cyrilzakka/clinical-trials huggingface dataset:
Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar

The Smart Bipolar RCT is a pragmatic RCT aiming to investigate effects of smartphone-based add on treatment in large scale clinical practice (N= 200 patients).

Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed, and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. IT solutions have during recent years emerged as a possible way to optimize treatment, but the effects of digital health interventions are rarely investigated scientifically in health care services.

This is an application from the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The Smart Bipolar randomized controlled trial is a pragmatic trial aiming to investigate the effects of smartphone-based add-on treatment in large-scale clinical practice (N= 200 patients). Findings from the study will have a great impact on future IT monitoring and treatment in bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* All patients in CAG Bipolar, i.e., with a main diagnosis of bipolar disorder in the five large centers, in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hilleroed, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup)

Exclusion Criteria:

* None
Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.

Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years old;
2. pathologically diagnosed with AEH for the first time;
3. desire to preserve their fertility;
4. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
5. no contraindication for metformin, megestrol acetate or pregnancy;
6. no hormone or metformin treatment within 6 months before entering the trial;
7. not pregnant when participating in the trial;
8. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.

Exclusion Criteria:

Patients who had one or more of the following conditions:

1. allergy history or contraindications for megestrol acetate or metformin;
2. pregnant when initiating the study;
3. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
4. high risk of thrombosis;
5. recurrent AEH;
6. endometrial cancer;
7. other malignancy history.
Ultrastructural Collagen Markers in Ehlers Danlos Syndromes

Establishing the diagnosis of Ehlers Danlos Syndromes (EDS)/generalized hypermobility spectrum disorders (G-HSD) is often problematic for patients. The absence of a precise unifying diagnosis in patients results in a significant emotional burden on the patient and caregivers, not to mention the hidden costs, including multiple recurring visits to several medical specialists and associated social and economic costs. To date, while collagen ultra-scale morphological heterogeneity has been used to comment on an EDS diagnosis, the mechanical properties of the collagen remain mostly unexplored.

From a biophysical point of view, collagen affected with hEDS can be described as biomechanically deficient. In the case of EDS, the skin's abnormal elasticity can be directly related to the organization of the collagen network within the dermis. Quantitative Nanohistology (QNH) is a newer method to evaluate both the structural and mechanical properties of collagen in-situ histological sections.

Therefore, the aim of this study is to define histo-biophysical markers of two most common types of EDS i.e. classical EDS (cEDS) \& hypermobile EDS (hEDS) at the single collagen fibrils level and matrix and to further explore the origin of collagen fibril properties deficiency in hEDS and cEDS.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 60 years who can provide informed consent in English
* Able to read, speak, and comprehend English without the assistance of a translator
* Have been diagnosed with hypermobile EDS as per the 2017 EDS criteria; or with genetically confirmed classical EDS (age and sex-matched). This diagnosis is carried out by the UHN GoodHope EDS clinic routinely for all patients on the basis of clinical exam and genetic testing, if indicated.

Exclusion Criteria:

* Subjects under the age of 18
* Unable to speak, read and comprehend English
* Unable to provide consent (cognitive impairment)
* Pregnant women
Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty

To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.

The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip 2. System due to at least one of the following indications:

* Osteoarthritis
* Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants
* Avascular Necrosis with sufficient bone stock for standard primary THA implants
* Post-traumatic Arthritis
* Secondary arthritis due to congenital hip dysplasia 3. Willing and able to provide written informed consent for participation in the study.

  4. Aged 18 - 80 years. 5. Able (in the Investigators opinion) and willing to comply with all study requirements and complete all study visits

Exclusion Criteria:

The potential participant should be excluded from enrollment if any of the following exist:

1. Body mass index ≥ 40
2. History of other orthopaedic surgery within 6 months prior to the index surgery that, in the investigator's opinion, could affect the recovery of the index THA
3. History of pyogenic arthritis in the surgical hip joint
4. Active or suspected infection in or around the surgical hip joint
5. A neurological disorder that, in the investigator's opinion, could affect lower extremity function and recovery from the index THA
6. The potential participant is incarcerated
7. Prior fusion to the index surgical hip joint
8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

9 . Any other contraindication to THA listed in the Entrada™ Hip Stem Labelling or Instructions for Use.
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. This study will test the safety as well as changes in cognitive function and brain activation with the administration of an accelerated rTMS protocol in chronic stroke.

The goal of this pilot study is to determine whether a repetitive high-dose form of non-invasive brain stimulation is a promising and safe treatment for stroke-related cognitive difficulties. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. In studies of rTMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, we are testing here whether cognitive function in individuals with chronic stroke could be improved by rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Have right hemisphere ischemic or hemorrhagic stroke within last 6 months chronicity
* Able to perform given cognitive tasks
* No metal implanted in the body
* A negative urine pregnancy test, if female subject of childbearing potential.

Exclusion Criteria:

* Primary intracerebral hematoma or subarachnoid hemorrhage
* Bi-hemispheric ischemic strokes
* Other concomitant neurological disorders affecting motor or cognitive function
* History of seizure disorder
* Preexisting scalp lesion or wound or bone defect or hemicraniectomy
* Substance use disorder
* Psychotic disorders
* Claustrophobia
Scandinavian Miller Collar Study

Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage


Eligibility Criteria:
Inclusion Criteria:

* Critical limb ischemia
* Need for bypass surgery

Exclusion Criteria:

* Can not participate in follow-up
* Has suitable saphenous vein
Lymph Node Dissection Before or After Cystectomy

The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy.

The study aims to answer two main questions:

* Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery?
* Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed?

Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy.

Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.

Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference.

The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC.

LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups.

Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery.

This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow

Exclusion Criteria:

* Previous pelvic lymph node dissection
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
* Admission estimated creatinine clearance =\< 50 cc/min.

Exclusion Criteria:

* Systolic blood pressure \< 85 mm Hg
* Cardiogenic shock
* Volume depletion
* Myocardial infarction, unstable angina within last 30 days
* Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
* Chronic hemodialysis
* Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
* Enrolled in another research protocol within last 30 days.
A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.

This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females.
* Normal ECG.
* Non-smokers (abstinence from smoking for at least 6 months before the start of the study) or smokers who smoke between 10 and 30 cigarettes, inclusive, per day, for at least 2 months prior to screening.
* Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Active peptic ulcer disease.
* Positive faecal occult blood.
* Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
* Female subjects who are currently or who are planning to become pregnant or who are lactating (from screening through at least 8 weeks after receiving study drug).
A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)

This study will identify a dose of ferumoxytol that can reliably detect changes in blood flow/volume in response to non-drug stimuli. The study will determine whether signal detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The following procedures will be conducted in each of two study periods: arterial spin labeling (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol. There will be a 3-week interval between the two study periods. The study will enroll 8 subjects, but an additional 4 subjects are permitted to enroll to preserve study power.

Study Design: Translational Medicine - Imaging Platform Development

Eligibility Criteria:
Inclusion Criteria:

* Participant weighs approximately 55-75 kg and has a Body Mass Index (BMI) of 18-25 kg/m\^2
* Participant is in good health
* Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion Criteria:

* Participant has a contraindication to MRI including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, or any other MRI-incompatible metal implants that cannot be safely removed
* Participant has a condition that would limit his ability to complete MRI procedures, such as claustrophobia or chronic back pain
* Participant plans to undergo MRI studies in the 3 months following the post-study visit
* Participant has a history of hemochromatosis or other conditions of iron overload or disease of iron metabolism
* Participant has a known sensitivity to ferumoxytol or iron-containing products or has a history of severe allergies, anaphylactic reaction, or intolerance to drugs and/or foods
* Participant has a history of stroke, chronic seizures, or major neurological disorder
* Participant is unable to refrain from the use of any medication, including prescription and non-prescription drugs or herbal remedies from approximately 2 weeks prior to the first dose of ferumoxytol until the post-study visit
* Participant has a history of significant head injury/trauma with loss of consciousness lasting for 15 minutes and one or more of the following: a) recurring seizures resulting from head injury; b) persistent neurological or cognitive sequelae of the injury; c) cognitive rehabilitation following the injury
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery

This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.

All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

* Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
* Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
* Patients with any signs of intraocular inflammation in either eye at screening.
* Patients who have received any prior intravitreal injections in the study eye.
Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder

To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.


Eligibility Criteria:
Inclusion Criteria - at Screening:

* The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ).
* The patient has a pre-defined Montgomery Aasberg Depression Rating Scale (MADRS) total score, and a pre-defined Clinical Global Impression - Severity of Illness (CGI-S) score at screening, and has had the current MDE for ≥10 weeks.
* The patient is currently treated for the current MDE with an adequate selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks.
* The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined Insomnia Severity Index (ISI) score.
* The patient agrees to protocol-defined use of effective contraception.

Entry Criteria to Treatment Period (Baseline Visit):

* The patient still fulfils DSM-IV-TR™ criteria for MDE.
* The patient received the same SSRI or SNRI antidepressant treatment at adequate dose during the entire lead-in period.
* The patient has a pre-defined MADRS total score.
* The patient's improvement in the MADRS total score is a pre-defined percentage compared to screening.
* The patient has a pre-defined Clinical Global Impression - Global Improvement (CGI-I) score.
* The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined ISI score.
* The patient has sleep disturbances confirmed by pre-defined Latency to Persistent Sleep (LPS) and pre-defined Sleep Efficiency (SE).

Exclusion Criteria:

- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Monitoring of Systemic or Organ Perfusion for Preterm Infants

To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.

Hemodynamic observational comparisons will be performed in 6 episodes below on each patient.

1. first 24 hours after birth
2. during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion
3. suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours
4. suspicion of sepsis: from the suspicion point for 48 hours
5. oligouria (\< 1 mL/kg/hour of urine): for 48 hours
6. hypotension (mean blood pressure \< 30 mmHg): for 48 hours

Eligibility Criteria:
Inclusion Criteria:

* premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

Exclusion Criteria:

* infants without the consent of their guardians