cyrilzakka/clinical-trials huggingface dataset:
Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients

To study the impact of emergency high risk GI surgery on HRQOL in elderly patients, seventy-five years or above and to explore the patients' experience with the informed consent process and the status 6 months after surgery.

We will identify all patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015.

The first part of the study will take place in the first postoperative week, while the patient is in hospital. After consent we will ask both patient and relatives/caregivers questions concerning the preoperative course and the informed consent. We will ask for permission to call the patients for a followup (the second part of the study) 5-7 months after discharge and permission to contact their closest relative. The closest relative is chosen by the patient and will after consent be asked the same questions in the first postoperative week and after 6 months.

The second part of the study will be initiated with a letter with SF-36 and an additional questionnaire . The SF-36 will be returned by letter. We will contact the patients by telephone 2 weeks after sending the letter ask them the questions from the additional questinaire.

We will compare the results from the SF-36 with age-matched controls (Data from the Danish SF-36 Manual).

If the patient is not capable of answering the questionnaires, the primary reason is noted (e.g. suffering from dementia or didn't speak Danish, dead).

We will aim at a 6 month follow-up period after discharge allowing a range from 5-7 months. Data acquisition will be done in the fall 2014 until late 2015.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 75 having an emergency GI laparotomy or laparoscopy between the 1st of November 2014 and the 30st of April 2015. We will also include reoperations after elective surgery (major bleeding, anastomotic leakage etc.) and endoscopic procedures converted during the intervention (upper GI-bleeding, unsuccessful stenting of obstructing colorectal cancer etc.).

Exclusion Criteria:

* appendectomies, negative laparoscopy/laparotomy, laparoscopic cholecystectomy, acute hernias without strangulation, sub-acute internal hernia after Roux-en-Y gastric bypass surgery, sub-acute IBD-surgery and sub-acute Colorectal Cancer-surgery. Sub-acute is defined as planned in less than 48 hours.
Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining

The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are:

Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes?

Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients?

Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy/axillary lymph node dissection; Lymph nodes with clear postoperative paraffin pathological results.

Part 2:

Patients aged 18-75 with one of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, or cervix; Undergoing surgical resection of lymph nodes; Lymph nodes with clear postoperative paraffin pathological results.

Part 3:

Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy; Sentinel lymph nodes with clear postoperative paraffin pathological results.

Exclusion Criteria:

Part 1 / Part 2:

Lymph node diagnosis is missing; Absence of lymph node component in the slice.

Part 3:

Sentinel lymph node diagnosis is missing; Absence of lymph node component in the frozen slice.
Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.


Eligibility Criteria:
Inclusion Criteria

* Resident of Canada
* Male sex
* Age 18 years or older
* Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression
* Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy
* Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment
* No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging
* Not received docetaxel for castration-resistant disease
* ECOG performance status 0 - 2, inclusive
* Life expectancy of greater than 6 months
* Serum testosterone less than or equal to 50 ng/dl
* Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks
* Neutrophils greater than or equal to 1.5 x109/L
* Platelets greater than or equal to 100 x109/L
* No prior hemi-body radiotherapy
* No impending or established spinal cord compression
* No unmanageable fecal incontinence
* Patient has good IV access
* Able to understand and provide written informed consent

Exclusion Criteria

* Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial
* Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug.
* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients who are claustrophobic
Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.


Eligibility Criteria:
Inclusion Criteria:

* Right colon cancer
* Intracorporeal anastomosis
* Laparoscopic surgery
* Elective surgery
* informed consent signed

Exclusion Criteria:

* below 18 years old
* IBD
* ASA IV
* T4b
* Metastatic disease
* Preoperative steroids
* Conversion to open surgery
* Emergency surgery
* concomitant major operation
* preoperative infective status
* benign disease
Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease

Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\&#39; bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-50 years.

Exclusion Criteria:

* Uncontrolled thyrotoxicosis
* Chronic kidney disease (eGFR \<30)
* Known Cushing's syndrome
* Previous gastric bypass and/or known ongoing malabsorption
* Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
* Use of oral or inhaled glucocorticoids within the past year
* Menopause (defined as 1 year without menstrual bleeding)
* Pregnancy (defined as elevated HCG)
* Ongoing infection
* Allergy to prednisolone or one of the excipients
* Systematic fungal infections
* Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination
* Not able to provide informed consent (e.g., dementia, not able to understand Danish).
Women's Depression Treatment Study

The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Current Major Depression
* History of sexual abuse prior to age 18

Exclusion Criteria:

* Bipolar disorder
* Psychosis or schizophrenia
* Active alcohol or substance abuse
Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)

The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* chronic respiratory, neurologic or cardiac disease
* swallowing disorders
* pregnancy
Effects of Dynamic and Kinesiology Taping on Balance and Kinesthesia in Healthy Adults

This study aims to investigate the acute effects of dynamic tape (DT) and kinesiology tape (KT) on balance and kinesthesia of the lower limbs in healthy young adults. Participants will undergo assessments of static balance and knee joint position sense before and after the application of each taping condition. The study seeks to determine whether DT or KT can provide immediate improvements in postural stability and proprioceptive accuracy.

Taping techniques are commonly used in rehabilitation and sports settings to support joint function, reduce pain, and improve proprioception. Dynamic tape (DT) and kinesiology tape (KT) differ in their mechanical properties and proposed mechanisms of action. While KT is elastic and mimics the properties of skin, DT offers higher elasticity and resistance, potentially providing enhanced mechanical support and proprioceptive feedback.

Although several studies have explored the effects of taping on balance and proprioception, direct comparisons between DT and KT, particularly when applied to both the ankle and knee joints, remain limited. This study seeks to address this gap by examining and comparing the immediate effects of DT and KT on static balance and kinesthesia of the lower limbs in healthy adults.

The findings may contribute to a better understanding of the clinical relevance of different taping methods and inform decision-making in preventive and therapeutic interventions targeting lower limb stability and proprioception.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-30 years
* No current pain or injury affecting the lower limbs
* Willingness to participate and provide informed consent
* No known allergy or sensitivity to adhesive materials

Exclusion Criteria:

* History of ankle sprain or anterior cruciate ligament (ACL) injury
* Any lower limb injury in the past 3 months
* Neurological or vestibular disorders affecting balance
* Skin conditions or wounds at the taping sites
* Participation in balance or proprioception training programs in the past month
Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations

The purpose of this study is to assess the feasibility of establishing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing at a federally-qualified health center (FQHC) during a global health crisis to mitigate COVID-19 disparities in socioeconomically disadvantaged populations.

Accurate and early diagnosis of COVID-19 infections are critical for rapid initiation of quarantine interventions to reduce population spread and to provide appropriate medical care to reduce related morbidity and mortality during the current pandemic. The purpose of this study is to assess the feasibility of establishing a drive-through rapid COVID-19 testing site at a federally-qualified health center (FQHC) during a global health crisis to mitigate health consequences in socioeconomically disadvantaged populations. The investigators also seek to evaluate the effectiveness of community-driven communication in increasing access to rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in this population. This will inform public health decisions about improving access to testing for SARS-CoV-2 in underserved populations, particularly those receiving care in FQHCs or community health centers.

The specific aims of the study are to:

Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. A rapid testing strategy (drive-through testing site) at a FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing will be piloted.

Aim 2. To compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. A simple random sample will be drawn of FQHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 and availability of rapid testing from the FQHC versus usual sources (control).

Eligibility Criteria:
Inclusion Criteria:

* This study will include all patients receiving clinically indicated testing for COVID-19 at a federally qualified health center (FQHC, Open Cities Health Center, St. Paul, MN).
* There will be no formal recruitment of patients in this research.

Exclusion Criteria:

-
Effect of Perturbation Training on Balance Control in Elderly Persons

The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.

A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.

Eligibility Criteria:
Inclusion Criteria:

* Be 70 years or older, male or female
* Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

Exclusion Criteria:

* Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
* Moderate-severe dementia (Mini-Mental Score \< 24).
* Serious visual impairment
* Severe peripheral or compression/entrapment neuropathies.
* Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
* Cancer, metastatic or under active treatment.
Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
All patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of semaglutide or standard of care (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) (cohort entry).

Eligible cohort entry dates:

Market availability of semaglutide/standard of care in the US started on December 6th, 2017:

* For Optum: December 6, 2017 - May 31, 2021 (end of data availability)

Inclusion Criteria:

* Age \>= 18
* Type 2 diabetes mellitus diagnosis
* Use of metformin
* At least 2 HbA1c records within the prior 280 days
* At least 1 HbA1c record within the prior 90 days

Exclusion Criteria:

* Missing age or gender
* Use of any other anti-diabetes medications
* Any insulin use
* Pregnancy
* Multiple Endocrine Neoplasia syndrome type 2
* CKD stage 5, ESRD, dialysis, or renal transplant
* Nursing home admission
Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports

This is a prospective, descriptive and observational study of the anticancer center practice


Eligibility Criteria:
Inclusion Criteria:

* Patient with any cancer, requiring a central venous catheter
* No contraindication for any surgery with local or complete anaesthesia

Exclusion Criteria:

* Previous Xylocaine or Lidocaine allergy
* Clinic superior vena cava syndrome
Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks

The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female migraine patients (age 18 to 65 years) with or without aura, diagnosed according to IHS criteria.
* Established migraine diagnosis for \>= 1 year.
* Age at migraine onset \<= 50 years.
* Well documented (for \>= 3 months) retrospective history of migraine with headache of moderate to severe intensity and with an attack duration of at least 6 hours and migraine frequency of 2-8 times / month
* Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache.
* Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
* Patient is in general good health based om screening assessment

Exclusion Criteria:

* Women of child-bearing potential without an adequate method of contraception
* Any woman of child-bearing potential not having a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
* Breastfeeding women
* Males not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilization, IUD \[intrauterine device\]) during the whole study period from the time of the first intake of study drug until three months after the last intake.
* History of hemiplegic, ophthalmoplegic, or basilar migraine or cluster headache.
* History of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compounds.
* History of , clinical evidence for, or screening/baseline findings suggestive of significant medical disorders (e.g. cardiovascular, peripheral vascular, hepatic, respiratory, haematological, renal, gastrointestinal, immunological, metabolic, hormonal, neurological or psychiatric disorders)
* Smokers ... (cont.)