cyrilzakka/clinical-trials huggingface dataset:
MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

Patients will receive radiotherapy on the MR-Linac treatment machine. The primary end point is 2-year local-recurrence free survival. The secondary end points are objective response rate, 2-y PFS, 2-y OS, safety of treatment, dose coverage of targets and dose to normal organs.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* Histologically or cytologically confirmed mediastinal cancer
* Patients with inoperable mediastinal lesions
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
* Informed-consent

Exclusion Criteria:

* Patients with contraindications for MRI
* Previous radiotherapy or excision for mediastinal tumor
* The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
* A cavity over 2cm in diameter of primary tumor or metastasis Bleeding tendency or coagulation disorder
* Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
* The use of full-dose anticoagulation within the past 1 month
* Severe vascular disease occurred within 6 months
* Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
* Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
* Uncontrolled hypertension (systolic \> 150mmHg and/or diastolic \> 100mmHg)
* Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
* Urine protein 3-4+, or 24h urine protein quantitative \>1g
* Severe uncontrolled disease
* Uncontrollable seizure or psychotic patients without self-control ability
* Women in pregnancy, lactation period
* Other not suitable conditions determined by the investigators
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement

This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.

The study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). The investigators will recruit children at risk for obesity in Erie County, New York (N=100, 50 boys, 50 girls). The study will include 4 visits at baseline and follow-up visits at 6 and 12 months. At the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. The participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. Then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. Following this, they will complete the loss of control test meal again. At the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. Participants will be compensated for their time after each visit. The details of the measures and procedures are outlined below.

Eligibility Criteria:
Inclusion Criteria:

* Children (male and female) ages 8-11
* At risk for obesity or with obesity (defined as either having a BMI percentile that classifies the child as having overweight-BMI \>85th percentile but \<99th OR one + biological parent with overweight/obesity-BMI \>25)
* Rating of neutral or higher for 50% of the study foods
* Consumption of one of the study foods at least twice/week

Exclusion Criteria:

* Children below age 8 or above age 11
* Not at risk for obesity (defined as having a BMI percentile that classifies the child as having normal weight-BMI \<85th percentile without having a parent with overweight or obesity)
* Allergic to study foods
* Dislike of study foods (Less than 50% of the study foods rated neutral or higher)
* Does not consume at least one study food at least twice/week
* Current diagnosis of a clinical eating disorder (ED)
* Use of medications known to affect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
* Unwillingness to complete study visits
Transcranial Direct Current Stimulation in Post-stroke Fatigue

This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with stroke at least 3 months post-stroke

Exclusion Criteria:

Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip \<60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored \>11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis

Study is looking at the effects of cystic fibrosis treatment on bone muscle.

Cystic fibrosis (CF) is a complex multisystem genetic disease, with pulmonary and gastrointestinal consequences dominating the clinical picture. The life-expectancy of CF patients has increased through several therapeutic advances. Although respiratory failure remains the major cause of mortality in CF, musculoskeletal impairments contribute to major morbidity. In the general population, musculoskeletal conditions are among the most common reasons for seeking medical care, and the risk of osteoporotic fracture increases with age. As the CF population ages, the morbidity related to musculoskeletal effects may increase.

The etiology of CF related bone disease is multifactorial and includes effects of pancreatic insufficiency, poor nutritional status, vitamin D deficiency, glucocorticoid treatment, inflammation, hypogonadism, and sarcopenia, collectively resulting in attenuated bone mineral accrual and low bone density The effect of cystic fibrosis transmembrane conductance regulator (CFTR) modulating drugs on bone disease in CF has not been evaluated. Effects of CFTR modulators may help counter the bone and muscle consequences of CF either directly by effects on bone or muscle cells, or indirectly by improved lung disease, improved nutritional status, decreased systemic inflammation or glucocorticoid use, or subsequent increases in physical activity.

The rationale that underlies the proposed research is that better understanding of the bone and muscle effects of CFTR modulator therapies will help guide strategies to optimize bone accrual, prevent osteoporosis and fractures, and improve functional outcomes in the aging CF population. Set on the backbone of a longitudinal observational cohort study, the study will systematically and comprehensively evaluate changes in bone and muscle mass and strength from baseline to 12 month and 24 month time points among patients receiving CFTR modulator therapies and also among controls not receiving CFTR modulator therapies.

Eligibility Criteria:
Inclusion Criteria:

* documented, confirmed diagnosis of CF

  * Age ≥18 years old
  * \>21 days since the start of their last pulmonary exacerbation at the baseline visit
  * Provide signed written informed consent to participate

Exclusion Criteria:

* • Estimated glomerular filtration rate (eGFR) \<30 ml/min/m2 using the CKD-EPI equation,

  * Treatment with any osteoporosis medication within 6 months for oral agents or 1 year for intravenous or injectable agents (Subjects may participate if therapy stopped earlier than these time periods).
  * Current treatment with growth hormone or IGF-1
  * Currently pregnant or lactating or planning plan on becoming pregnant during the duration of the study.
  * Life expectancy less than 12 months
  * History of lung transplantation
  * Conditions that in the opinion of the investigators would interfere with the ability to collect or interpret the data, or put the patient at higher safety risk from study procedures.
ZOE-AFFIRM: Relative Validation of a Novel Food Frequency Questionnaire

Dietary assessment is critical for dietary research. Food Frequency Questionnaires (FFQ) measure habitual dietary intake and are low user and researcher burden. The ZOE AFFIRM study aims to assess the relative validity of a novel FFQ compared to a widely accepted 24h dietary recall tool in a remote setting.

Research Question:

What is the relative validity of a novel FFQ (Food Frequency Questionnaire) compared to a widely accepted 24h dietary recall tool in a remote setting?

Research Aim:

This study aims to relatively validate the ZFFQ (ZOE Food Frequency Questionnaire; ZOE Ltd) by assessing its agreement with a widely accepted 24h diet recall tool, Intake24 (Newcastle University) in a remote population.

Design:

This study will be conducted in a single-arm design with the intake period under assessment comprising one month.

1. Participants will complete two periods of 3 consecutive days each (one weekend-day and two weekdays, i.e. Sunday-Tuesday or Thursday-Saturday), in which they will complete 6 total rounds of Intake24 (one completion per previous 24 hours). The two periods must be at least 14 days apart; participants will be given multiple options of dates to choose from in November/December that satisfy these requirements.
2. Once the two recall periods are completed, the participant will be asked to fill out the ZFFQ recalling food frequency (without portion sizes) over the preceding month (which encompasses the two recall periods).

Population: In brief, participants are generally healthy UK-based adults who provided consent to participation in this remote study. Please see the eligibility section for full criteria. Participants provided consent before undertaking any study procedures.

Data analysis: Agreement analysis will be used to compare both dietary assessment methods and evaluate the relative validity of the ZOE FFQ.

Data collection:

* Baseline demographic data (age, sex, BMI, ethnicity, smoking, socio-economic status)
* Dietary data (FFQ and 24hr dietary recall)

Eligibility Criteria:
Inclusion Criteria:

* Can provide written informed consent
* Are willing and able to comply with all study protocols
* Are willing to complete their dietary recall periods on specified dates
* Have BMI 18 and above
* Are any sex
* Are aged 18 years old and above
* Live in England, Scotland, Wales or Northern Ireland

Exclusion Criteria:

- Do not meet the inclusion criteria.
Psychological Screening and Nursing of Twin Pregnancy

Objectives This research will screen the psychological problems of twin pregnant women step by step and detect early and treat early in order to reduce the incidence of mental diseases and promote the health of mother and baby.

Method Twin pregnant women recruited for the study.The two groups were given routine treatment and nursing measures. The trained group members were given routine psychological care to the control group, while the intervention group was given step-by-step psychological care at the same time.

Evaluate the effect

1. Evaluation methods include process evaluation and result evaluation. Process assessment means that the researchers use the pregnancy stress scale, self rating depression scale and self rating anxiety scale to assess the stress, anxiety and depression of patients at different stages, and make intervention decisions according to the score results; Results evaluation means that if the intervention is effective at a certain stage, the researcher can use it again
2. The evaluation indexes included PPS / SAS / SDS, incidence of preterm birth, premature rupture of membranes and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of intrauterine twin pregnancy.
* The patients whose psychological screening scale score reached the critical value (pregnancy stress scale \>50 and/or Self rating depression scale ≥ 40 and/or The self rating Anxiety Scale (SAS) was more than 50.
* The outpatient department of the research hospital was established and antenatal examination was carried out regularly.
* No mental and communication disorders (including depression and other mental diseases).
* Voluntary participation in this study

Exclusion Criteria:

* Pregnancy complicated with severe physical diseases;
* Drop out of this study due to various reasons (including abortion, unwilling to participate in this study)
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

Clinical Trial to Evaluate the Efficacy and Safety of CKD-342

A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients

Eligibility Criteria:
Inclusion Criteria:

1. male, female, Age: over 13 years(no age limiation in upper)
2. subject who has experienced perennial allergic rhinitis for over 1 year
3. subject who has identified allergens throughout the year within 12 months
4. subject who has the symptoms of moderate to severe allergic rhinitis
5. subject who can record the the patient diary during the clinical trial period
6. subject who agreed to keep the same environment during the clinical trial period

Exclusion Criteria:

1. Asthma
2. Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis)
3. Patients with untreated localized infection in nasal mucosa
4. Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable
5. Patients with abnormal following laboratory test results at screening

   * AST, ALT\>2times the upper limit of normal at screening
   * Serum creatinine \>1.5times the upper limit of normal at screening
6. Previous history of acute or severe chronic sinusitis within 30 days at screening
7. The continue use of drugs that may affect the efficacy of the Investigational product
8. Start the immunotherapy or a change of doge within 1 month, at screening
9. If you have glaucoma or cataracts, herpes simplex, or around the eyes
10. Chronic obstructive pulmonary disease (COPD)
11. history of hypersensitivity reactions and for treaties or major components of the IP
12. Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods
13. Alcohol or illegal drug abuse or dependence in patients
14. participation in any investigational or maketed drug within 4weeks preceding the screening visit
15. Patients that can not be participating in a clinical trial by investigator's discretion
Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification

The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.


Eligibility Criteria:
Inclusion Criteria:

* Resident of U.S.
* At least 18 years old
* Capable of reading English
* Member of panel assembled by survey provider

Exclusion Criteria:

* Individuals under 18 years old
Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women:

The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with radiofrequency in lipolytic activity and lipid profile.

The adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides.

Fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. Thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. When fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders.

Recently the effectiveness of an innovative physiotherapeutic intervention - radiofrequency on adipose tissue has been studied. This therapeutic modality stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, radiofrequency seems to aid in the reduction of adiposity. In addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines.

The aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. In this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. In addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, C-reactive protein.

This study purpose understanding whether an aerobic exercise session associated with abdominal radiofrequency increases the level of lipolytic activity; To analyse the effect of four intervention sessions on abdominal adipose tissue

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Idex between 18,5 Kg/cm2 and 29,9 Kg/cm2

Exclusion Criteria:

* pregnant or intending to be in a period of an year
* participants with smoking habits
* participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations
* participants with electronic devices
* participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies) participants under the effect of beta-blockers or other drugs which influence heart rate participants submitted to other fat reduce procedure
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's disease on treatment with Levodopa-containing preparations as an adjunctive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria.
* Parkinson's disease patients in Stages 2 to 4 on the Modified Hoehn and Yahr Scale. (mH\&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
* MDS-UPDRS partIII score of \>= 15. (Evaluation at ON state)
* Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
* Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Exclusion Criteria:

* Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
* Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
* Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
* Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
* Subject who have received administration of adenosine A2A receptor antagonist.
* Either of the following criteria consecutively at screening and enrollment; Resting Pulse \> 100 bpm Resting systolic blood pressure \> 140 mmHg, or diastolic blood pressure \> 90 mmHg
* Significant dementia or a Mini-Mental State Examination (MMSE) score of =\< 23.
* Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
* Anyone otherwise considered unsuitable for the study by the investigator or subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.
Peripartum Mental Health Cohort Study in Guangzhou

The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes.

Peripartum mental health problems (such as anxiety and depression), affecting more than 20% of mothers, is one of the most common complications around childbirth and gradually have become global public health issues. However, little is known about the course of peripartum mental health problems and possible fluctuations, as well as related risk factors among Chinese women. In addition, there are no effective prediction and preventive strategies for postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect the epidemiological, clinical information and biological specimens across pregnancy and childbirth to establish trajectory of peripartum mental health and identify the factors influencing the fluctuations and build a comprehensive prediction model of postpartum depression, as well as explore its adverse outcomes. This study would help to determine the timing of screening and target interventions to improve women's and their offspring's health.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with \<20 weeks of gestation
2. Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
3. Permanent residents or families intended to remain in Guangzhou with their child for more than 3 years

Exclusion Criteria:

1. Combined with heart disease, hypertension, diabetes or hyperthyroidism
2. Taking anti-depressants and other treatments for depression
3. Participants was in infection status when the biological samples were collected
Survey on the Effectiveness of the PLAB Examination in Continuing Clinical Education in British Doctors.

Online survey for all international medical graduate doctors who decided to get a job in the UK; they must do GMC registration.


Eligibility Criteria:
Inclusion Criteria:

* Post-PLAB exam and GMC registration international medical graduate
* Candidates who practise in NHS as FY1 and FY2

Exclusion Criteria:

* Pass PLAB one exam
* Pass PLAB two exam
* Candidates pass PLAB one and two but still not working in NHS