cyrilzakka/clinical-trials huggingface dataset:
J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

OBJECTIVES:

Primary

* Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.

Secondary

* Compare the quality of life of patients treated with these procedures.
* Compare anorectal function in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.
* Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.

In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks.

Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.

PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the rectum

  * T2 or T3 disease
* Disease located in the mid- or distal rectum
* No evidence of metastatic disease
* No preexisting grade III or IV incontinence
* Completed preoperative radiotherapy (5 x 5 Gy) before study entry

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Working knowledge of the Dutch language

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No prior radiotherapy to the pelvis

Surgery

* No prior colon resection
* No prior anorectal surgery
* No concurrent abdominoperineal resection
A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer

This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. With either gender aged at least 20 years old
2. With venous reflux \>0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
3. With at least one venous ulcer on the lower leg (knee to ankle inclusive) and not healing for at least 4 weeks. The ulcer with the largest surface area will be selected as target ulcer. If two or more ulcers have the largest size, the one with the longest duration will be selected
4. With the target ulcer size of 2 cm2 to 50 cm2
5. Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
6. Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
7. Able to tolerate compression therapy
8. Subject has signed the written informed consent form

Exclusion Criteria:

1. Target VLU With active cellulitis or osteomyelitis
2. With target ulcer size decreased by at least 30% after 2 weeks of standard care
3. With poor nutritional status (albumin \< 2g/dl), poor diabetic control (HbA1c \> 12%), a leukocyte counts \< 2,000/mm3, abnormal liver function (AST, ALT\>3 × upper limit of normal range) tests within 14 days prior to Screening visit or 28 days prior to Randomization visit
4. Requiring treatment with chemotherapeutic agents
5. With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
6. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to Screening visit
7. (1) Female subject of childbearing potential who:

   * is lactating; or
   * has positive pregnancy test result at eligibility checking; or
   * refuses to adopt at least one form of birth control from signing informed consent to the end of study

   Note:

   Acceptable forms include:

   Established use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS).Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)

   7(2) Male subject with female spouse/partners who are of childbearing potential refuses to adopt at least one form of birth control (at least one of which must be a barrier method) from signing informed consent to the end of study)
8. With ankle brachial index (ABI) \< 0.6
9. Enrollment in any investigational drug trial within 4 weeks before entering this study
10. With any condition judged by the investigator that entering the trial may be detrimental to the subject
Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.

Autoimmune and auto inflammatory diseases are a growing group of disorders caused by a dysregulation of the innate immune system leading to episodes of systemic inflammation.

They represent a group of diseases characterized by excessive autoimmune or inflammatory reaction leading to various organ damage and drop in patient's quality of life, usually underlined by particular genetic factors and environmental triggers.

The progress of these diseases is often evaluated in the form of activity scores.

A number of scores are available to predict the evolution of autoimmune autoinflammatory diseases.

For a long time, these pathologies have remained slightly explored because of their complex physiopathology and the absence of specific therapies.

In the last few years, significant progress has been made in terms of both pathophysiology and treatment.

Treatment with biological targeted therapies transformed the prognosis and survival of the patients, improved their quality of life and underlined the necessity of a global management of these patients.

In Armenia, the epidemiological elements of these pathologies are not known, nor are the circumstances of their discovery. The initial biological manifestations and the management of these patients are variable from one center to another, whether in terms of supportive or specific therapeutic elements.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of at least one of following autoimmune systemic diseases:

   Behcet disease, ANCA -positive vasculitis, Takayasu arteritis, Giant cell arteritis, Systemic sclerosis, Sjogren syndrome, Rheumatoid arthritis, Spondylarthritis (psoriatic, ankylosing, crohn's related), Angioedema hereditary and acquired, Pediatric dermatology, Autoinflammatory diseases (hereditary and acquired), Unexplained infertility, Immune thrombocytopenic purpura/ Autoimmune hemolytic anemia (ITP, AHA), Primary anti-phospholipid syndrome (APS), Celiac disease.
2. Age: major and minor
3. Patients who have been informed and provided with written informed consent to participate Or consent from legal representative

Exclusion Criteria:

1. Patients refusing to participate in the registry
2. Non-consent from legal representative
3. Breastfeeding or pregnant patients
Genetic Determinants of Clindamycin/Rifampin Interaction

Main objective- To study the influence of the polymorphisms of nuclear receptor proteins pregnane X receptor (PXR), Liver X receptor alpha (LXRα), and Cytochrome P450 (CYP450) on the clindamycin clearance during clindamycin/rifampin combination therapy.

Secondary objectives To study the influence of these polymorphisms on clindamycin clearance, before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on CYP450 activity before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on the increase of CYP450 activity after clindamycin/rifampin combination therapy To study the difference between the expected and observed clindamycin serum concentrations after dosage adjustment, in patients with clindamycin dosage adjustment after combination therapy with rifampin

Eligible patients will be informed on the study during their hospitalisation in the unit for the treatment of bone and joint infection by the medical doctor. If they agree to participate in the study, the following samples will be performed :

* After at least 24 hours of clindamycin therapy and before combination therapy with rifampin:

  * 1 urine sample (5 mL) for CYP 450 activity phenotyping
  * 1 blood sample (5 mL on ethylenediaminetetraacetic acid (EDTA) tubes) for measuring clindamycin serum concentration and genotyping
* After ten days of clindamycin-rifampin combination therapy:

  * 1 urine sample (5 mL) for CYP 450 activity phenotyping
  * 1 blood sample (5 mL on EDTA tubes) for measuring clindamycin serum concentration and genotyping

Eligibility Criteria:
Inclusion Criteria:

* bone or joint infection
* aged ≥ 18 years old
* treatment with clindamycin/rifampin combination therapy \> 10 days

Exclusion Criteria:

* prescription of another treatment with potential action on CYP450
* pregnant or breast feeding patient
Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation

Heart failure causes significant morbidity and mortality, particularly in Navajo Nation. There are well-established evidence of improved mortality and lower heart failure hospitalizations with certain pharmacotherapies for heart failure with reduced ejection fraction (HFrEF). However, these medications are underutilized nationally, including in the Indian Health Service which is one important driver of poor heart failure outcomes. Therefore, as part of an EHR-based pragmatic clinic trial, we are implementing and testing a model that identifies American Indian HFrEF patients receiving care at one large Indian Health Service Site who meet clinical criteria for, but are not on appropriate therapy, and implements a model in patients are initiated and titrated on appropriate therapy over the phone with remote tele monitoring using home blood pressure cuff. We will evaluate the impact of this model to improve uptake of GDMT among HFrEF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure with reduced ejection fraction with last ejection fraction equal to or less than 40%
* Have a primary care physician at Gallup Indian Medical Center or Tohatchi Health Center
* Have been seen in the last 12 months at Gallup Indian Medical Center or Tohatchi Health Center

Exclusion Criteria:

* On hospice
* LVAD/translant
* Home inotropes
* No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
Transversus Abdominus Plane Block in Living Donor Hepatectomy

Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug

Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group

Eligibility Criteria:
Inclusion Criteria:

* all living hepatectomy donors in Mansoura liver transplantation program

Exclusion Criteria:

* refusal known sensetivity to used drugs
Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia

The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in victims of the Colombian armed conflict.

A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100 internally displaced victims of armed conflict living in Bogotá is being implemented. Participants are recruited from several governmental, non-governmental agencies as well as community organizations of victims. Participants are being randomly assigned to treatment condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly sessions covering the 8 modules of the original UP. The effects of the UP is evaluated through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.

Specific objectives

* To translate and adapt the UP, taking into account the cultural, social, economic and political context of individuals exposed to political violence in Colombia.
* Develop and adapt a set of assessment tools to identify victim's symptoms of anxiety, depression, and related disorders.
* Conduct a randomized clinical trial comparing outcomes of 12 biweekly sessions of the culturally adapted UP in a group participants randomized to immediate treatment to a waiting list control receiving delayed (6-week) treatment.
* To identify potential variables that mediate or moderate the effects of treatment with the UP.

Methodology Design. Allocation randomized Participants. 100 individuals presenting emotional sequelae of exposure to violent events of armed conflict in Colombia, 50 of which are being randomly assigned to treatment group and 50 to control group (waiting list).

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria. Individuals registered as victims in Colombian Victims Unit, 18 years or older, who meet the diagnostic criteria for one or more anxiety disorder(s), depressive disorder(s) or post-traumatic stress and related disorder(s) according to the Diagnostic and Statistical Manual (DSM-5, 2013) as determined by the International Neuro-Psychiatric Interview M.I.N.I.

Exclusion Criteria:

* Exclusion criteria. Individuals diagnosed with psychotic disorders, bipolar affective disorders, intellectual disability, dementia, substance abuse (as primary diagnoses, with hospitalization requirement for treatment) as well as individuals who endorse acute suicidal risk. Those that do not meet the inclusion criteria, but are in need of mental health attention, will be referred to entities of the Health System, so that they receive the pertinent treatment.
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.

Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant and non-nursing female aged 18 or older
* History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point numerical rating scale\] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs \[NSAIDs\], and muscle relaxants) of approximately 12 to 24 hours
* Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
* Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
* Female subjects of childbearing potential must be using a recognized effective method of birth control
* Written informed consent obtained at Screening, prior to any procedure being performed

Exclusion Criteria:

* Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
* Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* Corrected QT (QTc) interval of \>450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome, or an immediate family member with this condition
* Diagnosis of moderate to severe hepatic impairment.
* History of severe emesis with opioids
* Clinically significant sleep apnea
Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily.

By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: spontaneous intracerebral hemorrhage verified by CT
* Clinical indication for craniotomy or craniectomy
* Admitted to the hospital within 24 hours from assumed ictus
* Age over 18 years

Exclusion Criteria:

* Pregnancy
The ABC Study: Assessment of Breast Density Classification

The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, a subject must meet all the following criteria:

  * Attending a symptomatic or assessment breast clinic at the study site
  * Female sex
  * 18 years or older
  * Able to provide informed consent
  * Not in any identified, vulnerable group

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in this study:

  * Unable to mount MARIA® patient bed
  * Unable to lie in the prone position for a period of up to 15 minutes
  * Patients who have undergone biopsy less than 5 days before the MARIA® scan
  * Patients with implanted electronics
  * Patients with breast implants
  * Patients with nipple piercings (unless they are removed prior to the MARIA® scan)
  * Breast sizes too small or too large to be suitable for the array

Participants recruited the same day are not subject to any additional screening criteria other than that described above. However, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. This will include information on:

* Whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram
* Whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram
* Whether they believe that they have had a change in menopausal status since their last mammogram Participants who answer yes to any of the above will not be eligible for participation.
The Attitudes, Communication, Treatment and Support Intervention to Reduce Breast Cancer Treatment Disparity

The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale. The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community.

The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in white American women, an alarming disparity that cannot be explained by stage of disease at presentation. Nonadherence to breast cancer treatment and treatment delays from diagnosis to initiation of treatment may be among the reasons for worse breast cancer outcomes in black women. This recognition is critical because it suggests that breast cancer survival disparity can be decreased through clinical interventions that increase adherence to chemotherapy. The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale. The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community. This study is a randomized controlled trial that will test the efficacy of the ACTS Intervention vs. Usual Care on the primary outcomes of adherence to recommended breast cancer chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* African American, as determined by patient self report on their demographic form completed at first medical oncology visit
* Female
* Age 18 or older
* Diagnosed with invasive breast cancer
* Recommended (prescribed) chemotherapy by participating medical oncologists

Exclusion Criteria:

* Impaired cognition, as determined by a score of less than 22 on the Mini Mental Status Exam
* An inability to understand English