cyrilzakka/clinical-trials huggingface dataset:
HTN App for HTN Control and Cardiovascular Health Among African-Americans

The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* African-American (AA) adults that are established patients at Neighborhood HealthSource in Minneapolis, Minnesota.
* Receives primary care (i.e., has designated primary care provider) at the partnering FQHCs and intent to continue care there for next 12 months
* African American race/ethnicity
* Men and women aged ≥18 years
* Uncontrolled HTN (defined as Stage 2 HTN with a BP ≥140/90 mmHg \[as per 2017 American College of Cardiology/American Heart Association HTN Guidelines32\] at most recent outpatient evaluation, with or without BP medications)
* Documented diagnosis of HTN in EHR
* At least 1 office visit at the partnering FQHCs in the prior year
* Smartphone ownership (supporting iOS or Android Systems)
* Active email address and willingness to utilize it throughout the study
* Basic Internet navigation skills (for example, can search for information on websites, open and send emails)
* Access to the Internet on at least a weekly basis (such as at home, a family member's or friend's home, church, library/community center, school/university, Internet café, etc.)?

Exclusion Criteria:

* Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).
* No primary care provider at partnering FQHC
Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a booklet) to each other and to a no intervention group.

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomised clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about and attitude toward randomised clinical trials was assessed in a randomised, parallel group, evaluator-blinded trial among 415 outpatients recruited from four departments at a university hospital in Copenhagen. The patients were randomised to the following groups: control (no intervention), leaflet, brochure, or booklet in a 1:1:1:1 ratio. Knowledge (KN) was assessed by a 17-item multiple-choice questionnaire and attitude (AT) was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed.

Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach 's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Ability to read and understand Danish and written informed consent.

Exclusion Criteria:

* Patients under 18 years of age and patients enrolled in another clinical trial on the same day.
The Use of Q-Collar to Increase CSF Drainage in Low-pressure Hydrocephalus Patients

The investigators hypothesize that the Q-collar compression on bilateral internal jugular veins of patients with low pressure hydrocephalus will decrease venous drainage from the intracranial space, therefore increasing intracranial volume, decreasing brain compliance, and increasing CSF drainage through the shunt. This should improve persistent hydrocephalus symptoms and demonstrate improved ventricular drainage on imaging with decompressed ventricles.

Low-pressure hydrocephalus is an entity that is rare and difficult to manage. At this institution, Dr. Paul Camarata uses a method of "neck-wrapping" in those low-pressure hydrocephalus patients that were admitted for complications with their shunt, hypothesized to decrease venous outflow from the intracranial space, increase venous pressure within the cranium and therefore increase the turgor in the brain tissue allowing for CSF to more easily be pushed out of the ventricular space and through the drain. This would relieve the hydrocephalus symptoms and reduce ventricular size on imaging. The advent of the Q-collar for reducing TBI in contact sports functions in a similar way to the "neck-wrapping" used at this institution, but via the simplified tool of the collar. It functions by compressing the internal jugular veins bilaterally to increase intracranial volume and prevent "brain slosh" that can occur in contact sports that leads to brain injury. The collar in contrast to the neck wrap occupies a smaller surface area, which the investigators hypothesize will reduce the discomfort that is commonly associated with neck wrap. Furthermore, applying this Q-collar to low pressure hydrocephalus patients that struggle with symptom management while inpatient, the investigators hypothesize that CSF drainage will improve with wearing the collar via increased intracranial volume and lower brain compliance, therefore improving persistent hydrocephalus symptoms that are limiting on patient quality of life.

Eligibility Criteria:
Inclusion Criteria:

* adult with low-pressure hydrocephalus, able to cranial imaging, able to provide consent or have surrogate decision maker that is able to provide it for them

Exclusion Criteria:

* pediatric patients, patients that can't consent or don't have a surrogate decision maker, patients that can't get cranial imaging
Maintenance Therapies in Bipolar Disorders

The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium.

While having a manic or depressed episode patients will be assigned randomly (like tossing a coin) to receive appropriate medication either with or without additional individual psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy (the patient may not receive the same additional treatment this time). Patient response to treatment will be evaluated throughout the study. If manic/depressive symptoms return at any point during the study, the patient will be treated with appropriate medication and will continue the study.

An individual may be eligible for this study if he/she:

Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study entry, and is at least 18 years old.

The primary goal of this investigation is to examine the additive prophylactic potential of an individual psychotherapy based on interpersonal and social rhythm principles in bipolar I patients maintained on lithium carbonate (lithium). An adaptation of maintenance interpersonal psychotherapy, this intervention takes into account the specific vulnerabilities, symptoms, and interpersonal problem areas associated with bipolar disorder.

Acutely ill patients in a manic or depressed episode are randomly assigned to either individual psychotherapy or medication clinic visits in addition to appropriate pharmacotherapy (lithium carbonate). Patients who stabilize (HRSD and Bech-Rafaelsen \< 7 for four weeks) are then randomly assigned to preventative treatment with either individual psychotherapy or medication clinic visits in addition to pharmacotherapy. Thus, patients in this study receive one of four possible treatment strategies: 1) preliminary phase psychotherapy followed by preventative phase psychotherapy; 2) preliminary phase medication clinic visits followed by preventative phase psychotherapy; 3) preliminary phase psychotherapy followed by preventative phase medication clinic visits in addition to psychotherapy; or 4) preliminary phase medication clinic visits followed by preventative phase medication clinic visits in addition to psychotherapy. Those patients who experience a relapse (during the initial twelve weeks of the preventative phase) or a recurrence (after week 12 of the preventative phase) are treated with appropriate pharmacotherapy and continued in psychotherapy or medication clinic visits as dictated by their original randomization assignment. These patients are then followed for the remainder of what would have been their time in the protocol had they remained well.

Eligibility Criteria:
Inclusion Criteria:

-

Patients must have:

Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry.

-

Required:

Current treatment with lithium carbonate.
Effect of Classic Ballet Practice on School Children's Postural Balance

Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. The hypothesis is interventional group will improve the balance control more than control group.


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* 9 to 12 years of age

Exclusion Criteria:

* Musculoskeletal pain at last 3 months
* Perform other physical activity besides scholar's physical activity
* Has been participated Ballet class.
A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

The purpose of this study is to compare the safety, tolerability, pharmacokinetic (PK), and comparative bioavailability of repeated administration of GSBR-1290 in healthy overweight/obese participants.

This is a 2-part study in which Part 1 will compare the PK of GSBR-1290, administered as tablet and capsule, using a 2-period, 2-sequence, crossover design in approximately 16 healthy overweight/obese participants. Part 2 will evaluate multiple-ascending doses of GSBR-1290 tablet in 3 cohorts, using 3 different titration regimens. Secondly in Part 2, the study will evaluate the comparative bioavailability of GSBR-1290 tablet versus capsule at a potentially clinically efficacious dose at steady state in Cohort 3.

Eligibility Criteria:
Inclusion Criteria:

1. Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.
2. Healthy overweight or obese adult men and women.
3. Age greater then or equal to (\>=)18 and less than or equal to (\<=) 75 years.
4. Body mass index (BMI) \>=27.0 kilogram per square meter (kg/m\^2).

Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.
Study To Evaluate Long Term Treatment Effect Of Diapep277® In Patients Who Have Completed Study 901 And Study 910** (Extension To 901)

Open label study to evaluate long term treatment effect of diapep277.


Eligibility Criteria:
Inclusion Criteria:

1. patient that completed 901 and 910 study.

Exclusion Criteria:

1. cpeptide\<0.2
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia for more than 1 year
* A total score in the Positive and Negative Syndrome Scale (PANSS) \< 120
* Signed informed consent
* Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
* Men must agree to use a double-barrier method of birth control
* Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
* A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
* Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
* A diagnosis of substance dependence within 6 months before screening
* History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
* Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
* Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
* Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use

This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.


Eligibility Criteria:
Inclusion Criteria:

* Elective gynecological surgery under general anesthesia
* Duration of surgery 1-7 hours
* Duration of hospital stay \> 24 hours

Exclusion Criteria:

* chronic pain
* chronic analgesic medication
* neurologic disease
* psychiatric disease
* history of addiction
* kidney or liver failure
* allergy to any anesthetic or analgesic drug
* BMI \> 35
Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults

Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care

single centre randomised control trial with the aim of comparing the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study there is random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol daily single dose for the relief of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 75 years old with a diagnosis of mild asthma attending the participating primary health care centres in Bahrain, being managed with usual care (SABA or ICS and SABA combination) and no other medications

Exclusion Criteria:

* Health centre medical record or self-reported use of LABA, leukotriene receptor agonist, theophylline, anticholinergic agent, oral corticosteroids for regular maintenance therapy in 3 months before entry to the trial. \[NB. nasal corticosteroid is permitted
Hypothalamic Function Before and After Bariatric Surgery

The purpose of this study is to determine the effect of gastric banding or gastric bypass on hypothalamic morphology and function, gut hormones and systems biology in obese subjects with and without type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35-65 years;
* BMI \> 40 kg/m2;
* BMI \> 35 and \<40 kg/m2 with co-morbidity, which is expected to improve after surgically-induced weight loss;
* A history of longstanding obesity (\>5 years);
* Proven failed attempts to lose weight in a conventional way, or primarily successful weight loss with eventual weight regain;
* Intention to adhere to a postoperative follow-up programme.

Exclusion Criteria:

* BMI\> 50 or body weight \> 150 kg (because it is impossible to safely put people above this weight on a standard table for MRI);
* Subjects with disease related obesity, i.e. Cushing or medication related obesity;
* Use of medication known to affect glucose or lipid metabolism (i.e. prednisone)
* Monogenetic diabetes: MODY, Mitochondrial diabetes;
* LADA (adult-onset latent autoimmune diabetes); detected by c-peptide measurement on screening.
* Impaired renal function (serum creatinine \> 176 μmol/L);
* Leg ulcers, gangrene.
* Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting the brain
* Any significant chronic disease
* Renal or hepatic disease
* Pregnancy
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Aerobic exercise more that 3 times 60 minutes a week
* Alcohol consumption of more than 28 units per week at present or in the past
* Recent blood donation (within the last 2 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Contra-indications to operative procedures as regular in bariatric surgery
* Contra-indications to MRI scanning
MRI in Diagnosing and Monitoring CIDP

We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin

Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG).

CIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the patient.

New techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be used to detect injuries in the peripheral nerves

We want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve roots and plexus in patients with CIDP.

Moreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI

Eligibility Criteria:
Inclusion Criteria:

CIDP patients

* Age \> 18 and \< 80 years
* Diagnosed with definite and probable CIDP and fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria

Healthy controls

* Age \> 18 and \< 80 years
* No neurological disorders

Exclusion Criteria:

* Age \< 18 or \> 80 years
* Contraindications to MRI
* Pregnancy
* Other cause of neuropathy (incl. pressure neuropathy)
* Diabetes mellitus
Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease

Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.

Behçet's disease (BD) was first described by Turkish dermatologist Hulusi Behçet in 1937 as a triad of recurrent oral aphthae, genital ulcerations and relapsing uveitis. Behçet disease (BD) is an inflammatory vasculopathy with multisystemic involvement. The clinical course usually follows a relapsing-remitting course with heterogeneous clinical manifestations.

The complexity of signs and symptoms in BD can disturb an individual's lifestyle by causing limitation in activity. As a result, numerous psychological problems may arise. Furthermore, it was shown in some studies that in patients with BD with fatigue, there was a significant association with impaired quality of life.

Some studies reported the sleep quality in Behcet disease is very poor, and restless legs syndrome, fatigue, depression, anxiety, and activity of Behcet disease could affect to the quality of life.

However, to date, there have been limited studies regarding sleep quality, quality of life, and depression in Behcet disease patients. Extrapolating that Behcet disease, a kind of Vasculitis, also affects the sleep quality, it is considered a meaningful study to compare and analyze the relationship between disease activity and sleep quality, quality of life, and depression in Egyptian population of Behcet disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease).

Exclusion Criteria:

* Patients who refuse to participate in the study.
Delphi Study on Myofascial Pain Syndrome Challenges in Turkey: Patient Journey, Burden, Diagnosis & Treatment Needs.

Myofascial pain syndrome is a chronic pain disorder that affects many people in Turkey. This research study aims to explore the challenges faced by patients with myofascial pain syndrome in Turkey, including the disease burden, patient journey, and unmet diagnosis and treatment needs. The study will utilize the Delphi methodology, which involves gathering input from a panel of experts over multiple rounds to achieve consensus on the topic. The results of this study will shed light on the current state of myofascial pain syndrome management in Turkey and provide insights into the areas where improvements can be made.

The study will use a Delphi methodology to investigate the challenges faced by patients with myofascial pain syndrome in Turkey. A panel of 20 experts with diverse backgrounds in healthcare and pain management will be selected. The study will be conducted in three rounds, with the first round consisting of open-ended questions to identify key themes related to the disease burden, patient journey, and unmet needs. In the second round, experts will rate the importance of each theme, and in the third round, they will review the results of the previous round and provide additional feedback. Data will be analyzed using content analysis and descriptive statistics to identify the areas of consensus and divergence among the experts.

Eligibility Criteria:
Inclusion Criteria:

* Being an expert on healthcare.
* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Any disorder or condition that may negatively affect reading, comprehension, and form filling.