cyrilzakka/clinical-trials huggingface dataset:
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period.

Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) empagliflozin as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that empagliflozin will be safe, well tolerated and will improve glycemic control in overweight/obese adult patients with CFRD.

Specific Aim 1: Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.

Hypothesis 1: Empagliflozin will be safe and well tolerated, with no evidence for electrolyte abnormalities, metabolic acidosis, ketosis or increased risk of severe hypoglycemia in overweight/obese adults people with CFRD.

Specific Aim 2: Collect preliminary data to evaluate the effect of empagliflozin on glycemic outcomes.

Hypothesis 2: Treatment with empagliflozin will improve glycemic control as indicated by glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM).

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 years or older with CFRD and on insulin treatment
* BMI \>25 kg/m2
* A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method.

Exclusion Criteria:

* acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
* less than 12 weeks since start of a new CFTR corrector/modulator therapy
* type 1 diabetes
* Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
* A history of diabetic ketoacidosis
* history of recurrent genital or urinary tract infections
* pregnancy or lactation
* prior solid organ transplant
* Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times elevated above the upper limit of normal.
* chronic kidney disease (eGFR \< 60mL/min/1.73 m2)
* Hypersensitivity to empagliflozin or any excipients of Jardiance
* History of eating disorder
* Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)
Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

ABSTRACT:

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.

Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPA\] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing \[SRP\] ) in asymptomatic molar teeth.

Exclusion Criteria:

* Aggressive Periodontitis subjects
* Subjects with systemic conditions known to affect the periodontal status
* Medications known to affect the outcomes of periodontal therapy
* Hematological disorders and insufficient platelet count (\<200,000/mm3)
* Pregnancy/lactation
* Smoking and tobacco use in any form
* Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index \[PI\]16 \> 1.5) after re-evaluation of Phase I therapy were also excluded from the study.
* In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.
Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

Hypertension is considered a serious public health problem. The imbalance in autonomic nervous system (ANS) activity is one of the main triggers in the development and maintenance of hypertension. The non-pharmacological management of this disease is an important resource, especially in refractory hypertensive patients or in hypertensive crises, where the pharmacological treatment does not present an efficient response. It is known that transcutaneous electrical nerve stimulation (TENS) is capable of modifying the autonomic balance, however, the effects of Interferential electrical stimulation (IES) on this system in normotensive and hypertensive volunteers are not yet known. These electrotherapeutic resources may be a non-pharmacological tool supporting the management of hypertension. The objective of this research is to study the effects of different TENS and IC parameters on cardiovascular variables of normotensive volunteers and hypertensive patients.

Each volunteer will perform three assessments with a one-week interval. Each assessment will include assessment of autonomic balance, blood pressure, and blood collection (catecholamines). Interventions (placebo, low frequency TENS and IES) will be randomized. Volunteers will be accommodated in the supine position. With properly sanitized skin (70% alcohol) and self-adhesive electrodes (5x5 area) will be positioned in the cervical paravertebral region. All participants will be submitted to a placebo TENS session, a low frequency TENS session (TENS, 10 Hz/200μs) and an IES session (STEIN et al., 2012). The sessions will take place in the morning in a 12-hour fast, lasting 30 minutes, in an air-conditioned place (23ºC).

Eligibility Criteria:
Inclusion Criteria:

* Both sexes;
* Normal blood pressure (PAS \<130 mmHg; PAD \<85 mmHg) or Previous Hypertension diagnosis, systolic blood pressure (SBP) \> 140 mm Hg and/or diastolic blood pressure (DBP) \>90 mm Hg and clinical stability with no change in medications for at least 2 months preceding the study;
* The subjects that joined the study will be alphabetized volunteers;
* Age between 20 and 65 years old;
* With no symptoms of skeletal muscle disorders;
* No previous performing cardiovascular surgery;
* No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases;
* Without evidence of psychiatric diseases and/or cognitive déficit;
* Non-Smoker;
* Volunteers with a body mass index (BMI: kg/m2) greater than 35 will not be included in the study

Exclusion Criteria:

* On the day of the assessments who have consumed of the alcoholic drink, caffeine and citrus juice and who have performed intense physical activities 48 before the examination
Effects of AHEs on DrA in Postpartum Women

This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD, Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women.

Postnatal women wish to resume abdominal exercises shortly after delivery to improve trunk function and restore the pre-pregnant state of the body. Diastasis recti is a common occurrence in the postpartum period which is associated with both physical impairments and body image concerns. Despite the high prevalence, treatment options are still being explored to identify the best approach to resolve it. Exercise is a conservative method to reduce IRD and improve the associated symptoms and quality of life of postpartum females. Most of the previous studies have used either digital nylon calipers or digital palpation methods for the outcome assessment of DrA which has important implications. Fewer studies have used the gold standard US diagnosis. Despite various studies being conducted on the effect of exercise on DrA, the results are still nonconclusive with a deficiency of a standardized protocol. Multifaceted and clinically meaningful assessments have been proposed to be investigated by the previous literature.

Eligibility Criteria:
Inclusion Criteria:

* 12 weeks to 36 weeks postpartum
* Both vaginal delivery and C-section
* Lumbopelvic pain (NPRS \>4)
* Diagnosis of DrA by calliper: 3 cm below the umbilicus: \>22 mm, at the umbilicus: \>20 mm, 3 cm above the umbilicus: \>14 mm
* Primiparous females

Exclusion Criteria:

* Any conditions affecting the ability to perform exercise or activity of daily living.
* Previous spinal or abdominal surgery, and neuromuscular diseases.
* Severe DrA \>5cm with the herniation or requiring surgical repair.
* LBP associated with disc herniation, spondylolysis, and degenerative changes of the spine
Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea

Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.

This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI \> 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of resistant hypertension
* Apnea/hypopnea index \> 15

Exclusion Criteria:

* Cardiac surgery on last 3 months
* Serious arrhythmias
* Insulin dependent diabetes
* Debilitating neurological disease
* severe COPD
A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)

This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.


Eligibility Criteria:
Inclusion Criteria:

* Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
* Able to comply with the study protocol

Exclusion Criteria:

None
Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.

OBJECTIVES:

* Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone, etoposide, and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission.
* Compare the toxicity of these 2 regimens in these patients.
* Assess the quality of life of these patients.

OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.

All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.

Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.

* Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5.
* Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3.

Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy.

Patients are followed until death.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed de novo or secondary acute myeloid leukemia (AML)

  * Prior myelodysplasia allowed
  * Refractory anemia with excess blasts (RAEB) OR
  * RAEB in transformation
* No relapsed AML
* No chronic granulocytic leukemia in transformation
* No CNS disease

PATIENT CHARACTERISTICS:

Age:

* Over 55

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 2.5 times ULN

Cardiovascular:

* No severe or uncontrolled cardiac failure

Other:

* No serious medical, social, or psychological condition
* Not HIV 1 or 2 seropositive

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No plan for future autograft

Chemotherapy:

* No prior chemotherapy for myelodysplastic syndrome or AML

Endocrine therapy:

* Not specifed

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent aluminum or magnesium-based antacids
Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL

This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses

Eligibility Criteria:
Inclusion Criteria:

* good general health,
* willing to comply with study instructions,
* Visual potential of 20/30 or better,
* less than 1.5D of corneal astigmatism,
* normal macula,
* clear lens or cataract,
* pupil size greater than 3.5mm

Exclusion Criteria:

* known pathology to affect visual outcome,
* amblyopia or strabismus,
* pupil abnormalities,
* zonule problems,
* keratoconus,
* no prior ocular surgery,use of medication that could affect vision,
* uncontrolled systemic disease
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.

Eligibility Criteria:
Inclusion Criteria:

Age 18-75 years; Histologically proven colorectal adenocarcinoma; Simultaneous liver-limited metastases; Initially unresectable liver metastases determined by a local MDT; Life expectancy of \> 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens before treatment

Exclusion Criteria:

Previous systemic treatment for metastatic disease; Previous surgery for metastatic disease; Extrahepatic metastases; Unresectable primary tumor; Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; Acute or subacute intestinal obstruction; Second primary malignancy within the past 5 years; Drug or alcohol abuse; No legal capacity or limited legal capacity; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.


Eligibility Criteria:
Inclusion Criteria:

* For participants with AML:

  * Age \>=60 years, either sex, any race.
  * Diagnosis of CD33-positive AML by World Health Organization criteria.
  * Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
  * Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
* For participants with ALL:

  * Age \>=18 years, either sex, any race.
  * Diagnosis of ALL by World Health Organization criteria.
  * Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
  * Eastern Cooperative Oncology group performance status of 0 or 1.
  * Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
  * Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to \<=30 x 10\^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.

Exclusion Criteria:

* Known central nervous system leukemia.
* Previous hematopoietic stem cell transplantation.
* Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
* For AML, previous treatment with gemtuzumab ozogamicin.
* Known HIV infection.
* Known active hepatitis B or C.
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19

This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
* Male or non-pregnant female adult 40-80 years of age at time of enrollment.
* Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
* Meets definition of ARDS according to Berlin criteria.

Key Exclusion Criteria:

* Body weight under 55 kg (121 lbs)
* Serum creatinine level of over 1.5 mg/dL at time of randomization.
* Total Bilirubin ≥2 mg/dL at time of randomization.
* Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
* Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
* Chronic Obstructive Pulmonary disease GOLD stage above II.
Virtual Physical Therapy Support for Runners

This study will compare standard of care of home exercise for running rehabilitation to the combined treatment of home exercise with an individually provided four-session virtual physical therapy support program intervention on pain and physical function movements (controlled dual and single leg squat and lateral hopping in individuals post running injury. These collective findings will help provide new evidence of the responses to an individually provided virtual PT interventions among runners.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 65 years
* Regularly running at least 12 miles a week prior to development of musculoskeletal complaint.
* Free of surgical history of surgery to either lower limb
* No history of major bony injury to the lower limb such as traumatic fracture, within the past 12 months
* Presence of chronic lower body running related injuries (e.g., patellofemoral pain, IT band syndrome, Achilles tendinitis, chronic lower back pain after running)
* Body mass index (BMI) \<=35 kg/m2

Exclusion Criteria:

* Pregnant women
* \< 18 or 65 years
* BMI \>35 kg/m2
* Mental disablement (down's syndrome or dementia)
* Any persons incarcerated, on parole, on probation, or awaiting trial.
* Individuals with neurologic or degenerative musculoskeletal disease, such as rheumatoid arthritis, muscular dystrophy, or Parkinson's disease.
* Current acute running related or sport related injury (e.g., ankle sprain, hip labral tear, ACL strain during an event or run)
* Individuals with a history of strong risk factors for poor fracture healing, such as uncontrolled diabetes, chemotherapy, end-stage organ disease, dialysis or smoking
* Unwilling to forgo your potential in-person therapy visits for a month after enrollment