cyrilzakka/clinical-trials huggingface dataset:
Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.


Eligibility Criteria:
Inclusion Criteria:

* Individual who is a Canadian military member, veteran, or first responder with clinically significant levels of PTSD symptoms
* Must be willing to be audio-recorded for coaching sessions
* Intimate partner willing to participant and complete intervention modules together
* Access to high speed internet

Exclusion Criteria:

* Elevated suicide risk
* Severe physical aggression between partners in the past year
* Clinically significant PTSD symptoms in both members of the dyad
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of \< 20% bone marrow blasts per marrow biopsy/aspirate at screening.
* Participants must meet the following disease activity criteria:

  * Overall Revised International Prognostic Scoring System (IPSS-R) score \> 3 (intermediate, high or very high).
  * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2.
  * Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.

Exclusion Criteria:

* Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
* Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.


Eligibility Criteria:
Inclusion Criteria:

* Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington

Exclusion Criteria:

* Under 18 years old
* Non-English speaking, nonverbal, or extremely hard of hearing
Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)

We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention (during pregnancy) and postpartum.

The purpose of this study is to explore MAD as an alternative treatment option for OSA in pregnant women. We are recruiting a small number of 10 healthy pregnant women with uncomplicated OSA (absence of significant cardiovascular, metabolic or neurocognitive consequences) who, after being offered CPAP as the recommended standard treatment, prefer to use a MAD over CPAP. All patients are recruited from a single center. We would like to get a first impression on the comfort level of these women with the MAD and their self-reported compliance and any improvement of symptoms with treatment. Additionally, we would like to test efficacy in controlling OSA with pregnancy progression. Finally, we would like to derive overall treatment effectiveness of the MAD in pregnant women as defined as a combination of efficacy and compliance.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy, gestational week 14-20.
2. Age ≥ 18, English-speaking.
3. Reliable internet access (questionnaires/surveys)
4. Untreated mild to mild-moderate OSA defined as AHI between 5-20 events/hour on the most recent home sleep study
5. No significant hypoxemia on the initial sleep study defined as SaO2 nadir ≥70% and SaO2 equal or less than 30 minutes ≥88%
6. The sleep study must have been a home sleep test that uses Peripheral Arterial Tone signal for evaluation of apneic events. The home sleep test has to be a WatchPAT device (WatchPAT® Home Sleep Study Device \| Itamar Medical Ltd.).
7. No significant confounding comorbidities including restless leg symptoms and circadian disorders (shift work)
8. BMI less or equal to 40 and neck size less or equal to 40 cm
9. Good oral health with manual dexterity and at least 8 tooth per arch

Exclusion Criteria:

1. High risk pregnancy (age \>40y, superimposed preeclampsia, pre-existing cardiac disease, severe organ dysfunction such as liver or renal failure, any condition that requires anticoagulation), and any condition Dr. Pitts or Dr Smith deem serious risk to mother/fetus. Well controlled chronic hypertension and diabetes are allowed and will not be excluded.
2. Dental exclusion criteria: Complete edentulous arch, ongoing oral rehabilitation, uncontrolled periodontal disease, ongoing orthodontic treatment or completed treatment in a period less than 5 years, temporomandibular dysfunction (active acute pain or limitations on mandibula movements of any kind), prior oropharyngeal surgery, maximum protrusion less 5 mm
3. Significant acute health problems that are unrelated to pregnancy or dental diseases including unstable psychiatric disease
4. Non-English speaking
5. Unable to provide informed consent
Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (\> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.

Patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

- Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)

Exclusion Criteria:

* Age \<18 years
* Symptoms \>42 days
* Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial Vein Thrombosis started.
* Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).
* Planned treatment of Superficial Vein Thrombosis with a course of anticoagulant therapy.
* Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, Pulmonary Embolism, atrial fibrillation).
* Judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed varicose veins.
* proximal Deep Vein Thrombosis or Pulmonary Embolism within the past 12 months.
* Superficial Vein Thrombosis associated with sclerotherapy or an intravenous canula.
* A high risk of bleeding as evidenced by any of the following:

  1. Active bleeding
  2. Bleeding within the past 30 days due to a cause that has not fully resolved.
  3. Known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/L.
  4. History of ever having had spontaneous intracranial bleeding, or any intracranial bleeding within the past 3 months.
  5. Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).
* Elevated creatinine level is suspected and creatinine clearance has not been estimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.
* Clinically relevant hepatic disease (including Child-Pugh B and C) is known or suspected (example., associated with: International Normalized Ratio \>1.7; total bilirubin \>2 upper limit of normal; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>3 times upper limit of normal).
* Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole), Human Immunodeficiency Virus (HIV) -protease inhibitors, or strong Cytochrome P450 3A4 (CYP3A4) inducers due to the potential interaction with rivaroxaban.
* Pregnant or lactating women, or at risk of becoming pregnant.
* Life expectancy less than 90 days
* Patient is unwilling or unable to comply with the protocol (example. unable to attend follow-up visits because of geographic inaccessibility).
* Participating in a competing clinical investigation and receiving any other investigational agent(s).
Promoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology

The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. The PROSPECT framework is based upon a validated structured, team-work training model and novel web-based technology. The overarching goals of this project are to achieve the following:

1. Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
2. Minimize preventable harms in two environments: intensive care and acute care oncology units.
3. Reduce unnecessary healthcare resource utilization and associated costs.

This overarching project aims are to refine, implement, and evaluate a multi-faceted intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the project are as follows:

* Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect, dignity, and satisfaction of patients, care partners and staff on intensive care and oncology units.
* Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised of an electronic bedside communication center (eBCC) and a patient-centered microblog, to promote tailored patient and care-partner education, communication, collaboration, and engagement.
* Aim 3: To evaluate the relative impact of this intervention compared to usual care on patient reported outcome measures, adverse events (harms), post-discharge healthcare utilization, concordance in understanding the care plan, and satisfaction among care team members (patients/care partners, profession providers).
* Aim 4: To identify the barriers and facilitators of implementing this intervention to support dissemination.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Any patient admitted or transferred to designated care units
* Admitted or transferred to a MICU or Oncology service
* On the designated unit for at least 24 hours

Exclusion Criteria:

* Age \< 18
* Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service
PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function

The aim of this clinical trial is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following coronary artery bypass graft surgery or other coronary reperfusion.

This clinical trial is a pilot study, on patients with central sleep apneas syndrome and heart failure, undergoing coronary artery bypass graft surgery or other coronary reperfusion, and then randomized for the adaptive servo-ventilation treatment application or not after surgery.

The first objective is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient, in terms of ventricular recovery (ejection fraction improvement). This treatment will be instaurated just after coronary artery bypass graft surgery or other coronary reperfusion.

Secondary objectives :

* Assessment of adaptive servo-ventilation effect on the endothelial function, the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with non treated patient with heart failure and central sleep apneas.
* Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft surgery.
* Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue collected during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass graft surgery or other coronary reperfusion
* heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%\< LVEF ≤ 50% in 2D) or in 3D
* Patient with central sleep apneas syndrome (SAS)

Exclusion Criteria:

* Aortic or mitral valvular surgery
* Patient already treated for a central SAS
* Patient with an obstructive SAS
* Patient with malignant evolutive pathology
* Pregnant or lactating women
Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP

This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70, or older if specified by law
* Non-specific chronic lower back pain defined as:

  1. Having lasted ≥3 months in duration
  2. Current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale)
  3. No radiating pain below the knee
  4. ≥75% back or buttock pain rather than lower extremity pain
* Subjects who are willing and capable of providing informed consent
* Subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study

Exclusion Criteria:

* Any prior home use of the NexWave or any TENS/IFC device
* Any history of lumbar spine surgery or spinal fractures
* Subjects with a history of rheumatic disease
* Subjects with spine disorders, deformities, or severe spinal conditions such as scoliosis and kyphosis, Pott's disease, disc protrusion, or others that can be attributed to specific causes of back pain
* Subjects currently prescribed and adherent to opioid therapy
* Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices
* Active psychiatric or uncontrolled mood disorders including subjects on antipsychotic medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or clinical depression
* Subjects with a known history of allergic reactions to medical adhesives or any condition that could affect placement of the electrodes
* Women of childbearing potential who are pregnant or who are planning to become pregnant during the anticipated study period
* Subjects with health conditions that in the Investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation
* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study
Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by mothers, and parental consent on behalf of their infants
* Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
* Stated intention to remain in the clinic catchment area ≥6 months post-partum
* Singleton birth

Exclusion Criteria:

* None
Renin Angiotensin System - CoronaVirus

The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%.

We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later).

This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.


Eligibility Criteria:
Inclusion Criteria:

* Positive COVID 19 patients hospitalized in conventionnal hospitalisation
* Patients hospitalized in intensive care secondary to COVID-19 : Patient under invasive mechanical ventilation (PaO2 / FiO2 ratio \<300; PEEP\> = 5 cmH20; PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample; PaO2 / FiO2 ratio\> 300)

Exclusion Criteria:

* Minor patient
* Patient deprived of liberty
* Patient's refusal to participate in the study
* Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient stem cell mobilization in children with malignancies

Design: phase 2 study.

Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.

Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)

Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording

Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Analysis: sequential Bayesian study

Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years
* solid malignancy
* Lansky score \>70%
* more than 17 days since the beginning of the last chemotherapy cycle
* absolute neutrophil count (ANC) greater than 1×109/l
* no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

* clinical or biological conditions precluding the mobilization or collection procedure