cyrilzakka/clinical-trials huggingface dataset:
Use of Introduction Mode to Improve Interactive Voice Response Surveys in Bangladesh and Tanzania

This study evaluates the effect of two different introduction modes on interactive voice response (IVR) survey cooperation, response, refusal, and contact rates, in Bangladesh and Tanzania.

Using random digit dialing (RDD) sampling techniques, participants were randomized to one of two introduction modes, followed by a noncommunicable disease (NCD) risk factor survey. The two modes were computer assisted telephone interview (CATI), in which a call-center employee read the introduction to a participant and received oral consent from them, before sending them the NCD risk factor survey via IVR, or the entire survey, including the introduction and consent, being obtained via IVR. In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2). This study was conducted in both Bangladesh and Tanzania.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant in either Luo, Luganda, Runyakitara, or English languages.

Exclusion Criteria:

* Less than 18 years of age
The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.

The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.

The aim of this post-market retrospective study protocl P42201 is to collect clinical data of patients treated with Easy Flype or Easy Hi Flype for the stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery in routine clinical practice.

In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.

The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical devices EasyFlype/EasyHiFlype in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of EasyFlype/EasyHiFlype.

The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with at least one study stent according to the indications described in the IFU
* Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection

Exclusion Criteria:

* Patients treated less than 12 months prior to study start
Effect of Mechanical Interface Mobilization Technique on Pain and Functional Status in Carpal Tunnel Syndrome

The aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome.

The median nerve gets entrapped in the wrist, causing carpal tunnel syndrome (CTS), the most prevalent peripheral neuropathy in the upper limb. A number of clinical findings, such as sensory issues with the first three digits of the hand sensory distribution of the median nerve, a positive Phalen test, weakness and atrophy of the thenar muscle, and electrophysiological findings (prolonged motor and sensory distal latencies of the median nerve) are used to diagnose CTS . The most frequent occupational risk factors for CTS are repetitive wrist and finger motions or holding uncomfortable wrist positions for extended periods of time. Tenosynovitis of the finger flexors, a thicker transverse carpal ligament, a fracture or dislocation of the distal radius or lunate, rheumatoid arthritis, lipoma, diabetes, and hyperthyroidism are other non-occupational causes . A combination of techniques has been used in the studies of Seradge H. et al and Sucher Benjamin M. Et al which included mechanical interface and neuro-dynamics, but the isolated effects of each method is yet to be determined by further studies as their combined effects are more focused on in the current literature. And that leads to an unclear decision about, which group of manual therapy techniques has better effects on individuals suffering from CTS .

Eligibility Criteria:
Inclusion Criteria:

* Positive Phalen test and Tinel Test.
* Positive symptoms of CTS (Pain, numbness, or tingling in the first three and lateral half of the fourth finger.

Exclusion Criteria:

* No previous surgical treatments at the wrist joint, no fractures or open wounds at the wrist.
* Patients with thoracic outlet syndrome, and cervical radiculopathy.
* History of carpal tunnel release surgery.
* Steroid injection in the carpal tunnel.
* Pregnant females.
* Metabolic diseases such as diabetes, severe thyroid disorders and anemia.
Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model

The aim of the study is to develop a research-based pedagogic model to improve the interaction between the patient's motivation, influence and learning.The hypothesis is:

A neuro-rehabilitation effort in patients with severe traumatic brain injury based on a didactic model for improvement of motivation, involvement and re-learning of daily life competences will

* improve the patients experience of meaningful learning and influence
* provide staff with a tool which contributes to the experience to work in a targeted way concerning motivation, patient influence and re-learning daily life competencies

The aim of the study is to develop a research-based didactic model to improve the interaction between the patient's motivation, influence and learning.

Annually, about 7500 people get a traumatic brain injury (TBI) in Denmark. According to Danish and international experiences 250 of these get severe injuries. About 120 younger people often males need highly specialised neuro-rehabilitation at one of the two regional centres in Denmark. Due to the limited amount of research in this field it cannot be documented but assumed, that the patient's motivation and involvement in planning and implementation of rehabilitation improve subjective and objective outcome. Motivation, involvement and learning in patients with severe traumatic brain injury constitute a major challenge. The cases are individual, but often involve disturbances in language and perception, lack of realization, reduced initiative, tiredness and depression. The focus of this project is the intensive physical and psychosocial rehabilitation viewed as a process of relearning targeted daily life competences using the ICF levels of function, activity and participation.

Eligibility Criteria:
Inclusion Criteria:

1. Severe traumatic brain injury (GCS 3-9)
2. Older than 18 years
3. Post Traumatic Amnesiphase (PTA) at the end, 4 Ranchos Los Amigos (RLAS) score at minimum 4
4. Informed consent

Exclusion Criteria:

1. Younger than 18 years
2. In PTA phase
3. RLAS score lower than 4
4. No informed consent
Emergency Department MCG for Suspected Acute Coronary Syndrome

The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over.
* Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician.
* Has an electrocardiogram performed while in the ED.

Exclusion Criteria:

* Acute ST-segment elevation MI.
* Patient unable or unwilling to complete follow-up.
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Aged 11 - 18 years of age at the time of vaccination in this trial
* Signed Institutional Review Board (IRB)-approved informed assent / consent form.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a female, negative serum/urine pregnancy test.

Exclusion Criteria:

* Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
* Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might:

  * interfere with the ability to participate fully in the study; or
  * interfere with evaluation of the vaccine.
* Known or suspected impairment of immunologic function.
* Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
* History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
* Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
* Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
* Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
* Suspected or known hypersensitivity to any of the vaccine components or to latex.
Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol

Summary:

* Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study)
* Study phase: 3
* Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label
* Study treatment(s)/drug(s): Nebivolol versus Metoprolol
* Patients:

  * characteristics: patients with hypertension and left ventricular hypertrophy
  * planned total number: 50
* Study duration:

  * total enrolment period (months): 18
  * treatment period (months): 6
  * follow up period (months): 6
* Total study duration (months): 24

  * Number of Centres: 1
  * Country(ies): Romania (RO)

STUDY OBJECTIVES

1. PRIMARY:

   * Longitudinal myocardial velocities at rest (assessed by tissue Doppler echocardiography)
   * Systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest)
   * Brain natriuretic peptide (BNP, NT-pro BNP) after a 6-months period of treatment with nebivolol versus metoprolol. An improvement of more than 20% of the myocardial resting velocities of systolic functional reserve is considered to be clinically relevant. The working hypothesis is that the improvement of subclinical left ventricular dysfunction after 6 months of treatment is going to be greater in patients who receive nebivolol than in those who receive metoprolol.
2. SECONDARY:

   * Global systolic function (ejection fraction)
   * Radial myocardial velocities
   * Right ventricular function
   * Global diastolic function
   * Left ventricular mass index

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older, men and women, hospitalized and outpatients
* with a history of primary arterial hypertension
* with a daytime ambulatory blood pressure \>140 and/or \>90 mm Hg
* with left ventricular hypertrophy: LVMI \> 125 g/m2 for men, and \> 110 g/m2 for women, by Devereux formula, as recommended by the ESH-ESC guidelines (14)
* in sinus rhythm
* consented, by signing the Informed Consent

Exclusion Criteria:

* Severe arterial hypertension (systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg)
* Any history of coronary heart disease (stable angina, acute coronary syndromes, myocardial infarction)
* Any history of cerebrovascular disease
* Renal impairment (creatinine \> 1.5 mg% for men, \> 1.4 mg% for women)
* Left ventricular global systolic dysfunction (EF \< 45%)
* More than mild valvar (mitral or aortic) regurgitation
* Hypertrophic cardiomyopathy
* Pericarditis
* Cor pulmonale
* Pregnancy or lactating women
* Any significant co-morbidities
* Contraindication to beta-blocker therapy
* Concomitant treatment with other beta-blockers
* Participation to another investigational study in the last 3 months
H+ Mobilization With Dialysate Bicarbonate Variation

The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath \[HCO3-\] of 35 mEq/L and an \[acetate\] of 4 mEq/L, and second, to determine whether reducing bath \[HCO3-\] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood \[HCO3-\]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath \[HCO3-\].


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years or older,
2. Have been on dialysis for at least 1 year,
3. Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
4. Be reasonably nourished (serum albumin \> 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
5. Self-reported urine output of \<200 cc/day
6. Functioning arteriovenous fistulas or grafts for dialysis access
7. Currently dialyzing at a dialysate \[HCO3-\] of 33-37 mEq/L.

Exclusion Criteria:

1. Pregnancy,
2. Acute illnesses of any kind,
3. Hospitalization in the prior 3 months (except for vascular access related),
4. Significant congestive heart failure, liver or lung failure.
5. Pre-dialysis blood \[HCO3-\] \<19 mEq/L) (to reduce the risk of metabolic acidosis )
Prediction of Neonatal Hyperbilirubinemia

Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.

Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (TcB) values could reliably predict significant neonatal hyperbilirubinemia.

Methods: Data from neonates \>34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from January 2008 to December 2010 will be reviewed.

The registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). TcB and TSB values are plotted on a hour-specific chart.

A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics 2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.

Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy threshold level according to the AAP 2004 guidelines

Statistics: Independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to develop the strategy. At each step, CHAID chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. Categories of each predictor are merged if they are not significantly different with respect to the dependent variable.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term and late-preterm neonates

Exclusion Criteria:

* Admission to the NICU
Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability

This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty.

All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.

Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery.

Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population.

With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18+) patients presenting at the Pre-Admission Unit (PAU) at the General campus of The Ottawa Hospital (TOH) for total hip arthroplasty (THA)
* History of pain for ≥3 months (chronic pain)
* Anxiety scores of ≥8 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
* Ability to understand oral and written English or French

Exclusion Criteria:

* Refusal or inability to provide consent
* Severe depressive symptoms as indicated by score ≥ 20 on the Patient Health Questionnaire (PHQ-9) scale
* Prior mindfulness training experience
* Pre-planned same day discharge after surgery
Comparison of Mobilization and MET Post-Traumatic Elbow Stiffness

The purpose of this study is to find the effects of Mobilization and Muscle energy technique in patients with post-traumatic elbow stiffness.

A randomized control trial was conducted at Benazir Bhutto Hospital, Rawalpindi. The sample size with reference to parent article was 10 calculated through open epi tool. But 30 patients were included in the study to increase the statistical power of analysis. The participants were divided into two interventional groups i.e. Group A and Group B, each having 15 participants. The study duration was 1 year. Sampling Technique applied was non probability purposive sampling technique. Random Allocation will be through sealed envelope method into two treatment group i.e. Group A and Group B. Only 18-35 years old patients (both male and female) with Post-traumatic elbow stiffness were included in the study. Tools that were used in the study are NPRS, DASH questionnaire, TAMPA scale and Goniometer. Total duration of treatment for both groups was 3 weeks, 3 days a week. Pre and post assessment was done. Data was analyzed through SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

* Patients with post-operative elbow stiffness after distal end extra-articular humerus fractures.
* Patients with proximal radius ulna fractures.
* Minimum immobilization period of 3 weeks

Exclusion Criteria:

* Any ligament injury
* Patients with Diabetes
* Patients with RA
* Patients with Pathological fractures
* Revision surgeries
* Neuro-vascular disorders.
Asthma Control Among Patients Receiving Inhaled Corticosteroids in Thailand

The purpose of this study is to determine the percentage of patients who has reached the GINA guideline of asthma treatment after receiving any inhaled corticosteroid for 3 months or longer in actual clinical practice. Such percentage for each level of severity - mild, moderate and severe persistent asthma as well as the differences of these rates will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Established persistent asthma
* Currently treated with any inhaled corticosteroid therapy but not SYMBICORT nor SERETIDE for 3 months or longer

Exclusion Criteria:

* Currently participating or have participated in a study with an investigational compound within the last 30 days
* Current diagnosis of chronic obstructive pulmonary disease (COPD)
* Smoked more than 10 packs a year
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening).
* Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice):

  1. A Drooling Severity and Frequency Scale \[DSFS\] sum score of at least 6 points and
  2. A score of at least 2 points for each item of the DSFS and
  3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease \[mROMP\], Section 'III Drooling', Item A).
* A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline.

Exclusion Criteria:

* Non-neurological secondary causes of sialorrhea.
* Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study.
* Recent (i.e., four weeks) drug treatment for sialorrhea.
* History of recurrent aspiration pneumonia.
* Extremely poor dental/oral condition as assessed by a qualified dentist.
* Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation.
* Recent (i.e., four weeks) changes in anti-parkinsonian medication.
* Previous or planned surgery or irradiation to control sialorrhea.