cyrilzakka/clinical-trials huggingface dataset:
ED Observation for Opioid Use Disorder

This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU).

In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 years of age or older
* Is able to speak English sufficiently to understand study procedures
* Has a history of non-medical opioid use
* Is a potential candidate for ED-based MOUD treatment initiation and referral at the site as confirmed by clinical staff
* s not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
* Is willing to receive either standard ED care or enhanced ED care in EDOU depending on random assignment
* Presents to the ED during study screening hours

Exclusion Criteria:

* Unwilling or unable to provide written/electronic informed consent/HIPAA Authorization for research procedures, including research visits at baseline and Day 30 and Day 90, and/or consent for the release of health records and data matching for a period of 2 years following enrollment and 1 year prior to enrollment.
* Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
* Presents from a medical-based extended care facility (e.g., skilled nursing facility)
* Previous participation in the current study
* Inadequate locator information (unable or unwilling to provide one unique mean of contact).
* Has acute, severe medical, psychiatric, or concurrent substance use problem or meets other criteria that would exclude the patient (clinically) from placement in EDOU according to EDOU placement clinical protocols.
Anesthetic Efficacy of PECS II Block and Parasternal Block

The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery

All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded

Eligibility Criteria:
Inclusion Criteria:

* patients who need of quadrantectomy with or without axillary dissection
* ASA I-III patients
* age between 18 and 75 years
* filled informed consent

Exclusion Criteria:

* pregnant women
* obesity (BMI \> 39,99)
* radical mastectomy
* ASA IV patients
* chest wall abnormalities
* neurological disorders
* septic status
* chest skin infections
* coagulopathies
The Effect of Exercise on the Brain in Type 2 Diabetes

The goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. The main question it aims to answer is:

What is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes?

Researchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes.

Participants will exercise for 6 months, 3 times per week. Before and after these 6 months, they will undergo:

* a brain MRI scan
* cognitive tests
* blood sampling


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* no insulin therapy
* 30-75 years old
* right handed
* physically inactive

Exclusion Criteria:

* left handed
* MRI contraindications
* psychological disorders
* exogenous insulin therapy
* history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before T2DM
* suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (COPD), cerebrovascular or peripheral vascular disease
* severe hypertension (\>160/110 mmHg)
* ongoing cancer, severe neuropathy (limiting exercise participation)
* renal disease (GRF \<45 ml/min/1,73 m2)
* inability to regularly participate in the exercise intervention
* pregnancy
* breastfeeding
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.


Eligibility Criteria:
Inclusion criteria

* Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
* One prior chemotherapy regimen with irinotecan and 5FU
* Evidence of progressive disease within 6 months after last dose of irinotecan
* WHO Performance Status of 0, 1, or 2
* Measurable tumors
* Adequate hematologic status, liver and kidney function
* Life expectancy greater than 12 weeks
* Written informed consent obtained

Exclusion criteria

* History or presence of central nervous system disease
* Patients with a history of another primary cancer within 5 years
* Prior chemotherapy within 3 weeks before entry to study
* Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
* Investigational drugs within 4 weeks before entry to study
* Prior therapy with oxaliplatin
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical condition which could prevent participation in study
* Chronic kidney disease
* Acute or chronic liver disease
* Patients taking Coumadin
Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors

Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetic patients
* Must be able to swallow tablets
* never received DPP-4 inhibitors or SGLT2 inhibitors

Exclusion Criteria:

* uncontrolled diabetes (fasting plasma glucose\>200 mg/dL)
* receiving insulin therapy
* hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
* inflammatory disorders
* neoplastic disorders
* recent (\<3months) acute coronary syndrome and stroke
* any acute infection
Maternal Voice on Anesthetic Emergence Period

Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive an operation under general anesthesia

Exclusion Criteria:

* ASA PS III or IV
* with developmental delay or neurological diseases associated with symptoms of agitation
* refusal of consent
* with developmental delay
* with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)
The PREVAIL Study

To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.

Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.

Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.

Eligibility Criteria:
Key Inclusion Criteria

* Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
* Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.

Key Exclusion Criteria

* Acute Myocardial Infarction within the previous 72 hours
* Planned treatment involves a bifurcation
* Three vessel disease
A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan

The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).

The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient.

Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription.

After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older
* Patients that are being prescribed REVLIMID in combination with dexamethasone for the treatment of multiple myeloma and that have received at least one prior therapy
* Patient must be willing and able to provide informed consent
* Patients will be informed about the Registry and will have to sign a specific Registry Informed Consent Form
* Be able to ask questions prior to signing the Subject Information and Consent Form
* Be clearly informed that their involvement/participation in the registry is voluntary
* Understand that their medical care will not be altered in any way by their participation in the registry

Exclusion Criteria:

- A Patient who is unwilling or unable to provide informed consent will not be included.
Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics

This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.


Eligibility Criteria:
Inclusion Criteria:

• Diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age

Exclusion Criteria:

* Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness
* Any disorder that may interfere with drug absorption
* Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
* Pregnant or breast feeding
Upper Limb Functional Index

To translate and validate the Upper Limb Functional Index into Albanian for use in the Albanian-speaking population.

The cross-cultural adaptation will be carried out in accordance with the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.

Eligibility Criteria:
Inclusion Criteria:

* shoulder pain
* arm pain
* myofascial pain
* muscular pain
* trigger points
* arthritis

Exclusion Criteria:

* tumor
* metabolic disease
* neurologic conditions
Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence

The purpose of this study is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that are symptomatic despite having received CRT.

This is a non-randomized, prospective, multicenter complementary-study of the REBALANCE Registry. Patients who have been implanted with a CRT device at least 6-months prior to enrollment are eligible for this complementary-study. Up to 150 subjects will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients can be included if they were implanted with a cardiac resynchronization therapy (CRT) device at least six months (180 days) prior to informed consent and are planned for a de novo Barostim System implantation. Patients must sign an informed consent form before implantation with the Barostim System in order to participate in this study.

Exclusion Criteria:

* Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
Comparison of Two Temperatures to Treat Insomnia

Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.


Eligibility Criteria:
Inclusion Criteria:

Age \>/= 22

Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria

Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.

\>14 on the Insomnia Severity Index

Sleep -Wake diaries demonstrate sleep efficiency \<85% on at least 50% of nights

Exclusion Criteria:

Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.

Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.

Unstable medical conditions Raynaud's Disease

Irregular sleep schedules including shift workers;

A latency to persistent sleep \< 15 on either the sleep disorder screening night or the baseline PSG sleep night;

A sleep efficiency \> 85% on either the sleep disorder screening night or the baseline PSG sleep night;

An AHI (apnea hypopnea index) \> 10 and/or a periodic limb movement arousal index (PLMAI) \> 15 from SN1

Body Mass Index \>34

Use of medications known to affect sleep or wake function

Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.

Caffeinated beverages \> 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English
Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome

We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).

A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
* magnetic resonance imaging findings
* age between 45 and 70 years

Exclusion Criteria:

* Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
* cervical pathologies,
* clinical conditions accompanied by neuromotor or sensory dysfunction,
* history of malignancy,
* pregnancies,
* partial or total rupture in the supraspinatus tendon,
* adhesive capsulitis,
* diabetes or chronic liver, or kidney failure
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

* Men and women 18 years of age and older
* Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation
* Previously untreated unresectable Stage III or Stage IV melanoma
* Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug
* Measurable melanoma by physical or radiographic examination
* Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate hematologic parameters and renal and hepatic function

Key Exclusion Criteria:

* Primary ocular melanoma
* Active brain metastases with symptoms or requiring corticosteroid treatment
* Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies
* History of or current immunodeficiency disease, splenectomy, or splenic irradiation
* Prior anticancer therapy or investigational products \<4 weeks prior to enrollment
* Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies;
* Prior therapies with immunosuppressive agents within the past 2 years
* Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids
Comparison of Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte(PEG)

The goal of this quasi-experimental study was to compare the effect of single-dose and split-dose 3L compound polyethylene glycol electrolyte powder (PEG) regimen on the quality, comfort and tolerability of bowel preparation in patients who would undergo colonoscopy examination or treatment.

Participants in group A received a split-dose 3L PEG regimen, with 1L PEG taken on the night before the colonoscopy and 2L PEG taken 4-6 hours before the procedure. Participants in group B received a single-dose 3L PEG taken 4-6 hours before the colonoscopy.

Related guidelines recommend a split-dose method for bowel preparation. However, this regimen also has limitations, such as affect patients' sleep and that of other patients in the ward, and exacerbate their discomfort due to increased hunger. This quasi-experimental study aims to investigate the effect of single-dose and split-dose 3L compound polyethylene glycol electrolyte powder (PEG) regimen on the quality, comfort and tolerability of bowel preparation.

A total of 101 patients scheduled for colonoscopy in two gastroenterology wards in a Chinese university hospital from January to June 2021 were enrolled in the study.

Patients in one department (group A) were given the 3L PEG in two doses: 1L of PEG was taken from 8:00 pm to 9:00 pm on the night before the examination, and the remaining 2L of PEG were taken from 4:00 am to 6:00 am on the day of the examination, with 250 mL taken every 15 minutes until finished. Patients in the other department (group B) were given 3L of PEG in a single dose, which was taken gradually from around 3-4 am, 4-6 hours before the examination. Patients in group B were also instructed to take 250 mL every 15 minutes until the 3L were finished.

The bowel preparation quality, comfort, sleep quality, adverse reactions, acceptance, and compliance were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* inpatients aged 18 to 70 years, with informed consent and willingness to cooperate

Exclusion Criteria:

* intestinal obstruction and stenosis;
* a history of PEG allergy;
* constipation or taking laxatives