cyrilzakka/clinical-trials huggingface dataset:
Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)

The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:

* To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire.
* To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 \& 6 from Restless Legs Syndrome-6).
* To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores.
* To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3.
* To evaluate the development of behavioural changes under pramipexole treatment.

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of primary moderate to severe Restless Legs Syndrome.
2. Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study.
3. Male or female patients aged at least 18 years.
4. Written informed consent by the patient for study participation.

Exclusion criteria:

1. Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients.
2. Previous or ongoing treatment with Sifrol® (pramipexole).
3. Previous or ongoing treatment with dopamine receptor agonists.
The Imaging Genetic Study of Schizophrenia and Family

To investigate the brain abnormalities and the association with gene in schizophrenia patients and their relatives.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia（DSM-IV）
* total score of PANSS\>64

Exclusion Criteria:

* other psychiatric disease,
* organic disease
* neurological disease
* unstable physiological status
* age\>65
* pregnant
MASIMO Radical 7 and Laboratory Measurement

Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin concentrations through compared with laboratory measurement during major hepatic surgery, and to determine the source of discordance between two methods.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* American Society of Anesthesiologists Physical Status Ⅰor Ⅱ
* scheduled for potentially hemorrhagic major hepatic resection under general anesthesia
* requiring an arterial line

Exclusion Criteria:

* coagulopathy
* hemoglobinopathy
* cardiac dysrhythmias
* arrhythmia
* intracardiac shunt
* heart valve diseases
* tinea unguium
* arterio puncture failure
The Effects of Alkalised Cocoa on Human Vascular Function

The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa

A randomised, triple blind, cross-over design human intervention studies will be conducted in 10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism and vascular reactivity of cocoa flavanols. Participants will be requested to consume a standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and micronutrient content. Vascular measurements will be performed by using Flow Mediated Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine samples will be taken to measure the concentration of flavonoids from the cocoa drinks and markers of blood vessel function. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Male
* signed consent form
* age of 18-35 years inclusive
* BMI between 18.5-30

Exclusion Criteria:

* Blood pressure \> 150/90 mmHg
* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Cholesterol \> 6.5 mmol/l
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Suffers from any reproductive disorder
* Suffers from any blood-clotting disorder
* Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Any dietary restrictions or on a weight reducing diet
* Drinking more than 21 units per week
* On any lipid-modifying medication
* On any blood pressure lowering medication
* On any medication affecting blood clotting
* Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
* Regular or vigorous exercise (3 times/week, 20 minutes each session)
* Smoking
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders

The primary objective of this protocol is to implement the UG3 phase (Phase 1) of a National Institute on Drug Abuse (NIDA) UG3/UH3 grant (RFA-DA-23-049). This phase is dedicated to the pilot testing of NEAT-O, a digital Cognitive Behavioral Therapy (CBT) program tailored for individuals with opioid use disorder (OUD) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (INTDs). NEAT-O is based on an empirically supported CBT framework, specifically modified to address the complexities of comorbidity in substance use disorders (SUDs). This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD, with the goal of refining the program\&#39;s content and delivery methods. The results of the pilot study will inform a comprehensive RCT in the UH3 Phase (Phase 2) (N=300). Progression to the UH3 phase, with its funding, depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program\&#39;s acceptability and usability.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 to 65
* Current DSM-5 diagnosis of OUD (confirmed during MINI 7 interview)
* Current DSM-5 diagnosis of panic disorder with or without agoraphobia (PD/Ag) generalized anxiety disorder, social anxiety disorder, or major depression (confirmed during MINI 7 interview)
* Currently in treatment for OUD using MOUD
* Access to an internet-enabled smartphone for the duration of the study
* Currently residing in the United States
* Provision of informed consent

Exclusion Criteria:

* Current diagnosis of psychosis
* Current institutionalization (e.g., jail, hospital)
* Self-reported pregnancy
* Non-English Speakers
Pilot Study Investigating Intensity and Quality of Movement Performed During a Parkiboks Session

Studies have shown that non-contact boxing benefits individuals with Parkinson disease. Yet, the content of such sessions, has not yet been investigated. The following research question has therefore been asked: What is the physical intensity, in terms of both movement quality and quantity, as well as cardiovascular demand, in a group of individuals with Parkinson's disease during a one-hour session of Parkiboks? Though the study is exploratory, the investigators hypothesize to observe increases in cardiovascular activity during the session, as well as a high number of upper-limb repetitions of near maximal range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Official diagnosis of Parkinson disease Active participants of a non-contact boxing group for people with Parkinson disease located in Turnhout, Belgium Participating in non-contact boxing sessions for at least one month prior to the study

Exclusion Criteria:

* Unable to read and understand the informed consent document Individuals who are wheelchair-bound
Efficacy of Digital CBT-I Intervention During Pregnancy

This randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy for Insomnia in pregnant women. Particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. The experimental intervention is a digital CBT-I and the control intervention group is an assertive communication training. Both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. Furthermore, both interventions protocol include a baseline, half time and follow up assessments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnancy
* Women that not consume nicotine or alcool
* BMI \< 30
* Women who complains of insomnia or bad sleep quality

Exclusion Criteria:

* BMI\> 30
* Complicated pregnancy
* Women who consume nicotine or alcool
A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

The purpose of this study is to assess the safety (serious adverse events \[SAEs\]), and severe adverse events \[AEs\] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.

This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart (Group 2)

Eligibility Criteria:
Inclusion Criteria:

1. Age:

   Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group 2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.
2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parents or legal guardians as per Dominican Republic regulations.

Exclusion Criteria:

1. Previous Vaccinations:

   Group 1: Previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks.

   Group 2: Any vaccination against poliovirus
2. Group 2: Infants with birth weight (BW) \< 2,500 gm.
3. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
4. Family history of congenital or hereditary immunodeficiency.
5. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
6. Known allergy to any component of the study vaccines or to any antibiotics.
7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
8. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met).
10. Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months, or is scheduled to receive OPV during the study period.
11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Telephone Physical Activity Intervention in Obese Youth

The purpose of this study is to examine the effectiveness of a telephone-based physical activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The telephone-based PA intervention will increase PA levels above the mail group; and 2. The telephone-based PA intervention will provide changes in waist circumference and BMI z-scores above the mail group.

Obesity rates in youth have tripled over the past 20 years. Physical activity aids in weight loss and is critical for weight maintenance. Further, physical activity has other physiological and psychological benefits. Obese youth often see specialists for weight loss treatment. Treatment in a pediatric population uses a multi-component approach, but physical activity if often overlooked. Combining physical activity information with physician care and nutritional information could improve weight loss and the overall health of these obese children.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 18 years old
* attending the ECU Pediatric Comprehensive Healthy Weight Clinic

Exclusion Criteria:

* must be able to read and write in English
* must be able to participate in physical activity
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.

MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that:

1. The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas
2. Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone
3. Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

Eligibility Criteria:
Inclusion Criteria:

1. Age 15 or older
2. Admission CT Scan shows intracranial hemorrhage
3. Glasgow Coma Scale less than 15
4. Neurosurgery service determines initial care is nonoperative
5. Admitted for observation for TBI, to either step-down unit or intensive care unit

Exclusion Criteria:

1. Inability to provide informed consent or lack of a legally authorized representative (LAR)
2. Admitted and observed for \>2 hours prior to screening (i.e., has already received second neurological check)
3. Other injuries deemed non-survivable
4. Diagnosed with hemorrhagic shock or receives a large volume transfusion (\>3 units of any blood product within any 1 hour)
5. Planned surgical interventions/ procedures during study period (before the second CT scan)
6. Known prisoner
Tyrosine Kinase Inhibitors (TKIs) in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study

This is a real world study to evaluate the efficacy and safety of tyrosine kinase inhibitors after T-DM1 progression.

HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Trastuzumab emtansine (T-DM1) has shown great effectiveness in treating HER2-positive metastatic breast cancer, but therapies subsequent to T-DM1 progression are still controversial. Here, we investigated efficacy and safety of tyrosine kinase inhibitors (TKIs) based therapy in T-DM1 resistant HER2-positive metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female and 18-70 years old
* Metastatic or locally recurrent HER2-positive breast cancer
* Patients received TKIs-based therapy after T-DM1 failure in treatment for metastasis
* Complete and accurate medical data

Exclusion Criteria:

- Incomplete medical data
Oral Contraceptive During Menopausal Transition

Muscle or joint pain is one of the most common symptoms during menopausal transition. As this could be severe enough to affect social and daily life and to reduce quality of life, attentions should be paid about this.

Although understanding of muscle or joint pain related to menopause is still insufficient, estrogen can play an important role. Previous studies have shown that estrogen protects cartilage in both animals and humans.

However, perimenopause is different from postmenopause, in the point that estrogen is still secreted with a great fluctuation.

Until now, no study has been performed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition. Moreover, since menopausal symptoms vary according to ethnicity and culture, a study in Korean population is necessary.

Therefore, this randomized controlled trial was designed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition, compared to NSAID (non-steroidal anti-inflammatory drug).


Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal women aged 45 or more
* Women who have multiple joint or muscle pain for at least 3 months (at least two sites out of upper and lower extremities or axial)

Exclusion Criteria:

* Rheumatoid arthritis, ankylosing spondylitis, rheumatic polymyalgia, Inflammatory myopathy
* pregnancy
* History of hysterectomy or bilateral oophorectomy
* Vasomotor symptoms
* History of surgery of musculoskeletal system
* History of cancer
* Abnormalities of thyroid function
* Focal neurologic deficit
* Smoking within 1 year
* Uncontrolled hypertension
* Coronary heart disease
* Diabetes mellitus
* Stoke
* Active thromboembolism
* Undiagnosed vaginal bleeding
* Acute hepatic dysfunction
* Gastrointestinal ulcer
* Severe renal dysfunction
* Hypersensitivity to drugs
* Current hormone user or past users within 3 months
The Effects of Scapular Taping Techniques on Grip Strength and Hand Function

This study aims to investigate the effects of different types of taping applied to the scapular region on grip strength and hand function.

Disorders in the alignment of the scapula can lead to mechanical disorders in the proximal. This can lead to a decrease in proximal stability and a negative effect on force production in the distal.

Kinesio tape can stimulate mechanoreceptors through the skin with applied tension, create positional awareness, improve fascia alignment and reduce edema. It is also used to lift soft tissues in areas with pain and inflammation or to limit and increase movement. Rigid taping is performed using non-elastic material and is preferred to increase stabilization and prevent injuries . There are also studies showing that rigid tape increases sensorimotor and proprioceptive senses ).

In a study it was shown that kinesio taping applied to the scapular region improved upper extremity function. In a studyi, it was found that taping improved function in those with lumbar radiculopathy and that elastic taping was more effective than rigid taping. Although there are studies comparing kinesio taping and rigid taping on shoulder joint range of motion and muscle strength, there is no study examining the effects of different tapings applied to the scapular region on grip strength and hand function. In addition, the positive effects of shoulder stabilization exercises on hand skills and grip strength have been shown in the literature.

Studies examining taping and hand functions have generally focused on the forearm and finger areas. The relationship between interventions in the scapular region and grip strength and function has not been sufficiently investigated in the literature, and filling this gap is important for functional rehabilitation.

Previous studies have indicated that taping is effective in injuries affecting the scapular region and upper extremity. This study will examine the effects of different types of taping applied to the scapular region on grip strength and hand function.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 25,
* With undamaged skin tissue in the area where taping will be applied,
* Who are willing to participate in the study.

Exclusion Criteria:

* Individuals with a pathology, disease, or disability affecting upper extremity function,
* Who have experienced trauma/surgery affecting motor and sensory function in the upper extremity and neck region within the last 6 months,
* Who have normal joint motion limitations in the neck, shoulder, elbow, hand, and wrist joints,
* Who have received corticosteroid treatment in the shoulder region within the last 3 months,
* Who have received physiotherapy within the last 3 months.
Escitalopram in Patients With Social Anxiety Disorder

The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Eligibility Criteria:
Inclusion Criteria:

* The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases)
* The patient meets criteria set in the national SPC for escitalopram
* The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs

Exclusion Criteria:

* The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
* The patient has contraindications to escitalopram
* The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
* The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
* The patient is pregnant or breast-feeding
* The patient, if a woman of childbearing potential, is not using adequate contraception