cyrilzakka/clinical-trials huggingface dataset:
Wound Powder for Pressure Ulcers at End-of-life

This study will test a special powder for ulcers caused by a variety of conditions such as pressure that sometimes happen when a person is at the end of life. The powder will be applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who are being cared for by hospice or palliative care organizations will be invited to be in the study. The study will also find out if the powder is easy to use by caregivers as well as improving the comfort and quality of life of the person who has the ulcer.

Aim 1. In a comparative 2-group design, we will evaluate and compare the feasibility of the intervention through assessment in both settings (home-based and inpatient) on:

1. Adherence to RGN107 protocol by licensed care providers and/or family or other caregivers providing wound care; measures include implementation of procedures, frequency of dressing changes.
2. Reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.
3. Usability issues such as powder ability to stick to wound and ease of use of applying powder.

Aim 2. Estimate variability of outcome measurements and effect sizes and investigate the presence of a preliminary "signal" of clinical efficacy in two groups of hospice/home health/residential individuals receiving RGN107 in:

1. Physical wound symptoms outcomes, specifically pain, odor and exudate.
2. Quality of life of individuals receiving and caregivers using RGN107.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years or older
* Patient prognosis \> 1 month and \< 6 months
* Pressure wounds
* Pain or odor or exudate score \> 2 on VAS
* Wound caregiver able to perform required protocol activities

Exclusion Criteria:

* Known allergies to Turmeric, Mint, Sandalwood
* Using negative pressure wound therapy
* Currently using topical creams or ointments applied to wound bed (powder will not adhere to these products)
* Wound with eschar covering (powder will not stick)
Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa

Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.

Objective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.

Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.

Eligibility Criteria:
Patient Inclusion Criteria:

* diagnosis of anorexia nervosa (DSM-IV)
* aged 12 - 19 years
* female gender

Patient Exclusion Criteria:

- existence of a further disease with effect on body composition

Controls:

* no known disease
* normal weight
Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.

Healthy Adult subjects

The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 12 weeks. The subjects will attend two appointments in the clinic throughout the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 30 kg/m2
* Low, moderate, and high activity (self-identified) \*
* Self-identify as having fatigue, and abdominal issues (bloating, constipation etc.) \*
* Participants will be able to read, understand and sign an informed consent form (includes HIPAA and States requirements) and sign a photo release form.
* Participants are willing and able to follow all study directions, attend study visits as scheduled and must be willing to accept the restrictions of the study including but not limited to:
* Willing to refrain from introducing any new diets or dietary supplements for the duration of the study

Exclusion Criteria:

-
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya

This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial. The overall goal of this protocol is to determine whether risk stratification of PWLWH in conjunction with a tailored psychosocial support intervention can optimize health outcomes for the vulnerable women and infants. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties.

Among pregnant/postpartum women living with HIV (PWLWH) in low resource, high HIV prevalence settings, access to antiretroviral treatment (ART) has increased dramatically and mother-to-child transmission (MTCT) of HIV has decreased substantially, yet successful outcomes are not universal. Despite a 52% decline in new HIV infections among children under five from 2010-2019, recent UNAIDS data indicate global targets were missed by wide margins, with an estimated 160,000 new pediatric HIV infections annually. Sub-optimal retention of PWLWH is a major contributor to new pediatric infections. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties. As PMTCT programs in sub-Saharan Africa (SSA) aim for the elimination of MTCT in the context of decreased funding, there is need for research geared towards identifying and supporting the most vulnerable PWLWH with tailored interventions that can be implemented using available resources. This study aims to build on a previous study, Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE, R01HD080477), to develop and implement interventions that can promote proper taking of HIV drugs among PWLWH, namely a risk calculator to identify women at high risk for treatment failure and an adapted Problem Management Plus (PM+) intervention specifically geared towards women identified as high risk. Such interventions are critical in order to identify the most vulnerable PWLWH as early as possible to intervene with effective targeted interventions that will help improve maternal and child health outcomes.

Eligibility Criteria:
Inclusion criteria:

* Pregnant woman living with HIV attending an ANC clinic in Kisumu County, on/initiating ART
* At least 15 years of age
* At least 20 weeks estimated gestational age
* At moderate or critical risk of the combined outcome of treatment disengagement or viral failure according to the risk calculator
* Access to a cell phone (for those who share phones, have disclosed their HIV status to whomever individuals share the phone with.

Exclusion Criteria:

* Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders
* Less than 15 years of age
* Less than 20 weeks estimated gestational age or not currently pregnant
* Not HIV-infected at time of first ANC visit
Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.

Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.

Eligibility Criteria:
Inclusion Criteria:

1. patients with clinical diagnosis consistent with CD;
2. aged 16-75;
3. patients in remission (CDAI \< 150 and CRP \< 5mg/l, or Faecal calprotectin \< 50μg/g, or no ulcer under endoscopy);
4. patients with frequent disease recurrences (≥2) in the past years;
5. patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
6. those who have never experienced acupuncture;
7. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Shared Meditation Involving People With Cancer, Carers and Third Parties

Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.

This project is based on the hypothesis that there could be a benefit in meditating together.

The main aims of this randomised study are to improve well-being, strengthen links between carers, patients and third parties and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between carers and patients, and looking at oneself and others in a different way are experiences that aim to encourage exchanges and interactions between populations. For cancer patients (the target population), pain and other symptoms associated with the disease and its treatment will be better managed.

The pain experienced by carers, which is essentially linked to professional overwork and contact with illness, will be considered and managed through meditation, resulting in benefits for carers and their way of interacting with their patients.

The expected collective benefit is to develop and better live together our interdependence and humanity, by recognising suffering as a shared characteristic, despite our specific problems (as patients, carers or third parties).

The overall aim is to alleviate suffering, which is an integral part of the human experience, by cultivating our common humanity.

Eligibility Criteria:
Inclusion Criteria:

Criteria for all participants (patients, carers and third parties)

* Participant with no current or previous experience of regular or intensive meditation or comparable practice. Practice is considered regular and/or intensive if :
* it occurs more than one day a week for more than 6 consecutive months over the last 10 years,
* and/or more than 5 consecutive days of intensive practice (course or retreat) in the last 10 years,
* and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.

Patient-specific criteria (target population) - Cancer patients (regardless of location)

Specific criteria for carers

- All medical and/or paramedical care staff at the Centre François Baclesse in contact with patients (doctors, nurses, nursing assistants, radiotherapy technicians, etc.)

Specific criteria for third parties- Any volunteer not belonging to the two categories above

Exclusion Criteria:

* Participants with significant vulnerability factors such as alcohol or drug dependence, severe depression, severe social anxiety, recent bereavement, etc.)
* Participant unable to undergo trial monitoring for geographical, social or psychopathological reasons
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years
* Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
* With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
* WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
* Able and willing to give written informed consent for participation in the study

Exclusion Criteria:

Key contra indications:

* Hypersensitivity to the active substance or to any of the excipients.
* Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
* Severe coronary heart disease or unstable angina;
* Myocardial infarction within the last six months;
* Decompensated cardiac failure if not under close medical supervision;
* Severe arrhythmias;
* Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
* Pulmonary hypertension due to venous occlusive disease.
* Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.


Eligibility Criteria:
Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

1. Age ≥18 years
2. Leg/buttock pain with or without back pain
3. Failed nonoperative medical management
4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
6. Able and willing to give voluntary, written informed consent to participate in this clinical study

Exclusion Criteria

Candidates will be excluded from the evaluation if ANY of the following apply:

1. Back pain only
2. A diagnosis of central stenosis only
3. More than two levels requiring decompression
4. Fixed motor deficit
5. Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
7. Primary disc pathology and/or patients who will undergo a discectomy
8. Prior surgery of the lumbar spine at the level(s) of planned treatment
9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4)
10. Spondylolysis (pars fracture) at any level in the lumbar spine
11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25°
12. Symptomatic vascular claudication in the lower extremities
13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)
14. Evidence of active (systemic or local) infection at time of surgery
15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
16. Tumor in the spine or a malignant tumor except for basal cell carcinoma
17. Prisoner or transient
18. Recent history of known narcotic abuse
19. Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires
20. Involved in pending litigation of the spine or worker's compensation related to the back
21. Inability to communicate clearly in the English language
22. Morbid obesity (BMI \> 40)
23. Plans to relocate within the next 2 years
24. Pregnant or planning to become pregnant
25. Irreversible coagulopathy or bleeding disorder

    a. Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.
26. Subject unwilling to undergo blood transfusion, if necessary
Operative Versus Conservative Treatment of Scaphoid Fractures

The aim of this study is to compare the time to return to previous activity

level between operative treatment and non-operative cast immobilization of

patients with an acute complete fracture of the middle part of the scaphoid,

without any dislocation or comminution visible CT-scan.


Eligibility Criteria:
Inclusion Criteria:

* Mature skeleton
* Isolated, acute complete fracture of the mid third of the scaphoid

Exclusion Criteria:

* acute fractures of both hands
* one hand missing
* other injuries than scaphoid fractures
* rheumatoid, osteoarthritis or polyarthritis
* previous soft tissue injuries of the hand
* drug or alcohol abuse
* participant in trial during the previous month
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).

The non- Hodgkin lymphomas (NHL) represent a heterogeneous group of malignancies. Under the rubric of lymphoma exist some of the fastest growing cancers known to science, (Burkett's lymphoma, lymphoblastic lymphoma/leukemia), as well as some of the most indolent (small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma). This remarkable diversity of biology imposes significant challenges. Researchers are seeking to understand the cell of origin and differentiate what are sometimes subtle differences between the related sub-types of disease; and to identify the best treatments for these subtypes, with the ever-increasing likelihood that new understanding of the molecular pathogenesis of these diseases will result in an increase in new drugs for specific target populations.

Eligibility Criteria:
Inclusion Criteria:

Phase I: Patients must have histologically confirmed relapsed or refractory Non-Hodgkin's lymphoma, Hodgkin's Disease or multiple myeloma (defined by World Health Organization (WHO) criteria).

Phase II: Patients must have histologically confirmed relapsed or refractory T-Cell Lymphoma (as defined by WHO criteria).

* Must have received first line chemotherapy. No upper limit for the number of prior therapies
* Evaluable Disease
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Patients must have adequate organ and marrow function as defined in the protocol
* Adequate Contraception
* Ability to understand and the willingness to sign a written informed consent document
* Inclusion Criteria for Multiple Myeloma patients specified in the protocol

Exclusion Criteria:

* Prior Therapy

  * Exposure to chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
  * Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs
  * No other investigational agents are allowed
* Central nervous system metastases, including lymphomatous meningitis
* History of allergic reactions to Pralatrexate or Romidepsin
* Uncontrolled intercurrent illness
* Pregnant women
* Nursing women
* Current malignancy or history of a prior malignancy, as outlined in the protocol
* Patient known to be Human Immunodeficiency Virus (HIV)-positive
* Active Hepatitis A, Hepatitis B, or Hepatitis C infection
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone

The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening
3. Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and must not be breastfeeding
5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse
2. Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds
Empathy Levels Among Undergraduate Medical Students in Karachi, Pakistan - a Cross-sectional Study

Empathy is a concept native to the field of medicine. However, over the course of medical school, empathy levels are expected to decline. The aim of this study was to assess the empathy levels amongst medical students in relation to their year of study and specialties of choice in the future. A cross-sectional study was conducted to assess empathy levels among students from medical colleges in Karachi, Pakistan, using an online survey. The total duration of the study was two months. The authors analyzed the data using SPSS version 20. A total of 463 undergraduate medical students participated in this survey.


Eligibility Criteria:
Inclusion Criteria:

* undergraduate medical students

Exclusion Criteria:

* all the remaining population