cyrilzakka/clinical-trials huggingface dataset:
Reducing College Student Drinking by Integrating Self-Affirmation and Implementation Intentions

Two hundred and ninety-three college students who reported drinking in the past month were randomly assigned to condition in a 2 (self-affirmation: values vs. control writing task) x 2 (implementation intentions: formed vs. not formed) between-subjects factorial design. Participants first completed a self-affirmation or control writing task, then read an article describing the risks of drinking. Next, all participants reported their common drinking behaviors and contexts, and then selected two harm-reduction strategies making either general intentions to use the strategies or making implementation intentions to use the strategies. Alcohol consumption was measured 1 and 2 weeks after the experimental session.


Eligibility Criteria:
Inclusion Criteria:

* Must have reported drinking at least 1 drink in the last 30 days at time of first participation.

Exclusion Criteria:

-
Integrated Mental Health Care and Vocational Rehabilitation to People with to Common Mental Disorders

The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark

Background:

Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness.

Objective:

The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.

Method:

The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. A total of 800 participants with a common mental illness will randomly be assigned into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is difference between the two groups in time to return to work at 12 months.

Results/discussion:

This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria

* Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team
* Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks
* Resident in Copenhagen or Aarhus municipalities
* Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter
* Aged 18 or older
* Has given informed written consent

Exclusion Criteria:

* Pregnant
* High degree of suicidal ideation
* Dementia
* Abuse of alcohol or other drugs to the degree that participation in therapy is not possible
* A need for mental health treatment in secondary sector care
* Unstable somatic condition that is too severe for participation in the project
* The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group
Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction.

Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Thus, this analysis is of great scientific and therapeutic importance. Within the above, the objective is to use an autogenous connective tissue graft in order to eliminate the need to raise the full-thickness flap and compensate for soft tissue deficiencies, which may reduce dimensional losses after extraction, in addition to reducing the cost of the technique.


Eligibility Criteria:
Inclusion Criteria:

* Systemic health (absence of Hypertension and Diabetes);
* Indication of dental extraction of at least 2 teeth (with at least 2/3 of bone support, in the region of premolars or molars with indication for extraction;
* Signature of the consent form;
* Individuals over 18 years old.

Exclusion Criteria:

* Presence of periodontal disease at the time of surgery;
* Pregnant and lactating women;
* Smokers;
* Be under orthodontic treatment;
* Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonates group;
* Individuals under 18 years old.
Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)

Chest pain is a common clinical complaint. About 30% patients with chest pain will have a normal coronary angiogram and are described as having noncardiac chest pain (NCCP). It is estimated that 25% of the population complain of chest pain at some time in their lifetime. The pathogenesis of NCCP is unknown. Esophageal hypersensitivity as a result of inflammation is considered to be an important mechanism in the development of this pain sensation. Little is currently known about the interaction between inflammatory mediators and peripheral afferent nerve terminals in the esophagus. The mast cell is one of the most enriched pro-inflammatory cells in the gastrointestinal tract. Activation of the mucosal mast cell releases a variety of mediators into adjacent tissues. We hypothesize that mediators released by mast cells sensitize esophageal nociceptors and induce pain sensation.

1. Key Objectives: To determine the density and activation of esophageal mast cells in non-cardiac chest pain patients. We expect to find mast cell activation, as measured by mast cell count or degranluation, tryptase staining, and histamine release, will be greater in NCCP patients compared to controls, and the increased mast cell activation will correlate with the severity of NCCP. These results will expand our understanding of the pathogenesis of esophageal originated NCCP, and allow the development of new diagnostic and treatment options.
2. Study Population: (i) NCCP (ii) Reflux esophagitis (iii) Control subjects.
3. Summary of Procedures: (i) symptom assessment by chest pain questionnaire; (ii) esophageal reflux evaluation by review of records of 24-hour pH monitoring; (iii) evidence of esophagitis by endoscopy; (iv) esophageal biopsy by endoscopy; (v) mast cell activation study in biopsy specimen by mast cell count, tryptase and Transient receptor potential vanniloid-1 (TRPV1) staining, and histamine release assay.
4. Major Risks \& Discomforts: There are no major risks \& discomforts other than involved in standard upper GI endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* NCCP - presence of a history of chest pain with a negative cardiac evaluation, no evidence of gross esophagitis on endoscopy, and lack of any exclusion criteria; Reflux esophagitis - presence of chest pain or heartburn, negative cardiac evaluation, lack of exclusion criteria and presence of esophagitis on endoscopy;
* Controls - lack of history of chest pain, lack of exclusion criteria and lack of esophagitis on endoscopy. It is anticipated that patients being evaluated for heme positive stool or GI bleeding would be included as controls.

Exclusion Criteria:

- History of ischemic heart disease, history of asthma, significant food allergies, celiac disease, chronic inflammatory conditions (SLE, rheumatoid arthritis), atopic skin disease, varices, coagulopathy, recent drug treatment with steroids.
Construction of the Therapeutic Alliance Between Inpatient Psychiatric Patients and Nurses

Clarify the determinants of the construction of a Therapeutic Alliance (AT) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric Whether the quality of Therapeutic Alliance influences the continued support outpatient , after completion of full-time hospitalization.

This is a prospective, observational, multicenter inpatient units Parisian full time of the Etablissement Public Health White House (spread over 4 sites).

The study seeks to collect, on the one hand the level of AT obtained at the end of hospitalization in general adult psychiatry and, secondly, to understand how this one was built.

The AT will be measured:

* Firstly by the self-administered questionnaire STAR-P, translated into French by the "translation / back-translation" method.
* Secondly through semi-structured qualitative interviews, conducted at discharge by a health care setting or a specially trained and who did not participate directly in the patient's care included. Indeed, the questionnaires allow, through scales to measure the AT quantitative way through proposals (items) presented as so, and look for associations with some predefined decisive.

However, it is difficult to explore more complex combination of mechanisms. Conducting interviews can meet this goal. An interview grid will be conducted and organized around the search for representations and affects related relational patient / nurse(s) and caregiver(s) in the context of hospital care. The interviews will be recorded and fully transcribed. A thematic analysis will be conducted to identify the objects and themes. The inclusions in this qualitative analysis will stop when reaching the saturation process. In this type of study, it is generally necessary to include thirty people to reach saturation.

Finally, semi-structured group interviews (focus group) will be conducted by co-investigators and doctoral student psychologist caregivers with the discussion topic imposed: the AT construction. They will be directed to paramedics caregivers (nurses and caregivers) are not part of the investigation team conducting research but actively involved in care. Their goal will be to harvest their representations regarding the quality of the therapeutic relationship they're trying to build with patients. A focus group will be conducted by site (4 sites), with 5 to 12 volunteers per group.

Eligibility Criteria:
Inclusion Criteria:

* adult patient (\>18 years old)
* Adult psychiatric inpatients

Exclusion Criteria:

* Patients carrying perversion disorder or paranoia
* Patients trust whose legal representative refuses participation in the survey
* patients non covered by the french health system
* non consenting patients
Linagliptin in Schizophrenia Patients

Approximately one third of patients with schizophrenia show a poor response to standard treatment with antipsychotic medications. This treatment resistant group of patients represents a major challenge in everyday psychiatry, and consumes a disproportionate amount of time from the clinicians, resulting in considerable costs to the society and government. Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered in patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We postulate that this may play a role in the neuropathology of schizophrenia patients and by inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be able to improve and even ameliorate the symptoms of schizophrenic patients. However, until now there have yet any studies on the potential of these inhibitors in schizophrenia patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor, linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment, which will establish the feasibility of a larger trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above
* Diagnosis of schizophrenia.
* Clinically stable antipsychotic regimen for the last 3 months
* A total score of 80 or greater at baseline on the Positive and Negative Syndrome Scale
* Competent and willing to provide written, informed consent

Exclusion Criteria:

* History of substance dependence within the past 2 months
* Existing relevant physical health problems: such as uncontrolled cardiovascular disease and impaired liver/ renal function
* History of diabetes
* History of hepatic or biliary diseases / biliary obstruction
* A serious suicide/homicide risk in the opinion of the investigator
* Known allergy to linagliptin
Social Decision-making (SOCIAL-DECISION)

The purpose of this study is to investigate neural mechanism of healthy humans underlying group decision making and compare it with that of individual decision-making. Using functional neuroimaging technology combining with computational modeling, we examine how the human brain process social information to make a decision within a group, which often guides humans to make a better decision using collective wisdom.


Eligibility Criteria:
Inclusion Criteria:

* healthy human adult
* normal vision

Exclusion Criteria:

* depression
* potential addiction to alcohol/ nicotine
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma of at least 6 months duration.
* Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.

Exclusion Criteria:

* Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
* History of ventilator support for respiratory failure secondary to asthma.
* Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
* History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
* Inability to correctly use an oral MDI or a DPI.
* Participation in this study at another investigational site. Participation in a different investigational study at any site during the same time frame of this study.
* Randomization into this study more than once.
* Direct association with either the administration of the this study or the study staff.
Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough

Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the existence of a bronchial inflammation. In the management of chronic cough, the search for bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the prescription of inhaled corticosteroids. It has been shown recently that the existence of an HRB with Methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.

It is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial provocation test with mannitol. In a retrospective study, it was shown that an increased value of FeNO (cut-off \> 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.

The purpose of this study is to show that the use of the prospective value of exhaled NO can predict response to treatment with inhaled corticosteroids in adult with chronic cough. In addition we will assess the interest of the prognosis of bronchial provocation test with mannitol in this indication.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Cough during 2 months
* Social Security regimen affiliated
* Consent form signed

Exclusion Criteria:

* Smoking active
* Treatment with angiotensin converting enzyme inhibitor
* Clinical signs of obvious gastroesophageal reflux
* Clinical rhinosinusitis
* Recent respiratory infection (\< 1 month)
* Corticosteroid Treatment(oral or inhaled) within 2 weeks
* VEMS \< 1 L or \< 80% of the theoretical value
* Existence of an obstructive ventilatory disorder defined as a report (FEV/FVC) \< 90% of the theoretical value
A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection

To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.

The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.

The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older with body weight \>40kg
* Written informed consent
* Presented within 48 hours of onset of influenza-like illness
* Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:

  * Clinical criteria

    * Fever \>38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
    * At least one upper respiratory tract infection (cough, running nose, sore throat)
  * Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms

Exclusion Criteria:

* Age below 18 years
* Persons who lack the ability to care for themselves
* Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
* Pregnancy or lactation
* Coexisting liver disease
* Coexisting cardiovascular disease except stable hypertension without complication
* Coexisting chronic pulmonary disease
* Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
* Renal failure
* Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
* Known intolerance to oseltamivir or zanamivir
* Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
* Subjects who have received oseltamivir as prophylaxis for H1N1 infection
* Subjects who have received any investigational drug within 1 month prior to study entry
* Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma


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

Inclusion Criteria:

* Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
* No prior systemic therapy for RCC with the following exception:

  i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion Criteria:

* Any active CNS metastases
* Any active, known or suspected autoimmune disease
* Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
* Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply