cyrilzakka/clinical-trials huggingface dataset:
Examining Psychosocial Mediators of Exercise Behavior

The purpose of this study is to examine psychosocial mediators of exercise behavior.

BACKGROUND:

Physical inactivity is related to many health problems, including increased risk of cardiovascular disease, hypertension, and cancer. Despite the health consequences of a sedentary lifestyle, only 25 percent of Americans meet the recommended levels of physical activity. Researchers postulate that theory-based interventions effectively influence physical activity behavior by changing theoretical constructs believed to be important for behavior change (i.e., potential mediators), such as self-efficacy (i.e., confidence in one's ability to be physically active). Unfortunately, previous studies have generally failed to adequately test the mediating effect of theoretical constructs using appropriate statistical mediator analyses as recommended by leading behavioral scientists and statisticians.

DESIGN NARRATIVE:

The study will examine the mediating effect of theoretical constructs based on the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT). The study will address the methodological, measurement, and statistical limitations of previous studies. The investigators will randomly assign 420 healthy sedentary individuals to either a theory-based physical activity intervention or a contact control group. Physical activity behavior and the potential mediators will be assessed monthly over 12 months. They hypothesize that constructs based on the TTM and SCT (i.e., behavioral processes, cognitive processes, self-efficacy, and decisional balance) will mediate the relationship between group assignment (intervention vs. contact control) and physical activity behavior, such that the effect of the intervention on physical activity behavior relative to the contact control group will be attenuated when controlling for the mediators. They will also examine the importance of particular mediators for different population groups (e.g., age, gender), which will help to create more effective interventions for these groups. Finally, they will conduct a cost analysis to not only inform policy makers of the cost of delivering the intervention within our study but also to estimate the cost of delivering each component of the intervention (i.e., mediator). The analysis will estimate the cost of future refined interventions that incorporate those active components that affect the mediators and physical activity in this study. In summary, the study will identify which mediators (i.e., theoretical constructs) are most effective for increasing physical activity, which will have an important public health impact given that this will likely lead to more efficacious and less costly interventions.

Eligibility Criteria:
Inclusion Criteria:

* In good health
* Living a sedentary lifestyle
New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.

The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.

In a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence


Eligibility Criteria:
Inclusion Criteria:

* Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.

  * Epworth Sleep Scale \< 11
  * Pittsburgh Quality Sleep Index \< 6
  * Berlin Questionnaire: \< 2 positive categories
  * STOP BANG \<3
  * HADS normal
  * No RLS
* Group 2 (subjects with severe SAS - 2): AHI \> 30/h obstructive

Exclusion Criteria:

Non-inclusion criteria:

* Cardiac rhythm disorder
* Neurological or psychiatric pathology impacting on ANS
* Control group (healthy subjects - 1)

  * Complaint of sleep disorder
  * Known sleep disorder
* Experimental group (subjects with severe SAS - 2):

  o Associated sleep pathology at diagnosis of severe SAS
* Administrative reasons:

  * Unable to receive informed information,
  * Unable to participate in the entire study
  * Lack of social security coverage
  * Refusal to sign consent Exclusion criteria
* Control group (healthy subjects - 1):

  * Sleep pathology detected by polysomnography
  * Total sleep time less than 4 hours
  * Recording technically not usable
Identification of Liver Tumours Using BIP - Biopsy System

This clinical device investigation is conducted by performing liver biopsies using the BIP - Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours from surrounding tissue. In addition, user feedback is obtained to improve the usability of the investigational device. The study does not affect the traditional treatment procedure and only the patients in clinical need for diagnosis by liver biopsy are included on voluntary basis. The invasive products used in actual biopsy operation are designed so that their performance is essentially equal to the currently used biopsy devices, the only difference is the measurement capability of biopsy needle and connection to measurement device.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adults undergoing ultrasound-guided core liver biopsy to diagnose liver tumour or other abnormalities
* Identifiable non-tumorous liver tissue along the planned needle injection path.

Exclusion Criteria:

* Inability to give informed consent
* Being under aged
* Being pregnant
* Being high risk patient
* Lack of identifiable non-tumorous liver tissue along the injection path to the tumour location
* Known contraindications to liver biopsy.
Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)

Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients who do not take any drugs interfering with RAS. On the other hand expression analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.

After obtaining informed consent of patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum and descending colon.

Biopsies are investigated anonymously at the Institute of Physiology of the University of Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed with immunohistochemistry.

Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are measured.


Eligibility Criteria:
Inclusion criteria:

* Men and women aged 18-80 years
* BMI 18-35 kg/m2
* Group 1: patients taking daily RAS-active drugs, like ACE inhibitors or sartanes (treatment indication outside of this study)
* Group 2: no therapy with RAS-active drugs, like ACE inhibitors or sartanes Gastroduodenoscopy and/or colonoscopy with a treatment indication outside of this study
* Informed consent

Exclusion criteria:

* Severe pathologic alterations in the gastrointestinal tract (ulcers, tumors, celiac disease; GERD and gastritis are no exclusion criteria)
* Status after operations of the gastrointestinal tract (except uncomplicated appendectomy or inguinal hernia repair)
* Patients with malignant diseases
* Severe acute or chronic diseases which require treatment (e.g. renal replacement therapy)
* Patients with increased bleeding risk (e.g. oral anticoagulation, coagulopathy)
* Drug or alcohol abuse
* Mental disorders which limits the ability to fulfil all study requirements
Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect

PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease

Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.

Eligibility Criteria:
Inclusion Criteria:

1. Probing depth ≥7 mm at baseline
2. Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
3. Adequate keratinized tissue to permit complete tissue coverage of defect.
4. Radiographic base of defect ≥3 mm coronal to the apex of the tooth.

Exclusion Criteria:

1. Failure to maintain adequate oral hygiene (plaque index\>2)
2. Pregnant and lactating women
3. History of oral cancer or HIV
4. Periodontal surgery on treatment-targeted tooth within the last year.
5. Tooth mobility greater than grade II.
6. Study tooth exhibiting a class III furacation defect
7. Localized aggressive periodontitis
8. Radiographic signs of untreated acute infection at the surgical site
9. Recent history of smoking more than 20 cigarettes/day
10. Known allergy to E.coli-derived products
11. Using an investigational therapy within the past 30 days.
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years of age
* Written informed consent
* Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
* Good clinical condition as evidenced by history taking and physical examination

Exclusion Criteria:

* History of persistent hepatic, renal, cardiac or respiratory diseases.
* Clinical signs of acute illness at the time of entry into the study.
* Seropositive for antibodies against the human immunodeficiency virus (HIV).
* Pregnancy, lactation.
* Treatment with corticosteroids or immunomodulating drugs.
* Simultaneous participation in another clinical trial.
* Any previous history of allergy.
* Any concomitant vaccination or administration of immunoglobulin during the study period.
* Any abnormal laboratory value among the tests performed at screening
Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

The research will be prospective, randomised, placebo controlled and double-blinded.The research will be carried on with regards to Helsinki Declaration and following the guidelines of Good Clinical Practice.

The investigators plan this research to be prospective, randomized, placebo-controlled and double blinded. It will be held according to Declaration of Helsinki and in harmony with Good Clinical Practice guidelines. All patients would be required to sign informed consent, approved by the Ethics Committee of Clinical Hospital Center (CHC) Rijeka.

All patients will have at their disposal current medications for diarrhea based on guidelines, and education regarding side effects and dietary recommendations will be undertaken. One cohort will also ingest a probiotic (OMNi-BiOTiC® 10AAD), while other cohort will take a placebo, same in colour, shape, taste and smell; both medications will be taken 2 per day, every 12 hours, over 84 days (6 chemotherapy cycles every 14 days). After 84 days, a regular examination will be undertaken. Total follow-up would be for two full cycles, at least 160 days. (Stool analyses will take place before and after chemotherapy(6-8 weeks after chemotherapy) and eventually three month later) Patients will be followed up in six main control points, t1, t2, t3, t4, t5, t6, which all represent the 1st day of matching 2-week-chemotherapy cycle. Each cycle starts exactly and at least 14 days from the first day of previous chemotherapy cycle. There would be no additional invasive procedures done for this study, regular blood examinations will be expanded with additional parameters. All patients would have the right to withdraw their written consent to participate in the study at any given time and for any reason whatsoever. (fecal analyses only before and 6-8 weeks after the last chemotherapy cycle)

Eligibility Criteria:
Inclusion Criteria:

* A histologically confirmed diagnosis of colorectal cancer with metastasis;
* Patients older than 18 years of age;
* Patients starting first line of chemotherapy (FOLFIRI protocol);
* Signed patient consent form.

Exclusion Criteria:

* Present ileostomy;
* Decompensated patients;
* Terminal stage patients (\<6 months life expectancy);
* Patients not mentally able to adhere to the protocol;
* Patients using \>3 yoghurts per week or any other probiotics;
* Or any other condition which would not allow safe administration of the drugs.
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)

To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
2. Subjects with metastatic legion
3. Subjects aged 18 years or older
4. Subjects whose ECOG performance status is 0 or 1
5. Subjects who have laboratory value below; Hematology

   * Neutrophil \>= 1.5 x 109/L
   * Platelet \>= 75 x 109/L
   * Hemoglobin \>= 9 g/dL Liver function tests
   * Total bilirubin ≤ 1.5 xULN
   * AST, ALT ≤ 2.5 xULN
   * Alkaline phosphatase ≤ 2.5 xULN Renal function tests
   * Creatinine clearance \>= 30 mL/min
6. Subjects who understand and provide a written informed consent

Exclusion Criteria:

1. Subjects who have been administered an mTOR inhibitor
2. Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative
3. Subjects who participated in a clinical study using the study medication within 30 days before randomization
4. Subjects with clinically uncontrolled central nervous system (CNS) metastasis
5. Subjects with life expectancy of less than 3 months
6. Subjects with interstitial pulmonary disease
7. Subjects whose QTc interval is prolonged (QTc \> 450 msec for male or \> 470 msec for female)
8. Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug
A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Overall healthy adult Japanese males

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Assessment of Lung Structure and Function of Infants Born Prematurely

The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.

SPECIFIC AIM #1:

Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.

We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.

SPECIFIC AIM #2:

Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.

We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

* 37 weeks or greater gestational age
* Age 2 to 36 months

Group 2:

* 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
* Age 2-36 months

Group 3:

* 23-35 weeks gestational age

Exclusion Criteria:

Group 1 and Group 2:

* Congenital cardio-respiratory disease
* Hospitalization for respiratory illness
* Treatment with asthma medications
* Small for gestational age at birth

Group 3:

* Congenital cardio-respiratory disease
* Severe developmental delay
The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients

This prospective observational cohort study will investigate the impact of a bundle of nine preventive measures (Assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and ICU Diary) on the incidence and severity of Post-Intensive Care Syndrome (PICS) and clinical outcomes in critically ill patients

This is a prospective observational cohort study. It will include all adult patients, admitted to a surgical ICU (13 beds) and a medical ICU (10 beds), with a length of ICU stay of at least 2 day, from January 01 to December 31 2018. Patients with severe cognitive deficits prior to admission, identified by clinical history obtained by the psychology or through the Mental State Mini Exam (MMSE), traumatic brain injury and stroke patients with Glasgow coma scale \<14, will be excluded. On admission to the ICU, risk factors for PICS will be identified.

During ICU stay, the patients will be submitted to nine interventions aiming at the prevention of PICS: Assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and ICU Diary. At ICU discharge, the physical, psychiatric and cognitive components of PICS will be evaluated using the following tools: FSS-ICU, dynamometry and nutritional indicators (physical component), HADS (Anxiety and Depression), MOCA (cognitive dysfunction) and PCL -C (posttraumatic stress disorder). The duration of mechanical ventilation, duration of sedation, ICU LOS and hospital mortality will also be evaluated. Reassessments will be done 5 days after discharge from the ICU or at hospital discharge (what happens first) and 3 months after the randomization at the follow-up clinic. Patients identified with PICS at discharge from the ICU will be compared with those who did not develop the syndrome. The investigators will specifically evaluate the percentage of adherence to preventive measures, the presence of risk factors and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria: .

* Adult non pregnant patients
* Length of ICU stay of at least 2 days.

Exclusion Criteria:

* Severe cognitive deficits prior to admission.
* Traumatic brain injury with Glasgow coma scale \< 14
* Stroke with Glasgow coma scale \< 14
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.


Eligibility Criteria:
Inclusion Criteria

* Male or female patients undergoing first kidney transplant.
* Patients aged 18 -70 years.
* Patients receiving an ABO identical or compatible graft. Exclusion Criteria
* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
* Positive HBsAg test
* Pre-Transplant PRA \>50% or historical PRA \>75% Other protocol-defined inclusion/exclusion criteria may apply.