cyrilzakka/clinical-trials huggingface dataset:
QuitBet Phase II: A Digital Social Game That Pays You to Stop Smoking

This study is a randomized controlled trial (RCT) of QuitBet, a digital contingency management program for smoking cessation. QuitBet combines social gaming elements with participant-funded financial incentives in the form of a deposit contract. QuitBet "players" deposit (called the "bet") a specified amount of their own money into the game's "pot." All "winners" who achieve the game's goal split the pot equally, such that their bet is fully refunded plus they receive extra money from the forfeited bets of players who did not meet the goal. Participants (N = 550) will be randomly assigned to QuitBet or QuitBet-NS (deposit contract only, no social elements). All participants will be offered a second game after their first game (up to 8 weeks total game duration) and will be asked to complete a survey after each game and at 1 and 4 months after the end of the second game (3 and 6 months after the start of their first game). The study will compare QuitBet vs. QuitBet-NS on smoking behavior outcomes and examine potential mediators of outcomes such as motivation, engagement, and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Sufficient English fluency to complete study procedures
2. At least 21 years of age
3. U.S. resident of any state
4. currently smokes at least 5 cigarettes per day
5. has an email address
6. has a mailing address at which they can receive packages
7. owns an Internet-connected Apple iPhone or Android smartphone that is compatible with QuitBet
8. willing to deposit $30 via PayPal or a credit card
9. willing to receive financial incentives earned during QuitBet via PayPal or in a paper check sent by mail
Aerobic Exercise as add-on Treatment for Inpatients With Depression

The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).

Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.

Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. CG will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test. No other activities with moderate or high intensity are allowed throughout the intervention time.

All patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient treatment on the Depression ward
* International Classification of Diseases (ICD)-10: F32, F33 or F31
* HDRS-17\>16 Points
* written informed consent

Exclusion Criteria:

* Any physical condition that prohibits endurance exercise
* 3 or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes)
* pathological ECG
* BMI \> 35 kg/m2
* Pregnancy
* acute suicidal Ideation
* comorbid substance dependence (except nicotine)
* Major comorbid psychiatric disorder
* regular high intensity exercise prior to treatment
Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation

Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs.

In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits.

In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients.

Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.


Eligibility Criteria:
Inclusion criteria:

* exposed group: exposed caregivers and agents who worked in COVID units (medicine, resuscitation, screening) until their date of collection. An exposed agent or caregiver is defined by the entrance of rooms with a COVID-19 infection during their professional activity.
* low or unexposed group: caregivers or agents who have worked in non-COVID units in a non-COVID hospital

Exclusion criteria:

- refusal to participate
the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.

The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.

Eligibility Criteria:
Inclusion Criteria:

1. Identify the diagnosis of type 2 diabetes;
2. It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
3. eGFR ≥ 30 ml / min / 1.73 m2;
4. Age 18-75 years old, gender ＆ethnicity are not limited;
5. glycated hemoglobin ≤ 10%;
6. Blood pressure is controlled below 130/80mmHg

Exclusion Criteria:

1. Combine other ACEI and ARB application indications other than hypertension;
2. Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
3. Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
4. Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
5. Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
6. Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
7. pregnant or lactating women;
8. Patients who accepted other clinical trial studies on going ;
9. Patients who combined with serious diseases and dysfunctions in other organs.
Real-time Reminders To Decrease Late or Missed Meal Boluses

This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

Eligibility Criteria:
Inclusion Criteria:

1. Age 13 and over
2. On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
3. Willing to wear a CGM at least 70% of the time while in the study
4. Using an iPhone
5. Willing to wear an Apple watch on their dominant hand while awake
6. Missing or late in giving at least four food boluses in the previous two weeks
7. Understanding and willingness to follow the protocol and sign informed consent
8. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

1. Pregnant or lactating
2. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
3. Current treatment for a seizure disorder
4. Inpatient psychiatric treatment in the past 6 months

Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.
Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).


Eligibility Criteria:
Inclusion Criteria:

* Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement
* BMI \<35 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)
* Age ≤18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Expected life expectancy \<2 years
Virtual Reality Game Playing in Amblyopia Therapy

Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain".

Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children.

Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA \< 0.6 LogMAR) amblyopia, respectively.


Eligibility Criteria:
Inclusion Criteria:

- The best corrected visual acuity worse than 0.3 LogMAR

Exclusion Criteria:

* Patients with abnormal fixation
* Patients with neurological problems
* Patients with any types of ocular pathologies
Phamacological Reversal of Airway Instability During Sedation

The investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study in physostigmine versus placebo.

One of the most serious side effects of drugs administered for sedation is untoward respiratory events. The relative prevalence of such events is thought to be high, occurring in up to 41% of patients in some cohorts. Many specific drugs and combinations have been recommended for moderate sedation, particularly when provided by a non-anesthesiologist. The use of an opioid and a benzodiazepine is the most frequent combination, partly because the availability of antagonists for both drugs may make a "rescue" easier. However, this combination results in frequent respiratory arrhythmias (combinations of obstructions, pauses and changes in respiratory patterns).There has not been a comprehensive study of the mechanisms underlying the disruptions of respiratory rhythm caused by agents commonly used for moderate sedation. This specific research, and the line of research it opens, has the potential to make the administration of anxiolytics and analgesics safer for patients at high risk for respiratory events.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-45
* BMI below 25
* Healthy males

Exclusion Criteria:

* Psychiatric illness
* Substance abuse
* Airway disorders
* Bleeding abnormatlities
* Claustrophobia
* Sleep apnea.
The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation

After spinal cord injury (SCI), the muscular property altered due to the immobilization adaptation. The purpose of this study was to investigate the effect of remobilization with continuous passive exercise on the adapted paralyzed muscle properties after SCI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic spinal cord injury
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes

The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus

Primary Objectives:

* To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy
* To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy

Eligibility Criteria:
Inclusion Criteria:

* Those with Primary Hypertension and Type II Diabetes Mellitus (DM)
* Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent
* Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization.
* Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization

Exclusion Criteria:

* Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization
* Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening
* Those with a history of alcohol or substance abuse
* Those who are pregnant or nursing
* Those who have received other clinical trial drugs within 12 weeks prior to screening
* Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator
Study to Evaluate an Influenza Vaccine Candidate

The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion criteria:

* A male or female age 60 years or older at the time of the vaccination.
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
* History of hypersensivity to a previous dose of influenza vaccine.
* Previous vaccination against influenza within the 9 months prior to enrollment.
* History of confirmed influenza infection within the last 12 months.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment.
Comparison of Epidural Oxycodone and Epidural Morphine

The primary objectives of this study are to compare the efficacy of pain relief between epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean section and to compare the incidence and severity of pruritus. Secondary objectives are to compare other side effects of epidural administered oxycodone and morphine (nausea and vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean sections.

Undesirable side effects such as pruritus and nausea are common with epidural morphine and are thought to be due to mu-opioid receptor stimulation at the supra-spinal level. Recent studies of epidural oxycodone for abdominal and gynaecological surgery have shown that it is as effective as morphine with fewer side effects by this route. This has not been established in patients undergoing caesarean section. Oxycodone is a semi-synthetic opioid derivative that resembles morphine structurally and has similar lipid solubility. It has been reported that the analgesic action of oxycodone is more rapid in onset when compared with morphine and is mediated by kappa-opioid receptors in the spinal cord. The significance of our study would be to establish that epidural oxycodone reduces the side effects of pruritus of epidural morphine whilst still maintaining similar analgesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-2,
* aged between 21 to 50 years undergoing a term elective caesarean section and
* had consented for combined spinal-epidural (CSE) anaesthesia

Exclusion Criteria:

* concurrent opioid therapy,
* contraindications to CSE anaesthesia or any of the study medications,
* a history of pre-existing nausea and vomiting,
* failure to identify intrathecal space at time of anaesthesia,
* inadvertent dural puncture with the epidural needle and
* conversion of regional anaesthesia to general anaesthesia
Melatonin and Vaccine Response, Immunity, and Chronobiology Study

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

Vaccination is critical to public health and disease prevention. However, despite the many scientific advancements and vaccines on the market, they are not always fully effective. Adjuvants are often used to boost immunity, but they are associated with more side effects, possible allergic reactions and public mistrust that supports vaccine hesitancy. Many factors affect vaccine efficacy and host immunity. Sleep, circadian health and melatonin have been studied in the past to affect immune response to vaccines and infection. Patient education about better sleep habits and/or melatonin use are potentially safe, cost effective, and accessible interventions that may improve host immunity and vaccine effectiveness. However, neither have been studied rigorously and at this time, are not actively implemented in the clinical arena. Hence, we propose a study comparing vaccine immunogenicity based on sleep quality, chronotype, and exogenous melatonin.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Eligible to receive flu vaccination (at military hospital, DEERS eligible)

Exclusion Criteria:

* Allergy or contraindication to getting flu vaccine
* Pregnancy or likelihood of getting pregnant in next few weeks
* Medical history of doctor diagnosed immune-compromising condition (HIV/AIDS, cancer, diabetes, significant cardiovascular disease) or doctor diagnosed sleep disorder (insomnia, narcolepsy).\*Sleep apnea is an exclusion unless stable on treatment with cpap or oral device for more than3 months.
* Currently taking any immune suppressants or immunomodulating treatments (systemic corticosteroids, chemotherapy, etc, within the past 3 months) or sleep medication or supplement (including over the counter medications and melatonin, within the past 1 month).
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Prostate cancer confirmed by pathological findings;
2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
4. ECOG score of 0 - 1
5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy;
6. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria:

1. Any other tumor disease requiring treatment;
2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
3. A history of epilepsy or any condition that may lead to seizures;
4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases