cyrilzakka/clinical-trials huggingface dataset:
Consent for Use of Stored Patient Specimens for Future Testing

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.

During past, present, and future Adult AIDS Clinical Trials Group (AACTG) clinical trials, samples of HBM (e.g., blood, other body fluids and tissues) have been or will be obtained and stored until analyzed, as defined by the particular trial for which the patient provided consent. Some HBM may be left over after a trial is completed. Important questions may arise during the design of a study; some of these questions may be addressed only with archived (rather than prospectively collected) HBMs. To improve understanding of HIV disease and its optimal management, it is critical that HBMs be available to investigators for subsequent unspecified analyses.

All patients are asked to sign the informed consent form and specify whether or not they agree to allow their leftover samples to be used for secondary analyses and whether or not they agree to have one 14 ml blood sample drawn in this study for DNA archiving for use in currently unspecified genetic analyses. Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result from secondary testing. Patients who do not agree to either option will indicate this on the informed consent and will have no further involvement in this study. Declining consent does not in any way jeopardize participation in any other current or future ACTG clinical trial. Consent may be obtained at the same time the patient is being enrolled into any ACTG clinical trial, at some interval after the patient has entered but is still participating in a trial, or at any time after the patient has completed participation in a trial. The goal of this study is to allow archived HBM to be used for research purposes while protecting the identity of patients from whom such samples were obtained. The focus is on obtaining permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian willing to give informed consent, if applicable
* Either currently participating in or have ever participated in an AACTG clinical trial
Neuroendocrine and Adrenal Tumors

This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is designed to work in conjunction with IRB#831990 which is a retrospective protocol. The University of Pennsylvania will be a contributing site with the University of Michigan as the coordinating site for the A5 alliance, a multi-institutional collaborative designed to study neuroendocrine and adrenal tumors.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with neuroendocrine and/or an adrenal tumor

Exclusion Criteria:

* pregnant women
* prisoners
* people under the age of 18
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD with symptoms for more than one year before screening
* Body mass index of 18-30 kg/m2 and weight of 50-100kg
* Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
* FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
* FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion Criteria:

* Any clinically significant disease or disorder
* Exacerbation of COPD which was not resolved within 30 days of first dosing
* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
* Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
* Disease history suggesting reduced or abnormal immune function other than that related to COPD
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression

The goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (RHD) valvular pathology progression. This feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. These results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in RHD. Successful treatment of RHD would fundamentally shift the RHD management paradigm world-wide, improve the lives of millions afflicted with RHD, and subsequently, decrease health care spending on RHD management.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* History of RHD as evidenced by at least one echocardiographic examination
* No history of cardiac surgery

Exclusion Criteria:

* ≥ 75 or \< 18 years old
* Absence of RHD or RF history
* Active liver disease
* Impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal
* History of previous statin intolerance or muscle disorders
* Current pregnancy (by history or lab assessment of beta hCG) or plans for pregnancy in the next 18 months). Current lactation / breast feeding.
* LDL \<60
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing the informed consent
* Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
* Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
* HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
* Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening
* Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

Exclusion Criteria:

* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
* Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Strength Testing After Nitrate Delivery (STAND) in ICU Patients

It is well documented that intensive care unit (ICU) patients have lower levels of skeletal muscle strength compared to non-ICU patients upon hospital discharge, and this weakness affects the patient's ability to perform basic activities of daily living upon hospital discharge and for extended periods thereafter. Recently, critically ill ICU patients have been shown to have lower nitric oxide levels. These patients often suffer from a disturbed homeostasis with circulatory and metabolic abnormalities that may potentially contribute to their ICU acquired weakness. Given the recent research showing dietary nitrate supplementation can increase nitric oxide levels and improve exercise tolerance in healthy and diseased older individuals, our aim is to investigate the importance of nitrate supplementation in ICU patients with focus on physical function and ICU acquired muscle weakness.

The proposed study is an investigator initiated, double blind, placebo controlled experimental study designed to evaluate the effect of chronic NO3- supplementation via beetroot juice ingestion on the skeletal muscle strength and physical function in ICU patients. Patients will be randomized to receive either nitrate rich or nitrate depleted beetroot juice once daily during their ICU and hospital stay. Physical function and skeletal muscle strength will be measured at ICU (± 2 days) and hospital (± 2 days) discharge and 2 months (± 2 weeks) after enrollment. Plasma levels of nitrate and nitrite will be measured 1, 3 and 5 days after randomization into the trial and at ICU and hospital discharge. Skeletal muscle ultrasound will be performed to examine the size and echogenicity of patient muscles. Self-reported physical function will be measured using the Functional Performance Inventory Short Form (FPI-SF). The FPI-SF provides an overall score of patient self-reported functional performance in the areas of household maintenance, movement, family and social activities, work, avocation and recreation

Eligibility Criteria:
Inclusion Criteria:

* Age \> 55 years
* Mechanically ventilated via an endotracheal tube or mask who have begun spontaneous breathing trials or extubated within the previous 24 hours
* Lung Injury as defined by a PaO2 / FiO2 \< 300

Exclusion Criteria:

* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
* Cognitive impairment prior to acute ICU illness (non-verbal)
* Acute stroke
* Body mass index (BMI) \>50
* Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
* Hip fracture, unstable cervical spine or pathological fracture
* Mechanically Ventilated \> 80 hours
* Current hospitalization or transferring hospital stay \> 7 days
* DNR/DNI on admission
* Cancer treatment within the last 6 months
* Moribund
* Participation in another research study
* On nitroglycerine or nitrate preparations used with angina or phosphodiesterase type 5 inhibitors
* Body mass less than 60 kg
Amplify EP Registry

An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation


Eligibility Criteria:
Inclusion Criteria:

* Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.
* Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.
* De Novo or redo AF catheter ablation procedures.
* Able and willing to participate in baseline and all follow up evaluations.
* 18 years of age or older.

Exclusion Criteria:

* Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.
* In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.
Problem Solving Therapy for Prostate Cancer Spousal Caregivers

Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.

Participants were randomly assigned to an experimental group which received problem-solving therapy, or to a control group which relied on their standard methods of coping (e.g. their normal therapist, family and friends).

Participants completed baseline surveys regarding their distress and coping prior to randomization. They then completed these surveys again at post-intervention (approximately 2-3 months post-baseline) and 6 months post-baseline to determine lasting effects of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer within 18 months of study enrollment.
* The patient and significant other cohabited
* Couples resided in San Diego County
* Both patient and significant other were sufficiently proficient in English

Exclusion Criteria:

-
Oocyte Cryopreservation Registry (HOPE Registry)

Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)

Subjects will be enrolled at as many ART clinics that offer oocyte cryopreservation and are willing to participate in the Registry. Oocytes will be retrieved and cryopreserved from autologous or heterologous donors. When the subject decides she would like to get pregnant, oocytes will be thawed, fertilized and the resultant embryos will be transferred to the oocyte donor (for autologous use) or to another recipient (for heterologous use). The treatment regimen will be completed with births and well-baby follow-up of children at 12 months of age. Information on children will be submitted by their parents to the Investigators. Data collection for the Registry will be active for a maximum of five (5) years, including three (3) years of enrollment and two (2) additional years to complete the well-baby follow-up for all the children.

Eligibility Criteria:
Inclusion Criteria:

* Must be in an ART program
* Donor and recipients must be of reproductive age (18-50 years old, inclusive at the time of oocyte freezing and/or thawing) who intend to achieve a pregnancy by utilizing frozen thawed autologous or heterologous oocytes
* Female and partner (if applicable) must voluntarily provide written informed consent/HIPAA authorization prior to any Registry-related data collection
* Female and partner (if applicable) must be willing to provide a second written informed consent following each live birth prior to any Registry- related data collection on birth characteristics and twelve (12) month evaluation of offspring
* Children born from women who take part in this registry from birth to 12 months (+/- 1 month) of age

Exclusion Criteria:

* Have clinically significant systemic disease
* Have abnormal, undiagnosed gynecological bleeding
* Have any contraindication to Controlled Ovarian Stimulation (COS) for ART and to gonadotropins to be used in ART
* Also, in a rare situation, are undergoing ET with mixed embryos generated from fresh oocytes produced in the current cycle as well as frozen embryos generated from nonfrozen oocytes obtained in a previous ART cycle
* Children born from women who do not take part in this Registry
* Any offspring of woman who are not Registry subjects cannot take part in this registry
Traumatic Brain Injury Among Homeless Veterans

Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI) screening measure for use among homeless veterans; 2) identifying the prevalence of those that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing psychiatric and psychosocial outcomes between those with and without a history of TBI.

Short-term Objectives include:

1. Establishing the criterion-related validity of the Traumatic Brain Injury-4 (TBI-4) questionnaire in the Veteran homeless population using the Ohio State University TBI-Identification Method (OSU TBI-ID) (Corrigan et al., 2007) as the gold standard for establishing traumatic brain injury (TBI) diagnosis.
2. Identifying the prevalence of those that screen positive for a lifetime history of TBI among homeless Veterans.
3. Comparing psychiatric outcomes (psychiatric hospitalizations, suicide attempts and deaths, and clinical contacts) and psychosocial outcomes between those with and without a lifetime history of TBI.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs.

Exclusion Criteria:

* Failure to provide informed consent, not older than 89 years of age.
IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA

The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the formation of kidney stones.

The aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary hyperoxaluria, type 1 (PH1-Cohort A); OR
* Confirmed with AGXT mutation analysis (PH1-Cohort A)
* Diagnosed with idiopathic hypercalciuria (IHC- Cohort B);
* Potential subject diagnosed with PH1 or IH and has both data entered into the registry and has matched, archived random and 24-hour urine specimens obtained prior to any treatment intervention OR is consented and enrolled into the registry or this specific study during the program;
* Healthy siblings of PH1 patients known not to have PH or any another stone disease or chronic disease will be consented and enrolled into this study through the local sites where their sibling is being treated for PH1 (this study meets the criteria for expedited review through local or central IRBs);
* Healthy non-sibling controls known not to have PH or any another stone disease or chronic disease (Healthy Control-Cohort C);
* There is no upper or lower limit to the pediatric age range of enrolling infant, children and adolescent subjects, although it is understood that accurate and complete 24-hour urine collection in very young children and infants will be problematic and will be seriously considered in advance of individual patient or healthy controls enrollment;
* eGFR (Glomerular Filtration Rate) \> 60 mL/min x 1.73 m2 with PH1 and IH patient cohorts matched by mean eGFR from their initial study (or registry) enrollment/ data collection.

Exclusion Criteria:

* Unwilling to provide written parent consent or adolescent assent to enroll into the International Registry or this study;
* Potential PH1, hypercalciuria, or siblings of PH1 patients with other chronic or acute illness or disease that could potentially confound proteomic results;
* Healthy intra-familial siblings unwilling to provide a blood sample for serum creatinine;
* Unwilling to provide urine specimens or permit data abstraction for the registry or this study.
* Not covered by, or having the right to, Social Security
Examining Clinical Research Participation for Substance Abuse Disorder Patient

Clinical study participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future substance abuse disorder patients during clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of substance abuse disorder.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Pregnant or lactating woman
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population

The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.

Participants will be assigned to one of 3 study groups:

Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cystic fibrosis
* Family access to an internet-enabled device
* Camera and microphone
* Absence of exacerbations in the last 30 days

Exclusion Criteria:

* Patients with lung transplant or on the waiting list for lung transplantation
* Previous eye surgery (3 months)
* Hemothorax
* Active infection or inflammatory process
* Tumors
* Cognitive problems that make it impossible for them to use telematic devices.
Ivabradine in Hemodialysed Patients With Increased Heart Rate

A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.

Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.

Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.

Aim:

To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (\> 80 bpm)


Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients
* Sinus rhythm
* Pre-dialytic Heart rate \> 80 bpm

Exclusion Criteria:

* Atrial fibrillation/atrial flutter
* Heart failure
* Valvular disease