cyrilzakka/clinical-trials huggingface dataset:
Dapagliflozin After Transcatheter Aortic Valve Implantation

Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).

Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).

Only variables available during routine clinical practice will be collected and there will be no additional tests.

The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.

Eligibility Criteria:
Inclusion Criteria:

* SEVERE AORTIC STENOSIS UNDERWENT TAVI
* PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:

  1. Left ventricular ejection fraction ≤ 40% or
  2. Diabetes mellitus or
  3. Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2

Exclusion Criteria:

* Known allergy or intolerance to SGLT2 inhibitors.
* Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
* Systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg.
* An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
* Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
* Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
* Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
* Pregnant or breast-feeding patients
* Patients participating in other clinical trials.
The Impact of Innovative Tax Proposals on Purchase Patterns

This study will investigate the effect of four tax proposals (i.e. Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) on tobacco product purchasing patterns.

This study experimentally examines the effects of largely untried integrated tax proposals. Four tax proposals will be modeled: Tobacco Parity, Nicotine-Content, Harm-Reduction, and MRTP. Tobacco products are placed into three tax tiers: high-, medium-, and no-tax, according to the goals of each proposal. In a within-between subject design (tax proposals between subjects; control condition within subject), cigarette smokers will complete two conditions in the Experimental Tobacco Marketplace, representing one control condition and one of the four tax proposals. Within each condition, taxes will be increased proportionally across 6 trials (relative to tax tier) to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.

Eligibility Criteria:
Inclusion Criteria:

* provide informed consent
* provide a breath carbon monoxide sample ≥ 8 ppm,
* be at least 21 years of age (the legal age to purchase tobacco),
* smoke at least 5 cigarettes daily, and
* use other tobacco products less than weekly.

Exclusion Criteria:

* report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
* use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
* report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
* be pregnant or lactating, or
* have plans to move out of the area during the experiment.
Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.


Eligibility Criteria:
Inclusion criteria:

* All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
* All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) \< 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) \< 70% at Visit 1.

* Male or female patients, aged \>= 40 years.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
* Patients with score on the modified Medical Research Council (mMRC) \>= 1.
* Patients who walk \< 400 meters of 6MWT and have a score on the modified Borg \>= 4 at the end of 6 minute walk test (6MWT) at Visit 2.
* Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol.
* Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler.

Exclusion criteria:

* Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
* Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine \> x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
* Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
* Further exclusion criteria apply
Behavioral Activation for Smoking Cessation in PTSD

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.

Eligibility Criteria:
Inclusion Criteria:

* Report smoking an average of 10 or more cigarettes daily for at least six months
* Report a desire to quit smoking
* Meet criteria for current PTSD
* Speak and read English
* Agree to participate in the study
* Be 18 years old
* Be a veteran

Exclusion Criteria:

* Meeting criteria for psychotic or bipolar disorder
* Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
* Inability to give informed, voluntary, written consent to participate
* Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
* Use of non-cigarette tobacco products as a primary form of tobacco use
* Being currently suicidal or homicidal
* Being medically unable to use the nicotine patch or nicotine gum/lozenge
* Psychotropic medication changes within 3 months of study initiation and during active treatment
* Current engagement in evidence-based therapies for PTSD or depression
* Pregnant or trying to become pregnant
* Incarceration
Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery

This study intends to include hypertrophic cardiomyopathy patients over 18 years old who underwent cardiac surgery in our hospital. Patients were divided into medication group and control group according to the use of gastrodin during operation. The patients ' myocardial tissue samples were collected, the postoperative prognosis data were observed and recorded, and the data were analyzed. The degree of myocardial tissue cell damage and postoperative clinical outcomes were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
* Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
* Signed informed consent, good compliance.

Exclusion Criteria:

* suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);
* moderate to severe malnutrition, moderate to severe anemia;
* persistent infection;
* severe preoperative underlying diseases (such as severe liver and kidney dysfunction)
Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus

The purpose of this study is to determine whether chronic electrical stimulation of the primary auditory cortex is effective in the treatment of chronic, severe and intractable tinnitus

Severe and chronic tinnitus - the perception of sound in one or both ears or in the head when non-external sound is present - can be disabling and difficult to treat. Physiopathology of tinnitus can be considered as similar to neuropathic pain. Neuropathic and central pain are treated since ten years by chronic electrical motor cortex stimulation. The hypothesis of this study is that it will be possible to treat severe tinnitus by this stimulation as neuropathic pains are treated by motor cortical stimulation.

* Principal Objective : to evaluate the efficacy of chronic electrical stimulation of the auditory cortex for intractable tinnitus
* Secondary Objective : to evaluate the tolerability and the safety of chronic electrical stimulation of the auditory cortex for intractable tinnitus
* Study design : randomized, cross over, double blind, study to evaluate the efficacy of the chronic electrical stimulation versus sham in severe and chronic tinnitus
* Inclusion criteria :

Patient \>18 years of age and \< 70 years of age Permanent and chronic tinnitus during more than 2 years. A score over 19 at the STI (Quality of life index for tinnitus) Unilateral tinnitus

• Exclusion criteria : Deaf person Surgical or anesthetic contraindication History of psychiatric disorder or suicide Epilepsia

• Number of subjects : 10

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years of age and \< 70 years of age
* Permanent and chronic tinnitus during more than 2 years
* A score over 19 at the STI (Quality of life index)

Exclusion Criteria:

* Deaf person
* Surgical or anesthetic contraindication
* History of psychiatric disorder or suicide
* Epilepsia
Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults

Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
* The use of antibiotics or PPI within 2 months before the study
* The presence of dental carious or any untreated cavitated carious lesions and oral abscesses
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder

This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 5 to 17 years of age
* Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
* Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
* Patients are able and willing to swallow study medication suspension.

Exclusion Criteria:

* Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
* Patients who cannot discontinue anti-psychotic medication
* Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
* Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
* Patients who have received helminthic treatment
Implementation of Shared Decision-Making in Cancer Care

This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.


Eligibility Criteria:
Inclusion Criteria for participating patients:

* diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)
* admitted for inpatient or outpatient treatment at the participating clinics
* age \> 18 years
* German-speaking

Exclusion Criteria for participating patients:

* severe cognitive impairment

Inclusion Criteria for participating health care professionals:

* physician or nurse working at the participating clinics

Exclusion Criteria for participating health care professionals:

* none
Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA

A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.

A significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. Proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. In that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting.

In a sample of adults over the age of 21 with chronic pain undergoing a planned TKA, the objectives of this randomized clinical trial are to:

1. Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (painTRAINER) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a TKA.
2. Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 45 TKA patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 TKA patients randomized to treatment-as-usual.
3. Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 45 TKA patients randomized to treatment-as-usual.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age \> 21 years
2. Chronic non-malignant pain of at least 3 months duration
3. Morphine equivalent daily dose (MEDD) \> 40 milligrams for at least 3 months
4. Able to enroll at least 4 weeks prior to planned surgery
5. Able to speak, read and comprehend in English at the 6th grade or higher proficiency

Exclusion Criteria:

1. Pain of malignant origin
2. Current or past history of opioid use disorder (including those on medication-assisted therapy)
3. Revision of TKA
4. Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent
The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates

The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates.

Seasonal influenza causes 20,000 hospitalizations and 36,000 deaths in the U.S. each year. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. This type of planning prompt is a "nudge" in the direction of desired behavior that can be implemented at minimal expense and does not restrict individual autonomy. We conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates. We show that planning prompts can be successfully applied to improve health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Vaccine indications according to fall 2009 CDC criteria (age \>= 50 or chronic disease
* Employee at partner corporation that implemented the study

Exclusion Criteria:

* None
COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

COHIVE is an observational cohort study nested within four parent open label randomised clinical trials of first- and second-line antiretroviral therapies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE objective is to study the occurrence and outcomes of COVID-19 in people living with HIV across a variety of clinical settings. Taken together, these pivotal trials provide an established population and encompass a range of HIV therapies, HIV populations, and geographic regions to capture the full spectrum of these global public health emergency as it pertains to people living with HIV.

The sample will include participants who are possible symptomatic or confirmed COVID-19 cases, and participants who agree to enrol in the SARS-CoV-2 seroprevalence cohort (regardless of SARS-CoV-2 infection). Approximately 2,500 participants are enrolled in these 4 studies.

Enrolment into COHIVE substudy is voluntary and optional for participants in ADVANCE, D²EFT, DolPHIN2 and NAMSAL studies. Parameters relevant to COHIVE substudy including demographics, arm of randomised ART, medical and HIV history, immunological and virological results, adverse events at required time points will be collected as part of parent studies. Substudy specific assessments performed at baseline include optional sample collection for SARS-CoV-2 RT-PCR and serology; for the possible symptomatic or confirmed COVID-19 cases, the management of the patients, diagnostic test results, and outcomes, will be collected.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Either: i) Meet local testing criteria for COVID-19, or present with symptoms that in the opinion of the investigator are consistent with COVID-19 and do not have an alternative explanation, or have tested elsewhere and found positive for COVID-19; OR ii) Agree for serology testing for SARS-CoV2, regardless of history of COVID-19.
* Have signed the informed consent of one of the parent study.
* Give informed consent to the COHIVE substudy.

Exclusion Criteria:

* Refuse to participate in the COHIVE substudy.
* Any condition which would place the participant at risk if they participated.