cyrilzakka/clinical-trials huggingface dataset:
Enlighten: An Adaptive Technology Weight Loss Intervention

The Enlighten study is an 8-week trial investigating the response to use of a smartphone diet and activity application. Participants are enrolled as part of a worksite intervention, and will receive the LoseIt! weight loss smartphone application, which requires participants to self-monitor dietary intake and physical activity, a component shown to effectively produce weight loss. The application will be programmed to deliver dietary intake recommendations during the first three weeks of the intervention. At the 3 week time point, self-monitoring adherence via the smartphone application will be assessed and those who are not responding will receive 4 weekly telephone coaching sessions. Those individuals who respond at the end of 3 weeks will be encouraged to continue self-monitoring on the application. All participants will also receive regular text messages throughout the trial. The importance of the proposed research lies in the objective to reconfigure weight loss treatment so as to achieve the intended outcome more efficiently and in a manner that allows greater reach.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 25-39.9 kg/m2
* Weigh no more than 300 pounds.
* Weight stable (no loss or gain \>25 lbs for the past 6 months)
* Not enrolled in any formal weight loss program
* Not currently taking anti-obesity medications
* Interested in losing weight
* Own an Android Smartphone or iPhone, be willing to install the Lose It! Application, and agree to join the Enlighten group which will allow study staff to view participant data using a private coaching interface.

Exclusion Criteria:

* Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
* History of diabetes requiring insulin supplementation
* Crohn's Disease
* Diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
* Require use of an assistive device for mobility (e.g., wheelchair, walker, cane)
* BMI greater than or equal to 40, weight greater than or equal to 300 pounds
* Hospitalization for a psychiatric disorder within the past 5 years
* Those at risk for adverse cardiovascular (CVD) events with moderate intensity activity
* Those who cannot read the study questionnaires will be excluded
* Those currently taking weight loss medication or committed to following an incompatible dietary regimen.
* Female participants may not be pregnant, trying to get pregnant, or lactating.
* Bulimia Nervosa
* Binge Eating Disorder
* Active Suicidal Ideation
* those on medications known to cause weight gain (e.g., prednisone)
* current substance abuse or dependence besides nicotine dependence
* low motivation to change that would interfere with program adherence
Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.

Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization.

Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements.

Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed non-small cell lung cancer (NSCLC)
* Stage IV disease
* Previously untreated disease (before first line treatment)
* No symptomatic brain metastases
* Performance status (WHO) 0-2
* FEV1 (forced expiratory volume one second) ≥ 1 L or \>40% of predicted
* Written informed consent
* Life expectancy ≥ 12 weeks
* Platelet count ≥ 100,00/mm3
* Hemoglobin ≥ 10 g/dl
* WBC (White blod cells) ≥ 3,000/mm3
* Kidney function allowing chemotherapy
* Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy
* Willing and able to comply with study treatment

Exclusion Criteria:

* Requirement for daily supplemental oxygen
* Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence
* Concurrent severe and/or uncontrolled medical condition, including any of the following:
* Angina pectoris
* Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) \> 40%
* Myocardial infarction within the past 6 months
* Clinically significant infection
* Psychiatric illness or social situation that would limit compliance with study requirements
* EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction

The purpose of this study is test the safety and tolerability of BMS-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Healthy Subjects (Part A and B)

* Healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* Subjects must be willing and able to complete all study-specific procedures and visits
* Additional criterion for Japanese subjects in Groups BJ1 to BJ3: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for \> 10 years, and both parents are ethnically Japanese)

Heart Failure Patients (Part C)

* Left ventricular EF \<45% and \>25%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF \<40% and \>25% as assessed by echocardiogram at Screening or within 3 months of first dose of study drug; left ventricular EF
* Heart failure is considered to be stable at the discretion of the Investigator (i.e., no acute cardiovascular \[CV\] events or hospitalization (including emergency room visits) for CV causes within 3 months of first dose of study drug
* Regular sinus rhythm at Screening and no history of atrial fibrillation in the past 12 months

Exclusion Criteria:

Healthy Subjects (Part A and B)

* Major surgery within 4 weeks of (first) study treatment administration
* Inability to be venipunctured and/or tolerate venous access
* Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug

Heart Failure Patients (Part C)

* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* Major surgery within 4 weeks of (first) study treatment administration
* Inability to be venipunctured and/or tolerate venous access

Other protocol defined inclusion/exclusion criteria could apply
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HER2 overexpressing invasive breast cancer.
* Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
* Plan for neoadjuvant chemotherapy.
* Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.

Exclusion Criteria:

* Bilateral breast cancer.
* Inflammatory breast cancer.
* Presence of known distant metastases.
* Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)

Observing a lack of research investigating the chronic physiological and psychological responses to this type of exercise training the aim of this study is to investigate the optimal training configurations of DoIT to produce positive effects on health, performance and quality of life markers in sedentary overweight or obese adults aged 30-55 years. The DoIT program will be performed in a small-group setting indoor or outdoor implementing a progressive manner for 12 months and using bodyweight exercises with alternative modes.

This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:

1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
2. a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
3. At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
4. After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
5. After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.

All participants will be randomly assigned to the following four groups:

1. Control group (no training)
2. DoIT-1 (1 session/week)
3. DoIT-2 (2 sessions/week)
4. DoIT-3 (3 sessions/week)

Eligibility Criteria:
Inclusion Criteria:

1. inactivity (no exercise participation for ≥6 months before the study; VO2max \<30 ml·kg-1·min-1)
2. age of 30-55 years
3. overweight/obese (BMI 25.0-39.9)
4. body fat percentage for women \> 32% and for men \> 25%
5. waist circumference for women \> 80 cm and for men \> 94 cm
6. medical clearance for strenuous physical training
7. no smoking for ≥6 months before the study
8. no diet intervention or usage of nutritional supplements/medications before (≥6 months) and during the study
9. no weight loss greater \>10% of body mass before (≤6 months) the study
10. no diagnosis or symptoms of cardiovascular, metabolic, pulmonary, renal, musculoskeletal or mental disorders

Exclusion Criteria:

Participants will be excluded from the study if they:

1. will not participate in ≥80% of total exercise sessions
2. will adhere to a nutritional intervention during the study
3. will modify the habitual physical activity levels during the study
Effect of Insulin Sensitization on IGF-1 Response to Growth Hormone in SGA Children

This study is aimed to determine if Metformin treatment in children born small for gestational age (SGA) who are being treated with Growth Hormone (GH) for short stature improves the response to GH by producing greater concentrations of Insulin-like growth factor -1 (IGF-1) in the blood.

Growth hormone treatment (GH) is recommended in children born small for gestational age (SGA) who fail to catch-up. SGA is a heterogeneous condition as reflected in the varied response to GH treatment. Variable generation and resistance to Insulin-like growth factor-1 (IGF-1), the most important circulating mediator of GH action may underpin this heterogeneity. An association between the variants in the genes related to lower insulin sensitivity and reduced IGF-1 and growth response to GH therapy in SGA children have been reported recently. The hypothesis of this study is that insulin sensitivity may be causally linked to the response to GH therapy, and adjuvant therapy with an insulin sensitizer may improve IGF-1 generation, decrease IGF-I resistance and optimise growth response.

To explore this hypothesis, this study aims to determine the effects of insulin sensitization using Metformin as an adjuvant to a fixed dose GH therapy for 6 months in short SGA children. The patients will be short SGA children between age 4 -10 years and identified from three paediatric endocrine units in Denmark, Ireland and the United Kingdom. In this mechanistic study 24 subjects starting GH treatment will be randomised in a 1:1 ratio to adjunctive Metformin or placebo for 6 months and followed-up for another 6months. The participants will receive GH treatment for the entire duration of the study (12 months) and will undergo an oral glucose tolerance test and dual-energy x-ray absorptiometry scan to determine glucose metabolism and body fat mass respectively at baseline and 6 months, and will have 3 monthly measurements of height, weight and skinfold thickness. The primary outcome will be the area under the curve of IGF-1 levels measured at 0, 1, 3 and 6 months. Secondary outcomes will include changes in insulin sensitivity, height, body fat mass and safety measures at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* SGA children eligible for GH treatment according to European Medicines Agency (EMA) and The National Institute for Health and Care Excellence (NICE) criteria
* Gestational age at birth \>28 weeks
* Age 4-9 years in girls and 4-10 years in boys
* Prepubertal at start of treatment
* Naïve to GH therapy

Exclusion Criteria:

* Known or suspected allergy to GH
* Previous participation in a GH trial
* Severe learning difficulties
* Previous or active malignancy
* Benign intracranial hypertension
The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms

This exploratory trial investigates the effect of a chicken extract supplement on mental energy and its potential underlying mechanisms of action among healthy adults using a randomized, double-blind, placebo-controlled clinical trial design. Mental energy is a multi-dimensional construct comprising transient feelings about fatigue, vigor and motivation and cognitive performance in terms of sustained attention and reaction time.

A sub-study investigates the immediate biochemical changes after taking chicken extract.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at 35-64 years of age
* Assessed by investigator to be in good health
* Normal cognition based on investigator's clinical judgement per the routine practice
* Modified PSQI score \> 5
* Agree to participate in the study and provide written informed consent
* Agree to abstain from herbal extracts or dietary supplements throughout the study period

Exclusion Criteria:

* BMI \< 18.5 or ≥ 27 kg/m2
* Concurrent pharmacological treatments
* Current systemic diseases or current/history of neurological or cerebrovascular diseases
* Active peptic ulcer, or a history of peptic ulcer within the last 2 years
* Medications or interventions in the last 4 weeks, which in the investigators' judgement could potentially affect the outcome measures
* Regular significant quantities of dietary supplements or herbal extracts (\> 2 times a week) in the last 4 weeks
* Regular excessive caffeine consumption, heavy alcohol consumption or heavy habitual smokers
* Any drastic changes in lifestyle (including diet, smoking, sleep, exercise, and mental and physical activities) in the last 4 weeks
* Not able to maintain the same lifestyle throughout the study period
* Inadequate visual and auditory acuity to allow neuropsychological testing per investigator's judgment
* Inability to undergo fMRI scan
* Any consumption of chicken extract supplement, or carnosine or anserine supplement, in the preceding 4 weeks
* History of allergy to caseinate, milk, or chicken meat
* Women who are pregnant or lactating or intending to do so
* Current enrolment in another interventional study
* Subjects who show unstable sleep habits during the previous month
* Excessive blood donation or blood drawn prior to baseline
Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

COPD is characterised by irreversible airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response. This inflammation can be amplified with flare-ups that are commonly seen in COPD patients. Pulmonary rehabilitation is one of the most effective methods of managing chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation has been seen to induce improvements in functional capacity and quality.

In healthy individuals, exercise has been shown to induce an anti-inflammatory response when performed regularly. However, the effects of exercise on inflammation in COPD are unclear. Our initial CIMPRES-COPD study has looked into the effects of short-term exercise, as part of pulmonary rehabilitation, on inflammation. However, this trial will examine the inflammatory response in COPD patients who are most active following pulmonary rehabilitation against those who are least active.

This study will split participants into 2 groups according to physical activity level following pulmonary rehabilitation. We will recruit 40 COPD patients who provided a sample in the initial CIMPRES-COPD study to explore inflammatory responses in those who are most active and least active. By better understanding the mechanisms of how long-term physical activity levels affects inflammation in COPD, we could design better interventions to increase physical activity levels following pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. \>10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio \<0.70 and FEV\<80%)
* Previously enrolled on pulmonary rehabilitation providing at least one sample for the CIMPRES-COPD trial.

Exclusion Criteria:

* Any unstable ongoing cardiovascular events.
* Other active inflammatory conditions (e.g. rheumatoid arthritis, cancer).
* Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis).
Provoked Craving Assessment

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers


Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

Exclusion Criteria:

* Any disease that may interfere with the absorption, metabolism or excretion of the study product.
* A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia
Decision-making After Sleep Restriction

The aim of this project is to investigate whether enhancing sleep intensity locally in the prefrontal cortex (PFC) can counteract a deterioration of cognitive control and therefore the previously described increase in risk seeking during chronic sleep restriction. To this end, a controlled, counter-balanced study, consisting of two weeks of sleep restriction will be performed. During one of the sleep restriction weeks, sleep intensity in the PFC will be non-invasively enhanced by acoustic stimulation of slow waves during sleep.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-21 years or 26-30 years,
* Right-handedness,
* Good general health,
* Good understanding of German language (as all information is provided in German)
* Signed Informed Consent after being informed.

Exclusion Criteria:

* Contraindications on ethical grounds,
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
* Known or suspected non-compliance, drug or alcohol abuse (\> 5dl wine/ \>1l beer daily),
* Regular medication intake,
* Enrolment into a clinical trial within last 4 weeks,
* Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
* Sleep disorders (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.),
* Sleep complaints in general or excessive daytime sleepiness (Pittsburgh Sleep Quality Index \> 5; Epworth Sleepiness Scale ≥ 11),
* Irregular sleep-wake rhythm (e.g. shift working),
* Long (\> 10 hours per night) or short sleepers (\< 7 hours per night),
* Sleep efficiency \< 80% in screening night,
* Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to or during the study),
* \> 5 drinks or food items containing caffeine per day,
* \> 5 cigarettes per day,
* Body Mass Index \< 19 or \> 30 kg/m2,
* Skin allergy or very sensitive skin
* Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision-making).
* Red-Green Colour-Blindness (as the Risk Task requires the distinction between red and green),
* History of claustrophobia,
* Known hearing disorder (as acoustic stimuli will be applied during sleep),
* Magnetic Resonance (MR) contraindication (such as pacemaker, implanted pumps, shrapnel, etc.; full MR Screening form will be filled out).