cyrilzakka/clinical-trials huggingface dataset:
Dysregulation of Whole-body Metabolism in Ovarian Cancer: A Longitudinal Study

Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry.

Ovarian cancer is one of the deadliest gynecological diseases, with a 5-year survival rate of only 49%. It is well established that cancer cells have fundamentally altered metabolism, which contributes to proliferation and metastasis. Recent findings in the field have recognized that lipid metabolism is altered in ovarian cancer cells, with cells utilizing lipids as a primary energy source. Due to the high demand of energy from tumor cells, it's possible that other non-malignant tissues could reprogram their metabolism to create an environment that supports tumor growth. Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry. Markers of metabolism (e.g. glucose, blood lipids, lactate) will be assessed at each timepoint. This is a clinically significant project as understanding the full scope of dysregulated lipid metabolism in ovarian cancer patients will allow the identification of potential targets for treatment. The primary purpose is to assess feasibility and acceptability of this study protocol designed to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. The secondary purpose of this project is to collect pilot data and assess the metabolic profile and lipid metabolism of patients with presumed ovarian cancer. A tertiary goal of this project is to collect additional pilot data to better understand the potential link between metabolic health and other factors related to metabolic health among patients with ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age \>18
* Presumed ovarian cancer diagnosis (i.e. those being clinically evaluated for suspicion of ovary cancer)
* Planned treatment course for ovarian cancer involving cytoreductive surgery followed by chemotherapy
* Availability to commit to attending all study visits
* Internet access and consistent access to phone/email/text communication

Exclusion Criteria:

* Pregnancy
* Inability to provide voluntary informed consent
* Inability to consume the pre-study visit meal/snack and/or the study visit meal due to strict dietary restrictions
* Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
* Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators
Transitional Care Model Evaluation 2020

The study is a randomized controlled trial to estimate the effects of the transitional care model (TCM) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. The University of Pennsylvania, where TCM was developed, will be the coordinating center for the implementation. The study will be conducted in three large health systems spread throughout the U.S., drawing patients from seven hospitals in those systems. Eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (HF), chronic obstructive pulmonary disease (COPD), or pneumonia (PNA). The evaluation will be conducted by Mathematica.

The Transitional Care Model (TCM) is an advanced practice registered nurse (APRN) led, team-based, care management strategy designed to improve the care and outcomes of high-risk older adults transitioning from hospital to home. Eligible patients who agree to participate in the study will be randomly assigned to either the intervention group, which receives the TCM intervention, or the control group, which receives usual care (standard hospital discharge planning and post-hospital follow up services). The target sample size for the study is close to 1000, evenly divided into intervention and control groups, with 250 to 270 patients derived from each of UCSF and Trinity health systems, and another 450 recruited from the two VHA hospitals combined. Data will be collected at intake, prior to randomization, by enrollment coordinators at each of the participating hospitals. Followup data will be collected in a survey of patients conducted 90 days after discharge, and from claims data obtained from Medicare, Medicare Advantage plans, and the VHA.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* Admitted from home with Pneumonia OR with a history of HF or COPD with symptoms of HF or COPD exacerbation or whose symptoms suggest a new HF or COPD diagnosis
* English and non-English speaking, able to respond to questions
* Reachable by telephone after discharge
* Resides within the geographic service area
* Consent to participation

Exclusion Criteria:

* Enrolled in Medicare's Hospice or End-Stage Renal Disease programs
* Presence of active and untreated psychiatric conditions (ICD10: F10-F29)
* Long-term care resident
* Undergoing active cancer treatment
* Currently enrolled in another RCT
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients ≥ 18 years of age
* Removal of at least 10 L of ascites in the preceding 2 months for symptom relief
* Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
* Dietary sodium restriction \<90 mcg/d.
* Serum creatinine levels of less than 1.8 mg/dL for at least 7 days before study entry.
* Total bilirubin levels of less than 3 mg/dL.
* Expected survival of greater than 6 months
* Written informed consent

Exclusion Criteria:

* Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
* Presence of peritoneal carcinomatosis
* Evidence of extensive ascites loculation
* Obstructive uropathy
* Coagulopathy that could not be corrected to a prothrombin time INR \<1.8,
* Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
* Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
* Any condition requiring emergency treatment
* Pregnancy
* Inability to obtain informed consent
Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls


Eligibility Criteria:
Inclusion criteria:

- informed consent

Exclusion Criteria:

* inability to perform multiple breath washout testing
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg) at fasting state.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Implementation of REFOCUS Training Program in Mental Health Services

Training of mental health service teams in the orientation of care towards recovery through a 3-day training course: REFOCUS. This training aims to orient care towards recovery. Following this training, evaluation of the effectiveness of the implementation of REFOCUS training in mental health services.

The primary hypothesis is that the implementation of REFOCUS will facilitate the 1-year recovery of patients managed by trained professionals. The secondary hypotheses are that the implementation of REFOCUS will facilitate improved orientation of practices towards recovery; reduced costs associated with the use of mental health services; improved perceived stigma, self-stigma, stigma-related stress, well-being, perceived coercion, and general functioning among those involved.

Eligibility Criteria:
Inclusion Criteria:

* Age from 15 to 65 years old.
* Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder and schizophreniform disorder or bipolar disorder, borderline personality disorder, disabling anxiety or depressive disorder (DSM-V criteria; APA, 2013).
* Patients cared for by the team or unit benefiting from REFOCUS training
* French mother tongue.
* Patient affiliated or entitled to a social security scheme
* Patient having received information about the study and having confirmed their participation in the study by signing the consent form
* For minors (\< 18 years), information given to holders of parental authority and signature of consent.
* For patients under curatorship, form signed by the patient and information given to the curator

Exclusion Criteria:

* Age less than 15 years old
* Patients under guardianship
* Presence of an associated intellectual disability
* Neurological disorders of vascular, infectious or neurodegenerative origin.
* Taking somatic drugs with a cerebral or psychic impact (eg corticosteroids).
Double-Blind Naltrexone in Compulsive Sexual Behavior

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 21-75;
2. current diagnosis of compulsive sexual behavior

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 1 month) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring the "hedonic spectrum" (pain and reward responsivity), attention and its associated brain structures using brain scans (fMRI and DTI), as well as the stability of markers over time.

The issue of suicide has continued to puzzle researchers in the field of psychiatry. Edwin Shneidman, a prominent researcher on suicide emphasized "the most evident fact about suicidology and suicidal events is that they are multidimensional...containing concomitant biological, sociological, and psychological (interpersonal and intrapsychic)...elements". Yet, no study to date has attempted to integrate these dimensions when evaluating suicide risk. Considering the presence of a psychiatric illness is a primary predictor of suicide, it is important to develop a unified understanding of risk factors that integrate current clinical and neurobiological findings in this population.

Our aim is to: (1) identify an integrated biomarker model to predict risk of suicide attempt in patients with Major Depressive Disorder (MDD) with and without a history of suicide attempt, using neuroimaging, neurocognitive testing and behavioural tasks, and (2) test the stability of this model using a prospective 1 year design.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
2. Ages between 18 and 70 years
3. Hamilton Depression Rating Scale - 17 item (HAMD-17) \>= 14
4. Capable of giving informed consent
5. Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) \>= 2
6. Group 2 participants only: positive history of a suicide attempt within the last six months
7. Group 3 participants only: positive history of a lifetime suicide attempt

Exclusion Criteria:

1. Pregnancy/lactation
2. Medical condition requiring immediate investigation or treatment
3. Recent (\< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
4. Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
5. Individuals who are taking a daily sedative hypnotic, atypical antipsychotic or stimulant must be on a stable dose for at least 4 weeks prior to the neuroimaging scan. The dose must not be taken after 10:00pm the evening prior to the scan. Those receiving a benzodiazepine or an atypical antipsychotic on an "as needed" basis (taken, but not every day) will be washed out of their benzodiazepine/atypical antipsychotic for two weeks prior to neuroimaging. Those receive stimulants on an "as needed" basis will be washed out for 1-3 days prior to neuroimaging, depending on the stimulant half-life.
6. Participation in experimental treatment trials for the study duration.
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 12 to 65 years
* Severe hemophilia A
* History of more than 150 exposure days (ED) with clotting factor concentrates
* Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
* No current Factor VIII inhibitor or history of inhibitor
* Willing to use electronic patient diary

Exclusion Criteria:

* Presence of another bleeding disease that is different from hemophilia A
* Thrombocytopenia
* Abnormal renal function
* Presence of active liver disease
* Known hypersensitivity to FVIII
Behavioural Activation for Bipolar Depression: A Case Series

Bipolar Disorders affect around 2% of the population. Most people with Bipolar experience depression; these periods can cause difficulties with relationships, work and daily life.

Psychological therapies for "unipolar" depression (for people who experience depression but never mania or hypomania) are widely available, but there is little research in to how effective these therapies are for people with Bipolar. Knowing this could give greater choice to people with Bipolar in terms of the therapy they have, and how easy it is to get within the NHS. One such therapy is called Behavioural Activation (BA). BA is an established therapy for people with unipolar depression. It helps people to re-establish healthier patterns of activity, but so far there is very little research into offering BA to people with BD.

The current research involves a small number of people with Bipolar Depression receiving BA to see if it seems sensible and worthwhile to them, and to help us to make any necessary improvements to the therapy. The study is taking place in Devon and is sponsored by the University of Exeter. 12 people that are currently experiencing Bipolar Depression who choose to take part will receive up to 20 individual therapy sessions of BA that has been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews. The results of this study will not give the final answer on how effective BA is for people with bipolar depression, but will help to plan for a larger study that can answer this question.


Eligibility Criteria:
Inclusion Criteria:

* scoring in the clinical range on a self-report measure of depression severity (the PHQ-9)
* meeting diagnostic criteria for depression based on a Structured Clinical Interview for Diagnosis (SCID-5)
* meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5)
* participants will require working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator.

Exclusion Criteria:

* current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise ability to use therapy
* current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in the AccEPT clinic at the Mood Disorders Centre
* currently lacking capacity to give informed consent
* currently receiving other psychosocial therapy for depression or bipolar disorder
* presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis).
Continued Safety and Performance of the TIVUS System

The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:

* TIVUS™ Severe Resistant HTN Cohort
* TIVUS™ Moderate Resistant HTN Cohort
* TIVUS™ Failed RF Therapy Cohort


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 and ≤ 80 years of age
* For Cohort A: Documented office systolic blood pressure \> 160 mmHg (\> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure \> 140 mmHg (\> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure \> 150 mmHg (\> 140 mmHg for diabetic patients)
* Documented 24 hour systolic ABPM \> 135 mmHg
* Adherence to a stable drug regimen
* For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening
* Suitable renal artery anatomy
* Male or non-pregnant / non-lactating female
* Patient understands the nature of the procedure and provides written informed consent
* Patient is willing and able to comply with the specified study requirements and follow-up evaluations

Exclusion Criteria:

* eGFR \< 45mL/min/1.73m2
* Documented primary pulmonary hypertension
* Patient experienced \>1 episode of orthostatic hypotension coupled with syncope
* Documented indicator of a secondary renal hypertension
* History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months
* Planned major surgery or cardiovascular intervention in the next 6 months
* Surgery or cardiovascular intervention in the previous 3 months
* Hemodynamically significant valvular heart disease
* Severe debilitating lung disease
* Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
* Patient has a single functioning kidney
* Documented thrombocytopenia, clotting disorders or aortic aneurysms
* Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
* Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
* Concurrent enrollment in another trial
* Main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length
* Aorto-renal angle that prevents a safe cannulation of the renal artery
* Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
* Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
* Any renal artery stenosis \> 50% by visual assessment
* Any renal artery aneurysm in either renal artery
* A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)
MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs.

The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness.

The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test).

The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.

Participants with newly or recently diagnosed COVID-19 infection (inpatients and outpatients) will undergo multi-organ MRI (heart, brain, lungs, liver), blood work, and functional testing at one or more time points. Functional testing will include olfaction testing, cognitive testing, spiromety, and a walk test.

Eligibility Criteria:
Troponin substudy Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to provide informed consent
3. COVID-19 positive test (within 14 days of positive test date)
4. High-sensitivity Troponin-I \>100ng/L or Troponin T \> 52ng/L
5. Ability to obtain Baseline MRI imaging within 7 days (up to 14 days maximum) of Troponin result

Troponin substudy Exclusion Criteria:

1. Contraindication to MRI or MRI contrast
2. GFR \< 30ml/kg/min/1.73m2
3. Hemodynamic instability requiring inotropic agents
4. Active ventilatory support

Late cross-sectional substudy Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to provide informed consent
3. Previously diagnosed with COVID-19 \> 3 months ago
4. Ability to obtain MRI imaging at minimum 12 weeks from COVID-19 diagnosis

Late cross-sectional substudy Exclusion Criteria:

1. Contraindication to MRI or MRI contrast