cyrilzakka/clinical-trials huggingface dataset:
Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of anticipated study procedures.

This study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and cardiovascular health risks (CV-H). Our team's central hypothesis is that medication adherence and cardiovascular self-care (and eventual glycemic control, cholesterol control, health care use/cost) will improve with an intervention tailored to the unique context of CV-H.

This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the CV-Homes treatment manual through test cases (n=8). With a hypothesis that the CV-Homes manual and study procedures will be feasible and acceptable to CV-H as measured by self-report and post-treatment interview.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 yrs. or older
* English-speaking
* Living at Catholic Charities' Endeavors residence (Minneapolis, MN)
* Self-reported diagnosis of moderate or high CVD risk, defined as being told by a medical professional that the participant has hypertension, heart disease, hypercholesterolemail, prediabetes, or type 2 diabetes
* Plan to stay in local area or be reachable by phone for the next 16 weeks
* Willingness to work on one or more CVD risk reduction behavior change

Exclusion Criteria:

* Active intoxication
* Active psychosis
* Presence of a legal guardian
* Pregnant or lactating people
A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation

This study is looking for a better way to define rectal tumors undergoing pre-operative radiation. MRI scanning generally results in more clear definition of the tumor that CT scanning. Insertion of radio opaque clips in the tumor site could also help to visualize the tumor better for radiotherapy treatment planning. The investigators believe both techniques would help the physician to define to cancer better than using CT scan alone. The investigators also will compare both techniques to define the better way to define the tumor.

1. The use of endoscopically placed mucosal metal clips to define the superior and inferior extent of the rectal tumor will improve the accuracy of tumor localization in patients undergoing non-contrast CT simulation.
2. A 3T-MRI will provide a better localization of the rectal tumor and pelvic nodes compared to non-contrast CT simulation for radiotherapy treatment planning.
3. By comparing these two novel methods to the standard procedure, we would be able to define any difference between the three methods and obtain an estimate of the accuracy and reliability of each method for the localization of the rectal tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with adenocarcinoma of the rectum stage as T3/4 N0/1/2 M0 undergoing pre-operative chemoradiation
* Patients must be 18 years of age or greater
* Signed study-specific informed consent
* Not pregnant or lactating

Exclusion Criteria:

* Contraindication for radiotherapy or chemoradiation
* Contraindication for MRI scanning
* Prior chemotherapy or radiation therapy to the pelvis
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

Methodology:

Design:

Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV.

Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Duration of study:

24 weeks from starting the DAAs

Methods:

Patients will go through examination and lab. Workup three times in this study:

* FIRST time:

  * Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC.
  * Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men \>40, women\>50).
* Second time:

  * At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
  * Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
  * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.
* Third and last time:

  * At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
  * Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
  * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients have positive HCV-RNA and taking DAAS to treat it.
* Both sexes will be included
* Age above 18 to 75 years old
* Child Pugh score ( A and B )

Exclusion Criteria:

* Total serum bilirubin\<3 mg/dl
* Serum albumin \> 2.8 g/dl
* INR≥ 1.7
* Platelet count\< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study.
* HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
* Extra- hepatic malignancy.
* Pregnancy or inability to use effective contraception.
* Inadequately controlled diabetes mellitus (HbA1c\>9%).
An Analysis of Diabetes Control in Puerto Rico

Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low compliance by providers with national guidelines iii) barriers impose by health insurance in control of diabetes mellitus iv) effectiveness of a disease management program for treatment adherence by patients.

Method (s) The study will consist of three phases:

i) assessment phase,

ii) multimedia health education campaign for patients, providers and local health insurances for adherence improvement

iii) reassessment phase.

Target Population:

Phase I: 600 Hispanic, male and female, residents of Puerto Rico with a diagnosis of type 1 and 2 diabetes mellitus older than 18 of age.

Phase II: 600 patients identified in phase I with individualize health education interventions on the importance of adherence to prescribed medical treatment. 2) Spanish speaking population of Puerto Rico, health service providers, and health insurance companies through a multimedia health education campaign.

Phase III: reassessment of the 600 patients of Phase I.

Data Collection Tools:

i) Demographic information will be obtained by an interview questionnaire. Patients will be assigned a control number automatically by the data system.

ii) Laboratory blood samples for A1C, lipids (total cholesterol, triglycerides and HDL cholesterol), and serum creatinine.

iii) A comprehensive educational adherence program with different media strategies such as: radio spots, newspaper articles, public service announcements, telemedicine services.

Data Analysis: Data will be analyzed using SPSS for Windows.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 and 2 diabetic patients older tha 18 years old

Exclusion Criteria:

* 1. Hemophilia.
* 2. Persons younger than 18.
* 3. Persons in research studies of some drug.
* 4. Persons using steroids.
* 5. Patients with acute infections.
* 6. Pregnant diabetic patients.
Effects of Binaural Beat Music on Elderly Sleep

Background:

Older people in long-term care institutions often have poor sleep quality and depression, which may negatively affect their health and welfare. Binaural beat music (BBM) has been proposed as a possible intervention. However, its effects on older people with poor sleep quality in long-term care institutions is still unclear.

Objective:

This study aimed to examine the effects of binaural beat music on sleep quality, heart rate variability, and depression in older people with poor sleep quality in a long-term care institution

Methods:

A single-blind randomized controlled trial design was employed and 64 older participants with poor sleep quality were recruited from a long-term care institution in Taiwan. Participants were randomized into the BBM group or control (sham) group (32 per group) and received 14 days of intervention. During the intervention period, participants in the experimental group listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien oldies. Questionnaires and heart rate variability analysis were used to assess participants' sleep quality, heart rate variability, and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were participants who: were aged 65 years and older, had a PSQI score\> 7, were able to understand questionnaire contents and communicate in Mandarin or Taiwanese Hokkien, stayed in institution for 1 month and more, and did not receive antidepressant within 3 months prior to and during the intervention.

Exclusion Criteria:

* Exclusion criteria were those with hearing loss, history of bipolar disorder or schizophrenia diagnosed by a physician, and had an acute physiological disease, such as cold, fracture, or trauma.
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.

The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with legal age
* Body Mass Index \>27kg/m2
* Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin \>=1500 mg/day for at least three months
* HbA1c \>=7% and \<=9% at screening visit

Exclusion Criteria:

* Weight loss \> 5 kg within three months prior to screening
* Presence of any clinically significant endocrine disease according to the Investigator
* Presence of type 1 diabetes
* Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
* Previous participation in a clinical study with rimonabant
* Absence of effective medical contraceptive method for females of childbearing potential
* Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
* Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants for moderate and severe Bronchopulmonary Dysplasia（BPD）.

BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe BPD.

Eligibility Criteria:
Inclusion Criteria:

1. The participants meet the diagnostic criteria for moderate and severe BPD established by the National Institutes of Child Health and Human Development (NICHD) workshop.
2. The participants have abnormal respiratory manifestations.
3. Written consent form signed by a legal representative or a parent.

Exclusion Criteria:

1. Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis.
2. The participants who have complex congenital heart disease.
3. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
4. The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.
5. The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
6. The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
7. The participants who have severe sepsis or shock.
8. The participants who is going to have surgery 72 hours before/after this study drug administration.
9. The participants who have surfactant administration within 24 hours before this study drug administration.
10. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
11. The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
12. The participants who have the history of other clinical studies as a participant.
13. The participants who is considered inappropriate by the investigators.
Therapeutic Effects of Combination Tape in Knee Osteoarthritis

Taping is a non-invasive technique that has been used for various musculoskeletal conditions, including knee OA. However, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee OA.

Osteoarthritis (OA) is a common chronic condition, characterized by progressive loss of joint cartilage, leading to joint pain, stiffness, and functional disability. Knee OA is one of the most prevalent forms of OA, affecting millions of people worldwide. Various non-surgical treatment options have been reported, one of them is taping techniques. Combination taping is a unique treatment option, where two different types of taping is applied. However, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee OA. So this study will be conducted to explore therapeutic effects in individuals who are suffering from knee OA

Eligibility Criteria:
Inclusion Criteria:

* second degree knee osteoarthritis

Exclusion Criteria:

* Sever obesity, sever osteoarthritis, history of knee surgery, allergy to the tape
Use of Ultrasound Technology to Check Proper Placement of Tracheal and Endobronchial Tubes

tracheal and endobronchial misplaced will be checked quickly qith US


Eligibility Criteria:
Inclusion Criteria:

* all general anesthesia with trachea and endobronchial intubation

Exclusion Criteria:

* regional anesthesia
The Effect of Podcast Use Student's Skills in Nursing Education

This study was conducted to find out the effect of the use of podcasts in nursing education on nursing students' speaking skills, affective awareness towards instruction, and success in the course and to serve as a source for prospective studies on the topic.

Objectives This study was conducted to find out the effect of the use of podcasts in nursing education on nursing students' speaking skills, affective awareness towards instruction, and success in the course and to serve as a source for prospective studies on the topic.

Design Randomized controlled trial. Settings A nursing faculty Participants Fourth-year nursing students who were studying at the faculty of nursing and were taking the "Academic Presentation Techniques" were randomly assigned to the experimental group (n=20) and the control group (n=20).

Methods Every week during the semester, students in the experimental group could listen to podcast episodes any time they desired following the course. Both before the podcast intervention and at the end of the semester, the Effective Speech Scale and the Scale of Affective Awareness Towards Instruction were administered to experimental and control groups. Final examination grades were evaluated as the indicator of success in the course.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old,
* Volunteer to participate in research

Exclusion Criteria:

* be under 18 years old,
* not voluntarily to participate in research
Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration

The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.

The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine


Eligibility Criteria:
Inclusion Criteria:

* Woman whose age is 18 years
* Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
* Woman ASA I and II
* Term = 37 LIMITED COMPANIES
* Woman primipare or not
* Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol

Exclusion Criteria:

* Minor Woman
* Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm \> 38.5 ° C)
* Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
* The surgical histories of laparotomy
* The morbid obesity BMI \> 35
* Dysgravidies
* Woman not being affiliated to the national insurance scheme
* Woman under legal protection
* Woman not having signed an informed consent
Estradiol and Brain Age

The ovarian hormone estradiol (E2) is suspected to have a neuroprotective effect on the brain. Further, it is associated with mental health and brain plasticity, function and connectivity. During the menstrual cycle, women experience fluctuation of E2. This is closely associate with neuroplasticity in regions with high estradiol receptor density, such as the hippocampus, anterior cingulate cortex, amygdala, hypothalamus, or the striatum. In the current study we are interested on the effects of E2 on the brain age, indicated by the comparison between the chronological age and the predicted brain age. In a double-blind within-subject study design, naturally cycling females during their follicular menstrual cycle phase (when their endogenous ovarian hormone levels are low) were either administered estradiol valerate (E2) or a placebo (PLAC) to rapidly increase E2 levels independent of other cycling ovarian hormones. Structural brain scans were assessed.

In this project we assessed regularly cycling females in their early follicular menstrual cycle phase with/without experimentally elevated estradiol (E2) levels in order to examine E2's effect on the brain age. Thus, women were scanned twice in the MR-scanner (E2 vs. PLAC; separated by at least 2-3 months) to deduce underlying structural changes. E2 vs. PLAC were administered in a double-blind, counterbalanced, randomized order. E2 has been administered orally (in total 12mg; two doses à 6mg on two consecutive days). All participants additionally underwent a neuropsychological assessment (demographical data, psychological and clinical data: structured clinical interview, anxiety and depression traits, mood, verbal intelligence, cognitive flexibility, emotion regulation traits, self-esteem). Blood samples were taken to assess endogenous gonadal hormone levels before and after E2/PLAC intake.

Eligibility Criteria:
Inclusion Criteria:

* Biologically females (assigned sex at birth)
* Regular menstrual cycle lasting between 26 and 35 days
* Right-handedness

Exclusion Criteria:

* Present or past mental, neurological or endocrine disorders, neurological or head injuries
* Use of hormonal contraceptives during the last six months
* Any other medication intake including intake of antidepressants or neuroleptics
* Past and present pregnancies
* Contraindication for MRI such as:

  * People with non-removable metal objects on or in the body
  * Tattoos if not MRI-incompatible according to expert guidelines
  * Pathological hearing or increased sensitivity to loud noises
  * Claustrophobia
  * Surgery less than three months ago
  * Restricted vision