cyrilzakka/clinical-trials huggingface dataset:
Role of MRS in Brain Lesions

Aim of the study is evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm

The annual global age-standardized incidence of primary malignant brain tumors is \~3.7 per 100,000 for males and 2.6 per 100,000 for females . Rates appear to be higher more in developed countries (males, 5.8 and females, 4.1 per 100,000) than in less developed countries (males 3.0 and females 2.1 per 100,000). More than half of all brain tumors are Intraparenchymal . Diagnosis of brain lesions and other focal intracranial lesions based on imaging methods alone is still facing a challenging problem. Accurate diagnosis is fundamentally vital for clinical management in patients with brain tumors. CT and standard MRI are the first line imaging modalities in evaluation of brain lesions; however, it does not always provide more precise details and characterization of the lesions whether it is benign or malignant. Conventional imaging techniques do not provide exact information about vascularity, cellularity and metabolism of the mass lesion . Magnetic Resonance Spectroscopy (MR Spectroscopy) is one of the tools used to determine themolecular structures of compounds or to detect the compound presence. MR Spectroscopy provides metabolic information from living tissues. The major brain metabolites detected are choline, creatine, N-acetyl aspartate (NAA), lactate, myoinositol, glutamine, glutamate, lipids and the amino acids leucine and alanine. Brain lesions show abnormal values of these metabolites as compared to normal tissue.Our study aims to determine the accuracy of MRS in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm, Discriminating neoplastic from non-neoplastic brain lesions is extremely necessary since a misdiagnosis can lead to a severe effect on neurosurgery and exposure to toxic chemotherapy or radiotherapy, which may cause damage to brain tissues.

Eligibility Criteria:
Inclusion Criteria:

* patients with solitary intraaxial brain lesions
* patients with de novo lesions
* Patient age : any age

Exclusion Criteria:

* patients with multiple intra-axial brain lesions
* patients with extra-axial brain lesions
* patients with recurrent lesions
* patients receiving chemotherapy or radiotherapy
* patients unfit for surgery
Classroom Behavior Support (CBS) Project

The goal of the study is to conduct a randomized clinical trial to evaluate the impact of the Classroom Behavior Support Program (CBS; a multi-component, individually-tailored teacher consultation program) on teachers' classroom management practices (universal and targeted) and resulting student behavioral and educational outcomes relative to a best practices comparison consultation condition.

Participants will be 165 general education teachers (teaching Kindergarten through 6th grade) who have room for growth in classroom management skills, along with their classroom of students and one target student with inattentive and/or disruptive behavior problems. Teachers will be recruited over 3 cohorts (1 cohort per year). Teachers will be randomly assigned to one of two consultation conditions and participate for an entire academic year. Teachers in both conditions will be scheduled to receive consultation every other week between August and December and one time per month between January and March. The focus of the consultation will be teacher implementation of universal classroom management practices (Tier 1) and the targeted intervention applied with the target student (either a daily report card and organization intervention; Tier 2). Teachers will be observed weekly and data from observation will be incorporated into consultation sessions. Investigators will examine the main effects of consultation on growth in teacher practices (universal and targeted) and change in proximal and distal student outcomes (classwide and in target students), as well as the mediators and moderators of these effects.

Eligibility Criteria:
Inclusion Criteria:

TEACHER INCLUSION CRITERIA:

Teacher of a general education class in a participating elementary school (teacher grades K-6th grade) with at least one of the following from observation screening data.

* Below 51% response to student rule violations;
* A rate of praise per hour that falls below the 30th percentile for teachers of the same grade;
* A rate of student rule violations that exceeds the 70th percentile for that grade.

STUDENT INCLUSION CRITERIA:

* Student must spend at least 50% of his/her day in the teacher's classroom
* Student must receive at three or more scores that are lower than a 3 on a positive Daily Behavior Rating (DBR) subscale or three or more scores higher than 3 on a negative DBR subscale.
* Parents must provide consent.

Exclusion Criteria:

TEACHER: no exclusionary criteria.

STUDENT: Special education eligibility of cognitive disability, autism, or multiple disability.
Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)

The aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes. Type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing. There is need for extended support from both health care professionals and peers. Web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers. In a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* women with type 12 diabetes, included in early pregnancy (first trimester)

Exclusion Criteria:

* women who are illiterate, or do not read and speak Swedish
Reliability, Validity Of The Turkish Version Of The Back Performance Scale

In this study, we performed the validity and reliability of the Turkish version of Back Performance Scale.

Low back pain (LBP) is defined as the pain that occurs in the area between the lower border of the scapula and the buttocks and sometimes radiates to the lower extremities. In the community, lower back pain is the second most common health problem after cold. 15% of LBP cases are chronic. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of study is to determine the Turkish version, validity and reliability of Back Performance Scale. 180 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results evaluated using the Intraclass Correlation Coefficient method.

Eligibility Criteria:
Inclusion Criteria:

* Having a low back pain
* Literate persons

Exclusion Criteria:

* Cancer disease
* Trauma
* Pregnant
Web-based Instrument Intervention for Individuals with Shoulder Pain

Introduction: Shoulder pain is a condition of high prevalence in the general population. Studies indicate that physiotherapeutic treatment with exercise is effective in reducing pain and restoring function in patients with shoulder pain. Patients may have difficulty accessing the physiotherapy service due to the cost of treatment, transportation to the service, and long waiting lines. A possible solution is the use of a web-based exercise prescription instrument to increase access to physiotherapy for shoulder pain patients. Objective: To verify the effects of an intervention with a web-based instrument compared to a in person and supervised intervention. Methods: This study is a controlled, randomized, blinded clinical trial. There will be 184 individuals with shoulder pain who will be randomly assigned to two groups. One group will receive a web-based instrument intervention and the other group will receive the in person and supervised intervention. The intervention will consist of strengthening exercises with emphasis on the lateral rotator and scapulothoracic muscles. The primary outcome will be pain and disability (SPADI, Shoulder Pain and Disability Index), and the secondary outcomes will be function (DASH questionnaire, Disabilities of the Arm, Shoulder and Hand), self-efficacy (CPSS, Chronic Pain Self-Efficacy Scale), kinesiophobia (Cover Scale), patient expectation of treatment (7-point Likert Scale), and patient satisfaction (Global Change Assessment Scale). All outcomes will be measured before and after 12 weeks of treatment (2x/week), after 6 months and 12 months from the end of treatment. Normality of data will be verified by Kolmogorov Smirnov's test. Differences between groups will be verified using the mixed linear models with the interaction terms versus time. The effect size will be calculated for the variables between the groups. The significance level will be set at 5%.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60;
* Self-reported pain of intensity equal to or greater than 3 points on the numerical pain scale (NDT) at rest or arm movement in the anterolateral region of the shoulder;
* Duration of at least 3 months of shoulder pain;
* Have a mobile phone with Android 4.1 or higher.

Exclusion Criteria:

* History of trauma related to the onset of symptoms;
* History of clavicle, scapula or humerus fracture;
* History of surgical stabilization or rotator cuff repair;
* History of shoulder dislocation;
* Pain related to the cervical spine;
* Adhesive capsulitis;
* Systemic disease involving the joints and cognitive alteration that makes it impossible to carry out questionnaires or use the mobile application.
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic migraine
* More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).

Exclusion Criteria:

* Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
* Previous treatment with botulinum toxin of any serotype for any reason
* Previous treatment with topiramate
* On a ketogenic diet (high in fat, low in carbohydrates)
* History of acute myopia or increased intraocular pressure
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
* Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
* Insulin naive
* Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion Criteria:

* Type 1 diabetes patients
* Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Patients with a hypersensitivity to insulin or to any of the excipients
* Patient groups not approved in the product label
Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model

Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors.

The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.


Eligibility Criteria:
* Caucasian;
* female;
* age 30-45 years;
* Body Mass Index (BMI)\>30 m/kg2;
* non-smoker;
* not pregnant or lactating;
* Restraint Scale (Herman and Polivy, 1988) score \>15, indicating a history of chronic dieting;
* no recent myocardial infarction;
* no active neoplasms, Type 1 diabetes or insulin-dependent Type 2 diabetes, nor history of cerebrovascular or renal disease.
Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs

The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ≥ 19 years of age (on the day of screening)
* Body weigth ≥50.0kg, 18.5Kg/(m)\^2 ≤ (BMI) ≤30.0Kg/(m)\^2
* No congenital or chronic diseases and no abnormal signs determined by medical examinations
* Not abnormal or not clinical significant lab values
* Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Clinically significant disease with liver, renal, neurologic, respiratory, digestive, endocrine, hemato-oncology, urologic, cardiovascular, musculoskeletal, psychiatric system
* Subjects who have hypersensitivity for investigational products
* AST or ALT \> 2\*ULN, r-GTP \> 1.5\*ULN, Blood creatinine \> ULN (ULN, Upper Limit of Normal)
* SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 90 mmHg or \< 60 mmHg
* Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
* Subjects who previously participated in other clinical trials or bioequivalence Test within 6 months
* Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers

This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Body mass index 18.0 to 30.0 kg/m2 inclusive
* Female subjects who are either surgically sterilized or post-menopausal
* Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing

Exclusion Criteria:

* Suspicion of alcohol or drugs of abuse addiction
* Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
* Participation in an investigational drug or device study within three months before dosing
* Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
* Any familial history of early onset Alzheimer's disease
* Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Informed and subscribed consent before any procedure
* Age range : 2 - ≤5 years
* Male and female patients
* Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)
* PAI positive (at least one primary and two secondary ):

Primary:

1. one parent with asthma
2. Atopic Dermatitis
3. sensibilisation to air allergen

Secondary:

1. Food sensibilization
2. wheezing also not during the infective episodes
3. eosinophilia (\>4%)

Exclusion Criteria:

* story of severe wheeze requiring hospitalization
* treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks
* structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)
* Persistent infections
* aspiration lung disease (gastroesophageal reflux disease, etc.)
* Cystic fibrosis
* prematurity or bronchopulmonary dysplasia
* Tuberculosis
* primary ciliary dyskinesia
* congenital heart disease
* pulmonary foreign body
* bronchiectasis
* Immunodeficit
A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine

The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of febrile illness within 5 days prior to first dose.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
G-POEM for Treatment of Refractory Gastroparesis

This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic Myotomy "G-POEM" in patients presenting with gastroparesis.

Gastroparesis is a chronic digestive disorder best defined as severe nausea, vomiting, bloating, and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction. The most common etiology is idiopathic. Some of the identifiable etiologies include diabetes and post-surgical.

Endoscopic techniques to reduce pyloric tone mainly consisted of Botulinum toxin injection but failed to demonstrate significant symptom improvement compared to placebo. Another endoscopic method was transpyloric stenting which yielded symptomatic relief but is prone to stent migration and therefore is unlikely to provide a viable long term solution.

Surgical pyloroplasty has shown to be effective in reducing gastroparesis symptoms, but is associated with a risk of leakage and potential further narrowing of gastric outlet. It also carried all the risks of general anesthesia and requires advanced laparoscopic suturing skills. Therefore, the development of a less invasive reliable method of improving gastric emptying is highly desirable.

An endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. Gastric Per-Oral Endoscopic Myotomy (G-POEM) is feasible and can be performed by using techniques similar to those of esophageal per-oral endoscopic myotomy. Endoscopists who are experienced in esophageal per-oral endoscopic myotomy should be able to perform G-POEM because both use similar techniques, principles, and equipment.

The investigators theorize that a subset of patients with refractory gastroparesis, diabetic gastroparesis or post-surgical gastroparesis, may respond to endoscopic pyloromyotomy.

Eligibility Criteria:
Inclusion Criteria:

• Adult patient age greater than 18 years old who are undergoing a standard-of-care G-POEM procedure.

Exclusion Criteria:

* Previous surgery of the esophagus or stomach which has resulted in a resection of the antrum and pylorus
* Known active gastroesophageal malignancy
* Prior surgical or laparoscopic pyloromyotomy