cyrilzakka/clinical-trials huggingface dataset:
Islamic Trauma Healing: Feasibility Study

This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show improvement in quality of well-being. Feasibility will also be examined by examining at retention, satisfaction, and community feedback.

Islamic Trauma Healing is a lay-led, small-group intervention specifically targeting healing mental wounds of trauma within mosques. The six-session intervention combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles. A lay-led, group program promotes community building, acknowledges trauma's impact in the community, and facilitates wider implementation. The program is not referred to as "therapy" or "treatment" for "mental illness." It incorporates community building (e.g., shared tea, supplication), integrated Islamic principles that utilize cognitive restructuring through discussion of prophet narratives (e.g., faith during hard times, Prophet Job \[Ayyub\]), and exposure therapy through individual prayer, talking to Allah about the trauma. Ultimately, the program will follow a self-sustaining train-the-trainer model, led by group leaders, empowering lay leaders to facilitate healing in their communities. Further, training time is dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group discussion leading rather than training as a lay therapist or mental health counselor. Preliminary data from a community sample and from initial men's and women's groups show a strong perceived need and match with the Islamic faith, with large effects obtained for pre- to post-group across measures (g = 0.76-3.22). Qualitative analysis identified the intervention as operating on potential mechanisms of connectedness to the community, faith integration, healing, and growth. The preliminary data point to the program being well-received and offering a promising model for delivery of a trauma-focused intervention to Muslim communities. The next steps are examining Islamic Trauma Healing in low and moderate-income Muslim countries, examining the feasibility of implementing this lay-led program.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a DSM-5 trauma at least 12 weeks ago
* Report current re-experiencing or avoidance symptoms
* Islamic faith
* 18-65 year of age

Exclusion Criteria:

* Immediate suicide risk, with intent or plan
* Cannot understand consent/visible cognitive impairment
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Due to undergo non-urgent percutaneous coronary intervention (PCI)
* Planned treatment with aspirin and clopidogrel

Exclusion Criteria:

* Recent acute coronary syndrome
* Patients at risk for, or with prior recent, bleeding
* Patients have received recent prior treatment with an anticoagulant
* Creatinine clearance \> 30 ml/min
Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.

Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.

There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.


Eligibility Criteria:
Inclusion Criteria:

- All participants who are administered venetoclax for treatment of AML.

Exclusion Criteria:

None
The Fish and Fruit Study: Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease

Cardiovascular disease is the main cause of death in patients on dialysis for end stage renal disease. Omega-3 fatty acids and antioxidants have been shown to be protective in the general population. A diet of fish and fruit, which will provide the fatty acids and the antioxidants is being tried in dialysis patients to assess the effect on cardiovascular disease in this high risk group.

End stage renal disease (ESRD) is a devastating disease which affects Aboriginal Australians disproportionately: The average survival time for Aboriginal people in the Northern Territory is 3.6 years from the onset of kidney failure, compared to 12.3 years for non-Aboriginal people. There has been a dramatic rise in incidence of kidney failure over the past 20 years, with the prevalence doubling every 4-5 years in many NT communities and other remote parts of Australia. Mortality for patients with ESRD is approximately 5 to 10 fold that of the general population, with heart disease accounting for approximately half of deaths.

The aims of this study are to determine whether a dietary intervention of fish and fruit three times a week will decrease cardiovascular and all-cause mortality in patients on haemodialysis in Darwin and Alice Springs . There is a strong scientific rationale for this simple dietary intervention. Fish are a rich source of omega-3 fatty acids, believed to reduce the risk of heart attack. Fruit is a good source of anti oxidants and other chemicals that may amplify the beneficial effects of fish. Participants are randomized to either control and intervention groups according to their regular days of dialysis. Nutritional and cardiovascular status will be measured at commencement of the study and then at intervals of 3, 6 and 12 months.

Strategies have been incorporated into the project design to ensure understanding, informed consent and participation of Aboriginal people in a number of domains: the participant, their family, urban and remote communities, and service providers. If successful this intervention will result in changes to the clinical management of renal patients worldwide.

Eligibility Criteria:
Inclusion Criteria:

* All patients on hemodialysis

Exclusion Criteria:

* Malignancy
Evaluation of Hysterotomy Site After Open Fetal Surgery

This study is to review how the uterus heals after having open fetal surgery. Open fetal surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery by cesarean section; rarely, the same area of your uterus was used for both open fetal surgery and delivery. From other studies of surgery performed on a uterus, some of the uterine scars do not heal well. This study's intervention uses sterile saline to spread open the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An ultrasound called a sonohysterogram is performed to take pictures of the uterus, its inside and the walls of the uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound and evaluated. This is performed at least 6 months after delivery.

Primary Outcome:

Measure the depth of the scar and location of the scar 6 months or longer after delivery.

This is an Investigator initiated, prospective study reviewing medical records and performing a sonohysterogram on non-pregnant women at 6 or more months after delivery of an infant who received open fetal repair.

An evaluation is completed at SSM Cardinal Glennon (CG), Fetal Care Institute (FCI) of a woman who has decided to have open fetal surgery to complete a fetal repair before the infant is born.

* After open fetal surgery participant will be monitored and delivered appropriately.
* After the infant is born investigators will review the mother's and infant's electronic health records and FCI database records
* 6 months or more after delivery of an infant who has received open fetal repair the participant will go to Saint Louis University (SLU) Care for a sonohysterogram to evaluate the healing process.

Eligibility Criteria:
Inclusion Criteria:

* SSM Cardinal Glennon Fetal Care Institute evaluation
* Received Open Fetal Surgery
* Open fetal surgery of myelomeningocele: maternal age of \>= 18 yrs. and \<=50 yrs.
* If a woman \< 18 years old presented with a fetal tumor requiring open fetal repair, this would be done if deemed ethically sound by both CG and St. Mary's Health Center (SMHC) ethics committees. Given this, then the patient may qualify for this study. This is a RARE event.
* Agree to travel to SSM St. Mary's in St. Louis for sonohysterogram 6 or more months after delivery.

Exclusion Criteria:

* Presently pregnant
* Hysterectomy after delivery
* Menopause
* Using IUD (Intrauterine Device) for birth control
* There is no exclusion criteria for infants
Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring

Objectives: We aimed to (1) develop a caring program for health promotion among women who experienced trauma and (2) evaluate its effect on post-traumatic stress, depression, health-promoting behaviors, and self-esteem.

Methods: We conducted a quasi-experimental study using a group pre-test/post-test design. Data were collected from 14 women recruited from a self-sufficiency support center for sexually exploited women who experienced trauma, during December 2019-May 2020. Participants were assessed at pre-test, post-test, and at a one-month follow-up. We analyzed changes in outcome variables over time using repeated-measures analysis of variance and paired t-tests.


Eligibility Criteria:
Inclusion Criteria:

1. women aged over 18 years who had experienced a traumatic event, and
2. a PTS score of 64 or lower on the PTSD checklist for DSM-5 (PCL-5) developed by Weathers et al. (1993), revised by Weathers et al. (2013), and translated into Korean by Kim et al. (2017).

Exclusion Criteria:

1. presence of psychiatric conditions with hallucinations and delusions, and
2. diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. Although a standard cut-off was not present in the PCL-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.
Immunosuppression Reduction in Failed Allograft Guided by cfDNA

The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.

Eligibility Criteria:
Inclusion Criteria:

* Failed allograft requiring dialysis
* No living donor available for re-transplant option or anticipated deceased donor within the next 12 months
* Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis

Exclusion Criteria:

* 17 years or younger
* cPRA at entrance of 100%
* Primary non-function of the allograft
* Multi-organ transplant
Multiple Ascending Dose Study of CM338 in Healthy Volunteers

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, aged ≥18 and ≤65 years.
* Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
* All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria:

* Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
* Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
* Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
* Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners.

PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.

OBJECTIVES:

* Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners.
* Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress.
* Compare the effect of IECT vs usual care on relationship intimacy in these participants.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high \[\< 21\] vs low \[≥ 21\]). Patients and their partners are randomized to 1 of 2 arms.

* Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
* Arm II: Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary prostate cancer

  * Advanced or recurrent disease
* Receiving concurrent hormonal therapy
* Married and/or co-habitating with a partner for ≥ 1 year
* T-score \> 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)

PATIENT CHARACTERISTICS:

* Normal cognitive functioning
* Able to speak and read English
* No significant hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Presbyopia in Breast Cancer Survivors

Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%.

The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%.

The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Eligibility Criteria:
Inclusion Criteria:

* ages 45-60
* ability to understand and provide written consent in English

Exclusion Criteria:

* blindness
* visual defects leading to accommodative failure
* severe myopia
* recurrent breast cancer
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and, for subjects under legal adult age, signed assent
* Age ≥ 9 years
* Clinical diagnosis of facial acne vulgaris defined as:

  * At least 20 inflammatory lesions, and
  * At least 20 non-inflammatory lesions, and
  * Investigator Global Assessment of 3 or greater

Exclusion Criteria:

* Active cystic acne or acne conglobata, acne fulminans, and secondary acne
* Two or more active nodulocystic lesions on the face
* Clinically significant abnormal laboratory or ECG result
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
* Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
* Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
* Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
* Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
* Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.

Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.

Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) \> V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)\<V(+) indicates tip directs to outflow tract.

The investigators hypothesis this monitoring will help precisely placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of temporary transvenous pacing

Exclusion Criteria:

* Not applicate to IC-ECG monitoring.
Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.

Pre-specified Subgroup Analysis

The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:

* Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).

  * Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).

    * Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.

      * Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR \<0.75, 0.75-0.80, and \>0.80).

        * Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have stenosis (\>30% by visual estimate) in all 3-epicardial coronary arteries.
* FFR should be measured at all 3-vessels at the end of a procedure.

Exclusion Criteria:

* Depressed left ventricular systolic function (ejection fraction \< 35%)
* ST-elevation myocardial infarction within 72 hours,
* Prior coronary artery bypass graft surgery
* Creatinine level \>= 2.0mg/dL or dependence on dialysis
* Abnormal final myocardial flow (TIMI flow \< 3)
* Planned bypass surgery
* Failed FFR measurement
* Failed intended revascularization
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.


Eligibility Criteria:
Inclusion Criteria:

* patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.

Exclusion Criteria:

* admitted patients
* Patients who suffer from peripheral artery disease.
* Patients with an acute deep vein thrombosis.
* s/p leg skin transplant
* Patients with an active leg infection
* Patients who aren't capable of operating the device.