cyrilzakka/clinical-trials huggingface dataset:
Physical Activity as an Aid for Smoking Cessation

Including a tailored moderate-intensity physical activity intervention in a standard smoking cessation treatment program (pharmaceutical treatment and counseling) increases the chances of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight gain.

The main objective is to determine whether a tailored physical activity intervention involving moderate-intensity exercise is an added value to a standard smoking cessation intervention in term of likelihood of smoking abstinence.

The secondary objectives are 1) to determine whether this tailored physical activity intervention prevents weight gain, reduces withdrawal symptoms, stress and improve mood and self-confidence in quitting; 2) to assess the effect of this tailored physical activity intervention on body composition and leptin concentration.

We assess this intervention in a randomized controlled trial of 600 sedentary adults regular smokers recruited from the community allocated into one of the two groups (intervention group vs. control group) during a 10-week period and 3 follow-up visits (6 and 12 months follow-up). All subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy) and counseling. The intervention group attend the 10-week physical activity program blending moderate-intensity exercise (Swiss nationwide implemented program entitled "Allez Hop!") and lifestyle physical activity and the control group a 10-week health education program to ensure equal contact condition.

Eligibility Criteria:
Inclusion Criteria:

1. Current daily smoker \>10 or more cigarettes per day
2. Having smoked (on average \> 10 cigarettes/day) regularly for at least 3 years
3. Age between 18 and 65 years
4. Sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the Swiss Baseline Questionnaire.

Exclusion Criteria:

1. Current pharmacological agent use to quit smoking
2. Medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems
3. Presence of an unstable medical condition
4. Current or recent major cardiovascular event, such as recent myocardial infarction (\>12 months) or stroke, angina pectoris, major arrhythmia
5. Current psychiatric illness
6. Alcohol (\> 4 drinks/day for men and \> 3 drink/d. for women), or/and other substance abuse
7. Current or planned pregnancy
8. Systematic skin disease
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)


Eligibility Criteria:
Key Eligibility:

Inclusion Criteria:

1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
2. Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression
3. History of allogeneic stem cell transplantation
4. Age

   * Part A: ≥1 to \<12 years of age at the time of enrollment
   * Part B: ≥1 to \<22 years of age at the time of enrollment
5. Karnofsky or Lansky (subjects \<16 years of age) performance status ≥60

Key Eligibility:

Exclusion Criteria:

1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD
2. Received an investigational agent within 28 days before enrollment.
3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment
4. Progressive underlying malignant disease or active post-transplant lymphoproliferative disease
5. Any uncontrolled infection or active infection requiring ongoing systemic treatment
6. Known bleeding disorders
7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study is aiming at evaluating the characteristics of particle emission in subjects with different stages of chronic obstructive pulmonary disease (COPD) compared with healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, aged ≥ 18 years
2. COPD: Physician diagnosis of chronic obstructive pulmonary disease (COPD GOLD I to IV according to GOLD guidelines)9
3. Healthy smokers: current smokers with a history of at least 10 packyears and no signs of bronchial obstruction in spirometry (FEV1 \>= 80% pred, FEV1/FVC \>= 70%)
4. Able and willing to give written informed consent
5. Women will be considered for inclusion if they are:

   * not pregnant, as confirmed by pregnancy test, and not nursing
   * of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
   * of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence) - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study , implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
6. Available to complete all study measurements

Exclusion Criteria:

1. History of lower respiratory tract infection four weeks prior to the informed consent visit
2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to tuberculosis, bronchiectasis or cystic fibrosis)
3. History of drug or alcohol abuse
4. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
5. Inability to abstain from bronchodilators according to section 8.2 (Prohibited medication)
6. Risk of non-compliance with study procedures
Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device.

To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Objective of the research:

Primary To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Secondary

* To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g);
* To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated;
* To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor;
* To validate the accuracy of the Breezing® device.

Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device.

Benefits The advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iPhone or iPad of patients as a strategy to monitor metabolic control.

Eligibility Criteria:
Inclusion Criteria: over 18 years -

Exclusion Criteria: obesity

-
Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment

Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).


Eligibility Criteria:
Inclusion Criteria:

* Veterans aged 18 years or older;
* meets criteria for current PTSD;
* willingness to be randomized to either condition (e.g., EBP-Massed or EBP-TAU);
* decision to receive CPT or PE in a treatment planning session with a Durham Trauma Recovery Program clinic provider;
* ability to provide informed consent

Exclusion Criteria:

* High acute suicide risk;
* active manic symptoms that would likely interfere with treatment;
* active psychotic symptoms that would likely interfere with treatment;
* currently in a concurrent trauma-focused evidence-based treatment for PTSD
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females, 18 years of age or older
* Intubated and mechanically-ventilated
* Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
* Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
* Impaired oxygenation
* Clinical Pulmonary Infection Score (CPIS) of at least 6
* Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms

Exclusion Criteria:

* History of hypersensitivity to amikacin or other aminoglycosides
* Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
* Known or suspected bacteremia secondary to Staphylococcus aureus
* A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
* Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) \[Exception: Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\]
* Has been on mechanical ventilation for \> 28 days
* Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
* The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
* Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score \< 10
* Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage

The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.

Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* A mother with a child (0-3 years) from the African and/or Caribbean heritage
* Able to provide full consent for their participation
* A resident of the UK
* Able to complete a baseline assessment
* Score 5 or above on Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Less than 18 years
* Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
* Temporary residents are unlikely to be available for follow up
* Active suicidal ideation or any other severe mental disorder
* Non-residents of the UK
* Unable to consent
* Patients currently undergoing severe mental health treatment
* Unable to speak the English language fluently
* Other significant physical or learning disability
Effect of Monosodium Glutamate Supplementation on Gastric Emptying and Postprandial Nitrogen Kinetics

There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI 23 to 28

Exclusion Criteria:

* pregnancy
* allergy to milk protein
* gastrointestinal diseases
Assessing Better Bottles for Babies

This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.

Infants who gain weight rapidly have over 4 times higher odds of developing obesity as a child or adult; infants who are predominantly bottle-fed are at higher risk for excessive infancy weight gain and childhood obesity, yet there are not effective interventions to reduce excessive weight gain among infants who are bottle-fed. The investigators' preliminary work suggest that two novel intervention strategies are feasible and may reduce excessive infancy weight gain: reducing bottle size; and increasing bottle opacity. The investigators aim to test the independent and joint efficacy of these two intervention components among exclusively bottle-fed infants in a randomized, full factorial clinical trial. The investigators' primary objective is to measure the change in conditional weight gain z-score (CWGz) from birth to four months by study group. 4 groups are composed of two conditions: smaller bottles and opaque bottles, independently and in combination, via a 2x2 factorial trial design.

Eligibility Criteria:
Inclusion Criteria:

* Child is 3 days old to 1 month old
* Greater than 37 weeks gestational age at birth
* Birth weight greater than 3% for sex-specific WHO growth standard
* Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life
* Caregiver must speak English or Spanish as primary preferred language
* Caregiver age 18 years or older
* Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period

Exclusion Criteria:

* Multiple gestation
* Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth
* Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula
* Weight loss greater than 95% for population reference in the first two weeks of life
TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients

The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical practice, the intervals are usually at least three months. Regular flushing might lead to a decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not flushing the PORT-A-CATH® for 6 or 12 months.

Currently it is unknown if flushing a non-used PORT-A-CATH® every 4 weeks is a valid strategy to preserve its functioning. Even more, decision to keep the PORT-A-CATH® after completion of adjuvant therapy cannot be based on profound patient information as there exist hardly any data regarding PORT-A-CATH® related complications of non-used PORT-A-CATH®.

The proposed prospective, two arm trial aims to investigate if no flushing of a non-used PORT-A-CATH® over a period of one year has equal PORT-A-CATH® related complications compared to flushing the PORT-A-CATH® every 4 weeks.

The proposed trial also aims to examine the frequencies of PORT-A-CATH® related complications in non-used PORT-A-CATH®. The authors put up the hypothesis that there will be fewer port-a-cath related infections in the experimental arms compared to the infection rate mentioned in the literature up to 27 %, since the puncture of the PORT-A-CATH® and the administration of fluids are the main causes of infection.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients in curative setting, with port a cath Implantation for systemic chemotherapy, including neo-adjuvant and adjuvant chemo-immunotherapy and supportive therapy (e.g. parenteral Nutrition)
* Completion of curative Treatment with port a cath indication, operation included, regardless of a non-intravenous (subcutaneous or oral) given therapy (endocrine therapy, chemo-immunotherapy, radiotherapy)
* patients with pectoral port a cath systems
* No port a cath associated complications during curative therapy such as investigated events: persistent malfunction, thrombosis, infection of the port-a-cath (to puncture the port a cath under X-ray control is allowed except it results in diangosis of persistent malfunction)
* No therapeutic anticoagulant therapy (phenprocoumon/Marcoumar®, heparin)
* No evidence of metastatic disease
* ≥18 years
* Willing to participate

Exclusion Criteria:

* No signed informed consent
* Patients with port a cath systems other than pectoral port a cath systems (e.g. forearm port a cath System)
* Unable to attend control timepoints
* Use of the port-a-cath after the above defined curative treatment (within the investigational period)
* Willing to explant the port-a-cath
* Willing to become pregnant within one year after adjuvant treatment
* Patient with heparin-induced Thrombocytopenia (HIT)
Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine

The aim of this study is to show that the SPECT/CT whole body recording procedure lasting less than or equal to 30 minutes in a VERITON-CT™ camera, can be substituted for the classic procedure, giving at least equivalent information in searches for primary or metastatic neoplastic lesions.

Patients with thyroid cancer treated with iodine 131 will receive an iodine 131 activity of between 1100 and 3700 MBq delivered as a capsule orally to eliminate the remaining thyroid tissue. Hormone replacement therapy (HRT) is then started to correct the hypothyroidism.

3 days later, a 2D whole body recording will be associated with complementary Single Photonic Emission Computed Tomography CT scans (SPECT/CT). It enables visualising the fixation of iodine 131, provides information on the thyroid remnants left in place during surgical thyroidectomy and to carry out an extension assessment by visualizing the possible presence of metastases fixing iodine at the level of the regional lymph nodes or many distant sites, in particular, lung and bone.

In VERICATH study, the hypothesis is that this classic procedure could be advantageously replaced by a single full-body SPECT/CT recording of a limited duration (≤ 30 minutes), obtained with a camera state-of-the-art semiconductor device called the VERITON-CT™ (Spectrum Dynamics Medical) camera.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18, who have understood and signed the informed consent form.
2. Person suffering from thyroid cancer and for whom the multidisciplinary meeting has validated a treatment by iodine 131 (1100 MBq or 3700 MBq).
3. Person with no contraindication to carrying out the examination.
4. Person affiliated to a social security scheme.

Exclusion Criteria:

1. Person with a known allergy to one of the components of the radiopharmaceutical (Iodine 131 capsule).
2. Pregnant woman or woman of childbearing age and without suitable contraceptive means, or breastfeeding mother.
3. Person whose medical condition is unstable and/or unable to remain still in the supine position during recordings.
4. Person deprived of liberty by a judicial or administrative decision.
5. Person of full age subject to a measure of legal protection (guardianship, curators, safeguard of justice).
6. Adult person unable to express his consent and who is not the subject of a legal protection measure.