cyrilzakka/clinical-trials huggingface dataset:
Rowing Following Breast Cancer Chemotherapy

There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary invasive non-metastatic breast cancer, stages I-III
* female based on biological sex
* 40 to 80 years of age
* completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation
* absence of contraindications to exercise or study participation
* study clinician approval

Exclusion Criteria:

* do not meet inclusion criteria
* receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation
* lymphedema stage ≥ 2 prior to study enrolment
* any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
* current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
* consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months
NuShield in Surgical Peroneal Tendon Repair

The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.

The objective of this clinical trial is to evaluate both the safety and efficacy of using the NuShield® allograft in addition to standard of care surgical procedures in subjects requiring surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:

* Questionnaires

  * Visual Analog Scale Foot and Ankle (VAS FA)
  * FAAM Sport
  * PROMIS Global Health SF
  * Tegner Activity Scale
  * Foot and Ankle Outcomes Instrument (Q1, Q2)
* Swelling assessments
* Ultrasound imaging for tendon thickness, gliding and adhesion formation

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 60 inclusive
* If female, actively practicing a medically relevant method of contraception, abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
* Have a diagnosis of one of the following in relation to the peroneal tendon:

  * Tendonitis with MRI confirmation
  * Synovial inflammation
  * Tear
* Diagnosis resulting from acute injury to the tendon

Exclusion Criteria:

* BMI equal to or greater than 35
* Prior injury to the peroneal tendon
* Collagen disorders
* Inflammatory arteriopathies
* Immune compromised
* Diabetic
* Less than 6 months between injury and proposed surgery date
* Steroid injection within the past 6 weeks localized to the treatment area
* Pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to treatment
* History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or have received such medications during the screening period, or are anticipated to require such medications during the course of the study
* Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
* History of radiation therapy of the affected foot
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
* Currently involved in medical litigation, including Worker's Compensation claims of any type
* Unable to understand the objectives of the trial
* Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
* Having a known history of poor adherence with medical treatment
* Express an unwillingness to receive human allograft tissue
A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).

This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary study hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for ertugliflozin is greater than that for placebo.

The trial includes a 13-15 week run-in period prior to randomization, and a 26-week, double-blind, placebo-controlled treatment period followed by a 78-week double-blind, extension period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM in accordance to American Diabetes Association guidelines
* Participants must be receiving metformin monotherapy for less than 8 weeks prior to study participation or require change in their diabetes regimen to remain eligible to participate in the trial (including discontinuing anti-hyperglycemic agent \[AHA\] therapy) and must have a hemoglobin A1c of 7.0 to 10.5% (53-91 mmol/mol) after at least 8 weeks on a regimen of metformin monotherapy

Exclusion Criteria:

* History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
* A clinically significant electrocardiogram abnormality
* A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
* A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or glimepiride
* On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation
* A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
* Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
* Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in type 2 diabetic subjects.

Pharmacodynamics is the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period while the pharmacokinetics is the amount of the study insulin that can be determined in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for 12 months or longer
* Body Mass Index (BMI): 25.0-40.0 kg/m2, both inclusive
* HbA1c between 7.0 and 10.5% at screening
* Insulin treatment for at least 3 months prior to screening with a total daily dose of 0.6 and 0.9 U/kg body weight

Exclusion Criteria:

* Use of any oral antidiabetic agent within the past 2 months
* Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
* Hepatic insufficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 2 times the central laboratory's upper reference limit)
* Renal insufficiency (serum creatinine equal to or greater than 1.6 mg/dL for males; equal to or greater than 1.4 mg/dL for females)
* Recurrent hypoglycaemia
* Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females; WHO-criteria)
* Use of concomitant medications (prescribed or non-prescribed and other than insulin) which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
Kidney Function After Pneumoperitoneum and Analgesia

double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac

Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations.

Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* From 18 to 60 years
* Normal kidney function
* Free consented participation

Exclusion Criteria:

* Renal and hepatic dysfunction
* Prior (one month) use of anti-inflammatory agents
The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA

The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).

The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).

The study design involves case control Polymerase Chain reaction (PCR) analysis of nasal mucosal swabs, saliva swabs, blood serum, and home vacuum cleaner bags in patients with sinusitis and normal controls.

The hypothesis is that the quantity and type of fungal DNA present in the nose and home environment are directly correlated with quality of life. Our research aims to both quantify the amount of fungi present in the nasal mucosa as well as to measure the severity of the patient's chronic rhinosinusitis (CRS) as a function of SNOT-20 and SF-36 outcomes questionnaires. We hypothesize that the amount and type of fungi present in the nose and home environment will correlate with the severity of the patients' symptoms of CRS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with no sinus disease and subjects with chronic rhinosinusitis.

Exclusion Criteria:

* Immunocompromise
* Pregnancy
* Minors
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study

The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.


Eligibility Criteria:
Inclusion Criteria:

* Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma
* Karnofsky Performance status (KPS) ≥ 70
* Age ≥18 years
* Subject is able to understand and consent to study
* Glomerular filtration rate (GFR) ≥ 45 ml/minute

Exclusion Criteria:

* Indication for urgent craniotomy to relieve mass effect
* Only stereotactic biopsy indicated because tumour is located in eloquent brain.
* The enhancement on the T1 MRI sequence involves or abuts the basal ganglia
* Previous intracranial malignancy or any invasive malignancy unless free of disease \> 5 years
* Prior cranial irradiation
* Contra-indications to systemic radiation exposure: pregnancy or breast feeding
* Subject exceeds the weight limit of the PET scanner bed (204.5 kg)
* Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease
* Allergies or other contraindication to CT contrast or MRI contrast
Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.

The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.

Eligibility Criteria:
Inclusion criteria:

* CMV retinitis in one or both eyes
* At least 1/4 disk are of one CMV lesion photographable
* Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection
* Age 13 and greater
* Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis
* Absolute neutrophil count ≥ 1,000 cells/µl
* Platelet ≥ 25,000 cells/µl
* Serum creatinine ≥ 2.0 mg/dl
* Karnofsky score ≥ 60
* Informed consent

Exclusion criteria:

* Previous treatment of CMV retinitis
* Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days
* Known or suspected allergy to study drugs
* Pregnant or Lactating
CT Prediction for Transcatheter Tricuspid Interventions

The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans.

Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research.

One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life.

However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges.

Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy.

To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* the patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease
* a transcatheter tricuspid valve intervention is performed
* the patient is 18 years or older

Exclusion Criteria:

* none
Light Therapy in Parkinson's Disease

Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT) represents one such innovative therapeutic approach. Although light has an obvious to visual pathways within the brain, today it is known to additionally exert non-visual effects throughout the body. Recently our team has shown that non-visual, non-circadian light plays a major role in the regulation of sleep, as well as cognitive brain function in general. The retina, the primary conduit for the transmission of light information is weakened or thinned in Parkinson's patients. The dopamine system is known to enhance the processing of light information and intraocular injection of L-dopa in animal models of Parkinson's disease, can reverse associated motor symptoms. This allows for the possibility that LT would strengthen the dopaminergic tone in the central nervous system. However, to this date its effectiveness for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly controlled. Thus, through the convergence of basic and clinical data, a study examining the effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the effects on sleep, circadian system, mood, and cognitive functioning, is of extreme importance. With this information our hope is to determine if these polymorphisms allow for a predictive model of response to LT treatment.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkison's Disease, low or moderately severe
* Hoehn\&Yahr \<4
* 4 to \< 15 years of evolution·
* Between 45-75 years old
* Absence of dementia : MMSE \> 23·
* No severe depression
* Stable medication levels during the 5 weeks before inclusion

Exclusion Criteria:

* Secondary or severe Parkinson's disease
* Ocular pathologies (i.e. retinopathy)
* Photosensitive medication
* Antidepressant treatment·
* Major depression syndrome
* MMSE \< 23
* Circadian rhythm problems
* Sleep apnea syndrome
* Manifested or acute psychiatric comorbidities
* Pregnant women
Month 30 & 42 Extension Studies of CRD-004 Primary Study

The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Further details on the primary study can be found on our GSK study register (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier 101501.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
* Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
* Written informed consent obtained from the subject;
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
* Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
* Previous vaccination against HZ, except the study vaccine administered in the primary study;
* History of HZ (shingles);
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.
Early Detection of Cognitive Decline

The goal of this clinical trial is to evaluate the impact of a brief cognitive screener on provider behavior in patients completing an annual wellness visit (AWV). The main question\[s\] it aims to answer are:

* do appropriate referrals increase for patients using the new screener?
* do appropriate diagnostic orders increase for patients using the new screener? Participants will respond to 4 questions about their cognitive abilities as part of a larger AWV protocol.

Researchers will compare provider behavior for patients completing AWVs before and after implementation of the new screener to see if referral, diagnostic and prescribing behaviors differ.

In the course of this two-year project, the RAND team and partners (University of Pittsburgh Medical Center \[UPMC\] and Northwestern University \[NU\]) will conduct secondary data analysis to establish the validity of scores from the PCF item bank; use the resulting data to derive meaningful scoring criteria and interpretation guidance, and determine the best short form item set from the PCF item bank to use for standardized cognitive impairment screening during the Medicare Annual Wellness Visit (AWV); use qualitative methods to refine workflow for administering the screener in primary care; work with UPMC to integrate the resultant brief self-reported PROMIS cognition screener (PRO-CIS) into their workflows; and evaluate the effect of implementing brief standardized PRO-CIS with interpretive guidance on primary care providers' behaviors.

Eligibility Criteria:
Inclusion Criteria:

* has AWV within study period

Exclusion Criteria:

* provider uses non-digital AWV form