cyrilzakka/clinical-trials huggingface dataset:
The Effect of Acupoint Application on Postoperative Ileus

This study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

Postoperative ileus (POI) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. POI increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. Although the Pathophysiological mechanism of POI remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. Acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. In this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients are scheduled to undergo elective abdominal surgery;
* 2. Patients age between 20 to 80 years old;
* 3. Umbilical skin condition is good;
* 4. Written informed consent provided to participate in the study.

Exclusion Criteria:

* 1.Patients don't match the inclusion criteria;
* 2. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
* 3.Patients with mental disorder;
* 4. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
* 5. Patients received ostomy operation, such as jejunostomy;
* 6.Patients who have history of abdominal surgery or history of bowel obstruction;
* 7. Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc.
* 8. Patients who are allergic to the acupoint applicaton;
* 9.Patients who are unsuitable for study inclusion as determined by the investigator. (eg: patients with severe operation related complications)
Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment

As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported outcomes and survivorship issues. In view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. In the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related QOL.

The investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. Hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (PEG) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer were included if they met the following criteria:

  * 21 years or older
  * able to read and understand either English or Mandarin
  * diagnosis of Stages 1-3 breast cancer by a medical oncologist
  * completed adjuvant cytotoxic treatment

Exclusion Criteria:

* Diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
* Participants who agree to sign the informed consent

Exclusion Criteria:

* Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Eligibility Criteria:
Primary Inclusion Criteria:

* Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
* Willing and able to return for scheduled clinic visits and study assessments
* Noncustodial, stable address and phone
* Written, informed consent

Primary Exclusion Criteria:

* Pregnancy or lactation
* Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
Prevention of Lifestyle-related Disorders Based on Functional Examinations

The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life.

Relatively healthy 40-year-olds will be examined at baseline and 1 year with both standard medical and newly developed functional examinations and physical activity level will be measured with accelerometers. The intervention group will receive feedback on all their results. A functional profile will be compiled and explained to each participant and they will receive support in setting relevant goals for lifestyle changes and making realistic plans to achieve them. The control group will also be examined as above but will receive feedback and advice based only on the standard medical examination.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age
* Relatively normal general mobility - can walk without support and have no self-reported difficulties with using all four extremities - in order to be able to perform standardised functional performance tests.
* Self-assessed as physically inactive (level 1 or 2 on the Saltin Grimby Physical Activity Level Scale) as inactive people stand to gain most from this intervention.

Exclusion Criteria:

* Verbally self-reported physical activity at level three or four on Saltin Grimby Physical Activity Level Scale.
* Severe mental illness or intellectual impairment, as participants will be expected to fill out questionnaires and should have the ability to follow healthcare advice independently should they choose to do so.
* Pregnancy and/or on-going treatment requiring hospital-based services, to increase probability of baseline values which reflect usual capacity.
* No language restrictions are planned but participants needing interpreter help should arrange this themselves.
Vermont Oxford Network Very Low Birth Weight Database

Vermont Oxford Network maintains a database for live born infants \<=1500 grams or \<=29 weeks gestational age who are born at participating hospitals or admitted to them within 28 days of birth, regardless of where in the hospital the infant receives care.

The Database collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment. The data collected includes information on:

* Demographics of mother and infant
* Mother's health, labor and delivery
* Infant's health upon admission, procedures and interventions, and medical outcomes

These data are used to: provide member centers with reporting for use in quality improvement; examine associations between baseline characteristics, treatments, and outcomes; and track trends in incidences of disease and effectiveness of therapies.

Eligibility Criteria:
Inclusion Criteria:

* Any infant who is born alive and whose birth weight is \<=1500 grams or \<=29 weeks 6 days gestational age (inclusive) who is born at or admitted to a Vermont Oxford Network member center within 28 days of life without having first gone home, regardless of the where the infant receives care

Exclusion Criteria:

* Stillborn infants
* Infants discharged home prior to admission to a member center
* Infants admitted after 28 days
International Multicentre Prevalence Study on Sepsis

To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.

De---identified patient---level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De---identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30---60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.

Eligibility Criteria:
Inclusion Criteria:

To be eligible patients must have all of the following:

* Must be admitted or transferred to either the ED or an Intensive Care Unit.
* Have a high clinical suspicion of an infection
* Have sepsis as defined by an infection together with two or more SIRS criteria
* Evidence of acute organ dysfunction and/or Shock.

Exclusion Criteria:

* Patients less than 18 years of age
* Patients in whom the sepsis has been present from before the beginning of the study period
* Any patients previously included in the study during the same study period
Customised Mouthguards on Baseball and Softball Performance

Whether the use of customised mouthguards is effective in improving the athletic performance of baseball and softball performance

This study recruited 45 baseball and softball players, including 30 fielders and 15 pitchers. Using a randomized crossover experimental design, the study was divided into randomised divided into customised mouthguards trial (MG) and control trial (CON) without temporal positioning. After the participants wore the mouthguard, they performed the vertical jump and grip strength tests sequentially. At the end of the test, depending on the pitcher or fielder, a baseball pitching ability test or a hitting ability test was conducted using a radar baseball tracking system. It is expected to analyze the vertical jump height, grip strength, pitchers' straight and changeup ball speeds, rotation speeds, degree of displacement, on-base and off-base locations. Hitting ability was expected to be documented with respect to initial velocity, elevation, and consistency of elevation.

Eligibility Criteria:
Inclusion Criteria:

* has won the top 8 national level baseball of softball championships in the last three years.
* no cardiovascular and joint diseases.
* aged 20 or above who are adults
* continuing to train professionally more than 5 days a week for the past year

Exclusion Criteria:

* have not won the top 8 national baseball or softball championships in the past three years.
* have a cardiovascular or joint disease, or any injuries that may be impaired by exercise.
* participants who are underage or not in regular baseball or softball training
* have injury to the temporomandibular joint.
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

This study will evaluate T-20 in children.

Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are 3 through 16 years of age and have the consent of parent or guardian.
* Have a viral load of at least 5000 copies/ml.
* Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
* Have been on stable therapy for at least 4 weeks.
Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis

This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of subdeltoid bursitis
* age 20 or older 20
* at least one positive in the painful arc, neer test, or Hawkins test
* can attend three months of intervention and follow-up

Exclusion Criteria:

* history of malignancy
* previous shoulder operation or injury
* previous shoulder injections in the past three months
Evaluating the Fade to Fitness Program: a Barbershop-based Program for Black Men

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.

It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.

The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American or Black American male - 18 - 90 years of age
* Able to speak and understand English

Exclusion Criteria:

* Currently participating in another health promotion intervention
* On a special diet for a serious health condition
* Intending to move within 6 months of participating in the intervention
Mix Vaccine for Metastatic Colorectal Cancer

The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.

By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery

Of 737 consecutive patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma, 679 cases with curative intent surgery between 05/1996 and 03/2019 were included. Patients were categorized into: i) R0 without further resection (direct R0), ii) R0 after positive IOC and extension of resection (converted R0) and iii) R1.

This retrospective cohort study was performed at our tertiary referral center at the University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH Hölscher).

In this study, patients undergoing curative surgery between 1st May 1996 and 31st March 2019 with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included. Palliative resections and resections with transthoracic esophagectomy and gastric pull-up were excluded.

Demographics, perioperative treatment, survival and clinicopathologic data were obtained. Medical records were reviewed and complications were categorized according to Clavien-Dindo classification.

Depending on IOCs, extended resection and final pathology report a treatment flow-chart was created (Figure 1): Patients were grouped on a) IOC received (yes/no), b) IOC positive (yes/no), c) extended resection (yes/no), d) second IOC (IOC2; yes/no), e) IOC2 positive (yes/no) and final pathology results (R0/R1). The decision to perform IOC and to carry out extended resection in case of positive IOC was at the discretion of the treating surgeon. Patients were then categorized into 3 subgroups according to final R status: R0 after extended resection (i.e. converted R0), R0 without extended resection (i.e. direct R0) and R1.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* tumor resection via total gastrectomy and subtotal esophagectomy

Exclusion Criteria:

* no additional other solid or hematological neoplasias in the medical history
* pregnancy
* surgical procedures in palliative intention
Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.

Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.

Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube.

Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.

Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.

Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube.

Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation.

More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique.

Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age;
* Patients with gallbladder stones and known or expected concomitant bile duct stones;
* Informed consent.

Exclusion Criteria:

* Biliary drainage is already present, e.g. preoperative ENBD, PTCD;
* Women who are pregnant;
* Declined consent;
* Inability to follow the procedures of the study, e.g. due to language problems and psychological disorders of the participant;
* Morbid obesity (BMI \> 40);
* IV-VI class of the American Society of Anesthesiologists physical status classification;
* Contraindications for general anesthesia or surgery.