cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances

The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents (IPT-A) with depression works to change sleep and related biological markers found in saliva, namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is to understand the biological mechanisms of recovery from depression in order to assist in selecting and guiding personalized psychotherapeutic interventions with the highest likelihood of success for individual adolescents with depression.

The primary aim of this project is to examine whether adolescent depression and the associated symptoms of sleep disturbance are best treated using an empirically supported psychotherapy that is augmented with a sleep improvement module. Twenty adolescents (ages 12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood and also report elevated levels of sleep disturbance will receive Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) with an adjunctive sleep module that is integrated throughout the treatment. Identifying the best approach to treating both the adolescent's depression and the commonly associated symptom of sleep disturbance will have significant implications for the long-term outcomes of depressed adolescents. Moreover, identifying unique symptom and biological profiles at the outset of treatment may enable doctors to predict treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* outpatient participant
* parent or legally authorized representative must provide consent and assent by the participant
* Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria for a depressive disorder
* Clinical Global Assessment Scale (C-GAS) \< 65
* Quick Inventory of Depression Symptoms - Self Report 16 (QIDS-SR16) over 8 and less than 24.
* English speaking
* significant sleep complaints

Exclusion Criteria:

* co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum disorder, intellectual development disorder, conduct disorder or substance abuse disorder
* any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes, or any other conditions that represent as an inappropriate risk to the participant and/or could confound the interpretation of the study
* currently in active evidence-based psychotherapy for the same condition
* currently taking medication for a psychiatric diagnosis that is not a stable dose (4 weeks on the same dose).
* currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt in the past 4 months, or is currently reporting active suicidal ideation.
* history of alcohol or other substance abuse as defined by DSM-V within the last 6 months.
* evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep
* sleep treatment that might confound the interpretation of sleep outcomes.
Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being

Researchers at Massachusetts General Hospital are interested in learning more about the neurobiology of well-being in new mothers and novel ways to support them during their transition to parenthood. This study aims to evaluate well-being in new mothers and their infant and the impact of a probiotic dietary supplement on the gut microbiome. This study hopes to help improve the existing knowledge of maternal postnatal health.


Eligibility Criteria:
Inclusion Criteria

1. Able and willing to give written informed consent
2. Expectant mothers with singleton infant or mothers who have recently given birth to a singleton infant
3. At least 18 years of age
4. At risk for postpartum depression as defined: a hx of depression and/or, a hx of postpartum depression and/or by a prenatal EPDS score ≥ 8

Exclusion Criteria:

1. Has active substance abuse in the past 6 months or a history of opioid use disorder
2. Has diabetes mellitus except for diet controlled gestational diabetes
3. Has uncontrolled thyroid disease
4. Has inflammatory gastrointestinal disease
5. Has active suicidal ideation
6. Has a history of psychosis
7. Has a history of an autism spectrum disorder
8. Plans to take other probiotics (other than study product) during study participation
9. Plans to take systemic hormonal contraception during study participation (Note: intra-uterine device is allowed)
10. Is receiving any systemically administered immunosuppressant medication on a chronic basis
11. Has a clinically significant or uncontrolled concomitant illness or condition that would put the subject at risk or jeopardize the objectives of the study
12. Has a contraindication, sensitivity, or known allergy to any ingredient of the study product
13. Is considered, in the opinion of the Principal Investigator (PI), to likely be a poor attendee or unlikely for any reason to be able to comply with the study procedures
Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with overactive bladder aged 20 years or more
* subject who had the continuos symptom for 3 months or more
* subject prepare a symptom diary and was deemed eligible for the study by the investigator
* 8 times or more of daily mean urination frequency
* 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency

Exclusion Criteria:

* subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
* subjects with diseases prohibiting anti-cholinergics from administration
* subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
* subjects who received lower urinary tract surgery within 6 months
* subjects with a catheter placed or intermittent catheterization
* subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
* subjects who are within 1 month after other clinical study was completed
* subjects having 100mL or more of residual urine
* subjects who had acute urinary retention history
* subjects who have been administered Prohibited concomitant medications
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.

Eligibility Criteria:
Inclusion criteria

1. Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology
2. Admission within 96 hours of ictus
3. Aged between 21 and 75 years
4. A speaker of Chinese (Mandarin or Cantonese)
5. Informed consent from patients or their legally acceptable representatives

Exclusion criteria

1. History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm
2. History of neurosurgical operation prior to ictus
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter

The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

1. Patient understands the implications of participating in the study and provides informed consent
2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
3. Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia
4. Patient can be heparinized during the procedure

Exclusion Criteria:

1. Patients requiring an emergency ablation procedure
2. Patients hemodynamically unstable
3. Patients with NYHA Class III or IV heart failure
4. Women who are pregnant or lactating
5. Patients having cardiac surgery within the past two months
6. Patients with Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
7. Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
8. Patients with acute myocardial infarction within 3 months
9. Patients awaiting cardiac transplantation
10. Patients enrolled in any other clinical study
11. Patients with an age \<18 or \>75 years
12. Patients with stable/unstable angina or ongoing myocardial ischemia
13. Patients with congenital heart disease (not including atrial septal defect (ASD) or patent foramen ovale (PFO) without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
14. Patients with pulmonary hypertension (mean or systolic pulmonary artery (PA) pressure \> 50mm Hg on Doppler echo)
15. Patients with a left atrial diameter \> 55 mm
16. Patients with any arrhythmia currently being treated where the arrhythmia or the management may interfere with this study
17. Patients with active infection or sepsis
18. Patients with untreatable allergy to contrast media
19. Patients with a history of blood clotting (bleeding or thrombotic) abnormalities
20. Patients with any known sensitivities to heparin or warfarin
21. Patients with severe chronic obstructive pulmonary disease (COPD) (identified by a forced expiratory volume \[FEV1\] \<1)
22. Patients with severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids

Background: As the main alternative fuel to glucose for the brain, increased plasma ketones could potentially help compensate for brain glucose hypometabolism occurring during aging. The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in humans.

Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in young and older healthy adults.

Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2 g/d of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin will be measured over 6 h during two metabolic study days, one before and one at the end of the supplementation.

Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 30 or 65 years and more

Exclusion Criteria:

* non smoker
* pregnancy or breastfeeding
* diabetes or insulin resistance
* uncontrolled thyroid disease, hepatic or renal disease
* uncontrolled high blood pressure
* medical treatment influencing lipid or glucide metabolism
* ongoing or past severe drug or alcohol abuse
* dementia or psychiatric difficulties or depression
* chronic immune condition or inflammation
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
* Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
* Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
* Subject with presence of measurable disease based on RECIST 1.1
* Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

Exclusion Criteria:

* Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
* Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
* Subject with current active malignancy other than breast cancer
* Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
* Subject with significant renal or hepatic dysfunction
* Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
* Subject with insufficient bone marrow function
* Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
* Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Undergoing gynecologic laparoscopy

Exclusion Criteria:

* Suspected malignancy
* Incomplete adhesiolysis during initial laparoscopy
* Pregnancy
* Lactating
* Stage IV endometriosis
Early Variations in Immune Aging

Background:

Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.

Study design:

A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 60 years;
* Able to communicate orally in Dutch or English;
* Able to give informed consent.

Exclusion Criteria:

* Any systemic disease or condition, or the use of systemic medication, with the exception of the following:

  * Cardiovascular disease and related medication
  * Metabolic syndrome, including diabetes, hypertension, and hyperuricemia
* Pregnancy at inclusion (will be recorded during study);
* Acute illness or fever \<1 month before inclusion;
* Received vaccines or antibiotics 3 months before inclusion;
* Participation in an intervention trial;
* Legally incapacitated or unwilling to provide informed consent.
Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.

The Broad Challenge Area addressed in this proposal is (03) Biomarker Discovery and Validation, and the Specific Challenge Topic is 03-HL-101 (Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). Idiopathic interstitial pneumonia (IIP) is a lung disease(s) that primarily affects the elderly, but is present in all age groups. IIP causes respiratory insufficiency and is often fatal. In about half of the patients, the diagnosis requires an invasive lung biopsy which can cause complications, and is not always accurate.

The current diagnostic tools for IIP are inadequate. In addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. The challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (IIP), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (IIPs) by developing peripheral blood biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Sporadic cases of Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias.
* Family members ( with or without clinical disease) with a family history of pulmonary fibrosis.

Exclusion Criteria:

* None.
What Makes People Better at Retrieving Difficult Words?

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Participants will also complete some surveys and other measures. Collected data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to the ability to produce individual words.

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which a video is shown and definitions are presented. Participants will try to come up with a word that fits each definition, and then complete some surveys, including some about anxiety, mindfulness, attention, vocabulary, and demographics. Participation will take approximately 1.25 hours. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to peoples' ability to produce individual words.

Eligibility Criteria:
Inclusion Criteria:

* fluent speakers of English ages 18-30 or ages 65-80
Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge

The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myocardial infarction or unstable angina
* Hospitalized for the first time within 24 hours of onset of symptoms

Exclusion Criteria:

* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)
* Current participation in a clinical trial.
Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation

Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of HOD in Indian population and its treatment outcome. The investigators aimed to determine prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis.

Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in female) and parathyroid hormone (PTH) along with routine investigations. Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and DEXA scan repeated.


Eligibility Criteria:
Inclusion Criteria:

1. Liver Cirrhosis
2. Age 18-70 years
3. Informed and written consent

Exclusion Criteria:

1. Chronic renal failure
2. Prolonged steroid use more than 3 months
3. Patients on immunosuppressive therapy
4. Primary hyperparathyroidism
5. Post menopausal women
6. Pregnancy
7. Cushing's syndrome
8. Malignancy
9. HIV Co-infection