cyrilzakka/clinical-trials huggingface dataset:
Mental Stress Reduction in Defibrillator Patients

The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators

The study is a randomized controlled small clinical trial designed to determine whether a 10-week program of group cognitive-behavioral stress management (CBSM) versus a control "Patient Education" program can improve hemodynamic responses to mental stress testing in patients with Implantable Cardioverter Defibrillators. Comparison will be made between groups of heart rate and blood pressure responses to mental arithmetic and anger-recall mental stress, psychometric profiles, arrhythmia frequency and implantable cardioverter defibrillator firings before, immediately and up to 6 months after intervention. If benefit of CBSM is proven, study findings could lead to wider use of stress management programs, with increased life expectancy for implantable cardioverter-defibrillator patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21 years,
* ICD Implantation,
* \> 3 months following ICD implantation,
* willingness to give informed consent

Exclusion Criteria:

* Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction, Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital admission any cause,
* severe mental illness,
* life expectancy \< 1 year,
* hyperkalemia,
* hypokalemia,
* hypomagnesemia,
* hypermagnesemia,
* unwillingness to give informed consent
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia

The purpose of this study was to investigate the acute and chronic effect of whole-body vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following both acute and chronic WBV. Twenty-four women with FM were randomized into two groups: Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise twice a week for a total of six weeks, whereas the CG performed the same protocol without vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and 6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements were taken before and immediately following a session of WBV.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.

Exclusion Criteria:

* Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
* Participation in any other study.
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain

The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes.

After being informed about the study and potential risks, all patients giving written informed consent will be randomized to a behavioral writing intervention and a cold pressor task. Participants will be randomized to a gratitude or neutral writing condition.

Eligibility Criteria:
Inclusion Criteria:

* must be pain-free
* must be at least 18 years old

Exclusion Criteria:

* cardiovascular disease
* Raynaud's disease
* epilepsy
* being pregnant
* having a current injury to or open cut or sore on one's non-dominant hand
* history of fainting or seizures
* history of frostbite in non-dominant hand
* chronic pain conditions (e.g., fibromyalgia, neuropathy, arthritis)
* diabetes
* malignant tumor
* chronic lung disease
* liver disease
* kidney disease
* gastrointestinal diseases
* currently taking opioids
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport

This study is being done to see what impact having a Lifeport device has on quality of life for children with sickle cell who are getting chronic transfusions, from the child's perspective.

There is a paucity of research that focuses specifically on quality of life (QoL) among patients with sickle cell. This study aims to explore the QoL of children who are receiving chronic transfusion therapy (CTT) using a Lifeport device, which allows them to undergo erythrocytapheresis, rather than standard transfusion therapy. Erythrocytapheresis is less time consuming and is associated with less iron overload than conventional transfusion therapy; however, little is known about the implications for the child's QoL. This study will explore QoL from the child's perspective.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of sickle cell disease between the ages of 8 \& 18 years
* currently receiving chronic transfusion therapy via a Lifeport device
* Individuals have been utilizing the Lifeport for at least 6 months and no more than 18 months
* Individuals have received transfusions previously using conventional transfusion therapy (simple or exchange transfusions)
* Individuals have permission of parents (when applicable) and assent

Exclusion Criteria:

* Individuals who, in the opinion of the study staff, would suffer negative consequence, psychosocial trauma, or undue stress as a result of participation
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions

The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.

A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting conditions.

In each period one x 300 mg tablet was administered to fasting subjects. Subjects received the test product in one study period and the reference product in the other period. The order of the treatment administration was as per the dosing randomization schedule. Each dose was separated by at least a 7 day interval.

A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of which only twenty eight (28) subjects completed the clinical portion of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 to 65 years of age, inclusive with a body mass index (BMI) in the range 18-30 kg/m2 inclusive, measured according to Novum Standard operating Procedures
2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
4. Signed and dated informed consent form, which meets all criteria of current FDA regulations

Exclusion Criteria:

1. If female, pregnant, lactating or likely to become pregnant during the study
2. History of allergy or sensitivity to Zidovudine, or other antiviral or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
4. Presence of gastrointestinal disease or history of malabsorption within the last year
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication
6. Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives)
7. Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing
8. Receipt of any drug as part of research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months
10. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing
11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
12. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
13. Positive test results for drugs of abuse at screening
14. Positive serum pregnancy test
Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery

For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades.

The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. The aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a TAP block when compared with an epidural technique.

Caudal block (CB) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin.

Although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. The effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary.

Peripheral nerve blockades (PNB) are an alternative to CB and have a prolonged duration of the analgesic effect. More recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. The ultrasound guided technique improves the safety of margin. However, although this new technique seems to offer substantial advantages so far only experience from small case series are available. In particular, the TAP block has not been compared in a systematic trial with the "gold standard", the caudal block.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children aged 2 - 8 years
* physical status classification system (ASA) score I or II
* Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)

Exclusion Criteria:

* Hypersensitivity to Levobupivacaine
Adapta Pacing System Clinical Study

Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
* Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form

Exclusion Criteria:

* Subjects with a mechanical tricuspid valve
* Subjects with a life expectancy less than two years
* Subjects with a Class III indication for permanent pacing
* Subjects with lead integrity problems, unless leads are being replaced
Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension

In this study the diagnostic accuracy of a diagnostic tool for the diagnosis of post-capillary pulmonary hypertension will be investigated.

The diagnostic tool was designed based on artificial intelligence, using machine learning on a database of 344 patients with group 1 or group 2 pulmonary hypertension. The tool uses 20 non-invasive parameters which are derived from laboratory results, ECG, echocardiography and spirometry. Based on these parameters, the predictive tool estimates the probability of group 2 pulmonary hypertension.

During this clinical study, patients with an intermediate or high suspicion of pulmonary hypertension, with an indication for a diagnostic right heart catheterization, will be included. Patients with risk factors for group 3, 4 or 5 pulmonary hypertension will be excluded.

The necessary parameters to run the predictive model will be extracted from the patients medical file. Patients will undergo a standard of care right heart catheterization (gold standard). Afterwards the results of the predictive model will be compared to those of the right heart catheterization, to allow the assessment of the sensitivity, specificity, positive and negative predictive value of the predictive tool.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Male or female patients of at least 18 years old.
3. Availability of the results of a basic work-up:

   1. Medical history, demographic information and clinical information (including BMI)
   2. Laboratory tests including hemoglobin, hematocrit and uric acid
   3. ECG
   4. Pulmonary function tests
   5. Echocardiography
4. Intermediate to high probability of PH based on echocardiography according to the 2022 ESC/ERS guidelines (see Figure 2 and Table 2). (1)
5. Indication for RHC according to ESC/ERS 2022 guidelines. (1)

Exclusion Criteria:

1. Evidence of significant pulmonary comorbidity based on abnormal pulmonary function tests (FEV1 below 60%) or aberrant lung parenchyma more than mild on radiological imaging.
2. Perfusion defects and ventilation mismatch on a recent V/Q scan.
3. Arterial perfusion defects on a recent thoracic CT angiography.
4. The following comorbidities associated with group 1 PH:

   1. Connective tissue disease
   2. HIV infection
   3. Portal hypertension
   4. Congenital heart disease
5. The following comorbidities associated with group 5 PH:

   1. Hematological disorders such as chronic hemolytic anemia or myeloproliferative disorders.
   2. Systemic and metabolic disorders such as pulmonary Langerhans cell histiocytosis, Gaucher disease, glycogen storage diseases, neurofibromatosis or sarcoidosis.
   3. Chronic renal failure (eGFR below 30 ml/min) with or without hemodialysis
   4. Fibrosing mediastinitis
Persistence-Targeted Smoking Cessation

The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).

In this Stage I Behavioral \& Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 - 64 years old
* Must smoke at least 10 cigarettes per day for past 6-months
* Expired breath carbon monoxide (CO) \> 7
* Must have a working cellular phone

Exclusion Criteria:

* Must not be currently receiving tobacco dependence treatment counseling
* Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
* Must have no contraindications to using nicotine lozenge
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed acute symptomatic proximal PE with or without symptomatic DVT

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
* Other indication for VKA than DVT and/or PE
* The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
The Effect of Blood Flow Restriction With and Without Arginine on Physical Performance and Growth Hormone

The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON).

The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON). All group will participate in the same training regimen. The control group will train and ingest a placebo pill. The BFR group will train with BFR and ingest a placebo pill, and the BFR+Arg group will train with BFR and ingest an L-arginine pill. All placebo pills will be Maltodextrin. The performance outcome is leg press 1RM, while the blood markers are growth hormone (GH) and cortisol. This analysis will provide insight as to whether or not L-arginine supplementation in addition to blood flow restriction training improves performance and muscle hypertrophy measure more than blood flow restriction training alone.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* PAR-Q form complete and without contraindications
* Body Mass Index (BMI) of 18.5-29.9 kg/m2
* Stable body weight prior to participation in the study (fluctuation not exceeding 10 lbs. within the past 6 months
* Agreement not to change current diet or exercise program (other than adding the program for the purpose of this study)

Exclusion Criteria:

* Any diagnosed orthopedic condition that prevents exercise
* BMI \> 29.9 kg/m2 or \< 18.5 kg/m2
* Affirmative answer to any of the questions presented on the PAR-Q form
* Are currently pregnant or planning to become pregnant during the study
* Currently taking blood pressure medication
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Eligibility Criteria:
Inclusion Criteria:

* Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
* Age ≥21 years

Exclusion Criteria:

* Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at signing of informed consent.
* Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.
* Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
* Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
* HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines:

Exclusion Criteria:

* Treatment with chemotherapy in the recurrent or metastatic setting.
* Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.