cyrilzakka/clinical-trials huggingface dataset:
Psychiatric Disorders in Child and Adolescent Offspring of Parents with Schizophrenia and Bipolar Disorders.

Offspring of parents with bipolar disorder (BD) and schizophrenia (SZ) are vulnerable and at high risk for these disorders. Despite the fact that positive family history of SZ or BD is the strongest predictor for the development of these severe mental illnesses, there is limited evidence assessing young adults of SZ and BP simultaneously with lack of detailed handling of similarities in risk and developmental trajectories during adolescence

Offspring of parents with bipolar disorder (BD) and schizophrenia (SZ) are vulnerable and at high risk for these disorders. Despite the fact that positive family history of SZ or BD is the strongest predictor for the development of these severe mental illnesses, there is limited evidence assessing young adults of SZ and BP simultaneously with lack of detailed handling of similarities in risk and developmental trajectories during adolescence \[1, 2\]. SZ and BP are thought to share a common pathophysiological basis due to advances in the field of molecular genetics, which have yielded overlapping findings between the two disorders \[3, 4\]. The psychopathological base during adolescence is influenced by neurodevelopmental deviation prior to clinical onset of many severe mental illnesses \[5, 6\]. Moreover, the risk for developing psychopathology is high during adolescence and prodromal symptoms start even earlier and may overlap and are difficult to differentiate \[5-8\]. This has turned efforts towards identification and treatment of individuals at early stages of the illness, when first clinical manifestations emerge \[8, 9\].

Importantly, subthreshold symptoms of mania and depression along with unspecific behavioural, emotional, and cognitive manifestations are highly predictive of future manic and depressive episodes in BD as well as anxiety disorders, which is confirmed by the clinical staging perspective \[10, 11\]. Nevertheless, early recognition and intervention during the prodromal phase is still at an early stage in Sz \[12\] with limited research into valid prodromal criteria for BP \[13\]. Retrospective studies combining subjects with early-onset mania and early-onset first-episode psychosis have reported a similar pattern of neurodevelopmental and psychopathological features predating the appearance of more specific prodromal symptoms in both disorders \[14, 15\]. Therefore, the substantial overlap of symptoms in the initial phases suggests that early identification programmes should be aimed at detecting both the pre-psychotic and the pre-manic phases of SZ and BP \[16\]

Eligibility Criteria:
Inclusion Criteria:

- 6_18 years IQ \> 70 parents of schizophrenia \& mood disorders .

Exclusion Criteria:

* age \<6 or \>18 IQ \< 70 .
Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

Severe asthma is a heterogeneous disease characterized by the need for treatment with high doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it accounts for a significant percentage of the consumption of health care resources. Severe asthma comprises various clinical and pathophysiological phenotypes. In this current study, we aimed to clinical characteristics and cytokes profile in severe asthma patients.

To investigate the clinical phenotypes and inflammatory endotype by analyzing cytokines in severe asthma patients, it may improve characterization of the disease and contribute to improved selection of appropriate treatment. It could also help link genotypes with their phenotypic manifestations and their natural history and prognosis. A greater understanding of the phenotypes of severe asthma could enable identification of biomarkers for each phenotype, and identify the association between biokarkers and clinical outcomes in severe asthma patients.

Eligibility Criteria:
Inclusion Criteria:

1. Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic CS for 50% of the previous year to prevent it from becoming ''uncontrolled'' or which remains ''uncontrolled'' despite this therapy
2. Uncontrolled asthma defined as at least one of the following:

(1). Poor symptom control: ACQ consistently\>1.5, ACT\<20 (or ''not well controlled'' by NAEPP/GINA guidelines) (2). Frequent severe exacerbations: two or more bursts of systemic CS (\>3 days each) in the previous year (3). Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year (4). Airflow limitation: after appropriate bronchodilator withhold FEV1\<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)

Exclusion Criteria:

* (1). mild to moderate persistent asthma (2). COPD or other lung diseases (3). malignancy (4). long-term O2 therapy more than 15 hours/day (5). long-term NIPPV use (\> 6 hours/day) (6). no inform consent and cannot be followed regularly (7). active TB or other infection diseases
Patient Centered Simulation For Labor and Delivery

Patient satisfaction is an important outcome in the evaluation and development of healthcare services. Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care. Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes. Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries. Often fear is worsened by a lack of knowledge of what to expect during labor. Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery.

Patient satisfaction is an important outcome in the evaluation and development of healthcare services. Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care. Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes. Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries. Often fear is worsened by a lack of knowledge of what to expect during labor. Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery. Women in Centering Pregnancy groups will be approached and assigned to either the intervention or control arm by Centering Pregnancy group. Those in the intervention arm will participate in simulations in the following areas: 1) In-Utero Resuscitation Simulation: the process that may occur if a baby has a significant drop in heart rate during labor, 2) Cesarean Section Simulation: the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a laboring woman needs a cesarean delivery, 3) Pushing Simulation: the pushing process after a laboring woman becomes completely dilated. Those in the control arm will not receive this education. All patient will complete a modified Childbirth Experience Questionnaire the day after delivery. Responses will be compared between the woman that participated in the simulations to women who did not participate in simulations.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous pregnant women
* In third trimester

Exclusion Criteria:

• Not planning on delivering with Wake Forest School of Medicine OB/GYN
Ergogenic Properties of Magnesium Supplementation

The purpose of the proposed project is to determine if short-term dietary supplementation of magnesium will improve performance during a series of lab-based exercise tests, will favorably modify the gut-microbiota, and will augment skeletal muscle mitochondrial function.

Magnesium is the fourth most abundant mineral in the human body. It is critical to day-to-day physiological function including the regulation of metabolism, cardiovascular function, immune function, and the operation of the nervous system. In light of its important role in physiology, dietary supplementation of magnesium has been purported to improve athletic performance, although the precise mechanism is unclear. The foci of the proposed study is the ergogenic effects of magnesium, its potential influence on gut health, and its potential ability to improve skeletal muscle function. The investigators will be studying an athletic/competitive population of endurance-trained adults. This group is likely to be the most interested in the use of magnesium to enhance athletic performance. Also, by only recruiting habitual exercisers, the variability between participants is likely to be reduced compared with if the investigators had also recruited people who are usually sedentary.

Eligibility Criteria:
Inclusion Criteria:

* Competitive cyclists
* Adult males and females (18 - 40 years, inclusive) who have exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during the previous 2 years.
* Maximal oxygen uptake (VO2max) satisfying the minimum criteria for "Good" (sex- and age-adjusted) as defined by the American College of Sports Medicine.

Exclusion Criteria:

* Identification of a contra-indication to exercise during a 12-lead exercise stress test
* Use of a magnesium supplement within the previous 4 weeks
* Pregnancy or breast-feeding
* Unable to perform vigorous exercise
* History (previous diagnosis) of kidney disease
* Use of laxatives, Zinc, diuretics, proton pump inhibitors, over the counter agents such as certain heartburn and GI/gut treatments (laxatives) which contain magnesium, Zinc or other high dose cations which reduce absorption of Magnesium
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil

Iron deficiency anemia is the most common nutritional problem in the world.

The objectives of this study are:

* to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels.
* to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic

Study hypothesis:

* The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.
* The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.

Purpose

The objective of this study were:

* to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid.
* to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic.

A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.

Eligibility Criteria:
Inclusion Criteria:

* from 6 to 24 months
* born at term
* non-twins
* with parental approval for participation in the study
* attending municipal daycare centers with mor than four children each

Exclusion Criteria:

* Children with special needs
* low birth weight (\<2.500g)
* with growth-impairing heart diseases
* neurological syndromes
* sickle-cell anemia
* sickle-cell trait
* under treatment for anemia at the time of the first interview or screening performed by the pediatrician
* those no longer attending the daycare center
* the clinical trial excluded children with hemoglobin \>=7 amd \<=8g/dL.
* For the second objective: incomplete anthropometric surveys
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.

* Patients will take capecitabine orally twice a day for two weeks followed by a one week break period. These three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects.
* Thalidomide will be taken orally once daily in the evening. Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects. The dose will be increased in this manner until the daily dose is 600mg. If side effects do develop, the dose will either be held constant or decreased until the side effects resolve. If the side effects do not resolve, treatment will be stopped.
* Before starting treatment and periodically throughout the study, a physical exam, routine blood tests, scans and x-rays will be done to monitor the body's response to the treatment.
* For women patients, pregnancy tests will be performed every 3 weeks while on therapy.
* Scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to follow the effects of the study drugs on the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease
* Measurable tumor
* Serum creatinine \< 1.5 mg/dl
* Total bilirubin \< 2.0 mg/dl
* AST \< 5 x ULN
* ANC \> 1,500/mm3
* Platelets \> 100,000/mm3
* Hemoglobin \> 9.0 gm/dl
* Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment
* 18 years of age or older
* ECOG performance status of less than or equal to 2
* Life expectancy of greater than 12 weeks

Exclusion Criteria:

* Prior treatment with mitomycin C or nitrosourea compounds
* Prior treatment with capecitabine or thalidomide
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Peripheral neuropathy of grade 2 or greater severity
* Myocardial infarction in the past 6 months
* Major surgery in the past 2 weeks
* Uncontrolled serious medical or psychiatric illness
* Pregnant or lactating women
* Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Known allergy to 5-FU
Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab

The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic ccRCC.
* Age 18 years and older
* ECOG 0-1
* Progressive disease after treatment with single-agent nivolumab
* Life expectancy at least 3 months
* Presence of measurable disease per RECIST 1.1 criteria
* Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment
* Adequate organ system function
* WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Exclusion Criteria:

* Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol).
* Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs.

Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger

* Presence of a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration.

Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

* Unstable angina or uncontrolled congestive heart failure
* Uncontrolled hypercalcemia
* Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Presence of other malignant diseases, except non-melanoma skin care
* History of allergy to study drug components.
* History of severe hypersensitivity reaction to any monoclonal antibody.
* Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration.
* Women must not be pregnant or breastfeeding. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
* Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated
Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old
* Patients with clinical diagnosis of ACS
* Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

* Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
* LDL-C \< 1.8mmol/L in patients without statin therapy in 1 months
* Endstage congestive heart failure, or LVEF \< 30%
* Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
* Myopathy or increased creatine kinase (CK\>2 UNL)
* Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
* Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
* Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
* Pregnancy, lactation, or child bearing potential women without any effective contraception
* Accompanied with malignant disease or other disease, which cause life expectancy \< 6 months
* Participating in other interventional clinical trails using drugs or devices
* Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report

In this study we aimed to investigate the performance and effectiveness of NOL and/or NOLedge as a tool for pain assessment in geriatric and critical ill non communicating patients.

Our hypothesis was that NOL and the NOLedge may have good correlation with the health-care professional assessment PAINAD, BPS values, even with the use of the drugs affecting autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, Age \> 18 years old.
* Spontaneously breathing or mechanically ventilated
* Any patient who is unable to express his/her own level of personal pain by using visual scales according to the hospital standard
* Written informed consent provided by the participant (if they have capacity) or guardian (if they do not have capacity) or a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

Exclusion Criteria:

* A patient whose staff or research team believes that his or her participation in the research will cause suffering to the patient.
* Unstable condition preventing planned routine procedures of care, and conditions precluding the use of PMD-200: absence of sinus cardiac rhythm.
AZD5438 in Patients With Advanced Solid Malignancies

Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid malignancy
* Cancer refractory to standard treatments or for which no standard therapy exits

Exclusion Criteria:

* Radiotherapy within 3 weeks of the start of treatment
* Investigational product within the last 3 weeks
* Systemic cytotoxic anti-cancer therapy within the last 3 weeks
* Any significant clinical disorder that makes it undesirable for the patient to participate
DZX Mediated Insulin Suppression in Obese Men

The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.


Eligibility Criteria:
Inclusion Criteria:

* male
* age 25-50 years
* BMI 30-35 kg/m2
* stable body weight during 3 months before the start of the study
* glucose \<= 6.0 mmol/L
* C-peptide \>= 1.0 nmol/L
* HbA1c \<= 6.0%

Exclusion Criteria:

* comorbidity
* medication
* serum creatinine \> 120 micromol/L
* liver enzymes \> 2 times upper limits of normal
* gout
* alcohol use \> 2 alcoholic drinks a day
* drug abuse
* cessation of smoking less than 6 months ago