cyrilzakka/clinical-trials huggingface dataset:
Metacognitive Intervention for Individuals With Severe Mental Disorders

The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia

The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to:

1. Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
2. Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group.
3. Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of schizophrenia by a licensed psychiatrist
* Fluency in Hebrew
* t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version

Exclusion Criteria:

* Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
* Used drugs or alcohol
HMP for Addictions Study

The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.

Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.

This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.

Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.

Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years of age
* English-speaking
* Veterans
* Ability to understand and willingness to sign a written informed consent document
* Have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice
* Ability and willingness to attend all 6 session of the study, and to complete all assessment questionnaires
* Verified Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria
* On buprenorphine maintenance treatment for Opioid use disorder (OUD) for a minimum of 3 months

Exclusion Criteria:

* Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
* Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
* Previous use of Healthy Minds Program app
* Current suicidal intent and/or high self-injury risk, as determined from the interview
* Current psychopathology that interferes with study participation as assessed by interview
STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Eligibility Criteria:
Inclusion Criteria:

* M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
* ECOG performance status of greater than or equal to 2
* Measurable disease per RECIST criteria
* Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
* At least 4 weeks have passed since last chemotherapy or immunotherapy
* At least 2 weeks have passed since last radiotherapy.
* Life expectancy of greater than 12 weeks
* Clinical lab values within protocol parameters

Exclusion Criteria:

* Female patients pregnant or lactating
* Female patients of childbearing potential not using or not willing to use effective contraception
* Presence of a second malignancy other than nonmelanoma skin cancer
* Presence of a clinically significant and uncontrolled infection
* Presence of clinically significant arrythmias
* Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
* History of severe hypersensitivity reactions to taxanes
* Use of any investigational agents within 4 weeks prior to the first dose of study drug
Barriers to Therapeutic Exercise in Breast Cancer Patients Before, During, and After Chemotherapy

Cancer is one of the leading causes of mortality. First-choice cancer treatments, such as chemotherapy, have increased the survival of people with cancer, although they are not without adverse effects such as cardiotoxicity, fatigue, nausea, mental health problems or musculoskeletal disorders.

Therapeutic exercise is a safe and effective intervention that has shown positive results in the oncology population when implemented as an adjuvant to chemotherapy, during or after chemotherapy. Exercise improves cardiorespiratory capacity, fatigue, strength, anxiety, depressive symptoms and quality of life, among others, in cancer patients.

In the implementation of therapeutic exercise in the oncologic population undergoing chemotherapy treatment, it is necessary to take into account possible barriers related to the perception of therapeutic exercise, as well as the side effects derived from chemotherapy. It is necessary to know the barriers to the implementation of exercise in order to address them and favor patients' adherence to exercise programs.

The objective is to identify the barriers (physical, contextual and emotional) that may influence people with breast cancer who are in the pre-, concurrent or post-treatment phase, respectively, of chemotherapy treatment for the implementation of therapeutic exercise.

The study participants (n=111) will be distributed in the study groups according to the moment of chemotherapy treatment they are in (1: pre-chemotherapy, 2: during chemotherapy, 3: post-chemotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age with a diagnosis of breast cancer, stages I to IIIa.
* The sample will be distributed to three groups according to the time of treatment in which the patients are: a) patients diagnosed with breast cancer scheduled to start chemotherapy treatment, b) patients who at the time of the study are receiving chemotherapy and c) patients who have completed chemotherapy treatment 6 months ago or more.

Exclusion Criteria:

* Women with breast cancer relapse and/or other types of cancer.
* Patients who are receiving hormonal therapy at the time of evaluation.
* Patients presenting metastatic processes or any other relevant disease.
Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;
* Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;
* Availability and willingness to participate, given the schedule of the study;
* Agreement and signing the written form.

Exclusion Criteria:

* Acute systemic infections
* Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;
* Valvulopathies with hemodynamic consequences;
* Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;
* Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;
* Pregnancy (confirmed by examination of β HCG) or lactation;
* Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.
A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

This Phase Ia/Ib, open-label, multicenter study will evaluate the safety, tolerability, and preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in participants with previously untreated AML who are not eligible for intensive induction chemotherapy. Each arm will consist of two stages: a dose-escalation stage and an expansion stage. The dose-escalation stage is designed to establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for DCLL9718S alone (Arm A) or in combination with azacitidine (Arm B). The dose-expansion stage is designed to characterize the long-term safety and tolerability of DCLL9718S.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML per World Health Organization (WHO) criteria (except acute promyelocytic leukemia)
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Adequate end-organ function
* Willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment

Specifically for participants in Arm A:

* Age greater than or equal to (\>/=) 18 years
* Relapsed or refractory acute myeloid leukemia
* Participants cannot have received more than two prior regimens

Specifically for participants in Arm B:

* Treatment-naive participants with AML who are \>/=75 years old
* Treatment-naive participants unfit for induction chemotherapy for AML due to comorbidities who are \>/=65 years old

Exclusion Criteria:

* Diagnosis of acute promyelocytc leukemia
* Prior allogeneic stem cell transplant or solid organ transplant
* Active central nervous system (CNS) involvement by leukemia
* History of idiopathic pulmonary fibrosis, organizing pneumonitis (for example \[e.g.\], bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis
* Treatment with investigational therapy within 14 days prior to Cycle 1, Day 1
* Treatment with a monoclonal antibody within 30 days prior to Cycle 1, Day 1
* Positive for hepatitis C virus (HCV) antibody at screening
* Active hepatitis B virus (HBV) infection
* Known positivity for human immunodeficiency virus (HIV)
* History of other malignancy within 2 years prior to screening
* Family history of long QT syndrome, with a QTc interval greater than (\>) 480 millisecond (msec) at screening, or taking concurrent medications known to prolong QT/QTc interval
The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.

To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).


Eligibility Criteria:
Inclusion Criteria:

The diagnosed full thickness macular hole and psuedophakia.

Exclusion Criteria:

macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.
Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Evaluation of the efficacy and safety of Mecapegfilgrastim for the prevention of neutropenia and radiation esophagitis after hyperfractionation in patients with limited-stage small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with limited small cell lung cancer diagnosed by histopathology;
* ECOG 0-1 points;
* Weight ≥ 45 kg;
* Age 18-75 years old;
* It is expected that at least 2 cycles of EP chemotherapy will be completed as planned; once thiophene penicillin is used, chemotherapy should not be re-dosed within 12 days.
* Bone marrow hematopoietic function is normal, no bleeding tendency (INR\<1.5);
* Laboratory tests are subject to: (1) Blood routine examination: Hb≥90g/L; WBC≥4.0×109/ L; ANC≥2.0×109/L; PLT≥100×109/L. (2) Liver function, biochemical examination: ALT and AST≤1.5×ULN; TBIL≤1.5×ULN; Serum creatinine≤1.5×ULN.
* According to the researcher's judgment, the test plan can be observed;
* Volunteer to participate in this clinical trial, understand the research process and be able to sign informed consent in writing.

Exclusion Criteria:

* There are currently uncontrolled infections or systemic antibiotics within 72 hours of receiving chemotherapy;
* Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction;
* Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months;
* Patients with previous malignant tumors that have not been cured or have brain metastases;
* Liver function tests Total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are \>2.5 times the upper limit of normal; if due to liver metastasis, the above indicators are \>5 times the upper limit of normal;
* Renal function test: serum creatinine (Cr) \> 1.5 times the upper limit of normal;
* Those who are allergic to this product;
* suffering from mental or neurological disorders that cannot be matched;
* Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception;
* The investigator believes that it is not suitable for inclusion.
Effectiveness and Safety of High Frequency Electrotherapy in Patients With Meibomian Gland Dysfunction

This study is a prospective randomized double-masked sham-controlled clinical trial to determine the clinical improvement, safety and mechanism of action by evaluation inflammatory cytokine, and amount of bacteria and demodex, after high frequency electrotherapy or called quantum molecular resonance treatment in patients with meibomian gland dysfunction.

The Rexon-eye is quantum molecular resonance device which was published in previous study that could treat meibomian gland dysfunction. Participants in this study will have Rexon-eye treatment at baseline (after recording of baseline characteristics and giving and inform consent), day 7, day 14, day 21. The evaluation for most parameter except for safety parameter will be recorded at baseline, 1 month after last treatment, and 2 mont after last treatment. Safety parameter will be recorded in all 4 follow-ups. During study, all participant will instructed to use same artificial tears for four time a day.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand and sign an informed consent form
2. \> 18years of age
3. Able and willing to comply with the treatment/follow-up schedule and requirements
4. Presence of meibomian gland on each lower eyelid's meibography
5. Current diagnosis of stage 1-4 of MGD in both eyes, according to the International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction

Exclusion Criteria:

1. Contact lens wearer within the past 1 month and throughout the study
2. Recent ocular surgery or eyelid surgery within the past 6 months
3. Neuro-paralysis in the planned treatment area within the past 6 months
4. Current use of punctal plugs
5. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
6. Uncontrolled infections or uncontrolled immunosuppressive diseases
7. Subjects who have undergone refractive surgery within the past 6 months
8. Patients who had ocular infection within 6 months
9. Pregnancy and lactation
10. Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
11. Declared legally blind in one eye
12. Lipiflow treatment, or any equivalent treatments, within the past 12 months
Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 75 years old
* Gender: Male or female
* Status: Outpatients
* Mild to moderate essential hypertension

Exclusion Criteria:

* Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
* Patients with msSBP \>==180 mmHg and/or msDBP \>=110 mmHg at Visit 1, 2 or 3
* Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
* Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.

The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.

This protocol is therefore a feasibility study for the collection of data of interest.


Eligibility Criteria:
Inclusion Criteria:

* Woman undergoing microsurgical breast reconstruction using a free abdominal flap
* Age greater than or equal to 18 years

Exclusion Criteria:

* Pregnant patient
* Patient with an active implantable device such as a pacemaker or an artificial heart
* Patient refusing to participate in the study
* Age less than 18 years old
Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty

1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
3. This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.

1. participants

   1. eligible participants are randomly assigned to systemic strategy or selective strategy

      * participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test
      * subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia
   2. participants who are not willing to be randomized will be included in the registration group
2. revascularization

   1. a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed
   2. the duration from revascularization to PTA should be within 60 days
   3. percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
3. blood sampling, genotyping, and measurement of biomarkers and microRNA

   a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells
4. outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter

Eligibility Criteria:
Inclusion Criteria:

* Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA

Exclusion Criteria:

* Known CAD or unstable angina within past 3 months
* Acute myocardial infarction within past 6 months
* Known CAD status posterior percutaneous coronary intervention or bypass surgery within past 6 months
* Planning to do bypass surgery for known LEAD\\
* Pregnancy
* Documented active malignancy
* Needing emergency PTA
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
2. Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
3. Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility
2. The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
4. Documented life expectancy of less than 12 months.