cyrilzakka/clinical-trials huggingface dataset:
Imaging Study of Lead Implant for His Bundle Pacing

The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.

The study will evaluate implant lead electrical measurements and changes over time, estimate the correlation between lead location and selective vs non-selective His bundle pacing, and estimate the correlation between long-term lead performance and implant characteristics. Data from the study may be used to standardize the implant workflow to help improve the ease and predictability of His bundle pacing implants.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a Class I or II indication for implantation of an implantable pacemaker
* Subject (or legally authorized representative) has signed and dated the study-specific Consent Form
* Subject is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Subject is expected to remain available for follow-up visits

Exclusion Criteria:

* Subject is contraindicated for Cardiac CT
* Subject has an existing or prior pacemaker, ICD or CRT device implant
* Subject is intended to receive an implant of a LV lead or CRT device
* Subject life expectancy is less than 1 year
* Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence
* Subjects with exclusion criteria required by local law (e.g. age or other)
* Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
* Subject is enrolled in a concurrent study that may confound the results of this study.
Respiratory Critical Care Nurse Training Program

The goal of this clinical trial study is to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). The main question it aims to answer is: What is the effect of the respiratory critical care nurse in improving outcomes for critically ill patients? Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care.

A randomized controlled clinical superiority trial with triple blinding and a two-arm parallel group design will be conducted at Baqiyatallah University of Medical Sciences in Tehran, Iran between November 22, 2023, and November 10, 2024. The aim of this study will to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care

Eligibility Criteria:
Inclusion Criteria:

* They are at least 18 years old,
* Critically ill patients who need critical care,
* They have no history of heart disease, stroke, autoimmune disease, neuromuscular diseases, cancer, or cardio-respiratory arrest,
* They are willing to participate in the study.

Exclusion Criteria:

* Patients with pregnancy and breastfeeding women
* Patients at end-stage medical condition
* Patients with planned withdrawal of treatment
Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)

Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis) treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).

Age-Related Macular Degeneration (AMD) is a disease that affects central part of the retina, called macula, and is associated with progressive central vision loss. Moreover, AMD is known to be a leading cause of blindness in developed countries. In wet form of AMD, new abnormal blood vessels start to grow from the choroid towards the retina that leads to leakage from these vessels and, in turn, to impaired retinal structure and rapid vision loss.

Genetic factors were found to be important in development of wet AMD. Our previous research showed the association between some genetic polymorphisms and the risk of wet AMD as well as with specific clinical features of the disease. At present, anti-vascular endothelial growth factor (anti-VEGF) therapy with intravitreous ranibizumab (Lucentis) is considered to be the most effective treatment for wet AMD. However, treatment outcomes may vary significantly from improved vision to no effect. The aim of this research is to study how ranibizumab treatment outcomes depend on genetic factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 50 years old
* Neovascular age-related macular degeneration
* CNV in the central part of the retina (macular is involved)
* Active CNM (seen on fundus fluorescein angiography)
* CNV activity is on one of the following: sub-retinal hemorrhage, sub-retinal lipid, documented loss of 3 lines of vision during last 3 months
* Visual acuity of between 20/40 and 20/300 (ETDRS)

Exclusion Criteria:

* Patients under 50 years old
* Patients with CNM not caused by AMD
* Patients physically unable to tolerate intravenous fluorescein angiography
* Patients with medically uncontrolled glaucoma
* Patients with history of bronchial asthma, thrombophlebitis, polyvalent allergy, cancer
* Any intraocular surgery within 3 months in the study eye
* Prior retinal or vitreous surgery including vitrectomy or scleral buckling
* Any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome
* Individuals with physical or mental disabilities that prevent accurate vision testing
* History of any laser treatment of CNV in study eye (laser photocoagulation or prior photodynamic therapy), or anti-VEGF (ranibizumab or bevacizumab) in the past 2 years in the study eye.
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.

Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

* Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
* Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
* Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Eligibility Criteria:
Inclusion Criteria:

* Has a historical diagnosis of Type 2 Diabetes Mellitus.
* Has a body mass index between acceptable range.
* Is experiencing inadequate glycemic control.
* Body weight keeps constant.
* Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.

Exclusion Criteria:

* Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
* Has a systolic blood pressure beyond the acceptable range at Screening visit.
* Has New York Heart Association Class III or IV heart failure regardless of therapy.
* Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
* Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
Health Promotion Intervention to Reduce Child Morbidity

While household-level water, sanitation and hygiene has been investigated extensively, this is the first comprehensive study to investigate the impact of improved water, sanitation and hygiene and nutrition at household on child health in Yemen.

This study was conducted in Hufash district, Al-Mahweet Province, which is located on the southwest of the capital Sana'a, and takes about (113)kilometers from it. The study aimed to highlight the key role of the community based interventions in reducing child morbidity and mortality in rural Yemen.A community - randomized controlled field trail was implemented to evaluate the role of public health promotion on reducing child diarrhea, acute respiratory infection, nutrition, immunization in children under age of five at enrollment over a six month of study period. Due to the nature of the study, blinding is not possible so some measures would be done to reduce the non-blinding bias like, to keep the study staff blinded as much as possible, the observers and survey staff were not informed about the study design. The sample size required to measure the primary and secondary outcomes before and after the intervention in both groups was estimated using STATA 14.0.Based on data of a previous meta analysis, estimates of required sample size assumed a 20% reduction in the proportion of diarrhea. Intra-cluster correlation coefficient (ICC) was set low at 0.04 and the cluster sizes (number of subjects in a cluster, m) were expected to be 18. The sample size was multiplied by a design effect of 1.68, calculated using DE=1+ICC (m-1), to accommodate the clustering effect. The sample was further adjusted for a potential 20% loss to follow-up over one year, thus requiring a sample of 180 per group. Therefore, the present study estimated that a total of 20 clusters inhabited by 358 households with child aged 6 to 59 months would have 80% power to detect the 20% reduction in the proportion in diarrhea at 5% level of significance.

Eligibility Criteria:
Inclusion Criteria:

* At least one child aged between 6 - 59 months
* Family planning to stay in their home for the next 12 months
* Written consent taken from the head of household

Exclusion Criteria:

* Child had chronic diseases or severely malnourished.
* Family that might leave their house before one year.
* Household that the lord of house refuses to participate.
Mobile Devices as Educational Skin History Tools

Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. In part II, the study aim is to evaluate mobile technology as a way of improving patient understanding of diagnoses, treatments, and procedures. In this part of the study, eligible patients from part I will be randomized either to a control group that receives the current standard of care regarding in-clinic counseling, informational handouts, and access to their medical records, or to an intervention group that in addition to the current standard of care, is setup with a mobile app, allowing patients to view a skin history summary report and a reference on their skin ﬁndings and procedures. Patients then complete a survey to establish their baseline understanding of their clinic visit. Three weeks later the patient is emailed a follow-up survey to assess their understanding of their in-clinic visit. Differences in understanding between the two study groups will be assessed by comparing the number of correctly answered survey items regarding their in-clinic visit, both at baseline (immediately following their surgery) and three weeks later. Qualitative information regarding satisfaction and areas of improvement will also be collected via survey. Patients who have an appointment during the study period at the Penn Dermatologic Surgery clinic for a skin excision will be eligible for inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Have an appointment in the Penn Dermatologic Surgery Clinic for removal of a skin area during the study enrollment period
* Possession of a mobile device running iOS with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed)

Exclusion Criteria:

* Children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
* Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization.
* If the area being operated on is of the genitals or breasts
* If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufﬁciently such that photos are non-identifying
Rotavirus Vaccine Produced by Butantan Institute

The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.

Eligibility Criteria:
Inclusion Criteria:

* Male healthy
* Age ≥18-40 years
* Not taking immunosuppressive drugs
* No clinical history of gastrointestinal diseases or surgeries
* No history of cardiac, neurologic, immunologic or endocrine diseases
* Normal eligibility laboratory tests
* To be willing to participate and sign the informed consent form
* No participation in another clinical trial in the past 6 months

Exclusion Criteria:

* Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases

in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test


Eligibility Criteria:
Inclusion Criteria:

* Cared for as part of a respiratory rehabilitation program (ADIR association)
* Presenting diffuse fibrosing interstitial pneumonitis, documented by CT scan data and whatever its etiology
* Presenting severe hypoxemia in ambient air (SpO2\<90%) during an exercise test (6-minute walk test or functional exercise test)

Exclusion Criteria:

* Patient with a contraindication to carrying out a respiratory rehabilitation program
* Patient having presented an exacerbation of PID, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion
* Tracheostomized patient
* Patient with a contraindication to the placement of a nasogastric tube
* Pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out)
* Protected adult patient (guardianship or curatorship)
* Patient deprived of liberty by court or administrative decision
* Refusal of patient participation or consent
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 19 to 64 years at screening.
* Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health

Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.

Primary Aim: To compare the effects of providing sedentary employees with seated active workstations in combination with an ergonomic intervention and regular motivational emails (experimental group) against the ergonomic intervention and regular emails only (active control group) on occupational sedentary behavior over 16 weeks.

Hypothesis: The addition of a seated active workstation will result in significant reductions in daily occupational sedentary time compared to the active control group.

Secondary Aims: To compare the effects of the experimental group against the active control group on secondary measures of cardiometabolic disease risk factors, musculoskeletal discomfort, cognitive function and work productivity.

Hypothesis 1: The experimental group will result in reduced cardiometabolic disease risk, musculoskeletal discomfort and work limitations compared to the active control group.

Eligibility Criteria:
Inclusion Criteria:

* We will recruit overweight/obese (body mass index 25.0-40.0 kg/m2) adults (18-65 years) working in full-time (minimum 35 hours/week), sedentary (self-report sitting \>75% work time) occupations at an independent work site.

Exclusion Criteria:

* Working in an office that will not meet the space or electrical requirements of the active workstation, acute or chronic illness not under treatment of a provider, orthopedic limitations that prohibit physical activity, current or planned pregnancy, hospitalization from a physical or mental disorder in the past six months and/or taking medication that may impair physical activity
Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch

The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.

Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.

Eligibility Criteria:
Inclusion Criteria:

* The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study
* The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro®
* The patient must have a diagnosis of Idiopathic Parkinson's disease
* The patient must have signed the Consent form regarding study information, data transfer and use
* Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication

Exclusion Criteria:

Not applicable
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency

Resveratrol is a natural plant antitoxin widely found in grapes, mulberries, and other plants. Resveratrol mediates a variety of pharmacological effects, including antioxidant, immunomodulatory, anti-inflammatory, and anti-apoptotic, and plays a protective and therapeutic role in the development of several ROS-related diseases, including POI/POF.

The preliminary experiments of the investigators' group examined the gene expression in ovarian granulosa cells of POI patients and normal controls using high-throughput sequencing technology. The investigators found that the expression of NOX complex NCF1, NCF2, NCF4 and CYBB subunit genes were upregulated in ovarian granulosa cells of POI patients compared with normal controls, suggesting that the development of POI may be related to the NOX complex subunit gene and The development of POI may be related to the abnormal expression of genes and proteins of NOX complex subunits. Based on the results of previous experiments and available literature reports, investigators compared ovarian function, embryonic laboratory indices, pregnancy outcome and cellular level NOX/ROS/oxidative stress changes of POI patients in the RES-treated and non-RES-treated groups by collecting blood and ovarian granulosa cell samples to analyze the effects, mechanisms of action and specific RES application in antioxidant therapy for POI NOX subunit targets to provide a reliable scientific basis for the clinical treatment of POI by RES.

Eligibility Criteria:
Inclusion Criteria:

1. Amenorrhea or oligomenorrhea at least 4 months and two (\>4 weeks interval) basal FSH≥10mIU/ml；
2. The women aged \<40 years old；
3. Informed consent, voluntary experiment.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids\>4 cm or hysterectomy;
3. Patients with adrenal cortical hyperplasia or tumour；
4. Ovarian neoplasms patients；
5. Hydrosalpinx patients；
6. Hyperprolactinemia patients；
7. Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months;
8. Patients with a suspected or real history of alcohol and drug abuse;
9. Known allergy to the investigational drug or its components;
10. Other patients were deemed unsuitable for participation in this trial by the investigator.