cyrilzakka/clinical-trials huggingface dataset:
Switching Study From Warfarin to Rivaroxaban

The study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban.

84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind (Treatments A and B) design.

The first two groups (A, B) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an INR (international normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant treatment.

The first group (A) will receive rivaroxaban for four days, the second group (B) will take placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age;
* Normal body weight: BMI (body mass index) between 18 and 29 kg/m2;
* Pharmacogenetics: subjects who are homozygous for the wildtype allele 2C9\*1 and who are carriers of the C-allele at positions 6484 and 7566 of the VKORC1 (vitamin K epoxide reductase) gene, respectively

Exclusion Criteria:

* Relevant deviation from the normal range in the clinical examination;
* Relevant deviation from the normal range in clinical chemistry, hematology or urinalysis;
* Resting heart rate in the awake subject below 45 BPM (beats per minute) or above 90 BPM;
* Systolic blood pressure below 100 mmHg or above 140 mmHg; and Diastolic blood pressure above 85 mmHg;
* Relevant pathological changes in the ECG (electrocardiogram) such as a second or third-degree AV block, prolongation of the QRS (QRS complex in ECG) complex over 120 msec or of the QT / QTc-interval over 450 msec (QT interval in ECG, QTc interval corrected for heart rate);
* Subject is tested to be HIV-1/2Ab, p24Ag, HbsAg or HCV-Ab positive;
* Known coagulation disorders (e.g. von Willebrand's disease, haemophiliac);
* Known disorders with increased bleeding risks (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer);
* Known sensitivity to common causes of bleeding (e.g. nasal);
* Recent or planned surgical or diagnostic procedures at the central nervous system (CNS) or eye;
* Subjects with hyperlipidemia (Coumadin / warfarin warning)
A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus

GX-G6-002 is a Phase 2, 12-week, randomized, parallel group, multi-centre, double blind, placebo-controlled and an open-label active comparator study.

This study aims to establish the dose-response relationship of 4 dose cohorts of GX-G6 compared with double-blind placebo. These treatment cohorts will also be compared with open-label active control.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of T2DM ≥ 6 months prior to screening
2. HbA1c level of 7-10% (inclusive)

Exclusion Criteria:

1. Have known type 1 diabetes mellitus (T1DM)
2. History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
3. Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
4. Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
5. Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Eligibility Criteria:
Inclusion Criteria:

* Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Exclusion Criteria:

* Unwilling or unable to provide informed consent
Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with oncohematological diseases that requires cerebrospinal fluid, myelogram or both for staging and monitoring their treatment ( leukemia, lymphoma, solid tumors and bone marrow aplasia)
* Patients who is undergoing to collect cerebrospinal fluid, myelogram or both;
* aged between two and eight years;
* absence of tumor recurrence.

Exclusion Criteria:

* Previous neurologic disease;
* Using of opioid previously;
* Neurological developmental delay
Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults

To date, the effects of pain on motor learning have not been thoroughly investigated. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. The purpose of this research is to determine whether any altered retention of motor learning associated with acute pain is a true affect of pain or an affect of context (or both).


Eligibility Criteria:
Abbreviations: HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9.

Inclusion Criteria:

* 18-35 years old
* Self-identifying as generally medically healthy
* Able to read, write and speak English
* Able to provide informed consent
* Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

Exclusion Criteria:

* Resting HR \< 50 or \> 100 bpm
* Resting BP \< 90/60 or \> 140/95 mmHg
* Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
* Score on the MoCA \<23
* Score on the GAD-7 ≥ 10
* Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
* Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis
* Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
* Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
* History of serious concussion or head injury, defined as a loss of consciousness for \> 5 minutes and/or requiring medical treatment, or \> 2 concussions over the lifespan
* Any history of acute or chronic problems with balance, any dizziness, or \> 1 fall in the last 12 months
* Taking 4 or more medications
* Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
* Any current or chronic pain condition during the last year, located anywhere in the body
* Allergy to capsaicin or hot peppers
* Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
* Skin sensitivity to soaps/creams/perfumes or to heat
* Poor circulation in the area targeted for the painful stimulus
* Prior participation in a locomotor learning study in this lab within the last 2 years
Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis

The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.

High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.

Eligibility Criteria:
Inclusion Criteria:

* Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan

Exclusion Criteria:

* Coagulation disorders
* Skin infection of the vertebral region
Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

Addition of systemic herbal immunomodulators with scaling \& root planing (SRP) may enhance the therapeutic result of Chronic Periodontitis owing to host modulation \& anti-inflammatory properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.


Eligibility Criteria:
Inclusion Criteria:

1. Patients within age group of 30 to 55 years.
2. Systemically healthy individuals.
3. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria

Exclusion Criteria:

1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),
2. Smoking,
3. Chronic alcoholics,
4. Pregnancy or lactation,
5. Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013,
6. Confirmed or suspected intolerance to herbal medicines,
7. Periodontal therapy done within the january 2012 to Jun 2013.
ShearWave™ Elastography of Breast Lesions in Chinese Patients

We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.

Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 years of age or older
* known breast lesion that has not been managed or treated
* referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:

  * physical palpation
  * mammography
  * ultrasound exam
  * MRI

Exclusion Criteria:

* Women who are unwilling or unable to provide informed consent
* Women with breast implants
* Women who are pregnant or breastfeeding
* Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
* Women with previous ipsilateral breast surgery
* Women with no visible breast mass on ultrasound examination
* Women with axillary metastatic lymph nodes only
* Women with foreign body in the breast
* Women who are not Chinese nationality
Ultrasound of the Diaphragm in ICU Patients

Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.

Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.


Eligibility Criteria:
Inclusion Criteria:

* adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
* adults aortic vascular surgery

Exclusion Criteria:

* \< 18 years
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).

The purpose of this research study is to determine if a 3 oz water screening protocol is an effective screen for patients with openings in their airways (i.e. tracheostomies). This procedure is already in use for many different populations and is particularly useful for clinicians who want to understand who is at risk for having food or liquid enter the lungs while eating or drinking (i.e. aspiration).

Eligibility Criteria:
Inclusion Criteria:

* Has a tracheostomy
* Able to remain alert for testing
* Not on a modified diet for pre-existing dysphagia
* No head of bed restrictions
* Not NPO by physician for any reason other than possible dysphagia
* At least 18 years old

Exclusion Criteria:

* Does not have a tracheostomy
* Unable to remain alert for testing
* On a modified diet due to pre-existing dysphagia
* Head of bed restrictions for greater than or equal to 30 degrees
* NPO by physician for reasons other than possible dysphagia
* Less than 18 years old
The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial

The goal of this field trial was to compare in emale-headed households. The main question it aims to answer are:

determine the effect of education based on social cognitive theory on the social health of female-headed households in female-headed households in Gonabad.

Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks. The control group did not receive any training related to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study, being the head of the household, age range from 20 to 64 years, ability to speak and listen, reading and writing literacy, access to a mobile phone with Android operating system to receive educational messages (access to the Internet and virtual networks) or Having access to a person who will help him in using virtual networks, not suffering from acute diseases and hospitalization during the intervention.

Exclusion Criteria:

* Dissatisfaction to continue cooperation, not completing the questionnaire completely
Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis

Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism

Lateral epicondylitis is a soft-tissue lesion of the tendinous origin of the wrist extensor muscles at their origin on the lateral humeral epicondyle. The extensor carpi radialis brevis is the area of most pathologic changes. It begins as a microtear of the tendinous origin of the wrist extensor muscles and results in degeneration and reactive granulation tissue formation. Activities involving prolonged or repeated gripping, wrist extension, forearm supination, and pronation cause eventual failure of the affected portion of the tendon. The mechanical failure of the tendon results in an ensuring tendinitis and symptoms of lateral epicondylitis. It is aggravated with movements of the wrist, by palpation of the lateral side of elbow, or by contraction of extensor muscles of the wrist.

There are different treatment methods for lateral epicondylitis. Initially, lateral epicondylitis has been treated with ice, rest, counterforce tennis brace and/or non-steroidal anti-inflammatory drugs. But when the condition is not responding to initial treatment physical therapy is initiated

Eligibility Criteria:
Inclusion Criteria:

1. Both sexes will be involved
2. Duration of the disease is more than 12 weeks.
3. Patient's age ranges from 20 to 40 years

Exclusion Criteria:

1. Diabetic patients.
2. Hypertension patients.
3. Pregnant women
4. Cardiovascular patients
5. Patients with malunion fractures
6. Patients with cervical Radiclopathy
7. Patients with olecranon bursitis
Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso

The study aims at assessing which of two distribution channels for insecticide treated bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant women and children under 5.

The hypothesis that insecticide-treated bed net (ITN) effects may not be long-lasting in young children living in areas of intense malaria transmission due to interactions with the immunologi-cal development has now been refuted in a number of studies including the D4 study. The highly controversial question remains how African programmes can best reach a sustainable high coverage with ITNs in young children and pregnant women. Against this background it is planned to implement a cluster randomised controlled trial in Nouna Health District in Burkina Faso. Twenty-two peripheral health centres and their catchment areas will be randomised to (1) ITN provision to the general population through social marketing and (2) ITN provision to the general population through social marketing plus free provision to all pregnant women through antenatal services. The primary outcomes are ITN coverage in households and ITN use during pregnancy and infancy.

Eligibility Criteria:
Inclusion Criteria:

* Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso

Exclusion Criteria:

* Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Adding Desmopressin to Tamsulosin for Treatment of BPH

In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea

Investigators will give a group of patients tamsulosin and desmopressin and the other group will take tamsulosin and placepo and compare the outcome regarding symptoms of being prostatic hyperplasia especially nocturia and the effect on nocturnal polyurea in patients

Eligibility Criteria:
Inclusion Criteria:

Men with BPH Age more than 50years Patients with nocturia (2voids per night or More) Patients with nocturnal polyurea (urine volume More than 33%of urine allover the day) IPSS more than 12 Obstructed flow curve Post voiding residual less than 150

Exclusion Criteria:

* men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II

To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with anterior circulation acute ischaemic stroke
2. Time from onset to treatment 4.5h-24h
3. Patient's age is \>= 18 years，\<= 80
4. Pre-stroke mRS score of \<= 2
5. Clinically significant acute neurologic deficit
6. Baseline National Institute of Health stroke scale \>= 6
7. Vessel occlusion or severe stenosis ( ICA, MCA-M1/M2, ACA) on computed tomography angiography (CTA)/MRA
8. Multimodal CT/magnetic resonance imaging: perfusion lesion volume (DT \> 3 s) to infarct core volume ratio (rCBF\<30% or diffusion-weighted imaging lesion) \>1.2, absolute difference \>10 ml, and ischemic core volume \<70ml
9. Informed consent was obtained from patients.

Exclusion Criteria:

1. Intracranial hemorrhage or subarachnoid hemorrhage identified by CT or MRI
2. Rapidly improving symptoms (patient with an NIHSS score decrease to \< 4 at randomization)
3. Pre-stroke mRS score of \> 2
4. Contraindication to imaging with CT/magnetic resonance imaging with contrast agents
5. Infarct core \>1/3 middle cerebral artery (MCA) territory
6. Platelet count \< 100x10\^9/L
7. Symptoms were caused by low blood glucose \< 2.7 mmol/l
8. Severe uncontrolled hypertension, i.e. systolic blood pressure \>= 180 mmHg or diastolic blood pressure \>=100 mmHg
9. Current use of warfarin with a prolonged prothrombin time (INR \> 1.7 or prothrombin time \> 15s)
10. Use of low molecular weight heparin within 24 hours
11. Use of non-vitamin K antagonist oral anticoagulants (NOACs) within 48 hours
12. Use of glycoprotein IIb - IIIa inhibitors within 72 hours.
13. Arterial puncture at noncompressible site in previous 7 days
14. Major surgery in previous 14 days which poses risk in the opinion of the investigator
15. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 days)
16. Significant head trauma or prior stroke in previous 3 months
17. History of previous intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Risks were considered by the investigator
18. Hereditary or acquired haemorrhagic diathesis
19. Active internal bleeding
20. Symptoms suggestive or recent acute pancreatitis, active gastrointestinal ulcer
21. Severe liver disease, including liver failure, cirrhosis, portal hypertension and active hepatitis
22. Pregnancy or lactation
23. Various dying diseases with life expectancy ≤3 months
24. Other conditions in which doctors believe that participating in this study may be harmful to the patient
25. Patients participated in any trial in 30 days
26. Allergic to the test drug and its ingredients
Prognostic Value of Rb-82 PET Myocardial Perfusion Imaging

The physician would like to see if nuclear cardiac stress tests can predict cardiac health. For example, if a patient has an abnormal stress test, is he or she more likely to have cardiac problems in the future?


Eligibility Criteria:
Inclusion Criteria:

* Patient \> or = to 18 years of age
* Registered patient at MSKCC
* Patient with one or more 82Rb myocardial perfusion stress tests performed at MSKCC, 2008-2011

Exclusion Criteria:

* Patient is unwilling to participate