cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Case Managed Versus Non-case Managed Initiation of Hemodialysis

The purpose of the study is to compare the 90 day and 12 month composite end point of death (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to receive support from a dedicated case manager (intervention group) versus those not receiving support from a dedicated case manager (control group).

This is multicenter, prospective, observational, and randomized (the study drug is assigned by chance), 1-year study, in academic and community-based nephrology clinical practices that will examine the impact of a facility nurse case manager. In this study a group of patients guideline- based, algorithm- driven approach to hemodialysis initiation with targets (as per Canadian Society of Nephrology and/or International guidelines) will be used with facility nurse case manager and in control group same approach will be used without facility nurse case manager. Patients will be treated with any approved erythropoiesis stimulating agent for the correction of anemia, according to guidance in the current approved product monographs. All treatments will be prescribed by the physician according to actual clinical practice or standard of care for chronic kidney disease. The entire study duration for each participant will be approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who initiated hemodialysis and expected to be on hemodialysis for at least 1 year
* Patients initiating hemodialysis requiring treatment (erythropoiesis stimulating agent or red blood cell transfusion) to correct the anemia of chronic kidney disease who are receiving erythropoiesis stimulating agent treatment at study entry or patients who do not require erythropoiesis stimulating agent therapy (Hb within or above target range)
* Life expectancy should be more than 12 months

Exclusion Criteria:

* Patients contraindicated to receive erythropoiesis stimulating agent therapy (including but not limited to patients who develop pure red cell aplasia following treatment with any erythropoiesis stimulating agent )
* Patients entering the study on any other agent to increase red blood cell mass (such as androgen therapy, or investigational agents, or other non-approved erythropoiesis stimulating agent)
* Patients unwilling or unable to receive erythropoiesis stimulating agent therapy to correct the anemia of chronic kidney disease
* Patients with uncontrolled hypertension
* Patients who for any reason cannot receive adequate antithrombotic treatment
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.

This 18-week randomized, double-blind, parallel-group, proof of concept (POC), dose-ranging study compared multiple doses of HTD1801 to placebo in a 1:1:1 ratio. Since accumulation of hepatic fat is considered the "first hit" in the pathogenesis of NASH (Adams and Angulo 2006), change in liver fat content (LFC) by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) is an appropriate primary endpoint and is consistent with that used in other recent Phase 2 POC studies in NASH (Harrison et al., 2018, Madrigal Pharmaceuticals 2018).

The Harrison et al., 2018, Madrigal Pharmaceuticals 2018 study showed clinically meaningful absolute and relative reductions in LFC assessed by MRI-PDFF over 12-week treatment periods thus, it was considered that an 18 week HTD1801 treatment period would therefore be adequate to assess the study's primary endpoint and to maximize collection of exposure and safety related data.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NASH as assessed by MRI
* Clinically documented diagnosis of T2DM
* Body mass index (BMI) \>25 kg/m2

Exclusion Criteria:

* Liver disease unrelated to NASH
* Poorly controlled T2DM or Type 1 Diabetes Mellitus
* History of alcohol or substance abuse or dependence
* Inability to undergo MRI for any reason
* History of significant cardiovascular disease
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.


Eligibility Criteria:
Inclusion Criteria:

Follow-on participants of V72P12:

Healthy toddlers who completed Study V72P12, aged:

* 12 months or older - Groups 1a, 2a, 3a, 4
* 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
* 24 months (0/ +29 days window) - Groups 1c, 2c, 3c

Naive subjects newly enrolled:

* Group 5: healthy 18-month-old toddlers (0/ +29 days window)
* Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Exclusion Criteria:

* History of any meningococcal B vaccine administration (only for groups 5 and 6);
* Previous ascertained or suspected disease caused by N. meningitidis;
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
* Antibiotics within 6 days prior to enrollment;
* Any serious chronic or progressive disease;
* Known or suspected impairment or alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
The Effect of Additional Arm Therapy on Arm Function After Stroke

This study would focus on a new method of adding extra arm exercise to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected arm and hand that would be given to the client as homework and done in the client's hospital room. The program would be designed and monitored by a therapist that works in the hospital.

We believe that this program will: 1) increase arm and hand recovery over usual care received in the hospital, 2) help people make the move from therapist run exercise to self management of exercise, and 3) promote family involvement in therapy.

In total 250 participants admitted for stroke rehabilitation at 4 BC sites will be randomly assigned to either the experimental or the control group. The extra arm and hand exercise program (experimental group) will receive usual therapy plus 60 minutes per day of additional arm exercises. This program will last for 4 weeks while the participant is in the hospital. The arm and hand program will include muscle strengthening and stretching, repetitive reaching, folding, stacking, pushing and pulling tasks, picking up objects, and activities that use speed and accuracy. The family will be encouraged to participate in the program with the participant. The control group will receive usual therapy only.

Eligibility Criteria:
Inclusion Criteria:

1. 19 years of age or older
2. arm recovery as a rehabilitation goal
3. have palpatable movement of wrist extension
4. able to follow 3 step verabal commands

Exclusion Criteria:

1. unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
2. significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than stroke,
3. receptive aphasia
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* males who developed erectile dysfunction as a result of spinal cord injury. Injury must have occurred 6 months before the start of the study.
* at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance
* no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. Also cannot use any other erectile dysfunction treatment during the study.

Exclusion Criteria:

* Impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism
* History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant.
* History of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
* Significant renal problems within 6 months before starting the study. Also, active liver disease including jaundice at beginning of study.
* History of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.
Assessment of Food Intake in Hospitalized Patients

Food provision and consumption were assessed for all hospitalized patients over a 24h-period survey. This study is a part of a control quality programme and is performed every 4 years since 1999.

During one day, a team of dieticians assessed food provided, consumed and reasons for non-consumption in all hospitalized patients receiving 3 meals/day. Oral nutritional supplements, supplemental enteral and parenteral nutrition were taken into account. Nutritional needs were calculated according to the ESPEN recommendations.

Amount of energy and proteins provided and consumed were calculated using the nutrient analysis software Winrest (FSI, Noisy-le-grand, France).

In 2012, the presence of healthcare-associated infections was recorded during this study.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized patients

Exclusion Criteria:

* Exclusive enteral or parenteral nutrition
* Patients who do not receive three meals
Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema

The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation.

Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns


Eligibility Criteria:
Inclusion Criteria:

* isolated blunt Traumatic Brain Injury
* age 18-60 years

Exclusion Criteria:

* Pregnancy
* Intracerebral hemorrhage
* Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.
DEXA Bone Density Analysis of the CoreHip® Prosthesis System

The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip osteoarthritis
* Indication for CoreHip Standard hip stem according to preoperative planning
* Written Informed Consent
* Age 35-85 years
* According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits

Exclusion Criteria:

* Femoral neck fractures
* Pregnancy
* BMI \> 35
* History of femoral fracture or previous surgery on the same hip
* Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
* Intraoperative bone cracks
* Severe osteoarthritis of the contralateral hip
* THA of the contralateral side or other event leading to restricted weight bearing during the study period
Feasibility and Acceptability of a Body Dissatisfaction Program in Eating Disorders Patients

The cognitive model of Eating Disorders (ED) highlights dysfunctional cognitive patterns common to the different subtypes. Body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ED. It is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ED.

It is suggested that Acceptance and Commitment Therapy (ACT) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. ACT, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ED.

The investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on ACT therapy, in patients suffering from an ED.


Eligibility Criteria:
Inclusion criteria:

* Women over 16 years
* Eating disorder, according to DSM-5 criteria (all types of eating disorder are included: anorexia, bulimia, binge eating disorder, ...)
* Marked body dissatisfaction
* BMI \> 17.5 kg/m2

Exclusion criteria:

* Refusal to participate
* Current severe psychiatric condition other than an ED that may impair patients' ability to attend the group
* Pregnant or breastfeeding women
* Protection measure or deprivation of liberty by administrative decision
Short Clinical Outcome of Microscope Assisted Discectomy: Results of 90 Cases in Iraq

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). They are operated by Microscopic assisted discectomy and were followed by ODI and VAS for back pain and leg pain for 4 months after surgery

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). The diagnosis carried out using history, physical examination, MRI done for the patient to confirm the diagnosis and the level of disc herniation and know the direction and extend of disc herniation.Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.All the patients discharged on the same day of operation or a day after, mobilized soon as they were ready. Patient were reviewed in intervals of (2) weeks (2) months and (4) months after surgery using VAS for low back pain and leg pain and Oswestry disability index.

Eligibility Criteria:
Inclusion Criteria:

* lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy).

Exclusion Criteria:

* Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected
2. Age \>=18 years
3. Tuberculin skin test positive or negative
4. Laboratory:

   * Hemoglobin (Hgb) \>6.5 gm/dl;
   * Neutrophil count \>1,000 cells/mm3;
   * Platelets \>75,000/mm3;
   * AST (SGOT) \<122 U/L;
   * Creatinine \<1.5 mg/dl;
   * Beta HCG = negative
5. Karnofsky performance status \>=60
6. Signed informed consent

Exclusion Criteria:

1. History of TB in the last 3 years or current active TB
2. History of noncompliance to chronic therapies
IVUS Controlled Stenting

Stent placement is now widely accepted to improve the results of angioplasty (an operation to widen the blood vessel) and decreasing the need for further surgery. Despite their worldwide acceptance, stent usage is still limited by renarrowing which occurs within the stent (restenosis) in some patients within the first six months. In addition there still exists a small risk of heart attacks soon after the stent is placed.

The purpose of this study is to test the safety and tolerability of trying to place the stents using a different strategy of using low pressure oversized balloon inflations as opposed to the usual high pressure balloon inflations. This may reduce injury to the artery and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and effective way of performing the procedure the investigators intend to use an Intravascular ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to be the best way of ensuring optimal stent placement.

Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of oversized stenting at normal inflation pressures ( \< 10 atmospheres ) as compared to high pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging.

Secondary Hypothesis: There will be no difference in acute clinical endpoints (death, myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of oversized stenting at normal inflation pressure as compared to high pressure inflation.

Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand the study in order to reveal a decrease in stent restenosis using a strategy of lower pressure balloon inflations. The investigators will assess the deployment characteristics of drug eluting versus bare metal stents


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for a coronary angioplasty and stenting
* Single de novo artery stenosis are eligible for this study
* Target lesion needs to be less than 30mm long and located in a vessel more than 2.5 mm in diameter

Exclusion Criteria:

* Contraindication to antiplatelet therapy;
* Ostial lesion;
* Excessive vessel tortuosity;
* Lesion at a significant bifurcation (subbranch ≥ 2mm in diameter);
* Suspected intracoronary thrombus.
Fascia Iliaca Versus Quadratus Lumborum Block for Pain Management in Total Hip Replacement.

Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects.

The investigators aim to compare postoperative pain levels and opioid analgesic needs of fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip arthroplasty under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* All patients aging between 40-60 years ASA II, III with no known hypersensitivity for local anesthetics

Exclusion Criteria:

* Patient refusal
* Known allergy to local anesthetics
* Previous femoral artery surgery
* Local infection at the site of injection
* Those on anticoagulation therapy
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis


Eligibility Criteria:
Inclusion Criteria:

* Patient age over 18 years
* Patient scheduled for colorectal cancer surgery
* Patient is able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

* Patient has known allergy to nickel
* Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection
* Patients who are participating in another trial
* Patient on regular steroid medication
* Patients who are undergoing a stoma
* Patients with contraindications to general anesthesia
* Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis
* Patients after radiation
* Patients who refuse consent
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

The aim of this study is to estimate blood pressure in pediatric patients using a non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest.

Blood pressure is measured by an automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

Following parameters will be measured by non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest and will be used to estimate the biosignal derived blood pressure.

1. PAT(time between R peak of ECG and beginning of the pulse of PPG)
2. PEP(time between R peak of ECG and peak of accelerometer signal)
3. PTT(PAT-PEP)

The algorithm of the biosignal derived blood pressure will be made using the MATLAB 2016b(Mathworks, Natick, MA) program.

The agreement between the non-invasive blood pressure and the biosignal derived blood pressure will be analyzed using Cohen's Kappa or Bland-Altman plot.

Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anesthesiologist) Class I, II
* Scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* History of cardiovascular disease
* History of thoracic cavity disease
* Unable to measure blood pressure