cyrilzakka/clinical-trials huggingface dataset:
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.

Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* GERD for \> 1 year
* History of daily PPIs use for \> 6 months
* Moderate to severe typical or atypical GERD symptoms off PPIs
* Complete (responders) or partial (nonresponders) symptom control on PPIs
* Deteriorated gastroesophageal junction (Hill grade II or III)
* Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
* Willingness to undergo pH/impedance testing, if required
* Willingness to cooperate with the postoperative diet for 6 weeks
* Availability for follow up visits at 6 months and 12 months
* Willingly and cognitively signed informed consent

Exclusion Criteria:

* BMI \> 35
* Incompletely reducible hiatal hernia with residual of \> 5 mm
* Esophagitis grade D
* Barrett's Esophagus \> 2 cm
* Esophageal ulcer
* Fixed esophageal stricture or narrowing
* Portal hypertension and/or varices
* Active gastro-duodenal ulcer disease
* Gastric outlet obstruction or stenosis
* Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment
* Coagulation disorder
* History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
* Pregnancy or plans of pregnancy in the next 12 months
* Enrollment in another device or drug study that may confound the results
An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

* Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal).
* Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248.
* Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
* Provide written informed consent for this study.
* Be willing and able to comply with study procedures.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
* Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
* Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
* Subjects with severe dizziness or fainting due to postural hypotension on standing.
* Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 \[e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol\]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
* Women who are pregnant or breast-feeding.
* Use of an investigational drug throughout the treatment period.
Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia

Compare core body temperature after laparoscopic surgery using the forced air heating system versus the WARMTAC® (a carbon fiber electric blanket).

In order to prevent perioperative hypothermia, we will compare two different heating sistems, one of them is an electric pad made with carbon fiber and the other system is a forced-air blanket. Both of them will be situated under the patient during all the laparoscopic surgey.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age at the time of the preoperative visit.
* Patients who will undergo elective laparoscopic surgery
* Patients who sign the informed consent indicating that they have been informed of all relevant aspects of the trial.

Exclusion Criteria:

* Axillary temperature\> 37.5ºC
* Active infection
* Dysfunction of the autonomic system
A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer

This is a multicenter, non-interventional, retrospective, real-world study that enrolled patients diagnosed with HER2-positive unresectable or metastatic breast cancer. This study will be conducted to understand the treatment pattern and sequencing of therapies, survival outcomes, and associated burden of toxicities with line of treatment in the real world.

The treatment landscape has changed dramatically with the lack of real-world evidence for usage and the efficacy of newly approved drugs in China. This multicenter, retrospective, non-interventional study will include patients newly diagnosed with HER2-positive unresectable or metastatic breast cancer, or first recurrent from early breast cancer.

The primary objective of this real-world study is to describe the treatment patterns of HER2-positive unresectable or metastatic breast cancer in China. Secondary objectives will include describing the demographic and clinicopathological characteristics of patients, efficacy of different treatment regimens, treatment options and efficacy of brain metastases, and safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age at the time of diagnosis of unresectable or metastatic breast cancer
* Participants with first diagnosis of unresectable or metastatic breast cancer, or first recurrence of HER2-positive breast cancer since January 1, 2020. Participants were eligible if they were HER2-positive in the early operable stage and HER2-negative in the advanced stage. HER2 positive was defined with the reference to the Chinese guidelines for HER2 positive breast cancer at the time of testing
* Participants have received at least one systemic therapy for advanced breast cancer

Exclusion Criteria:

* Participants with concomitant cancer at the time of diagnosis of HER2-positive unresectable or metastatic breast cancer, except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis.
* Participants who are/were currently/previously enrolled in a clinical trial and have not been unblinded during the data collection interval of the study
* Participants with critical missing data from their medical records or other patients deemed by the investigator to be ineligible for inclusion
Mechanisms of Prediabetic States in Sleep Apnea

The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese
* Prediabetic
* Sleep apnea

Exclusion Criteria:

* Diabetic
* Severe hypertension
* Taking medications that can confound assessments
* Any history of known bleeding disorders
* Any underlying disease likely to limit life span or increase risk of intervention
* Currently pregnant, trying to get pregnant or nursing
Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

Acute severe ulcerative colitis \[ASUC\] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.

Exclusion Criteria:

Patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.
Pediatric Fast Fluid Trial 2

The purpose of this study is to determine which of two commonly used methods of manual pediatric fluid resuscitation (The "Push-Pull Technique" vs. the "Disconnect-Reconnect Technique") allows for the most rapid administration of normal saline when this is urgently required.


Eligibility Criteria:
Inclusion Criteria:

* Health Care Providers working or training at McMaster Children's Hospital, including staff nurses, staff physicians, postgraduate medical trainees, nursing students, and medical students
* may be asked to perform manual fluid resuscitation as part of their clinical care activities

Exclusion Criteria:

* Inability to understand English
* Limited manual dexterity, specifically resulting in an inability to perform manual fluid resuscitation involving syringes
* Have acted in a physically strenuous capacity that may result in significant hand fatigue in the 30 minutes immediately prior to performance of the intervention. Where this is the only criteria limiting subject participation, rescheduling of an alternate testing time will be permitted.
Exome and Genome Analysis to Elucidate Genetic Etiologies and Population Characteristics in the Plain Community

This study is designed to utilize whole exome and whole genome sequencing techniques to identify underlying genetic causes for undiagnosed disorders in the Plain Communities, and to do population genetic studies looking at genetic drift and founder mutations in this unique population.

The long term goal of this proposal is to establish a Translational Medicine Program for the Old Order Amish and Mennonite communities that is accessible to their members with decreasing cost and effective diagnostic strategies, and to leverage the genetic information obtained to better understand the genetic forces and risks driving the health of these populations. As a bridge to do so, next-generation sequencing technology will be used to identify genetic defects in Old Order Amish families/individuals who have a clinical picture suggestive of a Mendelian disorder but with unknown diagnosis. Investigators plan to develop targeted analytical NGS panels optimized for general use in the clinical setting when dealing with Plain Communities patients and families, yielding better and more prompt clinical intervention and improvement of outcomes. The study also involves use of whole genome sequencing for a mutant allele discovery platform to identify novel genetic risks in this population not yet identified in patients, and to use this platform to describe genetic differences in Old Order Amish communities across Pennsylvania and ultimately across the country. With WGS will be used to analyze population genetics by comparing the distribution of genetic variants among the various Amish communities and to compare these with their European ancestry variants available in 1000 genome project, to study the influence of founder-selection and genetic drift in these populations.

Eligibility Criteria:
Inclusion Criteria:

* Any person of Amish or Mennonite descent

Exclusion Criteria:

* Individuals who are not of Amish or Mennonite descent
Trilogy AB Acetabular Hip System Post Approval Study

This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.

To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese patients
* The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
* Patient is willing and able to give informed consent to participate in the follow-up program.
* Patient is suitable for surgery and able to participate in the follow-up program.

Exclusion Criteria:

* Skeletally immature
* Rheumatoid arthritis
* Osteoradionecrosis
* Infection
* Nerve or muscle disease that may have a negative affect on gait or weight bearing
* Loss of abductor musculature in the affected limb
* Poor bone stock
* Poor skin coverage around the hip joint
* Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
* Previous total or cemented hemi-arthroplasty of the affected hip
* Previous pinning or plating of the affected hip
* Patients with heavy labor jobs or extreme activity levels
* Patients who participate in sports activities or require deep flexion
* Patients who are obese
* Patients who have other disabilities
* Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.
Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults

The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

* The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).
* The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 49, inclusive at the time of enrolment
* in good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the investigator
* Male
* Must have received polio vaccinations with OPV according to the Polish National Immunization Program as a child based on vaccination cards or information given by subjects during interview with investigator
* Preferred: number (and date) of polio vaccinations known
* Willingness and ability to adhere to the study regimen
* Having a signed informed consent form

Exclusion Criteria:

* IPV or OPV booster dose after the age of 12 years
* Positive for HIV, Hepatitis B or Hepatitis C
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination
* Known or suspected disease or use of medication that may influence the immune system
* Known or suspected immune deficiency
* Systemic treatment with corticosteroids within one month before screening
* Administration of plasma (including immunoglobulins) or blood products three months prior to the study
* Blood donation within one month before screening
* Any vaccination within three months before screening and during the study until the last visit
* History of any neurological disorder including epilepsy or febrile seizures
* Evidence of excessive alcohol use or drug use
* Any infectious disease at the time of screening and/or inclusion
* Participation in another clinical trial within three months before screening
* Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
* Bleeding disorders or the usage of anticoagulants
Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease

In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.

Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and more
* Parkinson's disease according to UKPDSBB diagnosis criteria
* Motor difficulties in spite of dopaminergic per os treatment
* Not eligible for deep brain stimulation for one or more reasons (age\>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations)

Exclusion Criteria:

* Mattis scale \< 120
* Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment)
* Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)
The Impact of Lifestyle Changes on Non-COVID Deaths

The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.

Eligibility Criteria:
Inclusion Criteria:

* All cases of death reported to the Xuzhou CDC during the study period

Exclusion Criteria:

* no