cyrilzakka/clinical-trials huggingface dataset:
An Intervention to Improve Adolescent Headache Self-management

The purpose of this study is to test the efficacy of a new app to help adolescents with chronic or reoccurring headaches self manage pain.

Headaches dramatically affect adolescents' overall functioning and quality of life. We have developed a highly engaging mobile-based program that will help adolescents to make connections between behaviors and symptoms, and to ultimately improve functioning and quality of life. The mobile-based program will provide a state of the art pain tracker, a variety of coping strategies, and information about self-management of symptoms. This app will offer a maximally engaging way to help adolescents track their pain, make connections between lifestyle and pain, and learn key self-management skills.

The study involves the participant being randomized into either the experimental group, where he/she will be using this mobile application to track their headache symptoms, or the control group, where he/she will receive headache treatment as usual; the control group will not be using an app for this study. The intervention will last for two months.

Participants will be assessed at baseline, at 2-months post baseline, at 3-months post baseline, and at 6-months post baseline. All participants will be asked to complete online questionnaires about their headaches. We plan to enroll 144 adolescent participants with headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.

Eligibility Criteria:
\[The above age limits are specific to adolescent participants.\]

Inclusion Criteria - Adolescents

* Between ages 13 and 17 (inclusive)
* Able to read and speak English
* Has recurring headaches that are not related to another medical condition
* iPhone user with access to an iPhone \[4/4S or later\] for use during the intervention period

Exclusion Criteria - Adolescents

* Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain
* Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments

Inclusion Criteria - Caregivers

Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide

The main objective of this trial is to investigate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of liraglutide in male subjects with overweight/obesity (otherwise healthy) following subcutaneous administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with overweight/obesity (otherwise healthy) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12 lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body mass index (BMI) of 25.0 to 34.9 kg/m2 (inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
* Body weight greater than or equal to 70 kg
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medications except appendectomy or simple hernia repair
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis

Intracranial arterial prominent stenosis (IAPS) is one of main cause of stroke especially in Asia. Although antiplatelet aggregative or anticoagulant agent and even surgical operation are used to treat patients with IAPS, the incidence of stroke occurrence still remains high. In addition, symptomatic IAPS most common cause continuous deterioration, thus, increase the incidence of stroke. Therefore, there is a good method to reduce the inceidence of stroke that is to prevent the progressive deterioration of IAPS.

Huang-Chi-Wu-Wu-Tang is made of Astrgalus membranaceus (Fisch.) Gge , Paeonia lactiflora Pall , Cinnamom Twig , Zingiber officinale Rose , Ziziphus jujube Mill , and can treat hemiplegia in the traditional Chinese medicine writings. Astragaloside IV is a component of Astrgalus membranaceus, may reduce th cerebral infarction area in middle cerebral arterial occlusion mice. The investigators previous studies have known that paeoniflorin that a component of Paeonia lactiflora Pall can decrease the cerebral infarction area and neurological deficit in middle cerebral arterial occlusion rats. Therefore, the purpose of the present study was to investigate the effect of Huang-Chi-Wu-Wu-Tang on patients with IAPS.


Eligibility Criteria:
Inclusion Criteria:

1. Had received Transcranial Doppolar Sonography.
2. Age \>40 years old.
3. Gender: Male or female.
4. The subject or their legal representative gave written informed consent to participate.
5. Meet with one of the two Transcranial Doppolar Sonography results below:

   * The evaluated standard of MCA M1 stenosis of 50-99% are as follows:

     * PSV \>140 cm/s
     * MFV \>100 cm/s
   * The evaluated standard of BA stenosis of 50-99% are as follows:

     * PSV \>100 cm/s
     * MFV \>60 cm/s

Exclusion Criteria:

1. Refused to sign the Informed Consent Form.
2. Too irritable to accept the evaluation.
3. Age ≦40 years old.
4. Major diseases such as Myocardial Infarction、Heart failure、Chronic pulmonary obstructive disease(COPD）with dyspnea、Liver failure or Renal failure.
5. Pregnancy or breast-feeding.
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation

Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.

Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.

Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.

Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.

Indeed, experimental studies indicate a marked activation of inflammatory cells at the site of stent struts, which is likely to play a key role in the process of neointimal proliferation and restenosis. Indeed, tumor necrosis factor and interleukins 1 and 6 are powerful stimuli for smooth muscle cell proliferation.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.

The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on restenosis rate after successful stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
* Class I indication to elective percutaneous coronary intervention
* Stable conditions and no recent acute coronary syndromes
* Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
* Able to understand and willing to sign the informed CF
* Contraindications to DES Use (Clinical history difficult to obtain, Expected poor compliance with DAPT, Non-elective surgery required, Increased risk of bleeding
* Allergy to ASA or clopidogrel/prasugrel/ticagrelor, Indication for long-term anticoagulation, Large Vessels, Focal Lesions)

Exclusion Criteria:

* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
* Indications to DES Use (Small Vessels, Long Lesions Diabetes, In-Stent Restenosis, Complex lesions)
TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA

Arterial hypertension is an independent vascular risk factor and a frequent reason for consultation in Primary Care. It generates high cardiovascular morbidity and mortality (stroke, heart disease, kidney failure and other diseases). Moreover, given that it is a modifiable factor and that there are intervention and control measures that would lead to a significant reduction in cardiovascular incidence and morbimortality, it can be stated that ETS is a major public health problem.

The approach to this risk factor can be pharmacological and non-pharmacological. The non-pharmacological approach is based on lifestyle modification. Among the measures aimed at modifying lifestyles is the restriction of daily intake of sodium in the diet. Such restriction enhances the hypotensive effect of pharmacological treatment so that its application and intensification would delay the start of pharmacological therapy, as well as avoid the need to increase the dose of antihypertensive drugs or the number of drugs to be used for the control of hypertension.

In relation to salt intake in the Spanish population, the average is above the figures of less than 5 grams per day recommended by the WHO. Sodium intake can be estimated by determining the 24-hour urine sodium concentration. In addition, there is a positive correlation between systolic and diastolic blood pressure figures and the excretion of sodium in urine.

In the present work, with a prospective cohort observational study design, it intends to assess the effectiveness of the use of an educational program based on the follow up of a hyposodium diet and assessed through the routine use of urine sodium monitoring of the hypertensive patient in the primary care setting, in order to optimize treatment, as well as to review the clinical control in this group of patients. On the other hand, it is intended to establish guidelines in the form of practical guidelines to provide with a standardized clinical approach for primary care centers.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 40 years old.
* Patients diagnosed with HTA (according to criteria ESC/ESH 2018) in a PA consultation or through MAP at the health center.
* In treatment with single, double or triple antihypertensive therapy.
* Patients with ST figures ≥140.
* Patients with TD numbers ≥90.
* Patients with stable antihypertensive treatment or without modifications in the treatment at least in the last month.
* Patients who commit to follow up the study.
* Patients who have given written informed consent.

Exclusion Criteria:

* Patients with decompensated heart failure
* Severe renal failure.
* Decompensated liver disease.
* Taking non-insulin antidiabetic
* Hypertension of pharmacological origin and other causes.
Measuring Beliefs and Norms About Persons With Alcohol Use Disorder

Survey experiment to estimate drivers of stigma toward people with alcohol use disorder

Despite significant advances in scientific understanding of substance use disorders accompanied by significant advances in treatment and improvements in prognosis, substance use disorder remains highly stigmatized throughout the world. Previous studies suggest that portraying alcohol use disorder as treatable can reduce negative attitudes toward persons with alcohol use disorder. This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic alcohol use disorder vs. treated alcohol use disorder with complete response vs. treated alcohol use disorder with relapse, with and without adverse economic impacts. It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated alcohol use disorder with completed response would have the greatest effect on reducing negative attitudes toward persons with alcohol use disorder, followed by treated alcohol use disorder with relapse and untreated and symptomatic alcohol use disorder, and that adverse economic impacts will exacerbate negative attitudes toward persons with alcohol use disorder.

Eligibility Criteria:
Inclusion Criteria:

* All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age, with the exception of emancipated minors
* Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
* Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Complication Registry for Tonsil Surgery

Our aim was to establish a feasible method to prospectively register all tonsil surgery-related complications and to find their possible predictive factors. Our long-term objective is to create a surgical complication registration database, which would provide valuable information for quality assurance and give us a benchmarking tool to improve the results of this surgery in our department.

In a six-month period all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment. Demographic and clinical data were recorded prospectively in a database which included 57 variables, such as age, gender, co-morbidities, body mass index, American Society of Anesthesiologists Physical Status Classification, indication for surgery, educational level of surgeon (consultant vs. resident), surgical technique, duration of operation and length of hospital stay.

After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered.

Eligibility Criteria:
Inclusion Criteria:

* no age limits
* elective tonsillar surgery

Exclusion Criteria:

* procedures carried out due to malignancy
* as a part of multilevel surgery for obstructive sleep apnea
* re-tonsillectomies
* acute operations
eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

The goal of this randomized controlled trial is to compare the effect of eHealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.

Cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. International guidelines list cardiac rehabilitation after myocardial infarction as class IA recommendation. However, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide.

eHealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. Thus, we design a randomized controlled trial to compare the effect of a case manager-led eHealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.

Eligibility Criteria:
Inclusion criteria:

1. ≥ 20 years of age.
2. Within 6 months after the onset of acute myocardial infarction.
3. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation.
4. Unable or refused to attend center-based cardiac rehabilitation.

Exclusion criteria:

1. Unable to walk independently or use a stationary bike.
2. Unable to follow verbal command.
3. Not having a smartphone which can get on the internet.
4. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
5. Unable to provide informed consent.
Vitamin D Supplementation and Glycemic Outcomes

The investigators examined the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon.

A low serum 25-hydroxyvitamin D (25(OH)D) concentration has been shown to correlate with higher fasting blood glucose (FBG) and insulin levels and other metabolic abnormalities like dyslipidemia. Previous studies suggest that vitamin D supplementation is able to improve insulin sensitivity and metabolic markers. The aim of the study was to investigate the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon. Participants (n= 180; 93 men and 87 women) deficient in vitamin D were recruited from Saint Charles Hospital, Beirut, Lebanon. Four groups were recruited: normal-weight adults (n=30, age ≤ 65 years and BMI \< 25 kg/m²), overweight adults (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and BMI \< 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²).

Participants received a supplement of 10,000 IU cholecalciferol to be taken three times per week for a period of 6 months. Glucose homeostasis and metabolic markers were measured at start of treatment, at 3 months and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included

Exclusion Criteria:

* Participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded
Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively

The primary objective of this prospective multicenter study is to assess whether the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the functional outcome after conservative treatment.

Osteoarthritis (OA) of the knee (gonarthrosis) is a common medical condition and causes pain and disability. By 65 years of age, the majority of the US population has radiographic evidence of OA and 11% have symptomatic OA of the knee. In Japan, OA of the knee is more common due to the common sitting style with maximally flexed knees and parallel position of both legs.

High Tibial Osteotomy (HTO) for knee OA is a standard procedure in orthopedic surgery. Six years ago, HTO using TomoFix™ was introduced. Because Asian people have different geometric dimensions of the tibiae, an adaptation of size and shape was necessary, and the new TomoFix™ Small was developed. Although there is widespread literature concerning osteotomy for treating knee OA, literature assessing patient outcome after open wedge HTO using TomoFix™ is rare and for TomoFix™ Small, this data is still nonexistent. Therefore, the primary aim of the present multicenter study is to evaluate patient functional outcome using the KOOS. Since a proportion of patients with the indication for HTO refuse surgery and opt to receive conservative treatment, the functional results of patients treated with HTO using TomoFix™ Small will be compared with these patients.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age and older
* Patients with OA Grade 1-4 (Kellgren-Lawrence) or osteonecrosis (ON) Stage 2-4 (according to the Koshino classification)
* Indication for open wedge HTO with the TomoFix™ Small
* No ligamental laxity
* Signed written informed consent (by the subjects or legal guardian) and agreement to attend all planned follow-ups
* Willing and able to comply with the postoperative management program
* Able to understand and read country national language at an elementary level

Exclusion Criteria:

* Femoro-tibial angle (FTA) \> 185o (standing view x-ray)
* Flexion contracture \> 15o
* Total knee replacement or unicompartmental knee on the contralateral side
* Infections located between the middle of the femur and the ankle
* Systemic bacterial infections
* Severe osteoarthritis or surgery of the hip joint
* Smoking of more than 20 cigarettes per day
* Immunodeficiency or compromised host
* Patients who have participated in any other device or drug related clinical trial within the previous month
* ACL/PCL reconstruction of the same knee
* Severe osteoarthritis of the ipsilateral ankle joint

For conservative group only:

* HTO on the contralateral side
* Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed)
Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department

MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old
* Benign headache
* Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

Exclusion Criteria:

* Unable to provide informed consent
* Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection
* Known renal impairment
* Known hepatic impairment
* A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease
* Perforated ear drum
* Pregnant