cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus

The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with uncontrolled diabetes mellitus.


Eligibility Criteria:
Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea

The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.

The main goal of this SYNAPSE study is to evaluate, on a selected prospective cohort of subjects aged 67 years upon study entry, the incidence of sleep apnea/hypopnea and the prognostic values of ANS activity levels measured at preset times and of cardiovascular or cerebrovascular events.

Eligibility Criteria:
Inclusion Criteria:

* informed consent signed
* to participate in the PROOF study

Exclusion Criteria:

* prior myocardiac infarction
* prior stroke
* hearth failure
* atrial fibrillation
* insulin-treated diabetes mellitus
* cardiac pacemaker
* disease limiting life expectancy to \< 5 years
* contraindication to brain MRI
* living in an institution
* respiratory failure with oxygenotherapy
* sleep-related breathing disorders known and treated
Khon Kaen University's Thyroidectomy Registry

The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.


Eligibility Criteria:
Inclusion Criteria:

* The patients who underwent thyroidectomy at Khon Kaen University

Exclusion Criteria:

* None
Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks

The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum aspiration (EVA). The investigators hypothesize that operative times will be increased when using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Between 10 0/7 and 13 6/7 weeks of gestation
* Documented intra-uterine pregnancy
* Presenting for surgical induced abortion at RHS
* English-speaking
* Age 18 or older

Exclusion Criteria:

* Spontaneous abortion
* Failed medical abortion
* Multiple gestation
* Uterine anomalies
* Lower uterine segment or cervical myomas
* History of 3 or more prior cesarean deliveries
* BMI \> 40
* Having the abortion procedure performed by a provider who does not perform MVA and EVA between 10 0/7 and 13 6/7 weeks
Randomized Trial Comparing Colesevelam vs. Ezetimibe

A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for glycated hemoglobin (HbA1c) (\> 7.0%) and low-density lipoprotein (LDL) cholesterol (\> 2.0 mmol/L).

This study will enroll 200 adult patients with T2DM who are not at target for HbA1c and LDL cholesterol. Patients who are on baseline statin therapy will be randomly assigned in a 1:1 ratio to colesevelam 3.75 g daily for 24 weeks, or ezetimibe 10 mg daily for 24 weeks. If a patient has statin intolerance, they may be on a fibrate and/or niacin, or on no lipid lowering therapy. The primary efficacy objectives are

1. to demonstrate that colesevelam 3.75 g daily is non-inferior to ezetimibe 10 mg daily as add-on to statin therapy for patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24, and
2. to compare the proportion of patients achieving a composite target of HbA1c (≤ 7.0%) and LDL cholesterol (≤ 2.0 mmol/L) at week 24.

This study will also assess the primary composite outcome in a sub-group of patients on sodium/glucose cotransporter 2 inhibitor (SGLT2i) therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 2 diabetes \> 6 months
2. HbA1c level between 7.1 to 10.0% (inclusive) within three months of study enrollment
3. LDL cholesterol \> 2.0 mmol/L within three months of study enrollment
4. Receiving a stable dose of statin for a minimum of three months, which the investigator does not plan to change over the 24-week trial period. If patient has documented statin intolerance, may be on a fibrate and/or niacin, or on no lipid lowering therapy
5. Stable diabetes medications for previous three months (apart from adjustment of insulin dose)
6. Informed consent

Exclusion Criteria:

1. Use of a second lipid lowering therapy other than statin within three months of study enrolment, unless on a fibrate and/or niacin if patient has statin intolerance
2. Triglycerides ≥ 5.0 mmol/L or incalculable LDL cholesterol
3. Significant liver enzyme or CK elevation defined as CK or ALT ≥ 3x upper limit of normal (ULN)

5) Pregnant or breast feeding or planning to become pregnant or breast feed during the study 6) Chronic kidney disease (CKD) stage ≥4 or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m-squared 7) Severe gastroparesis or history of significant bowel resection 8) Current use of any Investigational Product
Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥18 years-old
* Diagnosed with chronic pain
* Have an already-implanted Eon Family IPG for a minimum period of 6 months
* Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
* Signed informed consent

Exclusion Criteria:

* Subject's overall Beck Depression Inventory II Score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
* Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
* Subject has an infusion pump or any other implantable neurostimulator device
* Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
* Subject's pain originates from peripheral vascular disease
* Subject is immunocompromised
* Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
* Subject has history of cancer requiring active treatment in the last 6 months
* Pregnancy
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms (AWS).

This is a phase IV, multicenter randomized (1:1), active drug-controlled study (double-blind, double dummy) with parallel groups evaluating the efficacy of SMO versus oxazepam in the treatment of AWS in alcohol-dependent patients.

A placebo-controlled design was considered but excluded, given that a gold standard treatment for AWS is available (i.e., BDZs).

Furthermore, considering that SMO and oxazepam have two different pharmaceutical formulation (suspension and tablets, respectively), a double-dummy design was adopted.

Thus, all subjects will receive both medications, tablets (oxazepam or placebo) and suspension (SMO or placebo), at the same time.

Eligibility Criteria:
Inclusion Criteria:

* age range 21-75,
* diagnosis of alcohol dependence according to DSM-IV criteria
* the presence of AWS as assessed by Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale, a scoring system for quantitative evaluation of physical symptoms of AWS.20 Only subjects with a CIWA-Ar score equal to or higher than 10 (defined as moderate or severe AWS requiring pharmacological treatment) were ultimately enrolled in the study.

Exclusion criteria:

* ≤55 kg of body weight;
* history of withdrawal fits within 24 hours pre-study;
* history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment;
* dependence from narcotics, BDZs or other drugs of abuse;
* documented pre-existent hypersensitivity to SMO or to BDZs,
* renal failure (blood creatinine \>2•5 mg/dl and/or documented proteinuria \>500 mg/die),
* heart failure,
* severe respiratory failure
* hepatic encephalopathy stage II-IV;
* psychiatric disorders requiring treatment with psychoactive medications before the start of the study;
* treatment with clonidine, haloperidol, bromocriptine during the last 3 months prior to participation in the study;
* participation to other clinical investigations in the previous month prior to recruitment;
* females whose could not assure not to become pregnant during the 1 month period of treatment, and during the subsequent 3 weeks;
* subjects without a stable social condition or homeless.
Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

A randomized, multicenter, investigator-masked prospective study of NTG patients currently on latanoprost 0.005% monotherapy, to study the effect of IOP change with the introduction of netarsudil 0.02% vs brimonidine 0.1%. Subjects will be assessed at a screening visit, and 1 follow-up visit. Clinical evaluations will include visual acuity and IOP .


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Diagnosed with normal tension glaucoma based on the following:

  * IOP ≤ 21mmHg
  * Optic nerve rim thinning and/or retinal nerve fiber layer (RNFL) loss consistent with glaucoma
  * Normal visual field OR visual field loss consistent with optic nerve or RNFL defects within the last year
  * Open angles assessed by gonioscopy
* Have been on latanoprost monotherapy for at least 6 weeks

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
* Other forms of secondary glaucoma.
* Patients with abnormal anterior segment examination other than cataract will be excluded from the study.
* Patients who have had incisional surgery for glaucoma (eg: MIGs).
* Patients with refractory CME or CME persisting 3 months or more.
* Children, cognitive impaired and critically ill subjects will not be enrolled.
* Central Corneal Thickness (CCT) ≤ 500.
* Prior allergy to brimonidine or netarsudil, and known to have previously failed either brimonidine or netarsudil.
* Ocular surgery (e.g., cataract, laser, refractive) during the study or 1 year prior to entering the study.

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Biomarkers in Samples of Bone Marrow From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
* To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
* To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
* To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.

OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved mixed-lineage leukemia (MLL) ENL AML rearrangement cells, normal karyotype and non-MLL rearrangement AML cells, and non-leukemic bone marrow samples from the COG tissue bank

  * 3 specimens of each type

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult immune thrombocytopenic purpura.

ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction and bleeding. Corticosteroids increase the platelet count in about 80 percent of patients.However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses. Rituximab 375 mg/m2 weekly for four weeks has significant activity in patients with immune thrombocytopenia. Furthermore, using lower dose rituximab the level of B-cell depletion and the response rates appear similar to those previously observed with standard dosages in a population of ITP.

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab (100mg IV days 1,8, 15 and 22) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura.

A complete platelet response is defined as an increase in platelet counts to \>150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial infusion to the first time of relapse (platelet count \<30×109/L)or to time of analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 30,000/mm3 on two occasions. Platelets \>30000/mm3 with bleeding.
* Normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years
* Subject is ≥ 18 years
* Subject has signed and dated written informed consent.
* No sepsis or fever
* No active infection requiring therapy
* No active chronic viral infection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion Criteria:

* Performance status above or equal to 2.
* Previous treatment with rituximab
* Immunosuppressive treatment within the last month
* Previous splenectomy
* Presence of malignant haematological disease
* Connective tissue disease
* Autoimmune hemolytic anemia
* Pregnancy and lactation
* Not willing to participate in the study.
* Expected survival of \< 2 years
* Known intolerance to murine antibodies.
Tele-video to Improve Daily Activity

This pilot study will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely (via Zoom) to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The intervention is called Tele-Video to Improve Daily Activity (T-VIDA) and will be administered with two cohorts of residents in a single community. The study has two main goals: 1) To determine if an OT-led program administered remotely over the internet using Zoom is useful in helping residents increase their physical activity; and 2) to determine if involving respected members of the community in the program as Advisory Committee members has an impact on how much other residents participate in program activities and engage in behaviors discussed. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. To evaluate the intervention pre- and post-program interviews will be conducted with participants over the phone, and activity monitoring will be conducted after both the pre- and post-program interviews for 7-days using an activity monitoring device. The following hypotheses will be tested: 1) at least 75% (3 of 4) of identified residents will accept the invitation to serve on the Advisory Committee; 2) Advisory Committee Members will attend at least 2 of 3 committee meetings; 3) Participants will on average participate in at least 70% (7 of 10) of intervention activities; 4) Residents knowing one or more committee members at baseline will participate in more intervention activities compared to those who do not; and 5) The influence of knowing a committee member on participation will be greater among residents reporting more pain at baseline compared to those reporting less pain.


Eligibility Criteria:
Inclusion Criteria:

* resident of the senior housing community of focus
* English-proficient
* ambulatory with or without assistive device (e.g., cane, walker)

Exclusion Criteria:

* requiring use of a wheelchair for ambulation;
* requiring highly specialized equipment (e.g., spinal cord injury, leg amputation, wound vacuum assisted closure, heavy leg boot);
* hospitalized within last 3 months;
* has probable dementia (TICSm score \<27);
* requiring ongoing complicated treatments (e.g., home oxygen use \>2 liters);
* has active mental health condition judged to pose significant barrier to participation; and
* meets CDC recommendations for physical activity (150+ minutes of moderate-intensity aerobic activity during typical week).
Infrapopliteal Drug Eluting Angioplasty Versus Stenting

In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.

Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Angiographically documented infrapopliteal disease.
* Rutherford category of peripheral arterial disease between class 3 to 6
* Lesion length between 70 to 220 mm
* Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.

Exclusion Criteria:

* Lesion length \< 70 mm or \> 220 mm.
* Lesions situated in the distal third of the tibial vessels
Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study

Breast cancer-related lymphedema is one of the most common chronic complications of breast cancer survivors. In existing studies, the reported incidence of lymphedema ranges from 2.5% to 42.9% . At present, there is no cure for lymphedema. Resistance training has been proved by many studies to alleviate the symptoms of lymphedema, improve the muscle strength of the upper limbs of patients, and improve the quality of life of patients, while not worsening lymphedema. Based on the best evidence, this study intends to construct resistance appropriate for this clinical scenario Training program: Conduct 3-month intervention for patients after breast cancer surgery to explore the effect of resistance training on the grip strength of the affected limb, the range of motion of the shoulder joint of the affected limb, the occurrence of lymphedema of the affected limb, quality of life, etc.


Eligibility Criteria:
Inclusion Criteria:

It was first diagnosed as grade I to III unilateral breast cancer by pathological examination； Breast cancer surgery was completed and axillary lymph node dissection was performed; To receive postoperative adjuvant treatment and follow-up in the outer fourth ward; Be able to communicate and exchange normally; Volunteer to participate in this research

Exclusion Criteria:

Extreme fatigue, severe anemia, ataxia, etc.; The presence of upper limb or shoulder problems from breast cancer treatment; Edema is in a non-stable stage (stable stage of edema means no treatment for edema in the past 3 months; No inflammation of the upper extremities requiring anti-infective treatment; No change in daily activities; Limb circumference change \< 10%) ； Limited limb movement due to trauma, shoulder periarthritis, etc.; Limb braking is required for health reasons. Patients are lost to follow-up