cyrilzakka/clinical-trials huggingface dataset:
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-79
* Must sign an ICF
* Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
* Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
* Must demonstrate a willingness to comply with daily telephone diary entry

Exclusion Criteria:

* Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
* Pregnant or breastfeeding females
* Refusal to discontinue prohibited concomitant medications
* Use of an investigational drug or participation in an investigational study within 30 days of screening
* Inability or unwillingness to use the touch-tone telephone data entry system
Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study

The purpose of the study is to evaluated the efficacy and tolerability of methyl aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to severe facial acne vulgaris in a randomized controlled and investigator blinded trial.


Eligibility Criteria:
Inclusion Criteria:18 years or older, good health, more than 12 inflammatory facial acne lesions -

Exclusion Criteria:skin type VI, pregnant or lactating woman. Oral retinoid use within one year, systemic antibiotics within 1 month, topical acne treatment within 2 weeks.

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Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers

This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals who are between 18 - 35 years of age. Have a body mass index (BMI) range of 18.0 - 24.9 kg/m2. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures

Exclusion Criteria:

* Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes. Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). Individuals who are lactating, pregnant or planning to become pregnant during the study. Have a known sensitivity or allergy to any of the study products. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. History of alcohol or substance abuse in the 12 months prior to screening. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2
The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.


Eligibility Criteria:
Inclusion Criteria:

* Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
* American Society of Anesthesiology (ASA) physical status 1 or 2

Exclusion Criteria:

* Surgery precluding placement of BIS monitor
* Non-English speaking, until additional language consent forms are approved
* Previous history of severe emergence agitation
Dialectical Behavior Therapy for Adolescents with Self-harm and Suicidal Behavior- an Open Trial

The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:

* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.
* to investigate how well DBT-A works at 12 months follow-up
* to investigate whether pre-treatment factors can predict who will benefit from treatment

Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-18 years
* Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
* Fluency in Norwegian
* One parent/trusted adult that can participate together with the adolescent.

Exclusion Criteria:

* Intellectual disability
* Significant learning or language impairments
* Autism spectrum disorder
* Anorexia Nervosa
* Any psychotic disorder
* Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.
Comparison of Two Multifocal Contact Lenses

The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.


Eligibility Criteria:
Inclusion Criteria:

* At least 35 years of age.
* Sign written Informed Consent
* Spectacle add of +0.50 to +2.50D.
* Best corrected visual acuity of at least 20.30 in both eyes.
* Currently wearing soft contact lenses at least 5 days per week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Currently enrolled in any clinical trial.
* Astigmatism \> 1.00D.
* Strabismus/amblyopia.
* Other protocol-defined exclusion criteria may apply.
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).

Eligibility Criteria:
Inclusion Criteria:

* A man or woman over 20 years old less than 70 years old.
* A man or woman who has below all characters and diagnosis as NERD.

  1. A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
  2. A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria.

     \*\* Symptom (heartburn and acid regurgitation) is confirmed by RDQ
     * Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness.
     * Experienced above 1 day in a week, heartburn of acid regurgitation above the middle.
  3. A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break.
* A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.

Exclusion Criteria:

* Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
* Who has ERD.
* Who get a diagnosis as a IBS within the last 3 months.
* Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (\* refer to the Concomitant medication in text.)
* Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
* Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
* Who has the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced.
* Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole).
* Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia

To determine palatability and extent to which escalating doses of a novel highly viscous polysaccharide \[NVP\] reduces postprandial glycemia when added to a liquid and a solid meal.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* 18-75 years old
* BMI less than 35 kg/m2

Exclusion Criteria:

* Medications influencing gastrointestinal function
* Pregnancy
A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements

This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c) \<9.0%
* Have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day (U/kg/day) and a total daily insulin dose (basal + prandial/bolus) \<1.5 units per kilogram (U/kg)
* Have C-peptide \<0.3 nanomoles per liter (nmol/L)
* Are able and willing to eat the protocol specified standard breakfast and other meals as required

Exclusion Criteria:

* Have corrected QT interval (QTc) prolongation \>500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus \[T1DM\]), hematological, or neurological disorders
* Have fasting triglycerides (TGs) \>400 milligrams per deciliter (mg/dL) (4.52 micromoles per liter \[mmol/L\])
* Have used systemic corticosteroids within 4 weeks prior to randomization
* Currently receive insulin pump or insulin degludec
* Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia
* Have history of gastroparesis or gastrointestinal malabsorption
* Require treatment with any drug other than insulin to treat diabetes
* Have a previous history of proliferative retinopathy
A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer

We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
* Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
* The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
* Karnofsky performance status was ≥ 80.
* Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
* Had measurable or assessable disease.
* Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
* Serum creatine and bilirubin \< 1.5 × the upper normal limit (UNL), aminotransferase \< 2 × UNL.
* Weight loss was less than 10% within 6 months before diagnosis.
* Written informed consent was required from all patients.

Exclusion Criteria:

* Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.
Milk Vs Wheat Protein Intake to Maximize Whole-body Protein Synthesis Rates in Healthy Older Adults

Dietary protein intake is essential for tissue renewal and growth. Current recommendations for protein intake are based on studies using egg protein as reference protein. Egg protein is an animal-based protein with a high quality. Protein quality is determined by the composition of (essential) amino acids and digestibility. Therefore, different proteins have a different quality. Due to the environmental crisis, an increasing number of people consumes more plant-based proteins. These plant-based proteins often have a lower protein quality compared to animal-based proteins. Therefore, the aim of this study is to investigate whether optimal protein intake depend on protein quality. The optimal protein intake of an animal-based protein with a high quality (milk) will be compared to the optimal protein intake of a plant-based protein with a low quality (wheat).


Eligibility Criteria:
Inclusion Criteria:

* Aged between 65-85 years
* BMI between 18.5-30 kg\*m\^-2
* Healthy, recreationally active (maximal one intensive exercise training per week)
* No physical limitations (i.e., able to perform all activities associated with daily living independently)

Exclusion Criteria:

* Smoking
* Diagnosed musculoskeletal disorders
* Use of any medications known to affect protein metabolism (i.e., corticosteriods, non-steroidal anti-inflammatories)
* Chronic use of gastic acid-suppressing medication or anti-coagulants
* Unstable weight over the last 3 months
* Diagnosed GI tract disorders or diseases
* Blood donation in the past 2 months
Pain Classification in Caregivers for Children With Cerebral Palsy

The care of children with Cerebral Palsy is a process that continues for many years. Individuals who take care of them experience musculoskeletal pain due to the difficulties they experience and face pain that becomes chronic over time. For individuals who take care of children with CP, determining the types of chronic pain is important in order to clarify the classification criteria and for individuals to reach better living standards by tailoring the treatments they will receive. Therefore, the aim of the study is to determine the types of chronic pain in caregivers for children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Having musculoskeletal pain complaints for the last 6 months or more
* experienced musculoskeletal pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 2 on a numeric pain rating scale
* pain that lasts at least 6 months
* To provide the documented diagnosis of Cerebral palsy of the child in the care of the participants.

Exclusion Criteria:

* Having severe psychological illness
* Having a cognitive dysfunction
* Not participating in the assessment or submitting incomplete answers for questionnaires
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule

This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (Cmax, AUC). Statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the Reference treatment and the four 25 mg capsules as the Test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg capsule under fed condition as the Test treatment for the second comparison.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential and/or male participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
* participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, vital signs which include BP and pulse rate measurement, clinical laboratory tests, and electrocardiogram (ECG).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,hepatitis B surface antigen (HBcAb) or hepatitis C antibody (HCVAb).
* Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

  * estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \<90 mL/min/1.73 m2;
  * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>upper limit of normal (ULN);
  * Serum (total and direct) bilirubin level \> ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= ULN;
  * Amylase and lipase level \> ULN.
Turkish Version of the Child Perceptions Questionnaire 8-10

The Child Perceptions Questionnaire (CPQ) is a widely used reliable measurement that provides for practitioners to assess child's current emotional, social, and functional well-being. The aim of the present study was to develop a translated version of CPQ8-10 into Turkish language and evaluate its reliability, validity, and reproducibility.

The CPQ8-10 was translated into Turkish as recommended in the literature. The intraclass correlation coefficient (ICC) was used for the test-retest reliability. The internal consistency was evaluated using Cronbach's alpha Coefficient. Construct validity and discriminant validity were calculated, exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were employed.

Eligibility Criteria:
Inclusion Criteria:

* being aged between 8 and 10 years,
* being mentally and physically sufficient to complete the questionnaire,
* having volunteered to participate in the study,
* speaking Turkish fluently,
* children who were attending their first visit to the dentist

Exclusion Criteria:

* those who were outside this age range (8-10),
* had physical, mental or systemic disabilities that prevented them from understanding and answering the CPQ8-10
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .

Process of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .

How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.

In the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.


Eligibility Criteria:
Inclusion Criteria:

* Patient with refractory diabetic macular edema at least one month after third injection

Exclusion Criteria:

* previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage