cyrilzakka/clinical-trials huggingface dataset:
Parenting a Child With Autism Spectrum Disorder and Marital Status

The purpose of this study is to investigate whether the presence of a child with Autism Spectrum Disorder places parents at increased risk for divorce.

Autism spectrum disorders (ASDs) are lifelong neurodevelopmental disorders involving a triad of impairments in communication and social reciprocity and increases in repetitive/restricted interests and behaviors. ASD includes: autistic disorder, Asperger's syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), Rett's syndrome, and childhood disintegrative disorder as pervasive developmental disorders (American Psychiatric Association \[DSM-IV-TR\], 2000).

Few disabilities appear to be more taxing on parents than ASDs.Parents of children with ASD fare worse on a variety of measures of well-being than parents of children without disabilities as well as parents of children with other types of disabilities.

Studies investigating the impact of a child with disabilities, specifically ASD, are inconclusive. However, parents of children with ASD may be at increased risk for divorce due to a variety of personal and disability related factors. In Israel the relationship of having a child with autism on the probability of divorce has not been tested yet. The aim of this study is to profile this relationship and determine the magnitude and directionality of the effect raising ASD children has on the resilience of the institution of marriage and the satisfaction both partners derive. This will be tested using a short telephone survey.

Eligibility Criteria:
Inclusion Criteria:

* parents to a child with ASD

Exclusion Criteria:

* none
The Standardized Management of Hypertension in Rural Shaanxi

The purpose of the study is to build a prevention and management system of hypertension in rural Shaanxi, China, which tries to use the standardized and economical methods to improve the outcome of chronic cardiovascular diseases.

Hypertension is common in China, but there are low rates of awareness (36.0%), treatment (22.9%) and control (5.7%) in the hypertension population of an estimated 200 million adults, a figure generated from the nationwide China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Person Project (MPP) . Substantial health and economic burdens are caused by hypertension, and adequate control of blood pressure (BP) has been a national public health priority. In China, nearly half of population are living in rural areas , where lower treatment and control rates of hypertension compared with urban areas. Expenditure of antihypertension medications and insufficient professional ability of rural doctors were the major problems facing hypertension management in rural areas of China with backward economies.

Absence of affordable medications prescribed may be a major barrier to adherence to medications. The rural doctors with insufficient professional ability had not to provide standard management of hypertension. So, an effective, cheap and simple hypertension control strategy was urgently needed in underdeveloped rural areas.

My center has been devoted to the study of hypertension in economically backward rural areas of Shaanxi Province in Western China for decades. We provided a cheap and simple hypertension management plan suitable for these areas. Because the cost of the management was about $10 dollars per year, the plan was called the ten dollars project (TDP). The TDP included a management system and a cheap treatment plan. The management software for hypertension was designed to help rural doctors with poor professional medical ability standardly manage hypertension adhering to the guidelines. Of course, a more effective and affordable treatment costing about ten dollars a year is the core of this system. The aim of this study was to measure whether the TDP can effectively improve the control of hypertension in rural areas.

Eligibility Criteria:
Inclusion Criteria:

* primary hypertension;
* Age ≥ 18 years old;

Exclusion Criteria:

* Secondary hypertension;
* the acute onset of cardiovascular events within three months;
* severe liver disease (ALT increased 2-fold greater than creatinine 2.5mg/dl);
* Severe cardiomyopathy, congenital heart disease, rheumatic heart disease
* malignancies
* allergic to study drugs
* with clear contraindications on study drugs
Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula

This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.

Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Aged 6-24 months
* Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance
* Patients on formula or mixed feeding, or formula/cow/buffalo milk

Exclusion Criteria:

* Severe acute malnutrition
* Hemodynamic instability (shock)
* Those on oral antibiotics or on excessive juices
* With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.


Eligibility Criteria:
Inclusion Criteria:

* Chronic constipation
* Male or female ages 18-75 years
* Non-pregnant, non-lactating female

Exclusion Criteria:

* Drug-induced constipation
* Subjects suffering from secondary causes of chronic constipation, such as:
* Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
* Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
* Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
* Surgery.
* Subjects with insulin-dependent diabetes mellitus
* Rectal evacuation disorder/outlet obstruction
* Subjects with intestinal perforation or obstruction
* Severe renal impairment
* Subjects with a history of alcohol or drug abuse
* Subjects with lactose intolerance
* Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes

Type 1 Diabetes (T1DM) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells. Overtime, obvious insulin deficiency develops which requires insulin therapy. T1DM accounts for about 5% to 10% of diabetes cases in Europe and United States. Currently, worldwide incidence is estimated to be around 15 per 100,000 people per year. Despite the advancement that has occurred in the field diabetes therapy, patient with T1DM still suffer from managing their disease as well as continuing to face diabetes related complications. The American Diabetes Association (ADA) recommend a goal of glycated haemoglobin (HbA1c) of \< 7%. However, only 21% of adults in the United States has achieved this recommended goal. Once again, a multinational, multicentre study shows that only 24.3% of participants achieved the glycaemic target of HbA1c less than 7.0 %. Unfortunately, intensifying the insulin therapy in order to reach the targeted HbA1c can result in serious adverse effects of hypoglycaemia and weight gain which is in its turn is known risk factor for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with type 1 diabetes for more than 1 year.
* Age 18-65 years.
* BMI ≥ 27 kg/m².
* HbA1c 7.5-10 % (58-86 mmol/mol)
* Inadequately controlled despite treatment with multiple daily injections of insulin for at least 1 year.

Exclusion Criteria:

History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome; family history of multiple endocrine neoplasia, type 2A (MEN 2A), medullary thyroid cancer, or familial medullary thyroid cancer.

* Insulin pump treatment.
* Any prior use of GLP-1 RAs or dipeptidyl peptidase-4 inhibitors, any medication (except insulin) that could interfere with glycemic control or affect a subject's safety.
* An estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2.
* Liver disease with raised alanine aminotransferase (AST), aspartate transaminase (ALT) or alkaline phosphatase (ALP)more than three times the upper normal range.
* History of pancreatitis.
* Gastroparesis.
* Pregnancy or lactation.
* History of alcohol or drug misuse, or any medical or psychological disorder that made the patient unsuitable for study participation.
* Acute symptomatic urinary tract infection or genital infection; chronic or recurrent (≥3 annual episodes) cystitis.
* Hypoglycaemia that required hospitalization or emergency treatment in the 3 months.
* DKA that required hospitalization or emergency treatment in the past 12 months.
* Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on Investigator's judgement) for the last 3 months.
3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia

The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).

In previous Russian AML multicenter studies it was shown that escalation of ARA-C dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. In the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ARA-C doses.

Eligibility Criteria:
Inclusion Criteria:

* de novo acute myeloid leukemia - age 15-60

Exclusion Criteria:

* secondary acute myeloid leukemia
* acute myeloid leukemia from myelodysplastic syndrome
* Ph+ acute myeloid leukemia
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery

To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes


Eligibility Criteria:
Inclusion Criteria:

* Patients who intend to undergo phacoemulsification cataract extraction

Exclusion Criteria:

* Patients who undergo secondary implantation
* Patients with vision loss induced by causes other than cataract
* Patients who the principal investigator/subinvestigator considers ineligible for enrollment
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject \>= 18 years;
* Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
* Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
* Adequate organ function assessed within 7 days prior to first trial treatment;
* ECOG score 0 or 1;
* Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;

Exclusion Criteria:

* Stage IV (metastatic) breast cancer;
* Inflammatory breast cancer;
* Previous anti-cancer therapy or radiotherapy for any malignancy;
* Major surgery for any reason within 28 days;
* History of uncontrolled intercurrent illness;
* Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
Cozaar XQ Re-examination Study (MK-0954-349)

This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion criteria:

* Participant with essential hypertension
* Participant who is treated with COZAAR XQ within local label for the first time

Exclusion criteria:

* Participant who is treated with COZAAR XQ before contract and out of enrollment period
* Participant who has a contraindication to COZAAR XQ according to the local label
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM

To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and Age ≤70 years
* T2DM patients,
* Control the blood glucose level only with diet and exercise in last 3 months;
* BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
* HbA1c ≥7.0% and HbA1c \<10.0%
* FPG \<13.9 mmol/L

Exclusion Criteria:

* Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history;
* History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis);
* History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening);
* Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months;
* Three or more episodes of hypoglycemia occurred in the six months prior to screening;
* History of hyperthyroidism within 6 months before screening;
* Severe cardiovascular disease. ;
* Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening;
* Liver function tests abnormal;
* Moderate or severe renal impairment;
* Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant;
* Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP \> 160 mmHg and (or) DBP \> 100 mmHg;
* Patients with uncontrolled hyperlipidemia.
Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective open laparotomy surgery.

Exclusion Criteria:

* Irregular heart beats,
* cardiac arrhythmia,
* moderate or severe valvular heart disease,
* preoperative left ventriular ejection fraction less than 40%,
* moderate t severe obstructive pulmonary disease,
* preoperative need of inotropics infusion,
* preoperative serum Cr \> 1.3ml/dl,
* moderate to severe renal or liver disease,
* acute lung injury or acute lung problem,
* coexisting open chest condition,
* severe bradycardia,
* patients with spontaneous breathing
Occipital Transcutaneous Stimulation in Chronic Migraine

This study evaluates the effect in chronic migraine patients of daily 20 minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.

Chronic migraine is a disabling neurological condition affecting 0.5-2% of the population.

CM is difficult to treat and preventive treatment options are limited. Due to the inefficiency of available and the lack of new preventive anti-migraine drug, neurostimulation methods have raised great interest in recent years.

The ONSTIM study showed a reduction in headache frequency in 39% of patients treated with active ONS during 12 weeks, compared to no improvement in the "non-effectively" stimulated or medically treated groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

* other diseases
Pilot Study: Safety of a Customized MRI System for Neonatal Imaging

The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).

The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.

Eligibility Criteria:
Inclusion Criteria:

* Any infant admitted to the NICU at CCHMC
* Medically stable as per the opinion of the attending neonatologist currently on service
* Parental consent obtained

Exclusion Criteria:

* Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants \>4.5 kg)
* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS.

The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.


Eligibility Criteria:
Inclusion Criteria:

* Trusted person or relative who has given oral consent or emergency consent
* Person of legal age
* Patient receiving ECLS for refractory cardiogenic shock requiring continuous renal replacement therapy
* Included within 12 hours of ECLS initiation

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant or breastfeeding woman
* Minor
* Severe hemorrhage under ECLS
Assessment of Accuracy and Safety of LabTest Checker

The goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is:

• how accurate and safe is LabTest Checker.

A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.


Eligibility Criteria:
Inclusion Criteria:

* adult
* requires laboratory test investigation

Exclusion Criteria:

* under 18 years old
* pregnant
* no need for laboratory test investigation
Clinical Evaluation of BW430C in Epilepsy

To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet


Eligibility Criteria:
Inclusion criteria:

* Epilepsy with partial seizures
* Tonic clonic seizures
* Generalized seizures of Lennox-Gastaut
* Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
* Concurrent AEDs: Subjects taking concurrent VPA.

Exclusion criteria:

* Previous participation in a study of Lamictal
* Known hypersensitivity to any drugs
* Pregnant women
* nursing mothers
* women who may be pregnant
* women contemplating pregnancy during the study period