cyrilzakka/clinical-trials huggingface dataset:
Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.

Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission in Crohn Disease(CD). Currently, it is believed that the use of UST for the preoperative treatment of CD patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of CD. However, there is still a lack of literature reporting the role of UST in preoperative optimization for CD. Semi-enteral nutrition refers to the provision of more than 50% of the energy required by the human body through enteral nutrition preparations. Semi-enteral nutrition can improve the nutritional status of patients with CD, but it does not induce remission of active disease. The treatment method of UST combined with semi-enteral nutrition can not only induce disease remission, but also improve the nutritional status of patients. Therefore, can the combined treatment regimen replace Exclusive Enteral nutrition (EEN) as a new therapy for preoperative optimization of CD? At present, there is a lack of relevant research, so this study intends to conduct a multi-center, prospective, randomized controlled trial to compare the efficacy differences between UST+semi-enteral nutrition and EEN in preoperative optimization for CD, and to clarify the preoperative optimization effect of UST combined with semi-enteral nutrition therapy.


Eligibility Criteria:
Inclusion Criteria:

* CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis;
* CD patients diagnosed prior to surgery;
* Patients aged 18-65;
* CDAI score of \>150;
* For patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study;
* The patients agree to participate in the study and sign an informed consent form;
* Patients who have not used ustekinumab prior to surgery;
* Patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery.

Exclusion Criteria:

* Emergency surgery;
* Had received exclusive enteral nutrition support within 3 months prior to surgery;
* Unable to tolerate enteral nutrition;
* Failed with UST;
* Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.
A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery

The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.

Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.

Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function.

We have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. Several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and EEG recordings will be involved in the trial. Moreover, we have assumed a few long-term follow-ups.

Given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.

Eligibility Criteria:
Inclusion Criteria:

1. Written consent given
2. Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia
3. ASA Physical Score I-IV

Exclusion Criteria:

1. Inability to give informed consent.
2. Contraindications to tropisetron.
3. Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.
4. History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
5. History of antipsychotic drug use.
6. Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10
A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer

A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for inclusion in the study only if all the following criteria apply:

1. Men or women who are 18 years of age or older on the day of signing the informed consent;
2. Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
3. Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;
5. Patients with a traceable medical history during treatment;
6. Subjects who are able to sign an informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;
2. Have not signed the informed consent form;
3. Pregnant or lactating women;
4. Other conditions deemed unsuitable for inclusion in the study by the investigator.
Effect of Oat Compounds on Postprandial Glucose Response

In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance


Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI 20-28 kg/m2
* Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)

Exclusion Criteria:

* fasting glucose \> 6.1 mmol/L
* metabolic diseases
* gastrointestinal disease
* chronic and/or psychological disease
* food allergy
* Vegetarian or vegan diets, or other special diets
Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy

Children with spastic diplegia are at an increased risk of spinal deformities. The most common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis may adversely affect balance in children with cerebral palsy . The treatment approaches for hyper-kyphosis involved both conservative and surgical treatments. The Conservative approach includes corrective exercises, positioning, and spinal braces. This study aimed to evaluate the effect of conservative orthotic management for kyphotic posture on balance control, and fall risk in cerebral palsied children of spastic diplegia.

Kyphosis is a posterior convexity of the spine. Children with cerebral palsy show a higher probability of progression of the kyphotic curve. If it is not adequately treated, it becomes fixed where it requires surgical management. Children with cerebral palsy have more probability to balance impairment and falls than normal children and the consequences of that fall are great. The current studies do not properly examine the effectiveness of conservative orthoses on the therapeutic management of kyphosis in children with cerebral palsy. Also, there is a shortage of studies that evaluate how correction of the thoracic kyphosis influences the balance performance and fall risk in children with cerebral palsy. TheraTogs orthosis which consists of an orthotic undergarment and external strapping system has been designed to provide a soft and passive body compression to maintain a typical body postural alignment and to improve posture control. Therefore, the objective of this study was to investigate how the correction of dorsal hyper-kyphotic posture by the TheraTogs orthotic system could influence balance control, and fall risk in cerebral palsied children of spastic diplegia.

Eligibility Criteria:
The inclusion criteria were:

* Children with a diagnosis of cerebral palsy of spastic diplegia.
* They were all between 8 and 10 years old, of both sexes.
* The degree of spasticity in the affected upper and lower extremity, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale (MAS).
* Children were cognitively able to understand and follow instructions.
* The levels of their gross motor function were between level I and II according to the Gross - Motor Function Classification System (GMFCS).
* They were able to stand alone for five to ten minutes without any assistance.
* The degree of the spinal kyphosis in the sagittal plane did not exceed 45° (Cobb's angle).

The exclusion criteria were:

* Children with any orthopedic condition or fixed deformity that interfere with the spinal and limbs functions.
* Children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study.
* Children with surgical interference for the lower limb and spine within the previous 2 years.
* Children with seizures, visual impairments, or perceptual problems.
Exploration of the Lipid Metabolism During the Diabetic Pregnancies

Justification:

Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to 50 % versus 10 % in general population) despite a good glycemic control. The consequences are : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high frequency of obesity and metabolic disorders in adults.

The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the fetal weight. Considerable interest has been generated over the last decade on the lipids and fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been described associated with macrosomia. Maternal nutrition before and during pregnancy plays an important role in fetal growth and subsequent development of an increased susceptibility to obesity and diabetes in later life.

Main objective:

Looking for an association between maternal and fetal blood lipid parameters and birth weight and body fat in a context of type 1 or type 2 diabetes.

Secondary objectives:

* Identify lipid markers associated with fetal macrosomia.
* Analyze the placenta by measuring the expression of genes implicated in the storage and the transfer of fatty acids.
* Analyze and compare the expression level of placental genes subjected to parental imprinting and validated in animal models.

Plan of study:

Longitudinal study on 3 groups: 70 type 1 diabetic women, 70 type 2 diabetic women and 70 women with normal glucose tolerance during pregnancy. Recruitment in the department of Diabetology and Obstetrics of CHRU of Amiens and Lille.

Nutritional survey and sampling of blood in the 1st, 2nd and 3rd trimester of pregnancy and at 6 weeks post partum.

Collection of cord blood and placental tissues. Histological and molecular analysis of placenta will be realized both in the departments of Anatomopathology of Lille and Amiens and in Biochemistry Molecular Biology of CHRU of Lille.

Homocysteine and folate assays on cord blood will be centralized in Paris (Hospital St Louis).

Main criteria of judgment

Fetal weight corrected by the gestational age.

Expected results:

* An inverse correlation between maternal and fetal blood fatty acids ratios (polyunsaturated fatty acids/ monounsaturated fatty acids + saturated) and birth weight in the diabetic groups.
* Differences of distribution of fatty acids of maternal and foetal erythrocytic phospholipids correlated with the fetal weight.
* Qualitative and quantitative variations of expression of placental genes such as lipases and genes submitted to parental imprinting.

The biologic parameters will be confronted with the data of the nutritional survey and with glycemic control during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women included before 16 amenorrhea weeks

Exclusion Criteria:

* obesity (BMI \> 40kg/m2)
* subject became pregnant with medical infertility treatment
* tobacco \> 10
* suspected abuse of alcohol
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma;
* On a stable regimen of asthma medications for at least 30 days prior to screening;
* Body mass index (BMI) 18 to 32 kg/m2;
* Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height;
* FEV1/FVC (forced vital capacity) ratio ≥70%.

Exclusion Criteria:

* More than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
* Asthma exacerbation within 8 weeks before screening;
* Unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
* History of intubation or intensive care unit admission for asthma in the past 5 years;
* History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
* Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute.
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are infected with HIV-1
* Patients have not yet received any treatment for HIV
* Patients with HIV viral RNA exceeds 5000 copies per ml
* Ages at least 20 years

Exclusion Criteria:

* Patients with acute or decompensated chronic hepatitis
* Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
* Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
* Patients with any medical disorder that the use of study medications is contraindicated
* Pregnant or breastfeeding women
* Patients who are lack of expectation to maintain assigned study medication during study period
* Patients who have received therapy with investigational drugs in the previous 3 months
Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon

The findings of this research will be a basis for improving the quality of care and welfare services for the disabled middle-aged and older people in Iran and Lebanon using the SERVQUAL model.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 of years and above.
* Being Disabled.
* Receiving Health Care Services out of 1 year ago.

Exclusion Criteria:

* Unwillingness to Participate in the Study
* Death and/or Migration
RapidShock Post-Approval Study

Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age or older and weight ≥ 55 lbs (25 kgs)
* Out-of-hospital cardiac arrest (OOHCA)
* Non-traumatic cardiac arrest

Exclusion Criteria:

* Weight less than 55 lbs (25 kgs)
* Do not attempt resuscitation (DNAR) orders
Active Lifestyle All Your Life-an Intervention Programme for Preventing Fall Injuries

The purpose of the project is to formulate, implement and evaluate a new type of activity-orientated, evidence-based prevention programme to prevent fall injuries among elderly people. The question examined by the study is whether the intervention programme can:

* significantly reduce accidents and incidents involving falling among the participants,
* influence variables such as satisfaction with life, confidence in one's own ability and a feeling of involvement,
* be shown to be cost effective in terms of the use of resources. The intervention programme - Active lifestyle all your life - is being developed in and for primary care for the cost effective prevention of fall injuries among elderly people using a method that results in continued active life. The aim is to ensure that the elderly person is able to continue living an active life with commitment and involvement, which can in itself prevent fall injuries. This presupposes a knowledge of how to avoid fall injuries and the measures and aids that are available to prevent such injuries. The programme will also provide the participants with a social community in self-supporting groups which, by their own efforts but also with social support, are able to continue some of the activities provided through primary care.


Eligibility Criteria:
Inclusion Criteria:

* 65 or older
* Fall injury in the form of radius fracture or other minor documented fall injury, or one or more fall incidents reported in the last six months (reported to a district nurse in the 75-year discussion)

Exclusion Criteria:

* Cognitive impairments
* Documented psychiatric problems that make participation in organized group activity impossible
* Considerable difficulties in speaking and understanding Swedish
Medication Exposure in Older Patients With Constitutional Hemorrhagic Disease

The improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. This increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "Franchini \& Mannuccio", BJH, 2009). The care of these comorbidities represents a new challenge for the medical teams. Toward multiple comorbidities, polypharmacy is often associated.

Many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or Willebrand disease.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling patients over 65 years with hemophilia (A or B)
* Community-dwelling patients over 65 years with Willebrand disease (Type1, 2 and 3, rate \<30%)

Exclusion Criteria:

* Patients without phone number
* Non French speaking patients
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer

This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 22 or older
* Able to sign the informed consent form
* Normal, healthy subjects or subjects with one of the following conditions:

  1. Benign non-genitourinary disease (e.g. heart disease)
  2. Non-genitourinary cancers (e.g. lung, CRC, breast)
  3. Genitourinary disease other than bladder cancer including:
  4. Benign prostatic hyperplasia (BPH)
  5. Microhematuria proven negative for bladder cancer through prior UCC evaluation
  6. Inflammation/infection
  7. Symptomatic sexually transmitted disease (STD)
  8. Urinary tract stones
  9. Genitourinary trauma
* Subjects with native bladder

Exclusion Criteria:

* Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
* Currently in work-up due to suspicion of cancer of any kind
The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy

Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy

Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study. Balance was assessed by Pediatric Berg Balance Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test. Kinesiology taping (KT) with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application. The comparison between before and after taping was analyzed.

Eligibility Criteria:
Inclusion Criteria:

DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle

Exclusion Criteria:

children who did not meet the above criteria were not included
Immunization To Prevent Acute COPD Exacerbations

Prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD exacerbations

Patients with chronic obstructive pulmonary disease (COPD) have been demonstrated to have an increased risk of pneumococcal disease. Pneumonia is frequent among patients hospitalized for COPD exacerbations and is associated with increased health care utilization and higher mortality. Up to 50%-70% of exacerbations can be attributed to respiratory infections by viruses or bacteria, even more in the most severe patients. They are often associated with the colonization of airways by multiple bacteria or viruses of low virulence that in normal conditions are parts of the normal flora of the upper airway. Current recommendations for immunization of patients with COPD include vaccination against influenza and Streptococcus pneumoniae. The aim of this study is to evaluate the potential benefits of immunization of COPD patients with PCV13 and/or against influenza in terms of clinical benefits and quality of life.

Eligibility Criteria:
Inclusion criteria:

1. Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would be based on COPD severity grade)
2. Ability to understand and complete the required QoL questionnaires
3. At least 2 years of clinical history available that includes records of previous moderate/severe exacerbations, influenza and pneumococcal vaccination history comorbidities and previous treatments.
4. Spirometry data (maximum 6 months old, or if not available at enrollment, to be performed as per normal clinical practice at visit 1 +/- one month)

Exclusion criteria:

1. Impossibility to perform prospective follow up
2. Present any immunocompromising condition
3. Present any other respiratory diseases as co-morbidity (subjects with overlap syndromes COPD-asthma will be excluded. Mixed phenotype defined as: symptoms of increased variability of airflow and incompletely reversible airflow obstruction)