cyrilzakka/clinical-trials huggingface dataset:
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation

To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy

The study was conducted with the participation of 96 patients who were referred for endoscopy for various reasons. Data were collected by two researchers. Patients between the ages of 18-70 who had scheduled upper gastrointestinal endoscopy appointments were included in the study, regardless of gender and underlying diseases. Patients who had undergone endoscopic procedures before, were using medication for anxiety and panic disorders, required urgent endoscopic intervention, had advanced dementia, had hearing problems, had anatomical or inflammatory disorders in the external ear canals, and those who did not want to listen to music for 15 minutes before the procedure were not included in the study.

Eligibility Criteria:
Inclusion Criteria:

- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments

Exclusion Criteria:

* Anxiety and panic disorders
* Urgent endoscopic intervention
* Advanced dementia
* Hearing problems
* Anatomical or inflammatory disorders in the external ear canals
Treatment of Muscle Cramps in Patients With Liver Cirrhosis

This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.

This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* previous diagnosis of cirrhosis
* adult (\>21 years)
* able to complete a written questionnaire in English
* stable and ambulatory
* MELD score \< 25, Platelet count \>25,000

Exclusion Criteria:

* people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation
* previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone
* previous diagnosis of porphyria
* previous diagnosis of psoriasis
* fulminant hepatic failure
* pregnant women
CREATION Health Assessment Tool for College Students

CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition. An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.

CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition.

Based on these principles, a health and wellness program, CREATION Health Wellness Program was developed. Since then various education/training plans using mind-body-spirit approaches have been implemented for different populations. Recently the Adventist Health System has plan to assess Adventist university students' health wellbeing and develop strategies to intervene and thus improve their overall wellbeing. However, literature review found that measures of these eight CREATION Health principles are often discrete and inconsistent. Therefore, there is an urgent need for a comprehensive, consistent assessment tool.

An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate college student
* Age 18 or more years
* Must be able to read and understand ENglish

Exclusion Criteria:

* Have previously taken the University Wellness Assessment
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease.
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
A Registry for People With Lung Cancer

Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Clinical stage I tumor (AJCC 8th edition) suitable for segmentectomy, according to the treating thoracic surgeon

  o Note: Patients must undergo segmentectomy for a peripheral lesion ≤2 cm to be included in the primary analysis. Individual ligation of the segmental artery(s) and segmental bronchus is the minimum definition for a segmentectomy. Division of the segmental vein and intraoperative frozen section to assess surgical margins and N1 lymph nodes are strongly encouraged, but the absence of either is not a criterion for exclusion.
* Pathology of NSCLC o Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology.

Other considerations:

* Patients with ground-glass opacities will have their tumor size recorded on the basis of the size of the solid component.
* Any non-lung cancer treated in the past with no obvious recurrence or ongoing treatment is not a criterion for exclusion.
* The registry study will be monitored by Thoracic Surgery team at MSK.
* This study will be in collaboration with the Thoracic Surgical Oncology Group (TSOG) of the American Association for Thoracic Surgery.

Exclusion Criteria:

* Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
* History of chemotherapy or radiation therapy for a previous lung cancer
* Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
* Carcinoid tumors
* History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
* Actively receiving treatment for other malignancies
* Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.

  * Multi-segmental resection from the same lobe is not a criterion for exclusion.
EPidural's Impact on Contractions and Fetal REsponse

This prospective observational study aims to assess the impact of epidural analgesia (ELA) on uterine contractility, cardiotocography (CTG) patterns, and maternal-fetal hemodynamics in term pregnancies. The study will recruit 200 laboring patient receiving ELA and evaluate changes in uterine contractions, Doppler blood flow parameters, and fetal heart rate tracings before and after ELA administration. Secondary analyses will compare outcomes between primiparous and multiparous women, as well as between uncomplicated and complicated pregnancies. Pain relief effectiveness will be correlated with observed changes. This study will provide a comprehensive understanding of ELA's effects on labor progression and fetal well-being, addressing gaps in existing research.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* singleton pregnancy
* signed informed consent form
* patients in labor
* cervical dilation ≥ 3cm,
* patient requesting and eligible for epidural analgesia
* normal CTG trace for at least 30 minutes before epidural analgesia

Exclusion Criteria:

* \< than 18 years old
* preterm delivery
* labor induced or stimulated by oxytocin
* multiple pregnancy
* fetal malformations
* \< than 3cm cervical dilation
* lack of CTG trace for at least 30 minutes before epidural analgesia
* patient not requesting or not eligible for epidural analgesia
* informed consent form not signed
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.


Eligibility Criteria:
Inclusion criteria:

* Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).
* Written informed consent will be obtained by the parents/ guardians before enrollment into the trial.
* Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients

The project examines the hypothesis that monoclonal allergen-neutralizing antibodies can be recombinantly produced from B lymphocytes isolated from pollen allergic patients. Patient samples suitable for antibody cloning are selected based on seroprofiling for the respective allergens. The study aims at isolating lymphocytes from patients with potential allergen-neutralizing IgG in serum and to clone antibodies from antibody gene sequences obtained from B cells of those patients.


Eligibility Criteria:
Inclusion Criteria:

* History of allergic rhinitis, conjunctivitis or asthma due to sensitization to grass- or birch Allergens
* Male or female patients older than 18 years
* Written informed consent for providing blood and also to allow experimental manipulation

Exclusion Criteria:

* Age \< 18 years
* Any corticosteroids within the last three days
* Oral corticosteroid therapy within the last ten days
* Parenteral depot corticosteroids within the last three months
Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance

The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite oral anticoagulation

OBJECTIVES. To evaluate whether Magnetic Resonance (MR) helps in predicting the risk of Intracranial Hemorrhage (ICH-OA) in patients with ischemic stroke who will receive Oral Anticoagulants (OA) for the secondary prevention of stroke. By allowing the detection and quantification of leukoaraiosis and microbleeding, MR aids in the assessment of hypertensive and/or amyloid angiopathy, two findings that may increase the risk of ICH-OA. The study of these and other known variables associated with the risk of ICH-OA will improve the selection of patients to be treated with OA. METHODOLOGY. A prospective, observational, multicentric study of 1000 patients with stroke, older than 65 y, candidates to receive OA indefinitely. The primary end-point is ICH-OA. A MR will be performed before starting the treatment, in which we will evaluate the presence and degree of leukoaraiosis (Fazekas's scale) and microbleeding (BOMBS scale). A visit will be scheduled at the first month after inclusion, and thereafter the patient will be followed-up during 2 years with phone interviews, to evaluate the appearance of the primary end-point. We will register data about demographics, vascular risk factors, anticoagulation, MR, echocardiography and co-morbidity. With those variables associated with ICH-OA in the univariate analyses, a regression analysis will be performed, in which ICH-OA will be the dependent variable. Finally, each independent predictive variable will receive a score to elaborate a predictive model of ICH-OA.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 65 y
2. TIA or ischemic stroke
3. The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke
4. No previous treatment with oral anticoagulants
5. Signed consent before performing a Magnetic Resonance
6. Long-term follow-up will be possible

Exclusion Criteria:

1. The patient will receive oral anticoagulation as a primary prevention treatment
2. The etiology that motivates the onset of oral anticoagulants is not cardioembolism
3. Absolute contraindication to receive oral anticoagulants
4. Arterial hypertension that is not controlled, hypertensive crisis
5. Dementia
6. Live-expectancy less than 1 year
7. Any social or psychological reason that prevents follow-up
8. Contraindication to perform a Magnetic Resonance examination
9. Patients who received oral antiacoagulants prior to the current stroke
10. The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants
Nuss Procedure: Clinical Options in Pediatric Pain Management?

A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.

Exclusion Criteria:

* None
Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fed Conditions

Objective:

to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck \& Co., Inc.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Sex: male.
  * Age: 18 - 45 years. .
  * Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  * Healthy and willing to participate in the study.
  * Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  * Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  * Clinically significant abnormal ECG or Chest X-ray.
  * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  * Pulse rate less than 50/minute or more than 100/minute.
  * Oral temperature less than 95°P or more than 98.6°P.
  * Respiratory rate less than 12/minute or more than 20/minute
  * History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  * History of alcohol or drug abuse
  * Positive breath alcohol test
  * Recent history of kidney or liver dysfunction.
  * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  * Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  * History of heart failure.
  * HIV, HCV, HBsAg positive volunteers.
  * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
  * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  * Administration of any study drug in the period 0 to 3 months before entry to the study.
  * History of significant blood loss due to any reason, including blood donation in the past 3 months.
  * History of pre-existing bleeding disorder.
  * Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
QuantiFERON Access Clinical Performance Study Protocol

Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.


Eligibility Criteria:
Inclusion Criteria:

* 1. Be ≥ 18 years of age,
* 2. Have received no TB treatment or received treatment for less than 14 consecutive days.
* 3. Provide Informed Consent.

Exclusion Criteria:

* 1. They do not meet the inclusion criteria,
* 2. Blood handling was not completed using QFT-Plus
* 3. Incubation was \<16 and \>24 hours
* 4. Improperly collected and/or stored samples per Instructions For Use
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment
* Ocular hypertension defined as an intraocular pressure (IOP) \> 21 mm Hg
* Subject has failed a conventional intraocular glaucoma filtering surgery
* Patient must be aged 18 years or more
* No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
* No previous cyclophotocoagulation procedure in the study eye
* Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.

Exclusion Criteria:

* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
* History of ocular or retrobulbar tumor
* Retinal detachment, choroidal hemorrhage or detachment
* Ocular infectious disease within 14 days before HIFU treatment
Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management.

This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).


Eligibility Criteria:
Age Limits:

* In United States (USA), minimum age will be 17 years old.
* In European Union (EU) countries, minimum age will be 18 years old.

Inclusion Criteria:

* Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening
* Genetically confirmed diagnosis of PWS
* HQ-CT total score ≥14 at screening
* Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs
* Stable body weight
* Negative pregnancy test for females of childbearing potential and nonlactating at screening.
* Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable)
* Patients must have at least 1 consistent and reliable primary caregiver

Exclusion Criteria:

* Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months)
* Risk of suicide according to the investigator's judgment
* Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration
* Poorly controlled hypothyroidism or hyperthyroidism
* Chronic or acute liver disease
* History of bariatric surgery procedure
* Uncontrolled obstructive sleep apnea.
* History of malignancy within 5 years of screening
* Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening.
* Use of weight-lowering pharmacotherapy within 6 months prior to screening.
* Known QT prolongation
* Clinically relevant laboratory abnormalities
* Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study
Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.

Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome

90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up

Eligibility Criteria:
Inclusion Criteria:

* any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence

Exclusion Criteria:

* Active Urinary tract infection
* neurologic abnormality
* Pure Stress urinary incontinence