cyrilzakka/clinical-trials huggingface dataset:
New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment

The present randomized, double blind, placebo-controlled trial aims at evaluating the efficacy of a tDCS treatment in improving the clinical outcome of adolescents with AN and investigate brain mechanisms acting in AN.

The investigators hypothesized that excitatory tDCS over the left PFC and inhibitory tDCS over the right PFC (anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in children and adolescents with AN, reducing their control over eating behaviors and improving the AN psychopathology. Furthermore, the investigators will employ TMS-EEG to directly explore the DLPFC activity of children and adolescent with AN, with specific attention to the differences between hemispheres. Moreover, paired pulse TMS and repetitive TMS protocols will be used to investigate the functional mechanisms within the prefrontal cortex of youth patients with AN. Then, the investigators will assess if potential changes of specific biomarkers, such as those related to the endogenous stress response system functioning, will occur after tDCS treatment and will correlate with clinical improvement.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition - DSM-5 (American Psychiatric Association \& American Psychiatric Association, 2013);
* condition of under-weight (BMI \<18.5 kg/m2);
* intelligence quotient higher or equal to 85 (IQ ≥ 85);
* ability to give informed consent under parents' surveillance and guidance

Exclusion Criteria:

* a personal history of neurological/medical/genetic diseases;
* a personal history of epilepsy;
* suicide risk;
* receiving CNS-active drug, other counseling or psychological therapies during the treatment.
Fitbit and Social Support in Knee Replacement Patients & Buddies

Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed among healthy populations. Knee replacement patients often expect their activity levels and function to improve following surgery, but the majority of patients' activity levels 5 years post-operatively did not meet their pre-operative expectations. Even though improvements are observed in pain and function, reasons for the maintenance of low levels of activity are unknown. Technology has the potential to increase physical activity levels in these patients, particularly as 81% of knee replacement patients in our recent study had a smartphone, and 40% were willing to wear a wrist-worn physical activity monitor. As the average age of knee replacement continues to decrease, we anticipate that the percent of patients with a smartphone and willingness to wear an activity monitor will increase. In addition to technology, social support is associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn physical activity monitor and providing additional opportunities for social support via the technology may increase physical activity levels in these patients. The current pilot study aims to gain preliminary data on the influence of wearables and social support on physical activity in knee replacement patients following surgery. Specifically, we aim to recruit 20 patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support. Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4 months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both the participant and "buddy" will be given a Fitbit and they will be asked to friend each other via Fitbit and wear the monitor for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Knee replacement patients must (1) have had a knee replacement in the last 12 months; (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4) willing to wear the Fitbit for 4 months, and (5) have a "buddy" willing to participate.
* Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be English speaking, and (3) willing to wear the Fitbit for 4 months.

Exclusion Criteria:

* Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.
COVID-19 in Home Healthcare

Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020.

Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* adult (\< 18 years) individuals and
* cared for in home healthcare in Östergötland county and
* positive COVID-19 diagnosis and
* diseased between March and September 2020

Exclusion Criteria:

* none
Talking Pictures Social Media Intervention in Reducing Depressive Symptoms and Improving Spiritual Well-Being and Quality of Life in Adolescent and Young Adult Cancer Patients

This clinical trial studies how well Talking Pictures social media intervention works in reducing depressive symptoms and improving spiritual well-being and quality of life in adolescent and young adult cancer patients. Talking Pictures social media intervention may help doctors better learn how to most effectively provide psychosocial support to adolescent and young adult cancer patients.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of a 10-week application (app)-based intervention.

II. To assess the impact of the intervention on depressive symptoms, spiritual well-being and quality of life.

III. To examine the content of participants recorded narratives for salient themes related to weekly content areas (e.g. identity, meaning-making, hopes, fears) in order to better understand the unique experiences and challenges of adolescent and young adult (AYA) patients.

OUTLINE:

Participants undergo Talking Pictures social media intervention for 10 weeks, receiving weekly assignments via email with requirements to use the Pixstori app to take and upload photographs with verbal narratives attached to a website. Participants can then share their pixstories to a group page and view and respond to others' pixstories.

After completion of study, participants are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent and young adult cancer patients who were diagnosed within three years
* English comprehension in written and oral format
* Current possession of a smartphone, tablet, or computer with camera and wifi capacity or data plan
* Valid email address
* Pregnant women will be included if they meet eligibility requirements

Exclusion Criteria:

* Diagnosis of mental retardation, severe or untreated psychopathology (e.g. schizophrenia), or dementia
* Adults unable to consent: Will not include
* Prisoners will not be included given lack of access to smartphone
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
* Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
* ECOG performance status score either 0 or 1
* Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of:

* Platelet count \< 50,000/µL
* AST or ALT \> 2 x the upper limit of normal (ULN)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/dL

and

* Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
* Uncontrolled hypertension
* Known history of porphyria, G6PD deficiency, HIV
Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure

This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.

Hypoxic respiratory failure is responsible for 1.9 million patient admissions per year in the United States alone, and the hospital mortality rate is as high as 20%. This rate is also increasing in Turkey. The most common causes include pneumonia, cardiogenic pulmonary edema, ARDS, and chronic obstructive pulmonary disease (COPD). Fast hugs is important in affecting the prognosis of patients with hypoxic respiratory failure in special clinics such as the Chest Diseases Intensive Care Unit. Therefore, new studies are needed. This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Being in the Chest Intensive Care Unit
* Having Hypoxic Respiratory Failure

Exclusion Criteria:

* Death during hospitalization
The Cognitive and Cardiovascular Health in the Elderly Study

The main objective of this study is to look for the interest forecast of the IPS as infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.


Eligibility Criteria:
Inclusion Criteria:

* free-living community-dwelling men and women aged ≥ 70 years,
* subjects free of clinical CVD related to atherosclerosis
* preserved basic activities of daily living (ADL = 6)
* without cognitive impairment (MMSE≥24)

Exclusion Criteria:

* subjects with clinical history of any of the following CVD diseases : coronary artery disease (angina, myocardial infarction, coronary revascularization), cerebrovascular disease (stroke, TIA, carotid revascularization), clinical peripheral artery disease (claudication, critical limb ischemia)
* subjects with neurodegenerative, locomotor and ophtalmological diseases unable to perform the cognitive tests
* subjects unable to give written informed consent.
Exercise is Medicine: a Pilot Study

Background: Regular exercise is beneficial to patients with hypertension and/or diabetes mellitus. However, most patients cannot maintain exercise habit. The investigators had developed a program called the "exercise is medicine"(EIM), combining motivational technique, information technology use and teaching exercise techniques. Before using this intervention in a main randomized controlled trial, the investigators would like to test its feasibility and acceptability. It is hypothesized that this program is feasible and acceptable to patients.

Method: 40 patients with HT and/or DM will be recruited to attend the EIM intervention. Primary outcomes will be the rate of recruitment and rate of retention. Other clinical outcomes will be obtained before and immediately after the 12-week program.


Eligibility Criteria:
Inclusion Criteria:

* clinic systolic BP(SBP) higher than 130mmHg (for HT class) because the Hong Kong primary care office guideline, as of Jan 2019, regarded good control of SBP to be ≤130mmHg, OR HbA1c \>7% (for DM class)
* self-reported regular exercise of ≤3 times per week - this cut-off is arbitrary but people who exercise more than 3 times may have little space for improvement; and these patients will unlikely be referred to EIM when it is implemented in routine clinical practice, - who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)

Exclusion Criteria:

* patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months) are excluded because there are other evidence-proven and well-structured programmes for these patients in the Hospital Authority (HA), for instance, pulmonary rehabilitation program conducted by physiotherapy and/or occupational therapist in HA. - - acute myocardial infarction in last 6 months
* ongoing angina
* uncontrolled cardiac arrhythmia
* acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
* known aortic stenosis
* known heart failure
* known obstructive left main coronary artery stenosis
* uncontrolled ventricular rates
* complete heart block
* known hypertrophic obstructive cardiomyopathy
* mental impairment that limit co-operation
* resting blood pressure with systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg
* known anaemia with haemoglobin level less than 11gm/dL
* known uncorrected electrolyte imbalance
* known uncontrolled hyperthyroidism.
* For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months) are also excluded due to reports that vigorous exercise may increase blood pressure and led to retinal bleeding in these patients
AcQBlate Force Confirmatory Study for Atrial Arrhythmias

AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)

Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent atrial arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 to 80 years at time of consent.
* Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or PerAF
* Willing and able to provide written informed consent to to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

Exclusion Criteria:

* In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis
* Continuous AF \> 12-months (long-standing persistent AF)
* Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
* An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
* Structural heart disease or cardiac history as described below:
* Left ventricular ejection fraction (LVEF) \< 35% based on transthoracic echocardiogram (TTE) within the previous 180-days.
* Left atrial size \> 55 mm based on TTE within the previous 180-days.
* Evidence of heart failure (NYHA Class III or IV).
* Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
* Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
* Coronary artery bypass graft (CABG) or coronary angioplasty (PTCA) procedure within the last 90-days.
* Unstable angina or ongoing myocardial ischemia.
* Severe uncontrolled systemic hypertension (systolic pressure \> 240 mm Hg, diastolic pressure \> 140 mm Hg recorded within the last 30-days.
* Moderate or severe tricuspid stenosis or regurgitation.
* Moderate or severe mitral stenosis or regurgitation.
* Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
* Presence of a left atrial appendage occlusion device.
* Previous PV stenting or evidence of PV stenosis
* Body Mass Index (BMI) \>40 kg/m2
* History of blood clotting or bleeding disease.
* Any prior history of documented cerebral infarct or systemic embolism (excluding post- operative deep vein thrombosis (DVT)).
* Pregnant or lactating (current or anticipated during study follow up).
* Current enrollment in any other study protocol where testing or results from the study may interfere with the procedure or outcome measurements for this study.
* Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center)
Prolonged Laryngeal Mask Airway ProSealTM Use

The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 3
* Age 19-85 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HR+/HER2- status after MBC diagnosis.
* Received palbociclib + AI or AI as first-line therapy

Exclusion Criteria:

* Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC
* First structured activity greater than 90 days after MBC diagnostic date
* Treatment with a CDK4/6 inhibitor as part of a clinical trial
Bortezomib in Intrahepatic Cholangiocellular Carcinoma

This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.

There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients.

Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.

So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
2. Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;
3. The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;
6. Normal liver,kidney and bone marrow function；
7. Subjects who understand and voluntarily signed a written informed consent form.

Exclusion Criteria:

1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis
2. There is any contraindication to use Bortezomib
3. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
4. A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
5. Pregnant or lactating women.
6. History of radiation within 4 weeks prior to enrollment.
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.


Eligibility Criteria:
Inclusion Criteria:

* Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
* At least 1 measurable lesion as defined by RECIST v1.1 per local review;
* Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
* Ability to provide scans for central imaging review

Exclusion Criteria:

* Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
* Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;