cyrilzakka/clinical-trials huggingface dataset:
B-suture Ileostomy in Clinical Practice: a Retrospective, Single-center, Propensity Score-matched Study

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

CONCLUSION: This study shows that B-suture ileostomy can simplify the surgical procedure, facilitate learning and promotion, shorten the stoma and surgical time, can reduce complications such as irritant dermatitis, peristoma infection, stoma stricture, stoma retraction, shorten the hospital stay, reduce postoperative pain, and is similar to the traditional procedure in terms of secondary surgical return, which is a surgical procedure worth continuing to explore.

OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.

METHODS: A retrospective single-center study analyzed 185 patients undergoing laparoscopic low anterior resection for rectal cancer combined with temporary ileostomy, collecting general case data, surgery-related data, postoperative-related complications, secondary surgical return data, and postoperative health status data, and divided into a B-suture ileostomy group (n=62) and a conventional method ileostomy group (n=123) according to the different stoma methods, by propensity score matching (pSM) for 1:1 matching (n=59 for both groups after matching). The advantages and disadvantages of the B-suture method ileostomy were evaluated by analyzing and comparing information on the perioperative period, postoperative related complications, and postoperative health status.

Eligibility Criteria:
Inclusion Criteria:

* If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list. For example:simultaneous laparoscopic low anterior resection of rectal cancer + temporary ileostomy;
* pathologically confirmed primary rectal cancer;
* rectal tumor height ≤12 cm from the anal verge;
* no tumor metastasis at the time of surgical resection;
* all surgeries were performed by the same surgical team with more than 10 years of experience in laparoscopic radical resection of rectal cancer and ileostomy.

Exclusion Criteria:

* patients who did not undergo stoma rejection due to tumor metastasis or recurrence;
* patients who were too old or in poor general condition to undergo stoma reversal surgery;
* patients with multiple primary colorectal cancers who underwent simultaneous multifocal resection;
* patients with incomplete clinical medical information.
Mental Health Curriculum Study

The purpose of this study is to investigate the acceptability, appropriateness, feasibility, and preliminary effectiveness of a college course grounded in skills from dialectical behavior therapy (DBT) titled, "Wellness and Resilience for College and Beyond." The study takes place on 5 college campuses in Pennsylvania and West Virginia offering the Wellness Course during the 2020 calendar year (Spring and Fall 2020 semesters). The Wellness Course is an undergraduate college course that includes 14 two and a half hour long lessons, weekly homework assignments and tracking of skills use via a "diary card," and a cumulative final exam at the end of the semester. Students who choose to enroll in the wellness course are offered the opportunity to enroll in the study and a comparison sample of students not enrolled are recruited from each site.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate College Students
* Enrolled at one of the five study sites

Exclusion Criteria:

* Students who are not undergraduates
* Students who do not fall within the age limits for the study (age 18-24 year)
* Students who are not enrolled at one of the five study sites
Safety, Tolerability and PK/PD Evaluation of Intravenous Administration of MRT5201 in Patients With OTC Deficiency

This Phase 1/2, first-in-human study will evaluate the safety and tolerability of single escalating doses of MRT5201 administered intravenously to subjects with OTC Deficiency (OTCD). This study will also evaluate the effect of a single dose of MRT5201 on metabolic markers of OTCD and ureagenesis; and determine an acceptable dosing interval of MRT5201.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of OTCD.
* Documented history of ≥1 symptomatic hyperammonemia event with ammonia ≥100 µmol/L
* Subject's OTCD is stable as evidenced by meeting the following criteria:

  * Ammonia level \<175 µmol/L during the Screening Period and at Baseline (Day -1)
  * No clinical symptoms of hyperammonemia during the Screening Period and at Baseline (Day -1)
* If using nitrogen scavenger therapy, must be on a stable regimen for ≥28 days prior to signing informed consent
* Subject has maintained a stable protein restricted diet (which may or may not include medical foods) and/or amino acid supplementation with no changes in calorie or protein goals and no changes in medical food and/or amino acid supplementation for ≥ 28 days prior to signing informed consent.

Exclusion Criteria:

* Any laboratory abnormality that may put the subject at increased risk by participating in this study.
* Have any significant concurrent or past medical condition that would represent an unacceptable risk to the subject or might jeopardize the collection of high-quality data from the study. These include but are not limited to:

  * History of liver transplant, including hepatocyte therapy/transplant
  * History of liver disease
  * Positive viral serology test results for HIV type 1 or 2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody
  * Type I or Type II diabetes that is poorly controlled, in the opinion of the Investigator
  * Poorly controlled hypertension (defined as systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg)
  * Use of anticoagulants or platelet inhibitors, including but not limited to heparin and non-steroidal anti-inflammatory drugs (NSAIDS). Acetaminophen is permitted
* Participation in previous clinical studies evaluating investigational OTCD therapies directed at expressing functional OTC protein (eg, OTC gene therapy studies, other mRNA replacement therapy) that has led to the presence of anti-OTC antibodies.
Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

The Purposes of this Study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Duloxetine might not have any good effects for you.


Eligibility Criteria:
Inclusion Criteria:

* You must be at least 18 years old.
* You must be diagnosed with major depressive disorder
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
* You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
* You have a serious medical illness.
Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

Temporomandibular disorder or TMD is characterized by a set of symptoms such as: pain, decreased range of motion and joint noise. It's origin is multifactorial, which may be related to biological aspects, environmental and psychosocial. The multimodal approach has been widely used in physiotherapy for the treatment of TMDs. Physiotherapy has been walking together with technology so that telerehabilitation can be a reality, contributing so that quality care reaches the patient, in the impossibility office-to-face service. The objective of this study is to verify the effect of telerehabilitation on pain outcomes, range of motion, functionality and biopsychosocial aspects in individuals with temporomandibular disorders. Will be a randomized, controlled and blinded clinical trial was carried out. The study will be divided into two moments: evaluation and intervention. Evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Clinical Protocol and Assessment Instruments (DC/TMD), the Fonseca Anamnesis Index (IAF), the Numerical Pain Scale (END) and the Functional Limitation Questionnaire (MFIQ). Individuals will be randomized into 2 groups: Group A (in person) Group B (telerehabilitation). Both groups will receive treatment physical therapy for 12 weeks. After collecting the data, they will be tabulated and analyzed using a 5% significance level.


Eligibility Criteria:
1. Age between 18 and 60 years;
2. presence of pain in the facial region in the last 6 months;
3. diagnosis of myalgia, arthralgia, headache attributed to temporomandibular disfunction and/or subluxation temporomandibular joint.
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

This study performed a retrospective analysis of patient images to develop software in determining dose delivered for each fraction treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years of age and over
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
* Relapsed or refractory disease after the last line of therapy
* Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function

Exclusion Criteria:

* Prior therapy with B-cell lymphoma-2 inhibitor
* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
* Known central nervous system involvement by lymphoma
* Clinically significant cardiovascular disease
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.


Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
* Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation or disrupted barrier at the treatment area
* Active eye disease or irritation
* Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
* Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
* Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
* Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

Goals of the study:

Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but lack explicit details about the clinical significance of the reductions they show in social anxiety symptoms. This project is funded by the German Association for Systemic Therapy, Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und Familientherapie: DGSF).

Study design:

The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders (SAD) in 32 patients.


Eligibility Criteria:
Inclusion Criteria:

* Social Anxiety Disorder (SKID: ICD-Diagnosis: F40.1, Liebowitz Social Anxiety Scale \> 30);
* Agreement to participate in the study and to be randomized into the two treatment groups

Exclusion Criteria:

* Acute drug or alcohol intoxication or dependency
* Anorexia with BMI \< 14
* Psychotic disorder
* Severe physical diseases
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.

Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms.

Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients.

The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.

The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.

Exclusion Criteria:

* hypotension (SBP \<90), initial temperature \< 30 °C, trauma, primary intracranial event, or active coagulopathy.
The Value of Diagnosis and Outcome Prediction in CTC for Metastatic NPC Patients

A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the observational prospective clinical trial, sensitivity, specificity, positive and negative predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of CTC in outcome prediction of mNPC patients will be uncovered.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or radiologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO II, III).
* NPC patients with distant metastasis including synchronous distant metastasis at diagnosis and metachronous distant metastasis after radical treatment.
* A Karnofsky performance status score more than 70.
* The participants provided written informed consent.

Exclusion Criteria:

* A history of previous or synchronous malignant tumors.
* Suffering from severe mental illness synchronously.
* Suffering from severe heart or lung diseases.
* Obvious abnormality in liver and renal function.
* Women in pregnancy or breastfeeding.
T Cell Dysfunction in ESRD

Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. However, few studies clarified the association of T cell dysfunction and clinical outcomes. This study is aim to explore valuable markers of T cell dysfunction predicting bad clinical outcomes including death, cardiovascular disease, infection and tumor. Hopefully, these finding will provide foundation for further mechanism research and better therapeutic options for ESRD patients in the future.

Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Recent evidence suggests uremia-related immune changes resemble to aging immune system, increasing immunological age of T cells by 20-30 years. As compared to an age-matched healthy control, ESRD patients present a lower thymic output of naïve T cells, a decline in the T-cell telomere length and an increase in the differentiation status towards the terminal differentiated memory phenotype with a large number of CD28-negative T cells. More importantly, these changes are strongly associated with a history of cardiovascular diseases and the occurrence of severe infectious episodes in this population, supporting the idea that T cell dysfunction is a critical feature in this population and will impact clinical outcomes profoundly. This study prospectively researched the predictive value of T cell dysfunction for all-cause mortality and clinical complication in hemodialysis (HD) patients.

Eligibility Criteria:
Inclusion Criteria:

* had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University

Exclusion Criteria:

* underwent any kind of cardiovascular or infection event in three months
* with hematological diseases, rheumatic diseases, active malignancies
* with history of human immunodeficiency virus infection
* currently use of any immunosuppressants
* not followed-up at Zhongshan Hospital, Fudan University
Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement

Although expert consensuses recommend the use of statins in the treatment of atherosclerotic renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis undergoing stent placement, the related investigation focused on renal protection by intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction remain uncertain. Therefore, we hypothesized that intensive lipid lowering could offer more benefits with respect to renal function in the patients with percutaneous renal artery stenting. We conducted the prospective randomized unblinded trial to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients underwent renal artery stenting (75 patients in each study group)


Eligibility Criteria:
Inclusion Criteria:

1. Angiographic evidence of severe atherosclerotic renal artery stenosis (diameter reduction≥ 70%) with ≥ 20 mmHg systolic translesional gradient or positive captopril renography in the target kidney;
2. Sustained systolic blood pressure ≥ 180 mmHg, and/or diastolic blood pressure ≥ 110 mmHg while not receiving drug therapy or systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90mmHg while taking standard triple-drug combination treatment (including one diuretic);
3. Estimated glomerular filtration rate≥ 10 ml/min/1.73m2 with longitudinal kidney length ≥ 7 cm supplied by target artery;
4. Serum creatinine level\<264umol/L；
5. Urine protein≤ 1+

Exclusion Criteria:

1. Allergy to rosuvastatin;
2. Myopathy;
3. Active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality;
4. Serious perioperative complications;
5. Severe chronic congestive heart failure (New York Heart Association functional class IV );
6. Patients who should be excluded basing on physician discretion.