cyrilzakka/clinical-trials huggingface dataset:
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.

Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.

The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).


Eligibility Criteria:
Inclusion Criteria:

1. Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
2. Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
3. Individuals who can comply with study procedures including follow-up .

Exclusion Criteria:

1. Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
2. Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
3. Progressive, unstable, or uncontrolled clinical conditions
4. Known hypersensitivity or allergy to any study vaccine component
5. Known history of Guillain-Barré syndrome or other demyelinating disease
6. Condition representing a contraindication to vaccination or blood draw
7. Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
8. Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
9. Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
10. Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.
Healthy Hearts in the Heartland

This study evaluates the ability of small primary care practices to 1) implement point-of-care and population management quality improvement strategies to improve cardiovascular quality of care (e.g., clinical decision support, patient education and counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood pressure control, cholesterol management, and when applicable, smoking cessation) and allow regional benchmarking. This minimal risk study is a practice-randomized trial to determine a) whether point of care strategies improve ABCS performance measures compared to baseline, and b) whether adding locally tailored population management strategies to POC strategies improves performance on the ABCS measures more than POC strategies alone.

The investigators specific aims are to:

1. Evaluate the ability of small practices in the investigators region to 1) implement point-of-care (POC) and population management (PM) quality improvement strategies to improve the ABCS, and 2) implement the popHealth quality measurement software to evaluate performance on the ABCS and allow regional benchmarking.
2. Conduct a practice-randomized trial to determine a) whether POC strategies improve ABCS performance measures (i.e. aspirin prescribing, blood pressure control, cholesterol management, and smoking cessation counseling) compared to baseline, and b) whether adding locally-tailored PM strategies to POC strategies improves performance on the ABCS measures more than POC strategies alone.
3. Deploy an open source quality measurement platform (popHealth) to establish a regional QI benchmark based on participating practice ABCS measures and enable longitudinal tracking of electronic clinical quality measures (eCQMs) across the investigators region. The investigators will perform a mixed-methods evaluation to examine changes in practices' perceived capacity for quality improvement and whether access to comparative quality data within a region improves the capacity of practices to sustain their quality improvement program around the ABCS and provides a long-term framework for practices to implement new QI activities.

Eligibility Criteria:
Inclusion Criteria:

* Providers practicing in Wisconsin, Illinois, and Indiana.
* Practice is adult primary care-focused; \[Further defined: health care organization dedicated to the provision of primary care, and a significant proportion of their patients are adults. Includes, but not limited to, family medicine, general internal medicine, general practice, geriatricians, nurse practitioners and physician assistants.\]
* Practice has 20 or fewer primary care providers; \[Community health centers with 20 or fewer lead clinicians may be included; multi-specialty practices that provide primary care and have ≤ 20 lead clinicians may be included.\]
* Providers must provide informed consent.

Exclusion Criteria:

* Non-English speaking providers
Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.

This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.

Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.

The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.

In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.

Eligibility Criteria:
Inclusion Criteria:

* Having ischemic or hemorrhagic stroke history
* Being at the age between 40 and 85
* MAS (Modified Ashworth Scale) \< 3 for upper extremity
* At least 6 months after stroke
* Participants who agree to participate in the study

Exclusion Criteria:

* Cardiovascular weakness (severe hypertension, coronary artery disease)
* Mini-Mental State Examination score \< 24
* Recurrent stroke
* Having other orthopedic and neurologic conditions that may affect upper extremity movement
* Having behavioral and cognitive problems
Effect of Individualized Patient Education Including Drinking Advice Using an App

Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.

Picoprep is a low-volume bowel preparation used to optimize visualization of the colonic mucosa during colonoscopy. Patients referred for a colonoscopy will be scheduled for an intake. During this intake patients receive education about Picoprep and will be asked about their health condition (medical history, medication use). Standard a face-to-face education is given by an intake nurse or doctor. The producers of Picoprep, Ferring BV designed an app including a drinking schedule adapted to the timing of the coloscopy, aiming a lag time between intake of the last Picoprep dose and the scopy of 2-4 hours. We hypothesize that the Boston Bowel Preparation Scale and patient satisfaction will be higher in patients receiving standard education plus using the bowel preparation app versus patients receiving single standard education.

Eligibility Criteria:
Inclusion Criteria:

* Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic
* Use of regular sodium picosulfate bowel preparation scheme
* Possession of an Android or iOS smart phone

Exclusion Criteria:

* Emergency colonoscopy
* Hospitalized patients
Determinants of Warfarin Metabolism

The anticoagulant effect of warfarin varies greatly among individuals. Some of this variability is attributed to differences in the activity of CYP2C9, the predominant enzyme involved in the metabolism of S-warfarin.

The present study is designed to define the differences in warfarin metabolism among healthy individuals carrying different CYP2C9 genotypes. In addition, the study will define the correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and warfarin metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Age range of 20-50 years old
* The absence of significant disease states

Exclusion Criteria:

* Known hypersensitivity to warfarin or phenytoin
* The presence of significant disease states
* Regular use of drugs (including birth control pills)
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients ≥ 65 years old.
* Patients with essential hypertension with an msSBP ≥ 140 mmHg and \< 180 mmHg, and msDBP \< 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
* Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
* Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria:

* History of renal artery stenosis.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy.
* Current diagnosis of heart failure (New York Heart Association Class III-IV).
* History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
* History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
* Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
Dexmedetomidine Adjuvant in Retinal Surgery

During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration and unexpected globe movement .so many adjuvant was added to LA to overcome this disadvantages of LA such as clonidine and fentanyl .

The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Going for elective vitreoretinal surgery.

Exclusion Criteria:

* History of coagulation abnormalities.
* Allergy to local anesthetics.
* Cardiac, hepatic or renal failure,
* Chronic clonidine or analgesic therapy.
* One-eyed patients
Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

The overall aim of the current project is to assess the acute and long term outcome of ECT (both patient and clinician rated) in a non-selected patient cohort from ordinary clinical activity, and to seek out factors predicting response and remission, side effects and relapse.

Patients reffered to electroconvulsive ECT are (after written consent) enroled in a research registry. Based on (clinician and patient rated) measures of depressive symptoms and overall cognitive function, the short and long-term (6 months) efficacy of ECT will be described, and factors predicting response and relapse identified.

The duration of possible cognitive impairment and factors predicting cognitive outcome will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013,
* written consent to enrolment into the Regional Register for neurostimulation.

Exclusion Criteria:

* ECT performed on other indications than major depression.
* No consent to the register.
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults

The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Fluent in English
* Right handed

Exclusion Criteria:

* History of oral nerve damage,
* presence of known taste or smell disorder,
* food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
* history of CNS disease,
* diabetes,
* history of DSM-IV major psychiatric disorder,
* including alcohol and substance abuse,
* chronic use of medication that may affect taste,
* conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies,
* recent smoking history),
* aberrant stimulus ratings,
* contra-indication for fMRI,
* uncomfortable swallowing in supine position,
* discomfort or anxiety associated with insertion an intravenous catheter,
* regular artificial sweetener use.
Effect of Exercises on Physical Health and Cardiorespiratory Fitness in Obese Women

The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.

Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.

The study will be a Randomized clinical trial and will be conducted in services hospital lahore. The study will be completed within the duration of ten months. Non probability convenient sampling study technique will be used to collect the data. The sample size of 50 patients will be taken in this study to find the effects of high intensity interval training versus moderate intensity exercises on physical health and cardiorespiratory fitness in obese women.

Patients will be divided into two groups (Group A will be treated with high intensity interval training and Group B will be treated with moderate intensity exercises). Eligible participants attended three session per week. Overnight fast, resting metabolic rate and blood pressure will be assessed. An oral glucose test will be assessed and baseline blood samples will be used for lipoprotein analysis. Pacer test and step test performed in the each session. A regular follow-up visits to department and a final assessment will be made at the end of last week by using questionnaire and resulting improvement will shown in results after completion. Data will be analyzed on SPSS 25.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 17-30 years

  * BMI 25-35kg/m2.
  * Sedentary (\< 30 minutes of structured activity per week)
  * Normal glucose tolerance ( fasting glucose \<100mg/dL)
  * No use of medications known to affect body composition or metabolism
  * All participants will be non smoker
  * No MI history
  * No previous surgery.
  * Free from known injury or known clinical conditio

Exclusion Criteria:

* BMI \< 30 kg/m2 Known clinical condition including family history of sudden death, uncontrolled hypertension, type 1 and type 2 diabetes and cardiovascular diesease. • Participants will be excluded if they report in competitive exericise
A 24-month Outcomes of Single- Vs Multiple-visit Revascularization

The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.


Eligibility Criteria:
Inclusion Criteria:

* Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
* Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
* Patient without previous endodontic treatment in affected tooth.

Exclusion Criteria:

* Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
* Patients taking medications that can interfere with healing or hemostasis.
* Patients with allergy to local anesthetics
* Children who will not comply to recall program.
* Teeth with extensive loss of coronal tissue that require restoration with a post
* Teeth with internal or external root resorption
Prospective Study on HIV-related Hodgkin Lymphoma

Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL as established in HIV-negative patients with HL.

Treatment schedule:

* Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation
* Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4 cycles of ABVD plus 30 Gy IF radiation
* Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts with far advanced HIV-infection. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation.
* Primary outcome measure: tolerability, treatment-related mortality
* Secondary outcome measure: complete remission rate, progression-free survival (PFS), overall survival (OS).


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 75 years
* proven infection with HIV 1 (Elisa and Western Blot)
* histology-proven newly diagnosed Hodgkin lymphoma
* written, informed consent.

Exclusion Criteria:

* severe cardiac, hepatic or pulmonary insufficiency
* severe renal insufficiency (creatinine \> 2,0 mg/dl) not caused by lymphoma
* bone marrow failure, not caused by lymphoma or HAART (neutrophils \< 1000/µl, platelets \< 70.000/µl)
* uncontrolled infection
* uncontrolled drug addiction or psychiatric disease
* pregnancy or lactation period
* prior chemotherapy of Hodgkin lymphoma
* life expectancy \< 6 weeks
* HIV-related wasting-syndrome
* active secondary malignancy with cervix carcinoma in situ, basalioma and Kaposi's sarcoma being excepted
Sub-clinical Inflammation and Iron Supplementation

Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a better understanding of the etiology to interpret the prevalence and to formulate appropriate measures to reduce these deficiencies is necessary. There is a growing concern on the role of sub-clinical inflammation on the nutritional status indicators during the nutritional status assessment. However, there is lack of information on the role of inflammation on the iron supplementation. The adolescent period is a window of opportunity to improve the preconceptional iron status of the girls and recently gained much attention. The purpose of the study is to understand the role of inflammation on iron and vitamin A status during iron and vitamin A supplementation. The findings will show the extent to which iron supplementation has been hampered by inflammation and to formulate the necessary measures to overcome the interference.


Eligibility Criteria:
Inclusion Criteria:

* adolescent girls (age 12-19 years)
* already experienced menarche
* anemic girls (Hb\<120 g/L)
* no known illness (apparently healthy)
* free from haemoglobinopathy
* No regular consumption of iron and vitamin A supplement during the last 3 months

Exclusion Criteria:

* subjects with chronic illness
* subjects with severe anaemia
* who do not give the consents