cyrilzakka/clinical-trials huggingface dataset:
Reducing Free Sugar Intakes: A Role for Sweet Taste

This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.

The primary objective of this randomised control trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugar. A total of 150 participants (age 18-65years) consuming diets \>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. All participants will be asked to reduce their free sugar intake to \<5% TEI, and to aid with this, they will be encouraged to reduce their intakes of specific foods identified as high in free sugars. Participants will also be advised to replace these foods with other foods dependent on their taste. Participants will be randomized to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) foods that are low in sugars, but high in other tastes; and 3) foods that are low in taste. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels at week 12.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years;
2. able to provide consent and complete all study materials;
3. consuming \>5% of TEI from free sugars;
4. residing in the South of England, and able to attend Bournemouth University for testing.

Exclusion criteria:

1. individuals who are pregnant or breastfeeding;
2. underweight (BMI \<18.5);
3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;
5. currently following a specific dietary programme (e.g.: Slimming World);
6. current smokers or have smoked within 3 months of the study start date.
Temperature Skin Check After Cryotherapy Application

The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.

It is a clinical randomized cross-sectional. This study was approved by the Ethics Committee of the Universidade Paulista - UNIP under protocol number 125 608 of 18/10/2012.

The study included 24 subjects randomly recruited from both sexes and from four different ethnic groups: white, brown, black and asian with different ages, individuals intolerant to cold, suffering any change in skin sensitivity, illness from infectious diseases or previously diagnosed to respond negatively to the use of cold were excluded.

The survey was conducted in the clinic Physiotherapy Universidade Paulista - UNIP in light and airy ambience, with recording of the mean daily temperature in degrees Celsius planned for the capital of São Paulo by newsletter Climatempo available and accessed http://www.climatempo.com.br/previsao-do-tempo/cidade/ Before all applications, the average temperature obtained in the days from the application was 21.93° Celsius.

For obtaining of personal data and anthropometric evaluations, a data sheet prepared by the authors to self-fulfillment, and then calculated the BMI of subjects, if in doubt, check the height and body mass was performed before the application of cryotherapy. Participants were divided into 4 groups of different ethnicities - white, brown, black and asian; ethnicity was proven through the birth certificates of volunteers, according to the classification described by the Brazilian Institute of Geography and Statistics - IBGE.

All participants were maintained in supine position for 20 minutes to rest and stabilization of body temperature, sleep after receiving an application through the cold thermal bag Thermo Gel ® brand size "P" consisting of a cellulose-based gel for subsequently receiving of cryotherapy in the middle third of the right thigh and left earlier, leaving 15-20 cm from the anterior superior iliac spine - ASIS side tested, depending on the stature of the individual being assessed and 5 cm away from the surface to be evaluated, according to manufacturer's instructions. The temperature was verified on site described before, during and after applications of cryotherapy which lasted for 30 minutes and then recorded. To check the temperature after application of cryotherapy was used a thermometer brand CASON ® INFRARED THERMOMETER AC 380 (- 32 º C 380 º C).

Eligibility Criteria:
Inclusion Criteria:

* belong to ethnic groups requested

Exclusion Criteria:

* suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold
Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement

This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.

Exclusion Criteria:

* The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.
3D Assessment of RV Function in Patients Undergoing LVAD Implantation

This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.

There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).

Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.

Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible to be included in the study if they receive either a left-sided:

  1. HeartMate III (Thoratec, Pleasanton, CA)
  2. HeartWare HVAD (HeartWare, Oakville CA)
  3. Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.

Exclusion Criteria:

* Patients will be excluded if::

  1. hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
  2. additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
  3. sternal closure at the end of the procedure is not possible
  4. RV mechanical support was introduced concurrently with LVAD implantation
  5. inadequate image quality required to obtain a 3D protocol
  6. known contraindication to TEE
  7. unexpected inability to advance probe into the mid-esophagus
TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.

Secondary Objectives:

To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.

To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.

To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.

To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.

To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.

To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.

To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.


Eligibility Criteria:
* Culture-positive, drug-susceptible pulmonary tuberculosis
Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.

Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy adults aged ≥ 18 years.
* Subjects have been informed properly regarding the study and accepted to be enrolled in this study.

Exclusion Criteria:

- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
Indonesia After Discharge LBW Infant HMF Supplementation Study

Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.

This is a prospective two arms parallel double-blind randomized clinical trial in LBW infants. Clinically healthy LBW infants discharge on oral feeding of human milk before 2 weeks of age (\< 15 days old) will be invited to participate in the study. Exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so.

After signing the informed consent by parent, subject will be randomized to one of four group. Randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. Study product will be labeled as A, B, C D in similar tin. Only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. Parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. Unblinded assistant will weight the tin before and after opening to estimate the HMF intake for 14 days.

This study will be conducted in several hospitals in Greater Jakarta.

Adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). These sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. The investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Low birth weight infants (1800-2499 g) with oral feeding
2. Exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/Kg BW/day) at discharge
3. Discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old
4. Live in greater Jakarta
5. Parents agree in writing to study participation and indicate their intention to follow study procedures.

Exclusion Criteria:

Any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment.

Participating in another intervention trial
AZD5423 Multiple Ascending Dose Study

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

OBJECTIVES:

* Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.

Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive adenocarcinoma of the pancreas

  * Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months
* No clinical evidence of gross residual disease at time of surgery

  * No focally positive margins (tumor at the margin)
* No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* More than 6 months

Hematopoietic:

* Granulocyte count greater than 1,500/mm3
* Hemoglobin greater than 10 g/dL
* Platelet count greater than 100,000/mm3

Hepatic:

* Bilirubin less than 2.0 mg/dL

Renal:

* Creatinine less than 2.0 mg/dL

Other:

* Able to maintain adequate oral nutrition
* Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study
* No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
* Non-metastatic prostate cancer allowed if more than 2 year survival likely
* No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent routine growth factors

Chemotherapy:

* No prior chemotherapy for pancreatic cancer

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior abdominal radiotherapy for pancreatic cancer

Surgery:

* See Disease Characteristics
Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma

This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.

Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.

Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

Study was cancelled by Sponsor prior to enrollment of patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C according to the Barcelona Clinic Liver cancer staging classification. - Current cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG performance status ≤ 1

Exclusion Criteria:

* Previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade ≤1 by the NCI-CTCAE. - Received any targeted therapy other than sorafenib.
* Active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - Clinically significant venous or arterial thrombotic disease within past 6 months.
Hypnosis: a Path to Appeasement

Hypnosis is a technique allowing the patient to focus his mental attention on a thought or a sensation, with the aim of reducing or modulating the intensity of a negative feeling or an ordeal encountered during the course of treatment. This tool can be used when patients are faced with chronic disorders (pain, anxiety, ...) or iatrogenic effects (nausea, asthenia, ...).

The patient is referred to hypnosis care by the doctor, psychologist or paramedics who follow him, when they detect a need.

Several scientific studies have shown the effectiveness of hypnosis in improving the quality of life of patients with breast cancer and in reducing pain during invasive procedures. On the other hand, in hematology, no research has measured the evolution of anxiety, over time, in patients receiving hypnotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old, fluent in French.
* Patients starting hypnotherapy for anxiety disorders.
* Anxiety score on the HADS scale (Hospital Anxiety and Depression Scale) greater than or equal to 8/21
* Patients with diffuse large cell B-cell lymphoma or follicular lymphoma, whatever the stage of the disease.
* Diagnosis announcement less than 2 months old

Exclusion Criteria:

* Persons deprived of their liberty by a judicial or administrative decision
* Adults subject to a legal protection measure
An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images

* The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization Transfer and Inversion Recovery) sequence provides at least as good visualization and detection of sub-endocardial scarring, fibrosis, and acute infarction as the current gold standard Inversion Recovery (IR) Turbo-Flash sequence.
* The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in detecting small sub-endocardial scarring than the inversion recovery segmented gradient echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the accepted current gold standard for the detection of myocardial viability.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age referred for a cardiac MRI with Gadolinium enhancement only at Advocate Lutheran General Hospital

Exclusion Criteria:

* \<18 years old,
* Adults unable to consent
* Adults for whom the MRI has not been previously scheduled
* Adults with an order for any MRI other than cardiac MRI with Gadolinium enhancement
Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B

Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Gestational age of 37 0/7 to 41 6/7 weeks.
* Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
* Adequate for gestational age and healthy infants.
* No other painful stimuli before study except for Vitamine K injection soon after birth.
* Interval from last feeding between 30 and 60 minutes.

Exclusion Criteria:

* Mothers that used opioid at gestation labor or birth.
* Delivery under general anesthesia.
* Apgar score less than seven in the 1st or 5th minute of life.
* Neonates that received any venous, arterial, capillary or spinal puncture.
* Any congenital malformation or CNS abnormality.