the lesions extent to \>2 cm, otherwise vessel segments will be treated as a single extended lesion
* eligible for an operative vascular intervention in case of complications during the PTA

Exclusion Criteria:

* Rutherford class 1,5 or 6
* more than two stenotic lesions in the target vessel requiring treatment
* inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
* in-stent restenosis of the study lesion
* strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of \>4 cm
* reference vessel diameter \<4 mm and \>6 mm
* guide wire could not be successfully advanced across the lesion
* lesions below the knee requiring treatment
* target lesion is located in the PII-segment of the popliteal artery (A.pop.) or within a bypass graft
* acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion
* potential loss of leg due to critical or acute ischemia
* no patent distal run-off vessel
* medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months
* female patient who is pregnant or lactating
* under 18 years of age
* patients under administrative or judicial custody (§20 Act on medical Devices, Germany)
* expected life span of less than 24 months
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia

The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)

Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.

Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced PCa meeting the following criteria:

   1. Any Tumor, Node 1, Metastasis 0
   2. Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\]
2. Participants planned for administration of leuprorelin
3. World Health Organization status 0-1
4. Life expectancy at least 2 years

Exclusion Criteria:

1. Contraindications to administration of leuprorelin:

   1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
   2. Surgical castration
2. Hormone-refractory PCa
3. Presence of another malignant tumor (except skin cancer)
4. Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
5. Previous administration of radiotherapy or chemotherapy course within 1 month
6. Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
7. Extremely high level of PSA (greater than or equal to 1000 ng/ml)
8. Other severe diseases in stage of decompensation
9. Other contraindications, that make the participant's participation impossible (by investigator judgment)
10. Previous enrollment in the present program