cyrilzakka/clinical-trials huggingface dataset:
Conduction System Pacing International Registry (CONSPIRE)

The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. In particular, this study will examine the use of conduction system pacing (CSP) in clinical practice. Information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments.

During this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. These approaches include His bundle pacing (HBP) as well as approaches which seek to pace the proximal left conduction system (LCS), including left bundle branch area pacing (LBBAP) or pacing in the region of the left posterior fascicle. Left ventricular septal pacing (LVS) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. These approaches utilize approved pacing systems and leads which are delivered to new targets in the His-Purkinje system or LV endocardial fibers. Despite the growing interest in HBP, LCS, and LVS, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes.

The goal of the Conduction System Pacing International Registry (CONSPIRE) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. The study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (CSP) as part of their routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or
* Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT).

Exclusion Criteria:

* Age \< 18 years
* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Pregnancy
* Difficulty with follow-up
Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care

This clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. The survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. The ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.

PRIMARY OBJECTIVE:

I. To determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app.

SECONDARY OBJECTIVE:

I. To validate the usability and effectiveness of the survivorship mobile application.

OUTLINE:

Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants then use the survivorship app for 4 months on study.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of childhood cancer attending Survivorship Clinic at University of California, San Francisco (UCSF) OR caregivers of a childhood cancer survivor attending Survivorship Clinic at UCSF.
* Must have a mobile device (smartphone or smart-tablet) with service plan.
* Must have ability to read, write, and understand English language.

Exclusion Criteria:

* An individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.
Endometrial Injury and Single Embryo Transfer

Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.

Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.

Eligibility Criteria:
Inclusion Criteria:

* woman age under 35 years
* history of primary infertility
* normoresponder (antral follicle count 5-10 in one ovary in early follicular phase
* having grade I or II embryos for transfer
* agree to undergo endometrial biopsy during the COH cycle. All patients were stimulated with luteal phase long protocol.

Exclusion Criteria:

* endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), any systemic disease, collagen disorder, hypercholesterolemia, sickle cell anemia, and a history of neoplasm; -high risk for or history of OHSS
* using any concurrent medication (e.g., insulin-sensitizing drugs, and GnRH antagonists)
* patients who did not proceed to follicle retrieval
* severe male infertility requiring TESA/TESA
* mullerian tract anomalies
* a history of endometrial instrumentation or surgery within a month of the study
* not agree to undergo endometrial biopsy during the COH cycle.
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Glucose of Obese Patients

Problem Formulation

1. Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers?
2. Does brisk walking affect blood glucose levels in obese sufferers?
3. Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers?
4. Is there a difference in the effectiveness between herbal bitter and brisk walking and the combination on blood glucose levels in obese sufferers?

Research Objectives

General Objectives :

The general aim of this research is to determine the difference in effectiveness between the herbal medicine Sambiloto and brisk walking as well as the combination on the blood glucose levels of obese sufferers.

Specific Objective :

1. Knowing the effect of herbal medicine Sambiloto on blood glucose in obese sufferers.
2. Knowing the effect of brisk walking on blood glucose in obese sufferers.
3. To determine the effect of the combination of herbal medicine Sambiloto and brisk walking on blood glucose levels in obese sufferers.

This type of research uses the Quasi Experimental method type Non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. The intervention group is divided into two groups, namely the group given the herbal medicine sambiloto, and the group given the Brisk Walking Exercise treatment. Quasi-experimental research design with research design in the form of two group pre test and post test design.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to be a respondent with informed consent
2. Obesity sufferers in the Jekan Raya District area
3. Have a BMI ≥ 25 kg/m2 (Obesity I)
4. Adult age (19-39 years)

Exclusion Criteria:

1. Not being present or out of town during the research
2. Unable to continue research due to serious illness or death
3. Withdraw while participating in the research
4. Have a history of drug allergies
5. Experiencing decreased consciousness
6. Experiencing an extremity injury
7. Have a history of cardiovascular disease, kidney disease or stomach ulcers
8. Have a history of bloody stools
9. Are pregnant or breastfeeding
DeepView Snapshot Handheld (DV-H) Comparison Study

his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn


Eligibility Criteria:
Inclusion Criteria:

.Age \>18 years and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so;

* Life expectancy \> 6 months;
* Thermal burn mechanism (flame, scald, or contact);
* The Study Burn(s) occurred less than 72 hours prior to the time of first imaging;
* Minimum burn wound size for patients is 0.5% TBSA per region
* Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn; and

Exclusion Criteria:

* Patients will be excluded if any of the following conditions apply:

  * Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints;
  * Subject has burns involving \> 50% total body surface area (TBSA);
  * Sepsis at the time of enrollment determined by diagnosis made by Principal Investigator or Sub-Investigator;
  * Immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment;
  * Concurrent use of investigational products with a known effect on the burn sites; and/or
  * Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.

Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.

Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.

Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).

The patients will be treated with Daylight Photodynamic Therapy, following these steps:

1. mild curettage of the AK lesions
2. application of a chemical sunscreen with sun protection factor (SPF) 30
3. application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face

Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.

Eligibility Criteria:
Inclusion Criteria:

-multiple (at least five) actinic keratosis on the face, grades I and II

Exclusion Criteria:

* phototypes IV, V and VI
* patients treated for actinic keratosis up to 6 months before
* history of allergy to methyl aminolevulinate
* history of photoallergy
* pregnancy
A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress?

Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

Participants will have access to the Digi-Coach chatbot during radiotherapy in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress? Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

A single-blinded parallel randomized controlled trial (RCT allocation ratio = 1:1) will be conducted, with baseline data collection at week 1 (T0) and three follow-up timepoints at week 8 (T1), week 12 (T2) following radiotherapy commencement.

Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discussed general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.

Participants in the intervention group will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and above
* are able to read and speak Cantonese or Mandarin fluently
* have a new, primary diagnosis of head and neck/laryngeal cancer
* are waiting to receive a full course of curative-intent, external beam radiotherapy with or without chemotherapy
* have a Karnofsky performance score ≥70
* have distress scored 3 or above on the NCCN distress thermometer

Exclusion Criteria:

* insufficient command of Chinese
* have any other factors precluding the ability to give informed consent or comply with the protocol
Helping Children's Centres to Enhance Home Safety

Many children have accidents, some are very serious and they are a major cause of death in children aged 1-4 years. Many accidents are preventable This study aims to find out the best way to help Children's Centres to provide home safety information about preventing fires to parents and carers of young children.

36 Children's Centres in four study centres, Nottingham, Bristol, Norwich and Newcastle will be recruited to the study. 30 families will be recruited from each Children's Centre. Children's Centres serving the most deprived populations will be eligible to take part.

Families will be eligible to take part if they have attended a participating Children's Centre in the previous three months, have parents who are 16 years or older, have a child under three years old and live within the catchment area of that Children's Centre. When 30 families have been recruited that Centre will be allocated, at random, to one of three groups. Children's Centres in group one will be provided with guidance about preventing fire-related injuries (an Injury Prevention Briefing (IPB))and help and support to implement the IPB, the second group will be sent the IPB and the third group will not be provided with the IPB ('usual care'). Children's Centres will devise their own programmes of safety advice for parents based on the IPB.

At recruitment and 12 months later, families and Children's Centres will complete questionnaires about fire safety practices. Children's Centres will also complete a paper-based tool about the implementation process at 12 months. Information about barriers and facilitators to implementing the IPB will be collected through interviews with Children's Centre staff.

The study will run from May 2011 to March 2014.


Eligibility Criteria:
Inclusion Criteria:

There are two levels of participation, Children's Centres as participants, who will be delivering the intervention, and families as participants, who will be receiving the intervention.

Children's Centres:

Phase 1 Children's Centres in the four study areas (Nottingham, Newcastle, Bristol and Norwich) Phase 2 Children's Centres in more disadvantaged areas (defined as those who have more than 50% of under 5 year-old children in their Centre catchment area who live in one of the 30% most disadvantaged Super Output Areas).

Families Any family who has attended the participating Children's Centre in the previous three months, who have a child under three years old, and lives within the catchment area of that Children's Centres.

Exclusion Criteria:

Children's Centres:

Phase 2 Children's Centres that are not in more disadvantaged areas as defined above and phase 3 or subsequent wave Children's Centres.

Families Families who attend a participating Children's Centre who do not have any children under the age of 3 years Any parent who is under-16 years of age.
Information Retention After Video (Augmented) Preoperative Anesthesiological Education

Patient education is continuously becoming more important to enable patients to participate in making decisions regarding their medical treatment. Specifically, this is also the case for preoperative education on anesthesia. Worldwide, there are many initiatives to improve preoperative patient education and subsequent level of knowledge of anesthesia, for example by using digital aids. The demand for such aids has increased significantly since the start of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic to facilitate remote preoperative anesthesiological screening. Although many videos to educate patients on anesthesia have been developed and circulate on the internet, there has been little effort to compare this method of educating patients with the traditional one-on-one conversation between the anesthesiologist and the patient.

Objective: To compare short, mid-and long term retention of knowledge after education on anesthesia by watching a video to the traditional one-on-one explanation by the anaesthesiologist.

Participants will be randomized into 4 arms. A control group that will only take the knowledge test after the consultation by the anesthesiologist, a baseline group that will take the knowledge test before and after the consultation to investigate the added value of a knowledge test to knowledge retention. The intervention group is divided into 2 groups. One group will see the educational video and take a knowledge test afterwards. The other group will see the educational video and visit the anesthesiologist afterwards and take the knowledge test after the consultation.

After 2 and 6 weeks patients will be asked to take the knowledge test again, to investigate knowledge retention.

The knowledge test that will be used is the Rotterdam Anesthesia Knowledge Questionnaire currently under development in the Erasmus MC Rotterdam.

Eligibility Criteria:
Inclusion Criteria:

* adults visiting the preoperative anesthesia clinic
* elective surgery
* able to read, write and understand the Dutch language

Exclusion Criteria:

* cardiothoracic surgery
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)

The study is a non-controlled retro- and prospective multi center patient registry study.

Subjects will be given a study ID number assigned at first brace fitting after consenting to partake. Participants will be asked to fill in a questionnaire either in electronic or paper version at first fitting. Additional follow up questionnaires will be implemented at 4 weeks, 6 months and 1 year post initial brace fitting. After that period patients will be contacted every year, until brace termination/ knee surgery or death.

This is a noninterventional registry study pertaining to knee OA braces. There are no comparative devices or treatments. Subjects are expected to follow the recommendations of the brace subscriber and other health care professionals at any time independent of their continuation within the registry.

Subjects will be enrolled at the clinic where their brace was prescribed or at the site where the brace was fitted.

There is no formal end date for this data registry. A revisit to this protocol may be motivated after 5 years, to assess if longer follow up is required.

For individual participants follow up will continue with annual questionnaires as long as the brace is in use. The questionnaires will be administered either through mail with a paper version, or through a link to an electronical version (ePRO). There is also a possibility of administrating the questionnaires as a phone guided interview, if that is a mean that serves the patient or clinics better. The planned follow-ups are at 4 weeks, 6 months, 1 year from brace prescription and then annually as long as participants are disposed as "ongoing" in the registry.

The questionnaires contains question about pain, function, medication, general brace use and quality of life question.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
* Older than 18 years

Exclusion Criteria:

* Younger than 18 years
* Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.
Psychological Profile of Women With Infertility in Egypt: A Comparative Study

The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women

Comparative cross sectional study

Eligibility Criteria:
Inclusion Criteria:

Control group:

* Pregnant women.
* At least one live birth.
* Age group 20-40 years.

Clinical group:

* Infertile women either primary or secondary according to (WHO,2013).
* Age group 20-40ys.
* Different levels of education.
* Different methods of treatment of infertility (medical or IVF)
* Half of them from rural area the other half from urban area.

Exclusion Criteria:

* Male factor of infertility.
* The women with psychiatric disorders.
* The women with physical and medical disorders.
* The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour).
* The women with history of intrauterine fetal death.
The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants

A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants with gestational age \<32 weeks or birth weight \<1500g
2. Parents agree to attend

Exclusion Criteria:

1. serious functional or organic diseases
2. severe congenital deformity
3. parents reject to attend