cyrilzakka/clinical-trials huggingface dataset:
Multi Point Pacing vs. Conventional STUDY PROTOCOL

The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months

Exclusion Criteria:

* \< 18 years and younger
* Pregnant or breastfeeding patients
* Non-LBBB patients (RBBB, intra-ventricular delay)
* Non-ambulatory NYHA class IV effort tolerance
* Myocardial infarction within 40 days before enrolment
* Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
* Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
* Patients with life expectancy of less than 12 months due to other medical conditions
* Patients who are involved in another investigational study (device or medical)
Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work

Psoriasis Vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease. Joint involvement is common along with skin involvement. However, metabolic diseases, such as cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive due to the quality of life and psychological status of patients can affect. For this reason, patients carry out various research on their diseases on social media and follow programs on these issues in other media such as television and radio. However, there is no study on how much patients are interested in these publications, how much they trust them, and how they reach and organize information via social media. The aim of the study will be to clarify how and how patients with Psoriasis Vulgaris use social media to obtain information about the diagnosis and treatment of their disease, the interaction of patient groups with each other, and how often social media is used, especially in which group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Psoriasis vulgaris patients

Exclusion Criteria:

* patients that don't want to answer questions
Rehabilitation for Patients With Pulmonary Arterial Hypertension

Patients suffering from pulmonary arterial hypertension (PAH) frequently remain symptomatic despite medical therapy. Symptoms include breathlessness, poor exercise capacity and reduced quality of life.

In many other serious heart or lung diseases it has been shown that physical rehabilitation improves patient's fitness and quality of life. In PAH there are no clear guidelines and in general physical activity has traditionally been discouraged, although evidence for this advice is lacking. Interesting research project in Germany showed significant benefit for in-patient rehabilitation in PAH patients.

In this study we will perform a controlled clinical study of out-patient rehabilitation of patients with PAH. We hypothesize that physical training of patients will result in increased exercise capacity and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 4 years of study enrollment): Mean PAP \>25mmHg at rest or \>30mmHg with exercise, by a PCWP \<= 15mmHg and by PVR \>3 Wood Units.
* Willing and able to participate in 24 bi-weekly rehabilitation sessions, and medical follow-up.
* Stable dose of current PAH-specific medication for 3 months prior to enrollment.
* New York Heart Association (NYHA) Class II-III.
* Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.

Exclusion Criteria:

* Functional Class NYHA Class I or IV.
* PAH due to congenital heart disease, left heart disease, chronic lung diseases (VC or FEV1 \< 60% of predicted) or chronic hypoxia.
* Acute intercurrent illness requiring hospital admission in the month proceeding screening.
* Any non-PAH medical condition likely to interfere with participation in rehabilitation, e.g. musculoskeletal disorders.
* Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
* Participation in another rehabilitation scheme within 6 months of enrollment in the study.
* Current participation in another clinical trial.
* Pregnancy or planned pregnancy during the study period.
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.

The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has underlying chronic conditions but assessed to be stable as per investigator
* Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Has a coagulation disorder contraindicating intramuscular vaccination
* Has a recent illness with fever
* Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
* Is expected to receive any pneumococcal vaccine during the study outside of the protocol
* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
* Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.

GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.

Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
* Participants can enroll up to 4 weeks after starting treatment

Exclusion Criteria:

- Participating or intending to participate in a concurrent interventional therapeutic trial.
A Randomized Exercise Trial for Wheelchair Users

People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.


Eligibility Criteria:
Inclusion Criteria:

* Be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home
* Have not been moderately to vigorously physically active for the past 6 months
* Be willing to attend the educational workshop
* Receive physician approval for participation

Exclusion criteria include:

* Presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise
* Pregnancy or planning to become pregnant
WASH Benefits Child Development Follow up

The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.

Globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. In low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. Water, sanitation and hygiene (WASH) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. A recent cluster-randomized controlled trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier: NCT01590095), found that improvements in WASH or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households.

This follow-up study, funded by the Bill \& Melinda Gates foundation, includes assessments of the children and caregivers originally enrolled in the WASH Benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. The original WASH Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. Our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. Investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the WASH Benefits trial.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the wash-benefits Bangladesh intervention

Exclusion Criteria:

* No Exclusion criteria
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be given
* Patient ≥ 18 years old
* Diagnosed with type I or type II diabetes mellitus
* Glycosylated haemoglobin, HbA1c, ≤ 12%
* Presence of diabetic foot ulcer or an amputation wound that meets following criteria:

  1. Size of the wound 0,5 - 12 cm\^2
  2. Wagner grade I or II
  3. Wound is not infected
  4. Wound present for at least 4 weeks
* If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm
* If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria
* Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.
* Able to understand and comply with the requirements of the trial

Exclusion Criteria:

* Known history of alcohol or drug abuse
* Use of any antibiotic medication within the last 7 days prior to the first application of study product
* Patients presenting with Wagner Grade III or higher ulcer
* Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (Hb\<100 g/L), neoplasia)
* Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
* Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the doctor
* Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
* Patients diagnosed with autoimmune connective tissues diseases
* Previous treatment under this clinical protocol
* Participation in another clinical trial up to 30 days before the randomization visit.
* Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
* Medical condition likely to require systemic corticosteroids during the study period
* Allergic to shellfish, chitosan or one of ChitoCare product compounds
* Immobile patients
* Pregnant and lactating women
* Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
* BMI \> 39 kg/m2
Intrathecal Hydromorphone for Labor Analgesia

The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will:

1. Prolong the duration and improve the quality of analgesia in labor, and
2. Decrease the incidence of epidural-associated temperature increase in labor.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks).

Exclusion Criteria:

* Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.
Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

The purpose of the present investigation will be to determine whether a combination of clown doctor and parental presence is more effective than a combination of sedative premedication and parental presence for reducing anxiety in children and their parents and for improving parental satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.

Exclusion Criteria:

* Children with prematurity, development delay, previous anesthetic experience will be excluded from this study
Perampanel Titration and Cognitive Effects

The objective of this study is to determine whether there are any differences in the cognitive abilities and/or behavioral response of normal healthy volunteers across different titration rates of perampanel.

This is a randomized, double-blind, parallel group design across different titration rates of perampanel in healthy volunteers. The study consists of 8 visits, 4 of which will occur at the participant's home, over a 7-week period. One hundred and three (103) normal healthy subjects will be treated with perampanel (PER) at one of four different titration rates: (1) 2mg/day PER for one week followed by 4mg/day PER for five weeks, (2) 2mg/day PER for two weeks followed by 4mg/day PER for four weeks, (3) 4mg/day PER for six weeks, or (4) placebo (0mg/day PER) for six weeks. Cognitive and behavioral function testing along with safety testing will be conducted at screening, pretreatment baseline, the end of each week during the titration and maintenance period.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between the ages of 18 and 55 years
2. Male or female (using approved birth control methods)
3. Informed consent obtained

Exclusion Criteria:

1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease.
2. Presence or history of drug or alcohol abuse or positive urine drug test at screening.
3. The use of concomitant medications, which are known to affect perampanel or the use of any concomitant medications that may alter cognitive function (see Section VIII.F for a partial list).
4. Prior adverse reaction to or prior hypersensitivity to perampanel.
5. Prior participation in studies involving perampanel.
6. Subjects who have received any investigational drug within the previous thirty days.
7. Subjects with IQ \< 80 as determined by the Peabody Picture Vocabulary Test after enrollment.
8. Positive pregnancy test. Women of childbearing potential will be required to use approved birth control methods during the study.
9. Presence of lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.
10. Invalid results on computerized cognitive tests at screening as indicated by a 'No' on any of the validity indicators generated in the CNS Vital Signs report.
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.

The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.

The aim of the present study is to determine whether

1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
2. Whether disease-specific survival or overall survival is improved by addition of zalutumumab
3. Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
4. Acute and late toxicity to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
* Curative intent and no prior treatment
* Age \> 18 years
* WHO performance 0-2 (incl.)
* No prior treatment with EGFr-I
* Informed consent according to local guidelines and national law
* The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
* Fertile women must use contraceptive devices (IUD or oral contraceptives)

Exclusion Criteria:

* Rhinopharynx or carcinomas of unknown origin
* Distal metastases
* Other malignant diseases (prior or current) except from planocellular skin cancer
Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx

Fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.

Patients in an ICU often require large amounts of IV fluid to maintain adequate cardiac function. In patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking. The FDA approved devices called Flotrac/Vigileo and Crit-Line are used in this setting to determine adequacy of fluid resuscitation. This study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.

Eligibility Criteria:
Inclusion Criteria:

* Indwelling arterial catheter
* Require dialysis
* CVP in place
* Use of Crit-Line and Flotrak device

Exclusion Criteria:

* Aortic Regurgitation
* Use of an intra-aortic balloon pump
* Weight less than 90 lbs
* Cardiac arrhythmias