cyrilzakka/clinical-trials huggingface dataset:
Growing Responsible Fathers Descriptive Program Evaluation

The overall evaluation plan for the Growing Responsible Fathers program (Fatherhood PRIDE) will utilize both a process evaluation and an outcomes evaluation, and will include both quantitative and qualitative approaches. Pre- and post-test surveys will be used to measure short-term outcomes outlined in the logic model including whether or not there has been an increase in self-efficacy and knowledge related to personal finance, parent engagement, healthy relationships, and education. Pre-test surveys will be administered at intake and/or prior to program activity and post-test surveys will be conducted at the conclusion of the program activity.

The overall evaluation plan for the Growing Responsible Fathers program (Fatherhood PRIDE) will utilize both a process evaluation and an outcomes evaluation, and will include both quantitative and qualitative approaches. Pre- and post-test surveys will be used to measure short-term outcomes outlined in the logic model including whether or not there has been an increase in self-efficacy and knowledge related to personal finance, parent engagement, healthy relationships, and education. Pre-test surveys will be administered at intake and/or prior to program activity and post-test surveys will be conducted at the conclusion of the program activity.

Intermediate outcomes will be measured using a follow-up survey at six (6) months after completing the primary components of the program. The follow-up surveys will be administered via a variety of methods in order to increase response rates and will measure outcomes identified in the logic model such as knowledge and self-efficacy.

Additional attempts will be made online through an email invitation as well as with phone calls. Center for Community Initiatives staff will be responsible for conducting the follow-up surveys with the program participants. Focus groups will be conducted with a volunteer sample of participants at the end of their program workshops to assess satisfaction with the program, what worked, and what could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Fathers or father figure

Exclusion Criteria:

-
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)

This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.


Eligibility Criteria:
Inclusion Criteria:

* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease
* Electrocardiogram (ECG) shows no clinically significant abnormalities
* Is in good health

Exclusion Criteria:

* Pregnant or lactating females
* Has prior exposure to surotomycin
* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
* Participants 18 to 49 years of age that has taken any regular, prescribed, or over-the-counter medication
* Has any significant concurrent therapies
* Has a positive drug screen
* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
* Has donated blood or blood products in the 60 days preceding screening
* Is an active intravenous drug user or abuses alcohol
* Has had a malignancy within the last 5 years
* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
* Has received any antibiotics within 30 days prior to first dose of study drug
* Has known hypersensitivity to daptomycin
A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients

Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.


Eligibility Criteria:
Inclusion Criteria:

1. Time since initial diagnosis (of patient) not longer than six months previously
2. Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
3. Provision of informed consent
4. Aged 18 or over, either gender

Exclusion Criteria:

1. Inability to give informed consent
2. Insufficient German language knowledge
3. Cognitive impairment impeding handling of questionnaires
4. Severe psychiatric disease (acute psychosis or acute suicidality)
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction

The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.


Eligibility Criteria:
Inclusion Criteria:

* A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours.
* A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent

Exclusion Criteria:

* A person with known allergy or any contra-indication to active control.
* A person who has received heparin during more than 48 hours before inclusion in the study.
* A person treated with warfarin (oral anticoagulant).
* A person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage.
* A person who has had a stroke within the last 6 months.
* A person with uncontrolled hypertension despite antihypertensive therapy.
* A person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells).
* A person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis.
* A person who has a coronary bypass performed during the previous month.
* A pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control.
* A person who has received any investigational treatment in the preceding month.
HF Tissue Registry

This is a registry study. This is an observational, non-randomized, open, long-term project to collect biological samples (e.g. tissue and blood samples) in addition to clinical information and laboratory test results, from end-stage patients who undergo LVAD implantation and/or heart transplantation. There are no investigational treatments, drug or procedures associated with participation in registry activities.

Data collection will not immediately influence the course of treatment for any patient.

After informed consent is obtained from the patient, the blood samples will be obtained either during a procedure from access lines inserted for the procedure or they will be drawn when other ordered lab work is done at specific time points. While blood samples collection is preferred, it is not required, and the decision to collect blood samples will be left to the discretion of the investigator.

* Tissue samples will be obtained at the time of LVAD implantation by keeping the part of the left ventricular apex that the surgeon is removing in order to place the inflow cannula of the LVAD. No extra tissue sample other than the tissue that has to be removed as a part of a standard LVAD operation needs to be obtained.
* Tissue samples will be acquired from the failing heart at the time of heart transplantation, after it has been excised and a donor heart has been implanted in its place.
* Control tissue samples will be acquired intraoperatively during cardiac surgery wherein any amount of excised tissue is routinely discarded.

In some cases, when a patient has an existing LVAD implant for destination therapy, and is not eligible for cardiac transplant, and is not scheduled for cardiac surgery in the foreseeable future, the patient will be approached for consent for blood samples. In addition, consent to obtain intraoperative tissue samples is requested in the event cardiac surgery occurs and/or the device is explanted for any reason in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be in one of the following groups:

   1.1. Patients must be eligible for a -
   * LVAD implantation or
   * Heart transplantation 1.2. Patients must be scheduled for another type of cardiac surgery during which tissue is excised that would normally be discarded after surgery.

   1.3. Patients must have a VAD already implanted as destination therapy with no cardiac surgery scheduled at the time of consent.
2. Patients must agree to one or more blood and/or cardiac tissue sample donation(s), and longterm storage of these biological samples.
3. Patients must be \> 18 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

1. The patient or the patient's personal representative is unable or unwilling to give written informed consent for participation.
2. Patients who are less than 18 years of age.
Acromegaly - Before and After Treatment

The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.

Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed with acromegaly
* Age above 18
* Written consent

Exclusion Criteria:

- Pregnancy
FITLIGHT Reliability and Acute Training Effects

The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a Physical Activity Readiness Questionnaire
* BMI under 30

Exclusion Criteria:

* Color-blindness
* Fractures within the past year
* Musculoskeletal injury limiting sports activity within the past 6 months
* Anterior cruciate ligament (ACL) injuries within the past 5 years
* Medical conditions that do not have physician clearance to participate in exercise
* History of concussion
* Diagnosed cognitive impairments
* Untreated attention deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)
* Prisoners
* Pregnant women
* Smokers
Exploring the Impact of a Sleep App on Sleep Quality

Sufficient sleep is crucial for good health, yet a third of UK adults have impaired sleep quality. Therefore, there is urgent need for population-level sleep interventions. However, many sleep interventions (such as Cognitive Behavioural Therapy for Insomnia) are resource intensive and not widely available. Research demonstrates that smartphone interventions are an effective way to reach the wider population. However, many commercially available smartphone sleep applications focus on one technique, and hence do not tailor to the diverse needs of individuals. A new sleep app offers six different techniques, allowing individuals to shape their own journey to improved sleep quality. The investigators aim to test the sleep app's efficacy and gather user experience data to allow app optimisation. The study is a two-arm pilot randomised control trial (RCT). After recruitment and screening, baseline measurements will be taken: subjective sleep quality data will be collected using the Insomnia Severity Index (ISI) and the Consensus Sleep Diary from all participants and objective accelerometry data via an Oura Ring (worn on finger for a week) on a subsample of participants. Participants will then be randomised to the intervention or control. Intervention participants will be given free use of the sleep app for 3 months. Controls will be informed that they will not receive access to the intervention and will be asked to abstain from using any other digital sleep-based intervention during the 3 months. All participants will be given the ISI after each month and will be given the Consensus Sleep Diary to fill out for one week again after 2 months. The planned Oura ring follow-up after 2 months for participants who wore the Oura ring at baseline has been cancelled due to COVID-19. User engagement will be assessed using the Digital Behaviour Change Intervention Engagement Scale. Telephone interviews will also be conducted with 20-30 participants to explore experience of using the app, how the comparison group felt about being allocated to the control group and how the COVID-19 pandemic may have affected their sleep and other measures of the study. Change in self-reported sleep will be the primary outcome and qualitative user data secondary. Appropriate tests (such as an ANOVA or linear regression controlling for baseline sleep and testing for effect of group when using continuous data) and thematic analysis of qualitative interview data will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Own a smartphone

Exclusion Criteria:

* Having a clinically diagnosed sleep disorder for which they are currently being treated
* Frequent use (once a week or more) of any sleep medication
* Enrolment on another sleep trial
* Being unwilling to cease usage of other sleep apps for the duration of the study
* Pregnancy
The Influence of MitraClip on Apnoea Asleep

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.


Eligibility Criteria:
Inclusion Criteria:

* patient suffer on severe symptomatical mitral insufficience
* male and female patients is planned an interventional MitraClip examination
* Dyspnea with a NYHA (New York Heart Association) II - III
* an high logistic Euro-Score (\> 20)
* no execution of surgical intervention because of relevant comorbidities

Exclusion Criteria:

* younger than 18 years
* pregnancy and breast-feeding
* persons without mental ability of capacity to understand and follow the instructions of the investigator
* persons in dependence from the sponsor or working with the sponsor
* participation in other studies
Loop Drainage: Effectiveness in Treating Cutaneous Abscesses

In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I\&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I\&D method for cutaneous abscess in the ED.

Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups.

Control Group- standard I \& D method for cutaneous abscess.

Study Group- Loop Technique:

1. Gather all of your material and bring to bedside
2. Clean area with chlorhexidine or iodine swabs
3. Anesthetize area
4. Use your scalpel to make small 5mm incision at most fluctuant area of abscess
5. Explore cavity with your hemostat and break down loculations
6. Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can.
7. For larger abscesses can repeat step 5 thus creating several LOOPs.
8. Irrigate cavity with saline flush
9. Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides.
10. Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely.
11. Slide syringe out, and trim free ends of loop. Make sure loop is mobile.
12. Cover site with dry dressing. Follow-Up-

    * Wound check in 1-2 days
    * Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
    * Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Presents to ED with simple cutaneous abscess
3. Provides informed consent.

Exclusion Criteria:

1. Under 18 years of age
2. Abscess too small for performance of procedure
3. Signs of systemic infection
4. Need for hospitalization
5. Previously treated for current abscess
6. Clinician determines abscess would not be amenable to drainage by loop technique
7. Patients known to be pregnant
8. Incarcerated patients
9. Students / Employees of the facility
10. Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

The objective of this observational study is to ascertain follow-up vital status data for patients who were randomized (assignment of study medication by chance) and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014 and CR005947). This study is designed to evaluate the imbalance of deaths that were initially recorded in the double-blind (neither physician nor patient knows the treatment that the patient receives) phases of two of these studies. Data will be combined from three sources: the databases of the 3 previous studies, forms from investigators, and data acquired during the present study. Investigator will obtain consent from the patients or their informant for participating in the study. Data on vital status will be obtained either from the patient or informant after obtaining informed consent. If a patient does not provide informed consent, documentation of contact with the patient will suffice as evidence that the patient is alive. If an informant does not provide informed consent or a patient cannot be contacted, medical or death records or death registers will be consulted when necessary to determine if a death occurred. If a patient was found to have died, the investigator records the cause of death, date of death, and the adverse events (unwanted consequence that occurs during the course of the clinical study, but not necessarily because of study medication) leading to death, by a review of medical records, autopsy records, and/or death certificates.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)

Exclusion Criteria:

* Patients not enrolled in above referenced studies
Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients during controlled motion.

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients during controlled motion.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Subjects whom the investigator consider ineligible for the study
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
* Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.

Exclusion Criteria:

* Patients unable to take oral medications.
* Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
* Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Any investigational drug therapy within 30 days prior to enrollment.
* Patients with other causes of liver disease.
* Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
* Patients with history of alcoholism or with an alcohol consumption of \>40 grams per day.
* Patients who are clinically unstable.
* Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
* History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.