cyrilzakka/clinical-trials huggingface dataset:
Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

The purpose of this study is to compare the effect of two educational interventions on adherence to blood pressure medications among adults with uncontrolled hypertension.

The study is a randomized controlled trial (RCT) consisting of a 4-session educational intervention (completed over the course of 4-8 weeks) and a 6-month follow-up period for adherence monitoring. Participants will be allocated to one of two educational intervention groups following a block randomization schedule, stratified on the hypothesized mediator variable of medication-related beliefs (high versus low scores on the BMQ Necessity-Concerns subscore) to ensure the groups are balanced on this variable. Primary endpoint is medication adherence at 6 month follow-up, defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period, measured by a pill bottle cap monitor (medication events monitoring device \[MEMS\]).

Eligibility Criteria:
Inclusion criteria are: (1) age 18 years or greater, (2) uncontrolled hypertension (BP above 140/90 mmHg), (3) Hispanic ethnicity, (4) Spanish or English-speaking, (5) at least one office visit at the study clinic in prior 12 months.

Exclusion criteria: Persons with stage 4 or 5 chronic kidney disease (CKD) will be excluded.
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Eligibility Criteria:
Inclusion Criteria:

* Age: 25yrs\~75yrs
* Fasting TG \<400mg/dL, LDL-C ≥130mg/dL
* 3months \> Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

* Type1 DM, Gestational diabetes
* Patient need to treat with Insulin
* Patient with operational treatment for severe diabetic complication
* Uncontrolled Hypothyroidism
* Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
* Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
* Renal disorder (Serum creatinine ≥ 2.0mg/dL)
* Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
* Creatinine Kinase \> 2.5 X UNL
* Gravida or lactation phase
* Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Identification of Molecular Biomarkers for Thyroid Cancer

This is a two part study; part A proposes to collect plasma samples to examine how ctDNA (circulating thyroid DNA) markers correlate with detection of recurrent disease, response to therapy, clinical outcome and pathological data. Part B aims to use tissue obtained from biopsies of primary or recurrent disease to establish cell lines and tumour explants to further investigate the biology of thyroid cancer in the preclinical setting

To collect blood and tumour tissue for Part A: molecular profiling, including extraction of DNA for sequencing, RNA for expression levels and to identify expressed fusion genes, and proteins for proteomic studies and Part B: for establishment of cell lines and patient derived xenograft (PDX) models of thyroid cancer.

1. To correlate BRAF V600E, RAS, RET/PTC, RET, PAX8/PPARϒ, βcatenin, p53, PTEN and PI3K mutations in ctDNA with Formalin Fixed Paraffin Embedded tumour tissue (FFPE) mutational analysis.
2. To correlate the quantity of ctDNA fragments 3 monthly in patients with advanced disease on routine follow up with conventional tumour markers (Tg, calcitonin, CEA).
3. To correlate the quantity of ctDNA fragments 3 monthly once relapse suspected by conventional methods (Tg, Calcitonin, CEA, radiological)
4. To correlate the quantity of ctDNA fragments with response (RECIST, Tg, Calcitonin and CEA) to targeted therapies
5. To assess prognostic significance of ctDNA levels in metastatic/advanced thyroid cancer
6. To isolate live tumor cells for studies of novel treatment strategies (combinatorial treatments), therapy resistance and thyroid cancer biology
7. Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites
8. To collect blood for analysis of noninvasive tests of tumour phenotype

Eligibility Criteria:
Inclusion Criteria:

* T3-4, N0-1b, M0-M1 thyroid cancer (papillary, follicular, poorly differentiated, anaplastic and medullary thyroid carcinoma).
* Patient able to provide informed consent
* Patient attending the Royal Marsden Hospital for inpatient or outpatient review
* Sufficient tissue sample available to perform analysis (archived or fresh)
* Adults \>16 years old

Exclusion Criteria:

* Patients unable to provide informed consent
* Thyroid lymphoma
* Metastases to the thyroid
* No histological confirmed diagnosis
* Only cytology available
How Easy-to-Follow Exercises Can Help Cancer Patients With Anxiety While Receiving Chemotherapy

Cancer is one of the main causes of death, and this study looks at how light exercise and stretching might reduce anxiety in patients receiving chemotherapy. The research took place in a hospital's daily care unit and used a study design where each patient was compared to themselves, measuring anxiety before and after the exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) with cancer receiving chemotherapy
* Signed patient consent

Exclusion Criteria:

* The denial of the patient
* The occurrence of side effects from the treatment (such as dizziness, nausea, severe fatigue)
* Patients with low cognitive level where they could not follow simple instructions
* Patients with hearing disorders that prevented them from following simple instructions
* Patients who could not mobilize independently.
Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial

Anxiety disorders are common pervasive conditions with serious psychosocial implications. Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency to interpret these sensations catastrophically, believing that they will have serious physical, psychological, or social consequences (Reiss, 1991).

Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et al., 2006). Unfortunately, access to effective psychological treatments is limited by a number of barriers such as a lack of treatment availability or qualified clinicians in an area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of a distance-based CBT program on decreasing AS among those with high AS. A distance delivery approach (e.g., via telephone) is one way to minimize treatment barriers and increase access to care while still delivering empirically supported treatment. Recent research suggests distance delivery is promising (Lovell et al., 2006).

The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's (2008) brief CBT for AS. The program will include weekly modules on psychoeducation, cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with high AS will be recruited and randomly assigned to the treatment condition or wait-list control (after twelve weeks the wait-list group will receive treatment). In the treatment condition, participants will be assigned weekly reading and homework from the treatment manual. In addition, a therapist will guide them through the treatment by providing individualized support and feedback through weekly half-hour telephone sessions. Treatment outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be assessed. We hypothesize that this treatment program will be effective in reducing high AS and anxiety symptom frequency and severity. We also expect this project to yield information about the utility of distance treatment delivery for mental health care.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* high anxiety sensitivity

Exclusion Criteria:

* cannot speak English
* illiteracy
* poor physical health (i.e., inadvisable to participate in physical exercise)
* engaged in another form of psychotherapy
* using pharmacotherapy for less than 3 months
* anyone who changes dose or type of pharmacotherapy during study
* psychosis
* suicidal ideation
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer

A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.

The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks' post surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy.

The primary aim of the present study is to investigate - in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment .

Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA.

Eligibility Criteria:
Inclusion Criteria:

* Surgically removed Adenocarcinoma of the colon or rectum
* Pathologically stage I or II disease, and radical resection
* Detectable ctDNA in two weeks postoperative plasma sample
* No indication for adjuvant chemotherapy according to DCCG guidelines (website)
* Age at least 18 years
* ECOG performance status 0-2
* Clinically eligible for adjuvant chemotherapy at investigators decision.
* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)
* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable •
* Written and verbally informed consent

Exclusion Criteria:

* Radiological evidence of distant metastasis, by CT- chest and abdomen
* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
* Previous treatment with 5FU or oxaliplatin
* Neuropathy NCI grade \> 1
* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
* Pregnant (positive pregnancy test) or breast feeding women
Food Supplement Treatment for Wasting Children in Indonesia

Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed.

Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 months (still included in under two years old children during the intervention period)
* Underweight children by weight-per-height less than -2.00
* Not received PMT Biscuits at the time of recruitment
* Parents agree to follow the research

Exclusion Criteria:

* Severe wasting (weight for height less than -3 Z-score)
* Severe food insecurity households (Severe Household Food Insecurity)
* Tuberculosis infection based on anamnesis
* The possibility of moving to another city within 6 months of intervention
Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.

A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls.

Skin biopsy from patients (psoriasis lesional and non lesional) \& control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis \& PCR.


Eligibility Criteria:
Inclusion Criteria:

* patients with psoriasis vulgaris
* patients over 18 years of age
* both sexes

Exclusion Criteria:

* patients on treatment for psoriasis within the last two months
* assoiciated autoimmune diseases eg SLE
* pregnancy
Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

A longitudinal study to examine the relationships among sleep characteristics, stress, and child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes

The purpose of this study is to examine the relationships among sleep characteristics, stress (allostatic load), and health among toddlers living in economically stressed communities. Sleep difficulty, including short sleep duration and poor sleep efficiency, is closely related to measures of stress, including interleukin (IL-6), cortisol, c-reactive proteins (CRP), secretory immunoglobulin A (SIgA), and body mass index (BMI) and may therefore contribute to 'wear and tear' on the body (allostatic load), a problem that places children at high risk of physical and mental health problems. Young children who live with socioeconomic adversity are especially vulnerable to both sleep difficulty and higher levels of physiologic stress (allostatic load).

Eligibility Criteria:
Inclusion Criteria:

* Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

Exclusion Criteria:

* If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.
Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study

To collect and analyze data on females with hemophilia so as to better define the difference between the study population and the male population with hemophilia.

This study is designed as an epidemiological study with retrospective clinical and genetic data collection and prospective quality of life (QOL) data collections and genotyping of subjects without current molecular diagnosis. Data on the genetic/chromosomal etiology of the condition will be collected through chart review. For those subjects who have not had molecular or cytogenetic analysis, molecular and cytogenetic testing will be offered after genetic counseling. Those subjects who agree to have genetic testing will have 5-10 ml of blood drawn and sent to the cytogenetic laboratory at Weill Cornell Medical College for testing to determine the chromosomal complement, and 5 ml of blood sent to Dr. Arupa Ganguly at the University of Pennsylvania for the identification of a factor VIII or factor IX mutation, and X-chromosome inactivation studies.

Eligibility Criteria:
Inclusion Criteria:

* Females with severe (FVIII\<0.01u/dl) or moderate (FVIII-0.01\<0.06 u/dl) hemophilia A
* Females with severe (FIX\<0.01u/dl) or moderate (FIX-0.01\<0.06u/dl) hemophilia B
* Willingness to participate in the study.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.
Smartphone Application in Reducing Dental Anxiety

evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test.

A total of at least 78 patients aged from 6-8 years will be included. All participants will be divided equally into two groups. Study group TPD using smartphone application and Control group (Tell-Show-Do) (TSD) using traditional behavior management technique.

Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be assessed during dental treatment

Eligibility Criteria:
Inclusion Criteria:

* School-age children aged from 6-8 years.
* Presence of carious primary molars without pulpal involvement.
* Parents have the ability to write, read and willingness to participate in the study.
* First dental visit to the clinic.
* Normal healthy children.

Exclusion Criteria:

* Children with previous dental experience.
* Medically compromised children.
* Children with special needs (physical or mental).
Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor

CARI Health aims to develop a methadone dose taken sensor that provides real-time data on interstitial fluid (ISF) levels that could be used as a methadone adherence monitor for daily doses. Use of such a monitor would allow for the physician, counselor, patient, and family member to remotely verify that a physician prescribed dose has been taken. Such a verification system can allow methadone clinics greater flexibility in the provision of take-home doses and thus retain more patients in the clinic.

Three specific phases and 9 aims are proposed for first-in-human studies of a remote medication monitor for dose taken in patients taking methadone for opiate use disorder.

Phase 1 detection over 3-6 hours (N=10)

Aim 1: Detect methadone and one or more of its metabolites in interstitial fluid (ISF) with differential pulse voltammetry (DPV) Aim 2: Correlate in vitro blood-based LC-MS and DPV Scans with Intradermal Microneedle based DPV Scans Aim 3: Accurately identify that a dose of methadone has been taken Aim 4: Determine the frequency and severity of any adverse events up to 6 hours.

Phase 2 detection over 12 hours (N=15)

Aim 5. Quantitate methadone and one or more of its metabolites in ISF with DPV over 12 hrs.

Aim 6: Determine the frequency and severity of any adverse events up to 12 hours

Phase 3 detection over 3 days N=20 ( 15 single dosed subjects, 5 split dosed subjects )

Aim 7. Quantitate methadone and one or more of its metabolites in ISF with DPV over 3 days.

Aim 8. Accurately identify a dose or half a dose has been taken Aim 9: Determine the frequency and severity of any adverse events up to 3 days

Eligibility Criteria:
Inclusion criteria for methadone group includes:

Age 18-70. A prescription for liquid methadone at a dose of 10mg or more. Taken methadone as prescribed in the last 2 days. Has been prescribed at least 3 take homes

Exclusion criteria for methadone group includes:

Age \<18 or \>70. A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, bleeding diathesis, recent blood donation, anemia, cancer, congestive heart failure, or tuberculosis. Any active severe depression (e.g., suicidal ideation) or mania symptoms.

Pregnancy, or intending to become pregnant during the course of the study. Patients determined to be unstable for enrollment or take homes by the Outpatient Treatment Program (OTP).

Under a conservatorship.
Effect of Teach-Back Method in Colonoscopy

This study aims to evaluate the effect of the training given to the relatives of patients undergoing colonoscopy with the Teach-Back Method on anxiety and knowledge level.

Research hypotheses:

H1: The training given with the Teach-Back Method decreases the anxiety level of patient relatives.

H2: The training provided with the Teach-Back Method increases the knowledge level of patient relatives.

Teach-back technique is an effective educational method that enables a person to rephrase what he/she has learnt in his/her own words to show that he/she understands. There is no study evaluating the effect of the education to be given with the Teach-back technique to the relatives of patients who will undergo colonoscopy. In addition, in this study, anxiety and knowledge levels of the relatives of the patients before and after the training will be discussed and will be a guide for future studies. The training to be given with the Teach-back technique will increase the level of knowledge of the patient's relatives and ensure that they know what to expect at every stage of the procedure. At the end of the study, the participants will be asked about their level of satisfaction with the Teach-back technique. According to the results of the study, it is expected that the use of Teach-back technique in the education of patients and their relatives will increase.

Eligibility Criteria:
Inclusion Criteria:

* To have the ability to communicate verbally,
* Volunteering to participate in the research,
* To be 18 years of age or older.

Exclusion Criteria:

* Lack of verbal communication skills,
* Not volunteering to participate in the research,
* Being under 18 years old.
Effectiveness of a Warm-Up With Foam Roller in Professional Basketball Players

The purpose of this study is to analyze the effectiveness of a foam roller warm-up on sports performance in professional basketball players.

Twenty-two professional basketball players, divided into two randomized groups, carried out a specific warm-up for three months with a foam roller. Three measurements were made, pre-intervention, post-intervention at 12 weeks and a four-week follow-up. In these measurements reference data were taken for jumping, ankle dorsiflexion and balance. During this protocol, they performed three series of sixty seconds of application with thirty seconds of rest between series, three days a week and applied to the calf muscles, hamstrings, quadriceps, gluteus and TFL.

Eligibility Criteria:
Inclusion Criteria:

* Masculine or feminine
* Minimum 18 years and maximum 30
* Professional players
* Practice 3 training sessions per week + competition on weekends

Exclusion Criteria:

* Musculoskeletal injury in the last 3 months
* Surgery in the lower extremity in the last year
* Present a diagnosed orthopedic or neurological pathology of the lower limb.