cyrilzakka/clinical-trials huggingface dataset:
Prevalence of IL28B Polymorphism in Hepatitis C Patients

Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT genotype at rs8099917 are associated with good treatment outcome. Asian populations have high prevalence of CC genotype in other studies, which can explain relatively good response to peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.

The prevalence of different genotypes of IL28B polymorphism in the local population will be studied. DNA will be extracted from the whole blood sample of hepatitis C patients with genotype 1, 2 and 3 infection. It will be amplified by real-time PCR and subsequently analysed for the genotypes of IL28B SNPs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive HCV IgG (EIA or RIBA test) and positive HCV RNA test (RT-PCR)
* HCV genotypes 1, 2 or 3 (determined by Versant™ HCV genotype Assay LiPA 2.0)
* with or without HCV treatment (peginterferon/ ribavirin).

Exclusion Criteria:

-Patients with acute hepatitis C infection.
A Study of Bedside Versus Hallway Rounding

The purpose of this study is to compare bedside rounding with hallway and conference room rounding on the neurology inpatient ward service at an academic hospital and identify best practices associated with educational and patient care outcomes. Specifically, this study will determine which rounding practices are associated with a positive educational experience for learners, greatest patient and care team communication, and time efficiency.

This study will evaluate the efficacy of bedside rounding and compare it to hallway and conference room rounding on the neurology ward service at the Brigham and Women's Hospital (BWH). The neurology ward service consists of two teams, each with 10-15 vascular neurology and general neurology patients. The teams perform daily attending rounds.

Each team consists of an attending physician, a senior supervisory resident, two junior residents, several rotating residents and interns from other departments, medical students, as well as a physician assistant who alternates daily between the teams. Neurology attendings spend two weeks at a time on a team.

During a two-week attending rotation, we plan to designate one of the teams as the "bedside rounding team" and the other team as the "hallway rounding team", which will serve as the control group. The bedside rounding team will carry out patient presentations at the bedside, with a focus on the patient, while ensuring nursing involvement in each patient's room. The hallway rounding team ("the usual method") will present patients outside of the patient's room, without an added emphasis on nurse participation. Halfway through the two-week rotation, the team designation will switch in a crossover fashion, so that the initial bedside rounding team will become the hallway rounding team, and vice versa. Our planned study period is Monday through Friday for a consecutive 6-8 week period, and we anticipate including about 150-200 patients in our study.

To evaluate staff educational experience, patient and interprofessional communication, and clinical care outcomes of these two rounding approaches, we plan to survey patients, resident trainees, attendings, and nurses on both teams. For collection of data, a student observer or research assistant familiar with the study purpose and methods will accompany a neurology team during weekday morning rounds and record data about the composition and timing of rounds.

Eligible participants include adult patients and providers (nurses; physicians, including residents and attendings; and ancillary providers) involved in the inpatient neurology service at BWH. Patients whose primary language is English will be included in the study with notation of this feature. Observations will focus on activities of the physician providers. Surveys for medical education will involve physician participants who give consent. Surveys of patient care and communication will involve patients and nurses who give consent.

Eligibility Criteria:
Inclusion Criteria:

* new admission to neurology team

Exclusion Criteria:

* comfort measures as sole treatment goal
Surgical Treatment in Diabetic Patients With Grade 1 Obesity

There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman with Type 2 diabetes mellitus (DM) aged between 25 and 65 years, with time since diagnosis of diabetes less than 10 years.
* Grade I obesity (BMI between 30-35)
* Inadequate glycemic control with HbA1c between 7.0 to 9.5% at baseline, in the presence of drug treatment for diabetes in the last year.
* Reserve pancreatic C-peptide\> 1.0 at baseline.
* Overweight stable defined as BMI\> 30 in the last two years.

Exclusion Criteria:

* History ketoacidosis, diabetes mellitus type 1, diabetes followed by pancreatitis.
* Repetition of measurements (ie, 2 or more within 1 week) fasting plasma glucose(FPG) \> 240 mg / dL during the pre-treatment.
* History of Severe Proliferative Diabetic Retinopathy.
* Autonomic neuropathy.
* Loss or gain significant weight within the last 12 weeks (range, 5% body weight)
* Renal insufficiency
* History of renal disease treated with immunosuppressive therapy, history of dialysis or kidney transplantation.
* Presence of other renal diseases (eg nephrotic syndrome, glomerulonephritis)
* Acute myocardial infarction, unstable angina (NYHA class III-IV), revascularization or stroke within the previous 3 months of the initial visit.
* Uncontrolled hypertension defined as diastolic blood pressure\> 100mm/Hg and diastolic blood pressure\> 160mm/Hg at the initial visit.
* History of Hepatitis B or Hepatitis C.
* Criteria for Hepatic insufficiency defined as Child B and C liver disease clinically active and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above 3 times the upper limit of normal.
* History of prior bariatric surgery.
* Inflammatory Bowel Disease.
* History neoplasm within the last 5 years (except for squamous cell carcinoma and basal skin and cervical carcinoma in situ)
* Clinically important hematologic disorder (symptomatic anemia, bone marrow proliferative disorders, thrombocytopenia, ..)
* History antibody positive human immunodeficiency virus (HIV)
* Surgery with general anesthesia within 12 weeks prior to the initial visit or incomplete recovery from prior surgery.
* History of drug or alcohol abuse within 3 years before the initial visit.
* Pregnancy or breastfeeding or planning pregnancy in the next two years.
Feasibility of Meal Delivery Postpartum

This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.

This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
* 18 years of age or older
* Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic
* Experienced a healthy singleton pregnancy
* 5-18 weeks postpartum at enrollment
* Body mass index \>= 30 at enrollment
* Residing within the meal company's delivery radius
* Willing to consent

Exclusion Criteria:

* Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
* Current treatment for severe psychiatric disorder (such as schizophrenia)
* Self-reported diagnosis of anorexia or bulimia
* Current use of medication expected to significantly impact body weight
* Current substance abuse
* Participation in another dietary and/or weight management intervention postpartum
* Unable to understand and communicate in English
* Unwilling or unable to consume study meals
Clinical, Immunological, Morphological and Genetic Characteristics of Patients With Dysferlinopathy in the RF

To evaluate specific characteristics of phenotype, immune status, molecular and genetic as well as morphological characteristics of adult patients with limb-girdle muscular dystrophy R2 in various regions of the Russian Federation.

A single-center, cohort clinical study. Subjects of both sexes aged 18 to 65 inclusive with genetically confirmed diagnosis of limb-girdle muscular dystrophy type R2, who have signed the written informed consent form for this study.

The control and case groups should be age- and gender-matched.

Study Objectives:

* To evaluate a clinical status of a subject (MMT score; 6-minute walk test; North Star Assessment for dysferlinopathy (NSAD));
* To assess blood biochemistry;
* To characterize muscle involvement based on MRI results;
* To evaluate the progression of muscle involvement based on repeated MRI;
* To assess cardiac function with ECG, EchoCG and MRI;
* To determine a gait pattern and balance characteristics in patients with limb-girdle muscular dystrophy using electrophysiological techniques (Neurosoft Gait Assessment System Steadys; stabilometrics and plantography with "SIDAS");
* To characterize changes in subpopulation compositions of T- and B-lymphocytes, phagocytic activity of leukocytes (a phagocytic index, a phagocyte number, an index of phagocytosis completeness, lysosomal-cation and NBT tests);
* To assess average blood cytokine levels in subjects with limb-girdle muscular dystrophy (type R2) in various regions of the Russian Federation;
* To assess average blood cytokine levels in healthy subjects from various regions of the RF;
* To analyze the relationship between blood cytokine levels and the presence of a mutation in the dysferlin gene;
* To study the expression (immunohistochemistry and western-blotting) and distribution of dysferlin in impaired muscles of subjects with LGMDR2.

The clinical study includes the stages as follows:

1. Subject enrollment - 24 months
2. Data collection and analysis - 12 months
3. Study Report - 30 days.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 (inclusive) years-old subjects of both sexes;
* A signed written informed consent form;
* Genetically confirmed diagnosis of limb-girdle muscular dystrophy (type 2B) (a case group)

Exclusion Criteria:

* A subject who is an investigator, study assistant, study coordinator and a member of the other personnel indirectly or directly associated with the conduct of the study;
* Acute medical conditions associated with visceral dysfunction, life-threatening conditions which occurred less than 6 months prior to enrollment into the study such as acute cardiac, renal, hepatic insufficiency, myocardial infarction or an acute cerebrovascular accident (stroke) as well as infectious diseases;
* Excessive alcohol consumption (\> 20 g/day).
Diaphragmatic Myofascial Release for Hyperkyphotic Subjects

kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.


Eligibility Criteria:
Inclusion Criteria:

* The participant's age ranged from 20 to 40 years.
* kyphosis angle 40-50◦
* reporting pain on palpation of the diaphragm

Exclusion Criteria:

* A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
* History of any trauma or fracture to the thoracic spine.
* inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
* Restrictive respiratory disease, smokers.
MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%\~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.

In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
* Age 14 \~ 70 years old
* ECOG(Eastern Cooperative Oncology Group）performance status 0\~2
* Stage I to II
* Life expectancy\>6 months
* Informed consented

Exclusion Criteria:

* Chemotherapy before
* Bone marrow transplantation before
* History of malignancy
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* LVEF≤50%
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Lab at enrollment ALT or AST \>3\*ULN, AKP or bilirubin \>2.5\*ULN Creatinine\>1.5\*ULN
* Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection
CKD-702 Plus Irinotecan in Gastric Cancer

CKD-702 is a tetravalent bispecific IgG1 targeting hepatocyte growth factor receptor (MET) and epidermal growth factor receptor (EGFR). The investigators will test a hypothesis that CKD-702 may augment the efficacy of biweekly irinotecan as a 3L or later therapy for gastric cancer overexpressing either MET or EGFR.


Eligibility Criteria:
Inclusion Criteria:

* Failed 2 or more lines of chemotherapy
* Tumor overexpressing either MET or EGFR
* Measurable lesion

Exclusion Criteria:

* Prior treatment with anti-MET/EGFR bispecific antibody
Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients

The aim of this study was to compare the effectiveness of myofascial pain treatment methods.

Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.

Eligibility Criteria:
Inclusion Criteria:

* pain localized in the TMJ or in the preauricular area.
* no other analgesic treatment in the area of head and neck during last 12 months

Exclusion Criteria:

* inflammation in the oral cavity that emerge as a myofascial pain
* earlier splint therapy
* pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants
* systemic diseases e.g. rheumatic, metabolic
* lack of stability in the masticatory organ motor system
* masticatory organ injury
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
2. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
3. Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive)at screening or baseline.
4. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
5. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.

Exclusion Criteria:

1. Cognitive impairment due to other medical or neurological factors (non-AD).
2. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
3. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
4. Inability to tolerate MRI examination or have contraindications to MRI examination.

6. Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.

7. Exclusion criteria related to general or laboratory tests, as listed in the protocol.

8. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.

9. Severe visual or hearing impairment, unable to cooperate in the scale examination.

10. Patients suspected to be allergic to Aβ antibody drugs and their excipients.

11. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.

12. History of drug abuse and/or drug addiction within 1 year prior to screening.

13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.

14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.

15. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.

16. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.

17. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
Epidemiology of Intracerebral Hemorrhage

Exploring the risk factors and associations of intracerebral hemorrhage

Exploring the clinical characteristics and prevalence of intracerebral hemorrhage in Assiut University

Eligibility Criteria:
Inclusion Criteria:

* both sex
* Age ≥ 18
* patients diagnosed with non traumatic hemorrhagic stroke on brain computed tomography scan

Exclusion Criteria:

* presence of space occupying lesion visible on brain computed tomography scan
* preceding brain trauma or post traumatic cerebral hemorrhagic stroke
* presence of ischemic stroke
* presence hemorrhagic transformation on top of acute ischemic stroke
Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer

This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice

Exclusion Criteria:

Olaparib treatment in a clinical trial
Levobupivacaine to the Surgical Wound Following Cesarean

The postoperative period following cesarean is associated with moderate to severe pain that requires a considerable amount of analgesics that carry with them side-effects such as nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable results, to find a more effective analgesia alternative such as infusion of local anesthetics through a catheter in the surgical wound sinus, a practice that has currently been widely used in clinical practice. Despite existing references on its use in the postoperative period following cesareans there continues to be a lack of information on other aspects. The investigators study hypothesis is that the use of levobupivacaine in the surgical wound will reduce the surface of hyperalgesia compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnant women who undergo scheduled cesarean surgery under intradural anesthesia.
* Duly informed patients who have signed the informed consent during the preanesthesia consultation, or after a period of consideration if necessary, expressing their consent to be included in the study.
* Between 18-45 years of age.
* ASA I and II.
* Sufficient intellectual ability to understand the technique as well as the equipment being used.

Exclusion Criteria:

* Failure to meet any of the above criteria.
* Presence of a major medical, cardiovascular, pulmonary, metabolic, renal or liver disorder.
* Preeclampsia and/or HELLP syndrome.
* Coagulopathy
* Profuse bleeding greater than 1000 ml or that which provokes hemodynamic instability that requires aggressive fluid therapy and/or transfusion.
* Allergy to any drug included in the protocol.
* Psychiatric or neurological pathology.
* Preexisting infection.
* Previous treatment with opioids or antidepressants or suffer from chronic pain.
* History of alcohol or drug abuse or known consumption of medications that interfere with LB metabolism.
Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease

This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.


Eligibility Criteria:
Inclusion Criteria:

The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):

* The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
* The patient is either male or female and over 18 years of age
* A Patient Data Consent form is signed and dated by the patient or by the legal representative
* The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
* The patient is receiving L-dopa as monotherapy or a combination therapy composed of L-dopa and a dopamine agonist other than Rotigotine
* The patient has been on L-dopa therapy for at least 6 months and is responding to initial L-dopa therapy
* The patient has a Hoehn and Yahr stage score of 1 to 4.

Exclusion Criteria:

* Patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to Baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.