cyrilzakka/clinical-trials huggingface dataset:
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects

This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.

Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.

Eligibility Criteria:
Inclusion Criteria:

* Patient is greater than or equal to 18 years of age.
* Patient can provide informed consent.
* Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
* Post resection defect \> 3cm.
* Lesion 2cm or greater from the dentate line.

Exclusion Criteria:

* Patient is \< 18 years of age.
* Patient refused and/or unable to provide consent.
* Patient is pregnant.
* Patient is currently incarcerated
Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open Trial

Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention.

The overall goal of this project is to examine the impact of intervening on weight bias internalization (WBI) in conjunction with evidence-based adolescent behavioral weight management (BWM) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from WBI. An open trial with 16 adolescents (2 cohorts; 8/group) will be conducted to test initial acceptability and feasibility of the 20-week WBI+BWM intervention in an open trial. Quantitative and qualitative feedback concerning acceptability and feasibility will be solicited to refine the intervention. Participants are adolescents (ages 13-17 years old) at higher weight status (BMI percentile at or equal to the 95th percentile) will participate in a 20-session weekly intervention focused on weight bias internalization and healthy weight management strategies.

Eligibility Criteria:
Inclusion Criteria:

* speak English
* 13-17 years of age
* BMI at or above \>95th%ile for age and sex
* have at least one caregiver available to provide consent and participate in sessions
* agree to study participation

Exclusion Criteria:

* Cognitive impairment or developmental delay impairing participation in a group setting
* Current participation in a weight management program or recent weight loss of 5% of body weight or more
* Medical condition known to impact weight or that would otherwise prevent participation
Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males

The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers 18-55 years of age
* BMI 18.0-30.0 kg/m2 and weight at least 50 kg
* Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive

Exclusion Criteria:

* Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
* Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
* Volunteer has history of suicide attempt
* Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months
The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes

Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring.

Objective: To determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group.

Design, Setting, Participants: We will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at National Taiwan University Hospital (NTUH) and NTUH Hsinchu Branch from 2018 to 2020.

Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-20 weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle intervention and self-monitoring of blood glucose. Pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks.

Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes, including primary CS, birth weight \>90th percentile, neonatal hypoglycemia, cord serum C-peptide \>90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. The primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant women after randomization.

Conclusion: This study will test our hypothesis that early screening and intervention of GDM improves pregnancy outcomes as compared to standard practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years old
2. First prenatal visit before 14 weeks of GA
3. Deliver a singleton at medical centers, including National Taiwan University Hospital (NTUH), and NTUH, Hsinchu Branch.

Exclusion Criteria:

1. Diagnosed with preexisting diabetes
2. Twin or multiple births pregnancy
3. Current exposure to steroids
4. Cannot tolerate an OGTT
Measuring the Effects of Touch Relaxation Painful Patients in Oncologie Nursing

Measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics


Eligibility Criteria:
Inclusion Criteria:

hospitalized in the oncology department at least 3 days

* presenting the cancerous type of pain caused by their disease or treatment
* numerical scale pain score = 4/10
* receiving weak and strong opioids
* platelet count\> 100
* can receive anxiolytic
* adult
* Patient of both sexes
* no other relaxation approaches

Exclusion Criteria:

* against indication to touch: wound, bruises, circulatory disorders, diseases psychiatiques
* risk of hematoma
* numerical scale pain score \< 4/10
* understanding of the difficulties of the French language
* no receiving weak and strong opioids
Assessment of Musculoskeletal Pain and Psychosocial Status of Athletes

The sporty performance exhibited by an athlete faces physiological, biomechanical and psychological activity of the athlete. It depends on both the psychological state and the elevation of the musculoskeletal system to a certain level so that the athlete can perform optimally and excellently. For this reason, we aimed to evaluate the musculoskeletal system pain of amateur and professional athletes in different disciplines and the psychosocial states such as sports confidence, depression and quality of life.

This study consists of 160 sportsmen who are participating in sports by doing sports in soccer, basketball, volleyball, athletics, table tennis, field tennis, kickboxing and archery branches between the ages of 15 and 36. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer for identifying their pain threshold, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

* The athletes and their coaches must be voluntary and willing.
* During the evaluation, the athletes must give careful and relevant answers to the measuring instruments.
* They have to actively run the sport they belong to.
* The dominant upper extremity should be the right side.

Exclusion Criteria:

* Having undergone a surgical operation due to sports injuries in the last 3 weeks
* The athletes do not want to answer the surveying instruments
Comparison of the Breast Tumor Microenvironment

The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.

There is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. In breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. This risk of recurrence varies between different types of breast cancer. The investigators seek to study the proteins produced in normal tissue surrounding breast tumors. The tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. A new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. This will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal A (less likely to recur) and triple negative (more likely to recur). Identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.

Eligibility Criteria:
Inclusion Criteria:

* Female, age greater than or equal to 40
* Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease
* Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status
* Clinically less than or equal to 3cm unifocal lesion
* Clinically node negative
* Must have diagnostic mammogram performed within last 6 months
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1
* Appropriate renal, liver, and hematologic lab values
* Ability to give informed consent

Exclusion Criteria:

* Multifocal disease
* Clinically N1 disease at diagnosis
* Invasive lobular carcinoma
* Metastatic disease
* Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation)
* Patients with known BRCA1/2 mutations
* Pregnant or nursing
Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. After having identified the key mechanisms of rumination, we developed an original EMG guided biofeedback technique with specific targets for correction, based on EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the potential effectivity of this treatment. In a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of a simplified biofeedback technique not requiring EMG-guided control.

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. In each patient 3 sessions will be performed over a 10-day period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events by questionnaries administered daily for 10 days) will be measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* relevant organic disease
Different Algorithm Models to Predict Postoperative Pulmonary Complications in Elderly Patients

Although a number of clinical predictive models were developed to predict postoperative pulmonary complications, few predictive models have been used in elderly patients. In this study, the researchers aim to compare different algorithms to predict postoperative pulmonary complications in elderly patients and to assess the risk of postoperative pulmonary complications in elderly patients.

Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has been an important predictor of postoperative pulmonary complications. As the world's population ages, more and more older people are undergoing surgery as indications for surgery expand. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we plan to use database information and different algorithms such as logistic regression, random forest, and other algorithms to build models respectively and evaluate the effects of the models.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65 years or older
2. receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

1. preoperative mechanical ventilation
2. procedures related to a previous surgical complication
3. a second operation after surgery
4. organ transplantation
5. discharged within 24 hours after surgery
6. cardiac surgery
Implementation of a Pain Management Protocol for Total Knee Arthroplasty

Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?

Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required.

Specific 5 arms include:

* Using all three anesthetics:

  o PI + FB + IO (arm 1)
* Using a combination of two anesthetics + normal saline substitute for control:

  * NS + FB + IO (arm 2)
  * PI + NS + IO (arm 3)
  * PI + FB + NS (arm 4)
* Control:

  * NS + NS + IO (arm 5)

The control arm would include IO as the sole intervention as this is simply added to the spinal anesthetic used for the surgery itself. It is felt that having a study arm without any long-acting analgesic medication (opioid or local anesthetic) as the "control" arm following a spinal anesthetic would not meet current standard of care and cause harm to the participant

The investigators hypothesize that the combination of three forms of long acting analgesia (PI, FB, IO) will result in the greatest outcomes compared to a combination of any two or control. Our aim is to demonstrate that this optimal analgesic combination will have an additive pain control effect and will minimize side effects thus translating to less acute pain, improve patient mobility, and attaining "readiness to discharge" quicker.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* primary total knee replacement for osteoarthritis
* agrees to a spinal anesthetic for TKR

Exclusion Criteria:

* History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month)
* general anesthetic for TKR
* major neurological deficit
* allergy to local anesthetic
* allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
* renal insufficiency
* liver failure
Insights Into Participating in Studies for Uterine Cancer

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this trial so that it may collect a variety of data about uterine cancer clinical study experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with uterine cancer who are invited to take part in medical study will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of uterine cancer
* No prior treatment for uterine cancer

Exclusion Criteria:

* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Enrolled in another research study
* Inability to provide written informed consent
Sensorimotor Control in People With and Without Neck Pain

This is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants.

The investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. These variables will be recorded by means of Inertial Measurement Unit (IMU) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.


Eligibility Criteria:
Inclusion Criteria:

* Population aged between 18 and 65 years old

Exclusion Criteria:

* Visual impairment not corrected by the use of glasses/contact lenses
* Migraine headache
* Complex regional syndrome
* Previous surgeries in the neck and/or head region
* Sensory and/or vestibular alterations, (f) Otogenic or idiopathic vertigo/dizziness
* Presence of tumors in the craniocervical region
* Previous fracture in the head or neck region
* Osseous deformities in the thoracic, cervical or cranial region
Effect of Endothelin-1 Receptor Blockade on Circulating Endothelial Microparticles Levels in Patients With Pulmonary Hypertension

Pulmonary hypertension is a progressive and life threatening condition. It is characterized by severe remodeling of the pulmonary vessel wall, obstructive plexiform lesions, multi-focal thrombosis, and enhanced vasoconstriction. All of these characteristics contribute to increased pulmonary vascular resistance.

Circulating endothelial microparticles (EMPs) play an integral role in the pathogenesis and perpetuation of pulmonary hypertension. Levels of EMPs are considered a reliable biological parameter of endothelial injury.

We propose to assess the evolution of both circulating and pulmonary venous EMPs in patients with PH. Assessments will be made before and after initiation of Endothelin-1 (ET-1) Receptor blocker therapy, and correlated to their patterns with the changes in mean PAP, the 6 Minutes Walking Distance test, and circulating Endothelin-1 values. Measurements of the endothelial microparticle circulating levels (assessed by flow cytometry methods) will be made before, 1 month and 3 months after initiation of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient's + 18 years with suspected pre-capillary pulmonary hypertension
* Prescribed Endothelial - 1 receptor blocker

Exclusion Criteria:

* Currently taking endothelium-active vasodilator therapy.
* Hemoglobin and / or hematocrit level blood the lower normal limit.
* Left ventricle dysfunction (LVEF \<50%)
* LV end-diastolic pressure \> 15 mmHg)
* Recent history (\<3 months) of pulmonary embolism
* Liver failure or abnormal liver function tests; aortic or mitral regurgitation or stenosis
* Current medication with endothelin-1 receptor antagonist, prostacyclin analogues or type 5 phosphodiesterase inhibitors.
* Subjects with conditions known to be associated with an increase in circulating endothelial microparticle numers, such as chronic renal failure (Creatinine Clearance \< 50 ml/min/m2) acute coronary syndromes and uncontrolled system hypertension.
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12

The specific aims of this research proposal are to:

1. Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
2. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

* Patients not diagnosed with Normal Pressure Hydrocephalus