cyrilzakka/clinical-trials huggingface dataset:
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the BMI to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to the comorbidities of the mothers published in the MOMS trial.

The MOMS trial proved prenatal repair of myelomeningocele was an advantage over postnatal repair for the fetus/neonate/child and is the standard of care for maternal/fetal dyads who meet the inclusion exclusion criteria. Investigators plan to maintain all inclusion exclusion criteria for open fetal repair surgery of myelomeningocele with one exception, the expansion of the maternal BMI to 40.0. This population of mothers with a BMI of 35.0 to 40.0 have not been studied. The morbidities of these mothers will be compared to morbidities of mothers with a BMI less than or equal to 34.9 currently in the scientific literature.

Eligibility Criteria:
Inclusion Criteria:

* Maternal BMI 35.0 to 40.0
* No maternal documented co-morbidities
* Fetal MMC begins between thoracic 1 and sacral 1, on the spinal column.
* Evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column).
* A gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion.
* Documented normal fetal karyotype.

Exclusion Criteria:

* History of maternal alloimmunization problem
* Kell sensitization
* Risk of preterm birth
* History of spontaneous preterm birth
* Cervix \<20mm in length
* Presence of cerclage
* Placental problem
* History of placental abruption
* Placental Previa
* Body-mass index of 40.1 or more
* Maternal contraindication to surgery
* Insulin-dependent pregestational diabetes
* Hypertension or preeclampsia
* HIV, hepatitis-B, or hepatitis-C positive
* Other medical condition of risk to mother
* Uterine problem
* Previous hysterotomy in the active uterine segment
* Severe fibroids
* Uterine malformation (bicornuate, arcuate, unicornuate, didelphys)
* No support person for periprocedural period
* Inadequate support at home for pregnancy
* Inadequate understanding of risks and benefits of fetal surgery
* Inability to comply with medical restrictions, follow up after fetal surgery
* Multiple gestation pregnancy (twins, triplets, etc.)
* A fetal anomaly unrelated to myelomeningocele (heart defect, lung lesions)
* Severe fetal kyphosis \>30 degrees (curvature of the back)
CASH- Children Active to Stay Healthy

The purpose of this study is to examine the effects of high intensity interval exercise (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our working hypothesis is that, compared with obese children prescribed moderate exercise, obese children prescribed HIIE will demonstrate greater improvements in endothelial function and inflammatory markers following a 6-week exercise intervention.

Obesity, even in children, is generally accompanied by a state of chronic inflammation. To combat childhood obesity, clinicians and scientists recommend lifestyle interventions that include increased physical activity and exercise in an attempt to promote weight loss and, consequently, decrease comorbidities associated with excess adiposity. More importantly, it appears that the influence of regular exercise may offer children with obesity a multitude of health benefits, independent of weight loss. However, the intensity of exercise required to elicit significant health benefits is still unclear. Therefore, the aim of the present project is to study the influence of high intensity interval exercise (HIIE) on the existing inflammatory state found in obesity. Specifically, the proposed project will examine endothelial function and markers of inflammation, such as TNFa, IL-6, hsCRP, and adiponectin, in children with obesity before and after an exercise intervention. The data will then be used to determine if changes in these values differ in magnitude based on the intensity of exercise. Children with obesity will be randomized into either moderate exercise or HIIE groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform ten, 2-minute bouts at 90%-95% of maximal heart rate. Outcome measures of body composition, aerobic capacity, blood lipids, glucose metabolism, endothelial function, and inflammation will be measured pre- and post-intervention. Results may help in establishing exercise protocols not only for children with obesity, but also other inflammatory diseases such as diabetes, cancer, and arthritis.

Eligibility Criteria:
Inclusion Criteria:

* 13-17 years old
* obesity (defined as as BMI≥ 95th percentile for age and sex as defined by the Centers for Disease Control

Exclusion Criteria:

* active participation in ≥30 minutes of vigorous exercise more than 2 days per week
* participation in an organized combined diet/exercise weight loss intervention
* acute inflammatory disease or febrile illness
* recent trauma or injury
* asthma requiring steroid use or that has resulted in hospitalization within 3 months prior to enrollment
* chronic disease known to affect inflammation (e.g. lupus)
* any renal, heart, or liver disease
Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily becoming a public health problem.Simotang is a classical formula that has been used to treat gastrointestinal disorders for hundreds of years \[9\] and was approved as an oral liquid drug by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with functional dyspepsia were divided according to the inclusive criteria into treatment group and control group randomly, who were given Simo decoction or Domperidone tablets for 14 days。And then the gastric emptying, Symptoms in plasma were observed before and after treatment in mult-center.


Eligibility Criteria:
Inclusion Criteria:

* patients met the definition of the Rome III criteria for FD

Exclusion Criteria:

-
Tinnitus Suppression for Cochlear Implant Recipients

Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2 percent of the population. Tinnitus therapy is based on counselling, cognitive and behavioural therapies in combination with sound therapies which mostly rely on masking.

For cochlear implant candidates, the ability to use hearing aids and maskers is limited by the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67 to 100% with a mean of 80%.

In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs when the implant is switched off. While the benefits of CI implantation on tinnitus are well documented, there is a group of recipients where tinnitus remains a concern in the implanted ear post-operatively.

The primary aim of this study is to investigate the benefits of using tinnitus masking via a CI sound processor that optimises tinnitus suppression with minimal annoyance to the user. Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of tinnitus in recipients.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Freedom or CI500 series implant
3. At least 3 months experience with the cochlear implant
4. Native speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Self-reported tinnitus in the implanted ear
7. Reside local to investigational site

Exclusion Criteria:

1. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
2. Additional handicaps that would prevent participations in evaluations
3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.

The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.

Hypotheses

* A more intensive protocol of treadmill training will increase walking onset in young children with CP.
* A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.

Specific Aims

* To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
* To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.

Study design •Prospective randomized controlled trial

Study population

•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
* Because young children often are not formally diagnosed with CP until 2 years of age, we will include children

  * who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
  * who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
  * who have been identified as high-risk for a motor disability by a physician

Exclusion Criteria:

* a history of uncontrolled seizures
* a diagnosis of a genetic disorder
* cardiac or orthopedic contraindications for standing and walking
* orthopedic surgery in the past 6 months
* use of spasticity-reducing medication or Botox injections in the past 6 months
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP

Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
3. Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Participation in another related investigational study that could affect the results of this study within the previous 30 days
4. Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
5. Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)

5) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)

This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
3. Ability to comply with the study protocol, in the investigator's judgment
4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121
5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

1. History of anaphylaxis or hypersensitivity to a biologic agent
2. Known active infection with encapsuled bacteria
3. History of Neisseria meningitidis infection
4. Planned surgery
5. Pregnant or breastfeeding, or intending to become pregnant
6. Clinically significant electrocardiogram abnormalities
7. Illicit drug or alcohol abuse
8. Known or suspected immune deficiency
9. Treatment with investigational therapy other than RAY121
10. Vaccination with a live vaccine within 4 weeks
Italian Register for the Study of Complicated Intra-Abdominal Infections

The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.

The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

Eligibility Criteria:
Inclusion Criteria:

All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)

Exclusion Criteria:

Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis
GWA Study in Patients With Inflammatory Bowel Disease

The aim of this study is to identify new genes in Chinese patients that help investigators to understand the biological pathway and functions in a population in whom the incidence of Inflammatory Bowel Disease (IBD) is increasing. And to explore the genetic variations in Chinese patients with IBD.

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory disorders of the gut that cause major life-long disability. Afflicting mostly young people at an age when they are most active both in their private and professional life, inflammatory bowel disease (IBD) represents an important public health problem affecting both the patients education, working abilities, social life . In the past two decades, the incidence and prevalence of CD and UC have been rapidly increasing in Asia. Familial aggregation, twin studies, and recent genetic studies suggest that there is an important genetic component to IBD. In the West, genome wide association (GWA) studies have identified more than 50 genes associated with CD including genes involved in bacterial handling, NOD 2, and the genes involved in autophagy ATG16L1 and IRGM. Only a few of these genes have been studied in Asian populations. Of those which have been studied, such as NOD2, there have been clear differences from Western populations. To date most of the GWA studies have been carried out in cohorts of Caucasian patients. Genetic studies in ethnically different populations may identify new causal variants in IBD, which are likely to lead to further insights into pathophysiology and potential treatments. The aim is to perform a GWA study in Chinese patients with CD and UC. Identifying new genes in Chinese patients will help the investigators to understand the biological pathway and functions in a population in whom the incidence of IBD is increasing. As part of a collaborative project with China, we aim to collect blood samples from 1600 IBD patients and 2000 control subjects in Hong Kong to conduct a GWA study. Samples of 300 IBD patients and 500 controls will be contributed to a collaborative project with China.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Informed consent given by patient or family

Case group (IBD patients) Diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology

Control group (non-IBD cases) Ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy.

Exclusion Criteria:

* No consent
* Controls will be excluded if they have previously been diagnosed with IBD or if they have a first or second degree relative with IBD.
The Influence of Histo-blood Group Antigen Polymorphism on the Composition of the Microbiota

A person's blood type is defined by the types of sugars they express on their red blood cells, with antibodies being made to non-self sugars and excluding blood cells expressing these sugars (the basis of blood transfusion reactions). These same sugars can be expressed by commensal bacteria in our gut lumens. The investigators hypothesize that a person's antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria in our guts. Supporting our hypothesis, a person's blood type correlates with the overall composition of their gut flora. Because these sugars are also used by certain pathogens to initiate infection, this information could directly inform our understanding of host susceptibility to various infectious organisms.

A member of the study staff will collect a small volume of blood sample through a finger prick and 2-3 milliliters of saliva from you. Using these samples, we will determine your blood type (defined by your expression of specific sugars on your red blood cells) and your expression pattern of these sugars in body secretions (e.g., saliva). You will provide us with a fecal sample collected the day of your appointment. The fecal sample should be collected in a pre-provided collection container and should be collected within 12 hours of drop-off. Using your fecal sample, we will determine the types of bacteria present in your normal gut flora and whether they express the same sugars expressed on your blood cells. Tests will be done only for research purposes and will not be evaluated or used to diagnose or treat any of your medical problems. Sample collection may need to be repeated if required for your medical care in the future.

Eligibility Criteria:
Inclusion Criteria:

* healthy,
* adult

Exclusion Criteria:

* younger than 18,
* older than 60,
* pregnant
Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit

The failure can be traced backed to operator causes, technical causes and patient causes.

the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis.


Eligibility Criteria:
Inclusion Criteria:

* All cases underwent ERCP in our center from 1st of January, 2013 to 1st of January. 2021 with any causes of jaundice or any indication for which ERCP was done.

Exclusion Criteria:

* incomplete data or missing files were excluded from this study
The 1 Year Follow-up Objective Oral Appliance Compliance

The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.

The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).

Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.

A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.

The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.

This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of sleep-disordered breathing
* started treatment with a titratable, duobloc mandibular advancement device
* participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)

Exclusion Criteria:

* dental exclusion criteria for mandibular advancement devices
* medical contra-indications for mandibular advancement devices