cyrilzakka/clinical-trials huggingface dataset:
Health SMART (Stress Management and Relaxation Training)

The study will examine the effects of a cognitive behavioral stress management (CBSM) group intervention on antibody and cellular immune function among women who are at elevated risk for breast cancer because of family history.

Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to HA vaccine compared to women in the comparison group.

Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who participate in the CBSM intervention will have larger primary and secondary in-vitro proliferative response to HA antigen, and increased primary and secondary in-vitro TH1 cytokine response to HA antigen compared to lymphocytes from women in the comparison group.

Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower levels of distress immediately after the intervention compared to women in the comparison group. Changes in distress as a result of the intervention will be associated with any significant changes in immune function discovered in Aims 1 and 2.

Cancer vaccines are emerging as important tools for cancer treatment and prevention. Unfortunately, the cohorts that ultimately will benefit most from the vaccines, those at elevated risk for cancer, are likely to be stressed. Chronic stress can impair immune function, including immune response to vaccines. An inadequate response to vaccines can weaken their protective effect. Women at elevated risk for breast cancer can experience significant levels of distress and have associated immune function decrements. Interventions to treat distress-related immune decrements among these women are needed because these women will be among the first candidates for breast cancer vaccines. In theory, stress-management interventions should improve immune function and response to vaccines; however, the findings to date are mixed. The proposed investigation will conduct an exploratory randomized clinical trial to collect preliminary data on the efficacy of a cognitive behavioral stress management (CBSM) group intervention among women who are at elevated risk for breast cancer because of family history and who are reporting elevated levels of distress. Study outcomes will include antibody and cellular immune response to hepatitis A vaccine and self-reported distress.

Eligibility Criteria:
Inclusion Criteria:

* Family history of breast cancer
* Fluent in English
* Working phone and address
* Plan to live in the area for one year
* Reporting elevated levels of distress at screening.

Exclusion Criteria:

* Prior cancer diagnosis (except non-melanoma skin cancer)
* Current major depressive episode
* History of Bipolar Disorder or Schizophrenia
* History of autoimmune disease
* History of Hepatitis A or HA vaccination
* Use of immune modulating drugs (e.g. corticosteroids, antihistamines), nicotine, or \> 3 drinks/ day alcohol
Italian Translation and Transcultural Validation of Frenchay Activity Index and Walking Handicap Classification in Stroke

This study is aimed at providing an Italian version of two assessment tools for participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC) by a standardized translation and transcultural validation protocol. The protocol includes a pre-test of the Italian version on ten patients, a final revision, and a validation on a sample of 60 stroke patients.

This study is aimed at providing an Italian version of two tools to assess participation in stroke patients, the Frenchay Activity Index (FAI) and the Walking Handicap Classification (WHC). These tools have been recently indicated for the assessment of participation in Stroke patients by the Italian Association of Physical and Rehabilitation Medicine (Minimal Stroke Assessment Protocol - PMIC2); they are currently used in Italian research and clinical settings, but no official translation exists. The process requires a standardized translation protocol, including forward and backward translation, using a multistep revision structure, to ensure conceptual and semantic equivalence. The validation process includes a pilot evaluation of on 10 individuals post-stroke admitted to the Neurological Rehabilitation Unit, Foundation Don Gnocchi Scientific Institute, and a validation on a sample of 60 stroke patients including reliability, internal consistency and concurrent validity assessment of the translated version against the Sickness Impact Profile (SIP) - Italian version and the Rivermead Mobility Index (RMI) - Italian version, respectively

Eligibility Criteria:
Pre-test: consecutive recruitment of 10 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute.

Inclusion criteria:

* age 18-90;
* stroke occurred within 3 months from enrollment;
* clinical stability (SIC = 0).

Exclusion criteria:

* stroke recurrence;
* visual and / or hearing disorders;
* cognitive decline (MMSE \<21) and/or severe aphasia, which would limit the the patients' understanding of and the reliable answering to the two assessment tools

Validation: recruitment of 60 post-stroke patients undergoing intensive rehabilitation treatment at the Neurological Rehabilitation Unit, Foundation don Gnocchi Scientific Institute-

Inclusion criteria:

* age 18-90,
* stroke occurred within 8 months from enrollment;
* clinical stability (SIC = 0).

Criteria for carrying out the interview with a proxy. If a proxy is not available, the patient is excluded:

* visual and / or hearing disorders;
* cognitive decline (MMSE \<21) and/or severe aphasia, which would limit the patients' understanding of and the reliable answering to the two assessment tools.
Itopride in Functional Dyspepsia:a Dose Finding Study

This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia.

The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.

Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia.

Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of functional dyspepsia (Rome criteria) -

Exclusion Criteria:

structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture

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Evaluation of Surgical and Obstetric Outcomes in Pregnant Women Undergoing Operative Laparoscopy

Laparoscopy, when applicable, is the current gold standard management for abdominal and pelvic surgery. Although accumulating evidence suggests that laparoscopy is associated with reduced intraoperative and postoperative morbidity, reduced hospital stay, better recovery and cosmesis compared with open surgery (laparotomy), the use of this technique in pregnant women is still debated. Considering this point, we aimed to collect retrospectively cases of laparoscopic surgery during pregnancy, regardless of the indication and gestational age, in order to analyze both surgical and obstetric outcomes during and after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (regardless of gestational age)
* At least one indication for laparoscopic surgery

Exclusion Criteria:

* None
Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents in Hemodialysis Centers in Croatia

This study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal disease in hemodialysis centers in Croatia. The total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other ESAs. In addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.


Eligibility Criteria:
Inclusion Criteria:

- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Uncontrolled hypertension
A Study of LY3451838 in Healthy Participants

The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).


Eligibility Criteria:
Inclusion Criteria:

* Male participants must adhere to contraception restrictions
* Female participants must be of non-childbearing potential due to:

  * Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
  * Surgical sterilization
* Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
* Have clinical laboratory test results within normal reference range or with acceptable deviations
* Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study
* Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality
* Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases
* Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions)
* Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing
* Have an abnormality in the 12-lead electrocardiogram (ECG) or Fridericia's corrected QT (QTcF)
* Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen
* Have donated blood of more than 450 milliliters (mL) within the last 3 months
* Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit (CRU)
* Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
* Current smoker of more than 10 cigarettes or equivalent per day and unable to stop smoking while in the CRU
* Have an abnormal blood pressure
* Have clinically significant proteinuria or hematuria
* Positive findings for known drugs of abuse
* Have received treatment with biologic agents within 3 months or 5 half-lives (whichever is longer)
* Have clinically significant allergies, or intolerance to corticosteroids, or severe post treatment hypersensitivity reactions
Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.

Type 2 DM is due to insulin resistance or low insulin secretion or sometimes a combination of both. Nanotechnology structured water is a type of water that is produced using energy field modulators to change the biological, chemical, and physical properties of water molecules and improve the bioavailability of this nano-water. Objective: To find out the effect of drinking nanotechnology structured water (Magnalife®) on the blood glucose levels in patients with type 2 diabetes mellitus.

This is a blind randomized control trial, according to CONSORT guidelines for randomization, "Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups.", that included 387 patients with Type 2 diabetes mellitus in Diabetes Care Center, Sulaymaniyah, Kurdistan region from July 2016 till February 2018. A total of 387 patients with type 2 diabetes who were patients in this center and agreed to participate in this clinical trial were included in this study.

In group A, patients were given nanotechnology structured water Magnalife® and in group B they were given ordinary bottled drinking water as a control . The bottles were unlabeled so that the patients did not know which water they were drinking. Then they were asked to eat their usual food and to drink their usual drinks, also they could drink water ad libitum after drinking the daily doses, and to have the same physical activities that they used to do in their usual daily life. They were instructed to take their medications as usual, and were told to come to test their blood sugar level at the end of the third month to get the HbA1c tested at the end of the three months of drinking the water.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Malignancy
* Steroids
* Immunotherapy
* Chemotherapy
* Radiotherapy
* Chronic infections
* Drugs that antagonize or synergies insulin effects
Music Therapy for Patients Being Weaned From Mechanical Ventilation

The purpose of the study is to determine whether Music Therapy interventions can be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management.Music used is varied according to subject's preferences.

Music therapy interventions will be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management. The intervention will consist of 40 - 50 minutes of active music therapy and improvisation in which the music is used as a distraction from the hospital setting and the procedure taking place. The intervention will end with 5 to 10 minutes of discussion of music activities/selections to be used between music therapy sessions. The intervention is individualized and can be modified accordingly to the subject's preferences.

Eligibility Criteria:
Inclusion Criteria:

* Anxiety
* weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours

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Anesthesia Related Neurocognitive Deficits in Children

The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia before the age of 36 months

Exclusion Criteria:

* neurosurgical interventions
* cardiac surgery
* preexisting hereditary or acquired cognitive deficits
* no informed consent
Pharmacokinetics and Tolerability of Zavesca® (Miglustat) In Patients With Juvenile GM2 Gangliosidosis

The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat, OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.

The GM2 gangliosidoses are a group of neuro-degenerative lysosomal storage diseases resulting from accumulation of GM2 and related glycolipids in the central nervous system (CNS). Tay-Sachs and Sandhoff disease are two variants which are indistinguishable in clinical grounds. According to the onset and rate of disease progression, the condition can be categorized in infantile, juvenile and adult forms. This open-label, single-arm study is designed to assess the pharmacokinetics, safety and tolerability of miglustat in juvenile patients. Miglustat will be administered at a maximum dose of 600 mg/day, divided into three doses per day. The dose used for patients in this pediatric age range will be related to the patient's body surface area. The pharmacokinetics assessments for the study will be performed in-hospital during a 24 hour period, and will take place at the day one and at the month 3 visits. The clinical (which includes safety and tolerability) assessments will be performed throughout the 24-month study period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GM2 gangliosidosis confirmed by demonstration of profound deficiency of β-hexosaminidase A or A \& B in peripheral blood leukocytes or cultured skin fibroblasts
* Aged 6 to 20 years
* Onset of characteristic clinical symptoms of the disease before age 15 years
* Normal renal or hepatic function

Exclusion Criteria:

* Fertile patients who do not agree to use adequate contraception throughout the study and for 3 months after cessation of miglustat treatment.
* Patients who cannot tolerate the study procedures, cannot be compliant to therapy or who are unable to travel to the study center as required by this protocol.
* Patients receiving other investigational agents within 3 months of study initiation.
* Patients with disease that may affect absorption or elimination of drugs.
* Patients suffering from clinically significant diarrhea (\>3 liquid stools per day for \> 7 days) without definable cause within 3 months of baseline visit, or who have a history of significant gastrointestinal disorders.
* Patients with swallowing difficulties.
* Patients with a high probability of dying during the study.
* Patients who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study.
Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness.

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Hepatic encephalopathy is categorized into Type A hepatic encephalopathy associated with acute liver failure; Type B hepatic encephalopathy is associated with portal-systemic bypass and no intrinsic hepatocellular disease; Type C hepatic encephalopathy describes encephalopathy associated with Cirrhosis and portal hypertension; type C hepatic encephalopathy is, in turn, subcategorized as episodic, persistent, or minimal.

A number of theories had been postulated, it was proposed that hepatic encephalopathy is a disorder of astrocyte function which play a key role in the regulation of the blood-brain barrier, maintaining electrolyte homeostasis , a role in the detoxification of chemicals, including ammonia.

neurotoxic substances, including ammonia and manganese cause morphologic changes in the astrocytes leading to Alzheimer type II astrocytosis in cirrhosis.

Hepatic encephalopathy may be due to accumulated neurotoxic substances in the brain as short-chain fatty acids; mercaptans; false neurotransmitters, such as tyramine, octopamine, and beta-phenylethanolamines; manganese; ammonia; and gamma-aminobutyric acid (GABA).

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.

Eligibility Criteria:
Inclusion Criteria:

* All the patients diagnosed as having liver cirrhosis Exclusion Criteria
* recent alcohol intake;
* Infection, recent antibiotic use or gastrointestinal bleeding;
* use of drugs affecting psychometric Performances like benzodiazepines, antiepileptics, psychotropic drugs
* History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
* Electrolyte abnormalities
* Renal impairment or hepatorenal syndrome
* hepatocellular carcinoma;
* Severe medical co-morbidities that affect quality-of-life measurement as heart failure pulmonary or neurological insults.
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.


Eligibility Criteria:
Inclusion Criteria:

* ≥18-40 year old women
* BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months
* Willing to use the NuvaRing as directed
* Not intending or wishing to become pregnant over the course of the study
* Capable of providing written informed consent

Exclusion Criteria:

* Current pregnancy
* Desire/intent to become pregnant over the course of the study
* Women who are less than 6 weeks postpartum
* Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years
* Current IUD
* Unable to comprehend consent material because of language barrier or psychological difficulty