cyrilzakka/clinical-trials huggingface dataset:
Reletex for Nausea in GERD Patients

Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently encountered in the health care setting. It affects roughly 40% of Americans monthly and 10% weekly. Of those with GERD, there exists a cohort that experience nausea with or without vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment options are limited and these symptoms may substantially alter their quality of life. New and novel therapies emerging include neuromodulation devices that may affect the central pathways leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery, in addition to standard anti-nausea medications. The investigators propose that through a similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of lives in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Any patient over the age of 18 with clinically diagnosed GERD as evidenced by the GerdQ assessment tool and/or ambulatory pH/ pH- impedance monitoring with a component of nausea with or without vomiting.
* Continued symptoms despite a stable dose of FDA approved daily PPI therapy in addition to or without supportive anti-emetics. We will include patients with twice a day PPI dosing, as this is a standard treatment for PPI non-responders.
* Previous gastric emptying study performed as part of the standard care work-up of nausea and vomiting. Patients will be recruited regardless of the results and this information will only be used as a potential predictor for symptom response.

Exclusion Criteria:

* Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks.
* Prior gastrointestinal surgery of the esophagus and stomach.
* Severe esophagitis (Los Angeles esophagitis Grade C and above), Barrett's metaplasia or eosinophilic esophagitis, achalasia or spastic motor disorder
* Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. Current drug or alcohol abuse or dependency.
* Current neurologic or cognitive illness or impairment which would make the patient an unsuitable candidate for hypnosis. This will be determined by the investigators before randomization using the Mini Mental Status Exam in patients with suspected impairment.
* Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder.
* Those with nickel, gold, or other metal allergies.
* Those with other neuromodulators or implanted electrical devices such as cardiac pacemakers, AICD's, neurostimulators or transcutaneous electrical nerve stimulation devices (TENS units).
* Females who are or might become pregnant during the study.
AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation

The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation (Phase II). Up to 500 unvaccinated and partially vaccinated subjects will be included (up to 100 in Phase I and up to 400 in Phase II).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Unvaccinated individuals, or individuals who have received only 1 dose of an mRNA vaccine
* Individuals who have received a positive SARS-CoV-2 result within 24-48 hours (lab-based PCR or antigen test)
* Willing and able to provide informed consent
* Ability to read, write, and comprehend English
* Have no functional limitation that would impede the use of the MouthLab device
* Willing to provide access to health information via electronic health records (EHR)

Exclusion Criteria:

* Currently receiving hospice care
* Have a left ventricular assist device
* Left-sided hemiplegia or any other motor deficits that may restrict the use of the device.
* individuals with cognitive deficits that impede their ability to comprehend and give informed consent.
* Individuals who are enrolled in any other investigational research studies of SARS-CoV2 or COVID-19
* Individuals who are treated with monoclonal antibody therapy prior to diagnosis
* Individuals who are admitted to a hospital or acute care facility at the time of diagnosis
* Individuals with pacemakers or implanted cardio-defibrillators (ICDs)
* History of hemoptysis, pneumothorax, thoracic or abdominal aneurysm, pulmonary embolism, or stroke
* History of unstable cardiovascular status, including recent myocardial infarction (MI within 30 days), unstable angina, or uncontrolled hypertension Color blindness
* Chest, abdominal or eye surgery within the preceding 14 days
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup

The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.

The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic arthritis of the hip indicating surgical intervention
2. Scheduled to undergo a primary total hip arthroplasty
3. Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -

Exclusion Criteria:

1. Patients less than 18 years of age, or older than 85 years of age.
2. Severe hip dysplasia (Crowe Type III or IV) in the affected hip
3. History of congenital dislocation
4. Prior arthroplasty of the affected hip
5. Active or prior infection of the affected hip
6. Morbid obesity (BMI \> 40)
7. Medical condition precluding major surgery
8. Severe osteoporosis
9. Neuromuscular impairment
10. Patients with known allergy to metals
11. Pregnancy
12. Patients on dialysis or creatinine \> 2.0
13. Patient is immuno-suppressed -
A Study on Hemodynamic Relationship Including Cerebral Blood Flow Using Phase Contrast and Signal Intensity Gradient of Brain Magnetic Resonance Imaging, and Carotid Doppler Ultrasound

Cerebral blood flow measurement, which is applied to patients with cerebrovascular-related diseases, provides useful information about hemodynamic status. There was a method using Doppler ultrasound and phase contrast (PC) MRI, but it was not widely used in clinical practice due to limitations in reproducibility between examiners, complexity of procedure, and time-intensive protocol. We intend to measure cerebral blood flow through the signal-intensity gradient (SIG) technique using Time-of-Flight (TOF) of brain magnetic resonance imaging, which can compensate for the shortcomings of the existing research methods. In addition, by analyzing the correlation with the previous methods, Doppler ultrasound and PC MRI, we will evaluate the effectiveness of our new method.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older who have been admitted to the neurology department due to a stroke, and those who have already performed brain magnetic resonance imaging
2. Among the patients (1) who underwent carotid artery Doppler ultrasound
3. Patients who fully understand the research objectives and procedures and wish to participate in clinical research voluntarily
4. If a patient is not fully understood due to a decrease in awareness or consciousness, the consent of the legal representative is required

Exclusion Criteria:

1. Patients whose extracranial artery occlusion or severe stenosis was confirmed in brain magnetic resonance images.
2. Those who judge that the subject is unsuitable for participation in clinical research due to other reasons.
Role of Andi-d in Dengue Fever: a Pilot Study

The purpose of this study is evaluate the role of anti-d in dengue fever.

This study was conducted in pgimer. Patients presenting with fever and thrombocytopenia in emergency medical opd / medicine opd were screened and all dengue serology positive patients were evaluated for enrolment into the study. We had proposed to enroll 30 patients with diagnosed dengue haemorrhagic fever. the diagnosis of the dengue fever was based upon the clinical history ,general physical examination and the lab tests : thrombocytopenia ( platelet count ≤ 20,000 ) ,and a positive dengue serology.

STUDY DESIGN : It was an open label inteventional study . one group of 15 patients ( intervention group ) received platelet support along with injection anti-d in a dose of 50 µg/kg (250IU/kg) intravenously while the other group of 15 ( control group) received platelet support only . a base line platelet count of all the participant of both the study groups was taken and then the level of platelets at 12 , 24 , 36 , and 48hr post treatment initiation was noted. The patients were followed till the time of discharge .

Eligibility Criteria:
inclusion criteria:

* fever and thrombocytopenia with/without bleeding manifestations
* dengue serology positive patients
* platelet count ≤ 20,000/mm3
* Rh positive patients
* willing to give written informed consent

exclusion criteria:

* dengue serology positive but platelet count \> 20,000/mm3
* Rh negative patients
* pregnant females
Localized Muscle Cooling on Balance in Healthy Individuals

This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.

Healthy young adult aged 18-30 years will be recruited from the College of Applied Medical Sciences (CAMS), King Saud University, Riyadh. Subjects will be excluded if they had a history of a hip or knee injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury. The protocol was submitted to and approved by the Ethics Sub-Committee of Rehabilitation Research chair (RRC-2018-011). Participants will be requested to sign a written informed consent form approved by the institution ethics committee. A total of 50 participants were randomly assigned to the quadriceps cooling (QC: n = 10), hamstrings cooling (HC: n = 10), calf cooling (CC: n = 10), back muscle cooling (BC: n = 10) or control (no cooling: n = 10) group by a lottery method.A baseline assessment of mean center of gravity (COG), sway velocity (degrees/sec) for the unilateral Stance (US) will be performed. After the baseline assessment, a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscle for 20 minutes. One thin dry towel will be kept between the cold pack and the skin to prevent skin damage. Before and after the application of ice application the skin sensibility will be assessed by testing the participant's to a pinprick.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* history of a hip or knee injury, sensory deficits in the lower extremity and lower back, a history of lower-extremity surgery, spinal surgery, or a history of a quadriceps or hamstring muscle injury.
Bowel Urgency in Inflammatory Bowel Disease

Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.

A meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged at least 18 years old
* Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
* Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria:

* Person unable to comply with study procedures
Registry of Dupuytren's Contracture Treatment Outcomes

Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the

* Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
* Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
* Effectiveness (with focus on functionality)
* Tolerability
* Patient-related outcomes: patient satisfaction, health-related quality of life
* Physician satisfaction with therapy
* Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
* Long-term outcomes


Eligibility Criteria:
Inclusion Criteria:

* palpable cord due to Dupuytren's Disease (pretreated or untreated)
* satisfactory knowledge of German to be able to fill out questionnaires
* written informed consent

Exclusion Criteria:

* contraindication to Microbial Collagenase (according to Prescription Information)
Effects of CFT in Individuals With CNLBP

This research aims to deepen the understanding of the interplay between chronic neuropathic low back pain and its effects on physical health, mental well-being, and overall quality of life. Additionally, it will evaluate the impact of cognitive functional therapy (CFT) and core strengthening programs on managing chronic neuropathic low back pain. The study is grounded in the hypothesis that CFT will offer a comprehensive, multidisciplinary, and holistic therapeutic approach for individuals suffering from chronic neuropathic low back pain.

In July 2020, the International Association for the Study of Pain (IASP) revised the definition of pain, according to which pain is an unpleasant aesthetic and emotional experience related to, or appears to be related to, real or potential tissue damage. Chronic pain is characterized by a long duration, exceeding 6 months. Chronic neuropathic pain is caused by damage or disease of the somatosensory nervous system.

Cognitive Functional Therapy (CFT) is a multidimensional, patient-centred intervention that directly explores and manages cognitive, psychological and social factors deemed to be barriers to recovery in chronic low back pain (Vibe Fersum K et al., 2013; Meziat Filho, 2015; Meziat Filho et al., 2016; O'Keeffe et al., 2015a; Rabey et al., 2015; Meziat-Filho et al., 2018). The CFT approach centres on the retraining of maladaptive movement patterns, reconceptualising patient pain beliefs, and addressing any relevant cognitive, psychological, social or lifestyle factors (O'Sullivan P., 2005). CFT is an integrated behavioral approach for individualizing the management of people with disabling LBP once serious (eg, malignancy, infection, inflammatory disorder, and fracture) and specific pathology (eg, nerve root compression with progressive neurological deficit with or without cauda equina symptoms) has been excluded (O'Sullivan et al., 2018).

Eligibility Criteria:
Eligible participants were

* adults (aged ≥18 years) with chronic (≥ 3 months) low back pain prior to surgery,
* who consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion criteria were

* serious spinal pathology (eg, fracture, infection, or cancer),
* any medical condition that prevented being physically active,
* being pregnant or having given birth within the previous year,
* inadequate Greek literacy for the study's questionnaires and instructions,
* surgery scheduled within 4 months,
* BMI greater than 40 kg/m2,
* history of psychogenic illness or manic episode,
* history of other neuromuscular disorder.
Postoperative Pain for Patients After TA-BSM

To retrospectively analyze the intraoperative and postoperative status of patients with hypertrophic cardiomyopathy undergoing TA-BSM, and to estimate whether paravertebral nerve block can improve postoperative pain for these patients.

Since conventional septal myectomy can be only assessed when the heart resumes beating, and the complications induced by cardiopulmonary bypass are inevitable, a novel transapical beating-heart septal myectomy (TA-BSM) has been invented, which provides real-time evaluation to guide resection while reducing surgical trauma. Postoperative pain after TA-BSM is unknown. Whether paravertebral nerve block can improve postoperative pain caused by TA-BSM is the objective of our study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~75 years
* American society of anesthesiologists classification II-III
* Elective TA-BSM was performed

Exclusion Criteria:

* Underwent multiple surgical procedures or required cardiopulmonary bypass assistance
* Combined other function decompensation disease
* Patients with incomplete medical records
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy

There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The investigators propose that vitamin C being an antioxidant will improve seizure frequency and EEG in children with idiopathic intractable epilepsy.

Is vitamin C; being an antioxidant based on the hypothesis of oxidative stress as a provocation factor for idiopathic epilepsy low in those with idiopathic epilepsy, and is it lower in those with refractory than those with newly diagnosed? Will vitamin C supplementation for 1 month be efficient to raise the vitamin C level and will it improve seizures and EEG findings in those with idiopathic epilepsy?

Eligibility Criteria:
Inclusion Criteria:

* Normal neuroimaging

Exclusion Criteria:

* Developmental delay.
* Suspected metabolic problems.
Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.

Dental implants are worldwide recognized one of the best manners to replace lost or hopeless prognosis teeth. There are different variables that creates proper conditions for long-term prognosis of implant treatments.

Implant position and surrounding bone around them, have been described in scientific literature to be key factors in the longevity of those treatments.

It has to be defined the \&amp;amp;#34;critical bone thickness\&amp;amp;#34; around implants. It basically means that implants has to be completely surrounded by bone, that will serve as protection. If the implants are not surrounded by bone, procedures as guided bone regeneration may be performed.

Those procedures can be executed before or simultaneously during the implant placement. In the standard procedure, the simultaneous guided bone regeneration during implant placement requires to leave the implant and the regeneration healing below the gingiva, needing a second surgery for accesing to those implants.

In this randomized controlled trial the hypothesis is to discover if not submerging this regenerations may show the same results than submerged ones.

For that, the objective is to study the different variables around these regeneration to evaluate the performance of non-submerged protocol.


Eligibility Criteria:
Inclusion Criteria:

* • Men and women over 18 years old.

  * Patients requiring single-unit implant restoration in any tooth site of the maxilla and mandible in between teeth.
  * Anticipation of a peri-implant buccal osseous dehiscence by means of a CT imaging (cone-beam computed tomography, CBCT) with a maximum vertical dimension height (VDH) of 50%.
  * Presence of adjacent teeth.
  * Presence of antagonist teeth.
  * Minimum primary stability of 25Ncm.
  * Non-smokers or light smokers (\< 10 cigarettes per day).
  * Absence of systemic diseases that could influence the outcome of the therapy (i.e., uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
  * Tooth extraction performed at least 4 months before implant placement.
  * Good level of oral hygiene (Plaque Index \< 25%) (Löe, 1967)
  * Written informed consent signed.
  * Keratinized mucosa of at least 2mm on the buccal and lingual of the implant.

Exclusion Criteria:

* Implant surgery requiring sinus lift procedure.

  * Previous bone augmentation at the implant site.
  * Active periodontal disease.
  * Acute infection at the rehabilitation site.
  * Long-term non-steroidal anti-inflammatory drug therapy (3 months).
  * Lactating females or currently pregnancy.
  * Severe cognitive or psychiatric disorders.
  * Unwillingness to return for follow-up examination.