cyrilzakka/clinical-trials huggingface dataset:
Explore Efficacy of FMT Treating Childhood ASD Patients

To explore the efficacy of fecal microbiota transplantation (FMT) in improving the gastrointestinal symptoms and autism symptoms in patients diagnosed as autism spectrum disorder (ASD) comorbid with gastrointestinal symptoms.

This trial is designed to reconstruct the intestinal micro-ecology of children with ASD by the interventional treatment of FMT. At the same time, combined with metagenomics and 16S rRNA sequencing techniques, the trial aims to study the efficacy of intestinal micro-ecology for the treatment of autism symptoms and the improvement of gastrointestinal problems and autism symptoms in autistic patients, and to explore potential new techniques for treating children with ASD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);
2. Patients with moderate to severe gastrointestinal symptoms which are not life-threatening and do not require immediate surgery;
3. Patients aged 3-17 years, male or female;
4. Patients who are suitable for receiving oral FMT capsules, and able to swallow the capsules without chewing;
5. Patients who are able to complete the study as required by the trial protocol;
6. Patients without known immunodeficiency diseases;
7. Subjects and/or their guardians are able to fully understand the informed consent of the trial, and voluntarily sign the informed consent form.

Exclusion Criteria：

1. Patients diagnosed with severe malnutrition;
2. Patients depend on tube feeding (liquid food);
3. Patients with a serious gastrointestinal disease requiring immediate treatment (or life-threatening);
4. Patients with primary immunodeficiency disease during screening;
5. Patients with a single-gene disorder;
6. Patients with a history of severe allergies;
7. Patients with severe fever and/or serious infection within 7 days prior to enrollment;
8. Patients with renal insufficiency and liver dysfunction (or creatinine \> 2 mg/dl, direct bilirubin \> 2 mg/dl);
9. Subjects with congenital or acquired immunodeficiency or immunosuppression (e.g., neoplastic disease or organ transplant) who have received or are undergoing chemotherapy, or have been diagnosed with HIV;
10. Patients with inflammatory bowel disease, celiac disease, large intestine irritation or eosinophilia, esophagitis, eosinophilic gastroenteritis or similar diseases;
11. Subjects with severe sensory or motor disorders (e.g., blindness, deafness, seizures, cerebral palsy);
12. Patients who are participating in other clinical studies, or have received interventions in other interventional clinical studies within 4 weeks prior to enrollment.
Multisensory Body and Space Representations (BASES-EXTINCTION)

To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 5 to 71
* Subject affiliated to the general social security scheme or a similar scheme
* Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study

Exclusion Criteria:

* Subject under tutelage or guardianship- Subject under tutelage or guardianship
* Subject not able to give informed consent, unable to receive information about the study
* Subject not affiliated to a French or non-French social security system holder of a European health insurance card
Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

The purpose of the investigation is to assess iodine status of pregnant women at week 16 of gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The investigators aim to assess whether pre-gestational initiation of iodine supplementation is more advantageous in comparison to supplementation start at the time of pregnancy detection.

Mild iodine deficiency is still a public health issue in many industrialized countries, especially during pregnancy. During the last decade there was no monitoring of the iodine status in pregnancy in Hungary.

Since urinary iodine concentration (UIC) only reflects recent iodine intake and carries limited information on individual existing iodine stores, another biomarker e.g. measurement of serum thyroglobulin concentration, would be useful to gain comprehensive information. In the present study, the purpose of the investigation is to compare UIC, UIC normalized to creatinine concentration and serum thyroglobulin as biomarkers of iodine supply in pregnant women in a geographical region where previously iodine deficiency had been found.

UIC, serum thyroglobulin level and thyroid function are measured, and information about iodine supplementation and smoking before and during pregnancy are recorded.

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women at week 16 of gestation

Exclusion Criteria:

* thyroid disease
Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate

Prospective, post-marketing, multi-center, open-label study to explore if the initiation of adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score using 36-joint plus 4-tendon scoring system, and validate the applicability of different simplified US joint scoring systems.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe RA despite treatment with methotrexate (MTX).
* Eligible to use adalimumab according to the local label without any contraindication.
* Naïve to adalimumab, and participants with prior exposure to any other biologic disease-modifying antirheumatic drugs (DMARDs) should have experienced at least five half-lives of the biologics after treatment discontinuation.
* Participants for whom investigators decided to prescribe adalimumab as per local label and are initiating adalimumab at baseline.

Exclusion Criteria:

* Other inflammatory condition which may affect the signs on joints ultrasound (eg, gouty arthritis, or other chronic rheumatic disease besides RA).
* Currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days of the baseline visit.
* Participants with contraindication or are not appropriate to use adalimumab according to local label or investigators' judgment.
Regorafenib Post-marketing Surveillance in Japan

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for gastrointestinal stromal tumors progressed after cancer chemotherapy.

A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Regorafenib/ STIVARGA and meet the product label.

Exclusion Criteria:

* Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.
48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA \<10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with pegylated interferon (PEG-IFN) monotherapy.

Despite the introduction of newer drugs for the treatment of chronic hepatitis B, there is still no optimal treatment. Pegylated interferon alfa has proven sustained efficacy in approximately 30-40% of patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. It is likely that combination therapy of pegylated interferon alfa with ribavirin in chronic hepatitis B is more effective than pegylated interferon alfa monotherapy. In chronic hepatitis C, adding ribavirin to pegylated interferon therapy doubled the sustained response rate (29% vs. 56%) and has become the standard option of treatment.

To investigate the effect of the treatment with pegylated interferon and ribavirin on the amount of inflammation and fibrosis in the liver, a liver biopsy will be performed within one year prior to screening and at the end of follow-up.

When patients with chronic hepatitis B are treated outside any study with pegylated interferon, they visit the outpatient clinic approximately every month for blood samples. So in this study the amount of blood samples taken from every patient is not increased as compared with treatment outside a study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B
* Biopsy performed within one year prior to screening or during screening
* ALT \> 1.5 x ULN
* HBeAg negative, anti-HBeAg positive
* HBV DNA \> 10E5 copies/ml
* Age 18-70 years
* Written informed consent
* Hepatic imaging without evidence of HCC
* All fertile males and females must be using two forms of effective contraception

Exclusion Criteria:

* Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
* Severe hepatitis activity as documented by ALT \> 10 x ULN
* Advanced liver disease
* Pre-existent leucopenia or thrombopenia
* Co-infection with HCV,HDV or HIV
* Other acquired or inherited causes of liver disease
* Alpha fetoprotein \> 50 ng/ml.
* Evidence of severe renal disease
* Hyper- or hypothyroidism
* Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes
* Immune suppressive treatment within the previous 6 months
* Contra-indications for alpha-interferon therapy
* Pregnancy, breast-feeding
* Any medical condition requiring chronic systemic administration of steroids
* Substance alcohol or drug abuse
* Subjects with clinically significant retinal abnormalities
* Subjects with clinically significant hearing abnormalities
* Hemoglobinopathies
* Subjects with known hypersensitivity to ribavirin
D-chiroinositol Administration in Hypogonadal Males

D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.


Eligibility Criteria:
Inclusion Criteria:

* Men, with a diagnosis of Late-Onset Male Hypogonadism
* Insulin resistance (HOMA Index \> 2,5)
* BMI between 25 and 30

Exclusion Criteria:

* Alcohol intake and/or drug abuse
* Recent hormonal treatment
* Smoking
* Obesity
* Systemic or endocrine diseases
* Male accessory gland infection
* Clinical history of cryptorchidism or varicocele and micro-orchidism
Lifestyle Intervention in Primary Health Care - the Björknäs Study

The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease

Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.

Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program

Eligibility Criteria:
Inclusion Criteria:

* Patients from one single health care centre with a diagnosis of:

  * Typ 2 diabetes,
  * Hypertension,
  * Obesity or
  * Dyslipidemia

Exclusion Criteria:

* Coronary heart
* Disease,
* Stroke,
* TIA,
* BP \>180/105,
* Dementia; or
* Severe psychiatric disease
Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls

This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.

Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our previous study showed that combined exercise program in overweight children increases DAG with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on GOAT, AG, and DAG in obese girls.

Eligibility Criteria:
Inclusion Criteria:

* girls between 16 and 18 years
* being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2-18 years.
* After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.

Exclusion Criteria:

* participation in any weight-management programme in the past 6 months
* engagement in other exercise programs except for regular physical education at school
* smoking
* amenorrhea for consecutive 2 months or more
* being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
* taking any medication or supplements for weight control
Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.

Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide \[LCM\]and carbamazepine immediate release \[CBZ-IR\]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).

A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period \[21 days\] and Maintenance Period \[21 days\]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Subjects are between 18 and 55 years of age (inclusive)
* Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m\^2 (inclusive)
* Subjects must be in generally good health with no clinically relevant health conditions

Exclusion Criteria:

* Subject has previously been randomized in this study or subject has received LCM or CBZ
* Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study
* Subjects may not have a history of drug or alcohol abuse within the last 2 years
* Subjects may not consume more than 40 g of alcohol per day
* Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines
* Subjects may not score ≤ 70 on the Peabody Picture Vocabulary Test (PPVT)
* Subjects with a lifetime history of suicide attempt or suicidal ideation in the past 6 months may not participate
* Subjects with a diet that deviates notably from the normal amounts of protein, carbohydrate, and fat, as judged by the investigator are ineligible to participate
* Subjects may not consume more than 600 mg of caffeine/day
* Subjects may not smoke more than 10 cigarettes per day or have done so within 6 months prior to Screening
* Subjects may not have a positive alcohol breath test or urine drug screen at Screening
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients

Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.


Eligibility Criteria:
Inclusion criteria:

* clinically proven breast cancer with an indication for breast conserving surgery with max. 50% volume reduction
* physical and psychological ability to take part in relaxation training

Exclusion criteria:

* serious psychiatric disorder
* to time span to surgery shorter than 2 weeks or longer than 20 weeks
Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury

The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.

The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.

Eligibility Criteria:
Inclusion Criteria:

* All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.

Exclusion Criteria:

* Missing data
* Renal transplant or tumor
* Solitary kidney
* Established CKD
* Obstructive uropathy
* Renal artery stenosis
* Pregnancy
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* between 18 to 75 years
* the first episode
* from onset to admission within 72 hours
* NIHSS scores:5\~22

Exclusion Criteria:

* had other intracranial pathologies (e.g., tumor, infection)
* had a neurologic or psychiatric disease
* had a coexisting condition that limited their life expectancy
* had significant drug or alcohol misuse
* had high-grade carotid artery stenosis for which surgery was planned
* were pregnant or nursing
* participated in a clinical trial with an investigational drug or device within the past 3 months
* were unlikely to be available for follow-up
Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.

Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Mayo Clinic employee in procedural and surgical area.
* Suspected COVID-19 exposure.
* Completed PCR test twice with negative results.

Exclusion Criteria:

- Refusal to participate in this study.