cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-Based Cognitive Therapy for Suicide Prevention

The purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans.

Every month the VA becomes aware of approximately 1,100 Veterans in VA care who attempt suicide. While the VA has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. Primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, Mindfulness-Based Cognitive Therapy (MBCT), for Veterans on the VA's High Risk for Suicide List. The investigators' adapted version of MBCT for suicide (MBCT-S) integrates mindfulness meditation techniques with the VA Safety Plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. This study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal Veterans for whom evidence-based therapies are severely limited.

Eligibility Criteria:
Inclusion Criteria:

The following criteria were formulated to recruit a sample at high risk for suicide behavior.

* The subject has experienced a suicidal event during the past 30 days. A suicidal event involves

  * 1) psychiatric hospitalization due to suicidal risk,
  * 2) psychiatric hospitalization if subject was already on the High Risk for Suicide List,
  * 3) suicidal ideation with suicidal intent,
  * 4) suicidal preparatory behaviors, or
  * 5) actual, interrupted, or aborted suicide attempt.

AND

* The subject is on or will be placed on the VA High Risk for Suicide List

  * OR The subject had an actual, interrupted, or aborted attempt in the last year
  * OR In the study clinician's opinion (i.e., Masters or Doctoral level study personnel with formal mental health training) in consultation with the PI, the suicidal event is significant enough to warrant treatment to reduce suicidal risk.

Exclusion Criteria:

* cognitive deficits that decrease the likelihood of benefit from MBCT-S
* severe symptoms of hallucinations or delusions
* disorganized or disruptive behaviors
* medically unstable
* current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months
The GLOW Study - The YANG System

This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. In addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.


Eligibility Criteria:
Inclusion Criteria:

T1DM patients

* Subjects willing to sign an informed consent form (ICF),
* Adult subjects, age ≥ 18, ≤ 50 years old
* Body Mass Index (BMI) 20≥, ≤ 27.5 \[kg/m2\]
* Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
* Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening
* Subjects being on insulin pump for at least 12 months

Healthy Volunteers

* Subjects willing to sign an informed consent form (ICF),
* Adult subjects, age ≥ 18, ≤ 50 years old
* BMI 20≥, ≤ 27.5
* Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
* Healthy subjects, as self-declared and confirmed by screening assessments and Principal Investigator's judgment

Exclusion Criteria:

* Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid)
* For people with diabetes: History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
* For people with diabetes: History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
* Any blood disorder identified by haematocrit \<30% or \>55%
* History of hepatitis B, hepatitis C, or HIV
* A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration
* Female subjects who are pregnant, planning on becoming pregnant or nursing
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
* Any long-term drug treatments other than insulin, such as statins, low-dose aspirin, fibrates etc.
* The presence of any other active implanted device except for insulin pumps (as defined further in protocol)
* The presence of any other CGM sensor or transmitter located in abdomen (other location is acceptable)
* Impaired fasting glucose or impaired glucose tolerance (for healthy volunteers)
* Any contraindication to the use of the Yang system as listed in the device IFU (i.e. any known allergy to PDMS)
Expand Your Horizon: An Online Writing Intervention for Women

The purpose of this research study is to test a new writing-based intervention that helps young adult women increase their body acceptance and fosters creativity.

In this study, participants will be asked to do the following things:

1. Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
2. \~1-hour long online surveys immediately after the program (1 week), and 1 week after the program. Questions will ask about eating behaviors and attitudes, body image, feelings of weight stigma, and mental health.
3. Be contacted through email to remind participants to complete the writing assignments/survey

Eligibility Criteria:
Inclusion Criteria:

* women ages 18 to 25 years
* enrolled in postsecondary education at VCU
* endorse some degree of WBI (as measured by the WBI-M) or body image concerns

Exclusion Criteria:

* men
* pregnant women
Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

The purpose of this research study is to understand the effect of nutritional ketosis on CNS oxygen toxicity in undersea divers. The investigators hope this will provide a starting point to develop methods for improving the safety of Navy divers, warfighters and submariners.

Participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. Eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. Subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. All tests and procedures will be completed again at least one week later with the diet not assigned for the first session.

Eligibility Criteria:
Inclusion Criteria:

* Males \& females between 18 and 50 years old
* Able to pedal a bicycle ergometer continuously for 15 minutes
* Non-smoker
* No history of cardiovascular disease, including coronary artery disease, valvular disease, cardiomyopathy or hypertension.
* No history of lung disease

Exclusion Criteria:

* Prolonged QTc on initial ECG
* Currently pregnant or attempting to become pregnant.
* Have a history of:

  1. Smoking
  2. Coronary artery disease
  3. Hypertension
  4. Seizures
  5. Exercise intolerance
  6. Psychiatric disorder
  7. Previous pneumothorax or pneumomediastinum
  8. Hypo or hyperglycemia
  9. Diabetes
* Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.
Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing

Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%.

The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.


Eligibility Criteria:
Inclusion Criteria:

* Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology.
* Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair.

Exclusion Criteria:

* Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).


Eligibility Criteria:
Inclusion Criteria:

* Male/Female children aged 5-11 years
* Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
* children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
* Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.

  6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

Exclusion Criteria:

* Past or present diagnoses of cardiovascular, renal or liver disease
* Known hypersensitivity to the active treatments
* Exacerbation of asthma symptoms within the previous 4 weeks
* Inability to perform the required breathing technique and blood sampling
* Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
* Lower respiratory tract infection within 1 month prior to inclusion
* Disease (other than asthma) which might influence the outcome of the study
* Obesity, i.e. \> 97% weight percentile by local standards
Perinatal Attentional Retraining Intervention for Smoking for Minority Women

The proposed research intends to randomize 50 abstinent pregnant Black or Hispanic smokers to receive either the attentional retraining (AR) or control VP task. Participants will be asked to carry around a smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy (Phase 1).

The smartphone will sound an alert randomly during the day, at which time participants will be asked to respond to a short set of questions assessing subjective states; this will be followed by a request to complete the AR (or control) procedures. This same procedure will be repeated for 2 weeks immediately after delivery (Phase 2).

Women will undergo a follow-up visit 3 months after the end of Phase 2, and complete an unmodified VP and follow-up assessments.

There are 2 specific aims that this study intends to address.

Specific Aim 1: To examine whether AR delivered on a smartphone can modify attentional bias to smoking-related stimuli and craving for tobacco cigarettes.

Specific Aim 2: To examine whether AR delivered on a smartphone can modify attentional bias to stress-related stimuli and reduce perceived stress.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of smoking 5+ cigarettes per day that have achieved abstinence during pregnancy by 32 weeks gestation.
* The ability to speak and write English.
* An Edinburgh Postnatal Depression Scale (EPDS) score \<10.

Exclusion Criteria:

* Current substance abuse (e.g., alcohol, benzodiazepines, marijuana).
* Current major depressive disorder, minor depression or dysthymia, or history of any of these disorders in the last 6 months.
* The presence of an Axis I psychotic disorder.
* Plans to relocate out of the area.
* Imminent incarceration.
* Planned inpatient hospitalization during study period.
* Plans to breastfeed. Women who plan to breastfeed will be excluded since this is a powerful, independent motivation for remaining abstinent and may decrease the relapse event rate.
Automated Hovering for Congestive Heart Failure Patients

Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering to improve outcomes among CHF patients at high risk of readmission.

Using a 2-arm, randomized, controlled trial (RCT) among congestive heart failure (CHF) patients at the University of Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering to improve outcomes among CHF patients at high risk of readmission. This will leverage the electronic medical record (EMR), the Penn Data Store (an electronic repository that can be used to identify study cohorts), and the NIH-funded Way to Health platform, which provides linkages between home-based remote monitoring devices and a server that can provide automated feedback to patients. The primary outcome will be hospital readmission rate during the 12 months of study enrollment. Secondary outcomes will include cost, medication adherence and death. The investigators will enroll CHF patients discharged from UPHS and randomize them to either: usual care with no additional intervention; or 1) the provision of wireless pill bottles and scales with daily lottery incentives to encourage daily adherence 2) asked to provide the name and contact information of a family member or friend to serve as their support partner 3) have their weights monitored for clinically significant threshold, with verified weight gains alerts sent to the managing physician through the EMR. Managing providers will also be sent a weekly report of all weight measurements from the electronic scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent University of Pennsylvania Health System hospital (UPHS) discharge of congestive heart failure (CHF) aged 18-80 who will receive follow-up in a UPHS outpatient clinic.

Exclusion Criteria:

* Patients will be excluded if they will not or cannot give consent or have a markedly shortened life expectancy (listed for heart transplant,have a ventricular assist device, are inotrope dependent, metastatic cancer, or dementia)
* end-stage renal disease (since they may not produce urine and be responsive to diuretics).
* on dialysis
* Heart failure managed with a CardioMEMS monitor
* Receiving another remote monitoring/telemedicine intervention
* Receiving follow up care outside of UPHS
Cytisine for Smoking Cessation

The goal of this clinical trial is to evaluate the safety and effectiveness of cytisine as a smoking cessation treatment in individuals with concurrent alcohol use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years;
* Have TUD assessed by structured clinical interview for DSM-5;
* Have past year AUD (active) assessed by structured clinical interview for DSM-5;
* Report daily cigarette consumption in past month and expired carbon monoxide (CO) measurement ≥10ppm at screening;
* Have Fagerstrom Test of Nicotine Dependence (FTND55) score ≥4;
* Have motivation to quit within 30 days i.e. Contemplation Ladder56 score ≥7;
* Be willing and able to comply with all study procedural and assessment demands;
* Be able to provide voluntary written informed consent.

Exclusion Criteria:

* Report prolonged smoking abstinence in the past month preceding screening;
* Be using other smoking cessation aids
* Enrolled in another smoking cessation program
* Be pregnant, breastfeeding, or intending to become pregnant or breastfeed;
* Exhibit suicidal thoughts or behavior in the past month;
* Enrolled in another study which would interfere with study procedures or represent a potential risk to the participant
* Have a serious unstable psychiatric or medical condition preventing participation in the trial. This includes some forms of schizophrenia, ischemic heart disease, heart failure, arterial hypertension (systolic BP above 150; diastolic BP above 100), cerebrovascular diseases, occlusion of blood vessels, kidney and/or liver disease, hyperthyroidism, ulcer, diabetes, Chromaffin tumours of the adrenal medulla, and gastroesophageal reflux disease (GERD)
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome

Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from sickling of red blood cells, that can lead to pain or organ complications such as acute chest syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound important for dilating the blood vessel wall. Citrulline is a substance that is known to increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of continuous IV citrulline that can be given to individuals with sickle cell disease experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side effects.


Eligibility Criteria:
Inclusion Criteria:

1. Sickle cell disease genotypes (HbSS, HbS/β0-thalassemia, HbS/β+-thalassemia, HbSC)
2. Ages 6 to 50 years old
3. Patients with sickle cell disease aged 6 to 50 years old Presence of sickle cell pain crisis defined by the presence of pain requiring hospitalization and parental opioid therapy
4. Presence of acute chest syndrome defined by the presence of a new CXR infiltrate and any one of the following respiratory symptoms of fever, shortness of breath, wheezing, chest pain, cough or new onset hypoxia.

Exclusion Criteria:

1. Presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, etc.
2. Severe anemia (hemoglobin \< 5g/dL)
3. History of red blood cell transfusion within the last 30 days
4. Systemic steroid therapy within the last 48 hours
5. Pregnant (as confirmed by a negative urine pregnancy test) or lactating female
6. Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
7. Subject has the following serum creatinine:

   * Age 6 to 13 years \> 0.9 mg/dL
   * Age 14-17 years 1.0 mg/dL
   * Age 18 years \>1.5mg/dL
8. Patients with an inability to give consent will be excluded
Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)

TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic Medication Adherence Support System (MASS) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.


Eligibility Criteria:
Inclusion Criteria:

* Stable systolic heart failure
* New York Heart Association functional class II-III, with a decreased pump function (left ventricular ejection fraction (LVEF) \<45%)
* Titrated to the most optimal doses of ACE-inhibitor or Angiotensin Receptor Blocker, and beta-blocker
* Receiving stable doses of at least 3 heart failure medications (at multiple times during the day) for 1 month with no plans to add or adjust heart failure medications or titrate further in the immediate future.

Exclusion Criteria:

* Age younger than 50 years
* Diastolic heart failure (intact pump function)
* Myocardial infarction, invasive treatment (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), or hospitalization within 1 month prior to inclusion
* Life-threatening comorbid conditions (e.g., cancer)
* Diminished mental capacities (suspected cognitive decline will be confirmed by a mini mental state examination (MMSE))
* History of psychiatric disorders apart from affective disorders (depression and anxiety disorders)
Partial Breast Irradiation in a Low-risk Population Screened With MRI

This is a pilot study to determine if partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy in patients screened with MRI provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3D-CRT to the whole breast.


Eligibility Criteria:
Inclusion Criteria:

* Stage 0 or I breast carcinoma
* 40 years or older
* Post menopausal
* Lumpectomy with clear margins (\>2mm)
* Patients with invasive disease must have undergone an axillary staging by axillary dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy
* Gross disease must be unifocal with pathological tumor size 2cm or less
* Target lumpectomy cavity must be clearly marked with surgical clips (the target lumpectomy cavity/whole breast reference volume must be \<=30% based on the postoperative imaging)
* Bilateral MRI of the breasts within previous 6 months of radiation therapy (RT) planning
* If patient is eligible based on postoperative imaging, partial breast irradiation (PBI) is judged to be technically deliverable
* Patients with a history of malignancies are eligible if they have stable disease as determined by their attending oncologist
* Patient must have signed the consent form

Exclusion Criteria:

* Men are not eligible
* Patients with Stage II, II, or IV breast cancer
* Pre- or peri-menopausal patients
* Patients with positive lymph nodes
* Patients with suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign
* Patients with multifocal, multicentric, or bilateral breast cancer
* Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation
* Patients with a history of breast cancer
* Clear delineation of the extent of the target lumpectomy cavity is not possible
* Breast implants (patients who have had implants removed are eligible)
* Prior breast or thoracic RT for any condition