cyrilzakka/clinical-trials huggingface dataset:
Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes

Introduction: Diabetes Mellitus (DM) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. The exercise is an important factor of prevention and control, thereby decreasing the risk of metabolic diseases, cardiovascular diseases and improving the functionality of the patient with diabetes.

Objective: Evaluate the response of resistance training associated with whole-body vibration on peripheral circulation and functional performance of elderly with type 2 diabetes.

Methods: This is a clinical trial study, controlled, randomized and blinded, which will follow the guidelines established by the Consolidated Standards of Reporting Trials (CONSORT). Patients will be recruited in the light of the eligibility criteria and randomly divided into 3 groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham (G2) and control group-guidelines about foot care (GC), establishing 36 treatment sessions, three times a week for the G1 and G2.


Eligibility Criteria:
Inclusion Criteria:

* Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO, 2009)
* Be functionally independent
* Having cognitive ability to respond and perform the exercisesevaluated by Mini-Mental State examination (MMSE), prepared by Folstein et al. (1975) and translation/modification proposed by Lawrence and van Heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (BRAZIL, 2006)
* Inactive (0 to 5 points) or less active (6 to 11 points) according to the Questionnaire of Habitual Physical Activity (QAFH)
* Patients without severe foot deformities requiring therapeutic shoes
* Do not have orthopedic deficiencies
* No indications of deep vein thrombosis
* Do not use locomotion auxiliary equipment

Exclusion Criteria:

* Change in the drug program in during the research
* Performing other physical activity during the training
* Hypertensive Peaks during treatment
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of vincristine given as an IV push dose in combination with continuous infusion cyclosporine and oral etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of other toxicities of vincristine in this regimen in these patients. III. Determine a safe and tolerable dose of vincristine under these conditions to be used in phase II studies. IV. Seek preliminary evidence of antitumor activity in this setting in these patients.

OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion. Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12 patients per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin of the tumor is clearly in the pons Must be registered within 28 days of diagnosis Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or ataxia) No diffuse leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal: Creatinine normal for age OR Creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Illuminiation

Purpose: To analyze the clinical benefits of using the NGENUITY 3D Visualization System in vitreoretinal surgery with low levels of endo-illumination, focusing on functional and structural retinal protection in patients with idiopathic epiretinal membranes (ERM).

Design: Prospective, randomized, comparative study. Methods: Forty pseudophakic patients (29♀, 11♂; age 60-80 years) with ERM underwent 27G pars plana vitrectomy (PPV) and were randomly divided into two groups: Group I (20 eyes, stand-ard microscope \[Hi-R 900\], endo-illumination 3.2 Lm) and Group II (20 eyes, 3D heads-up NGE-NUITY system, endo-illumination 0.5 Lm). Preoperative and 6-month postoperative evaluations included slit-lamp examination, intraocular pressure (IOP, Pascal tonometer), Distance Best Correct-ed Visual Acuity (DBCVA, logMAR), Central Subfield Thickness (CST), Retinal Nerve Fiber Layer Thickness (RNFL, OCT), Pattern ERG (PERG), multifocal ERG (mfERG), flash ERG (ERG, IS-CEV standards), and retinal sensitivity (HFA macula test). Surgery time, xenon light exposure, ERM/ILM peeling time, fundus autofluorescence (FAF), metamorphopsia incidence, and intra-/postoperative adverse events were analyzed. Results were statistically evaluated (p \< 0.05).


Eligibility Criteria:
Inclusion Criteria:

* DBCVA \> 0.1 (Snellen charts)
* Pseudophakia
* ERM without other abnormalities
* Patient's consent to participate in the project with a 6-month follow-up after surgery.

Exclusion Criteria:

* Glaucoma
* AMD
* Systemic diseases known to influence retinal function (e.g., diabetes)
* Psychiatric disorders
* Advanced stages of cardiovascular diseases
* Previous PPV
* High myopia.
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the elbow and back of forearm in a topical balm format in healthy adults.

This is a randomized double-blind, placebo-controlled pilot study with no crossover for the assessment of any changes to the microbial make-up of the skin (The local skin microbiome), detection of colonisation by the probiotic bacterium (BLIS Q24) on the skin and to evaluate the changes in skin quality parameters following topical application of probiotic in a balm format.

Eligibility Criteria:
Inclusion Criteria:

* In general good health 18 - 80 years of age.
* Practice good general body hygiene

Exclusion Criteria:

* Have a history of autoimmune disease or are immunocompromised.
* Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
* People with allergies or sensitivity to dairy.
* People with an open wound on the Blis Q24 application sites.
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control

This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.

Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking

Exclusion Criteria:

* No smartphone
* Use of oral corticosteroids in prior 4 weeks
* Pregnancy
* Psychiatric conditions
Age-related Changes in Posture Control and Cortex Activity Under a Dynamic Perturbation

With aging, the elderly decreased ability to control postural balance will be accompanied by increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it increased with age (Skelton, \& Todd, 2004). In view of this, age-related posture control has become important issues of modern preventive medicine and family care.

Many clinical studies have been developed assessment tools and measurements for clinical staff to provide balanced assessment and intervention. However, the factors of affecting postural control are diverse and complex, not all tools or measurement could effectively detect a risk of falling. In daily living, the postural control involved integration of sensation, biofeedback, movement response, and kinesthetic sense to maintain postural stability, and finally integrated into the neuromuscular system and coordination to help achieve the perfect postural control. Current clinical tools used to assess the fall or research methods to detect the incidence of falls and the lack of effective relevant and contradictory, and it's difficult to effectively evaluate the risk of falls (Gates, et al, 2008).

With the development of postural balance issues associated with aging process in older people, there is no set of standardized equipment, and lack of effective methods for the assessment of normal and older people who fall. In response to these problems, if we can provide a virtual reality interfaces, and with daily living activities as gait, across obstacles activity, sit to stand, will be able to better meet the desire to explore the issue of real significance to enhance researchers for aging, motion analysis, and brain cortex activity mechanism in postural control mechanism.

Eligibility Criteria:
Inclusion Criteria:

* able to walk and climb the stairs without assistive devices,
* could follow the instructions, and
* without well-known balance related diseases or impairments.

Exclusion Criteria:

* With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study.
TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven

The overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and (2) fostering greater support for mental health by training a trusted network of community members in trauma-informed counseling.

Proposed is a type I hybrid effectiveness/implementation study using a neighborhood-level, stepped-wedge trial design across six primarily Black/Latinx, socially vulnerable neighborhoods in New Haven. Residents of each neighborhood who have been affected by incarceration (i.e., currently have a family member incarcerated or a person returning to the community from prison within the last 12 months) will be eligible for our intervention for a period of 6 months. The Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science frameworks will be used to measure and track processes in achieving outcomes. A mixed methods approach will be used, primarily the use of quantitative methods for this study, along with qualitative focus groups will be conducted to assess some implementation outcomes. The primary outcome, rates of gun violence at the neighborhood level, are obtained from administrative data. Survey data will be collected for some implementation process measures (e.g., assessing acceptability and appropriateness of the intervention).

Eligibility Criteria:
All residents in the study neighborhoods are eligible for outcome assessment. For the intervention component of housing support, the below inclusion and exclusion criteria apply.

Inclusion criteria:

* Age 18 or above
* Family member currently incarcerated or person returning from prison within the last 12 months
* Live in one of the six neighborhoods with highest rates of gun violence in New Haven, Connecticut

Exclusion criteria:

* Plans to leave the study area within 1 year
Evaluation of Measurable Residual Disease in Patients With Acute Myeloid Leukemia as Surrogate Endpoint for Survival

Objectives To demonstrate that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival and thus an early read-out for drug efficacy Study design Surrogate endpoint trial to establish that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival

Acute myeloid leukemia is a genetically and phenotypically heterogeneous disorder with an incidence of 3 to 4 per 100 000 men and women per year and a median age at diagnosis of about 70 years. Prognosis, especially in older patients, has remained very poor. In patients considered suitable for intensive chemotherapy, the combination of an anthracycline and cytarabine remains the standard of care. For patients achieving a complete remission (CR), postremission therapy (PRT) ranging from chemotherapy to allogeneic hematopoietic stem cell transplantation is required; intensive PRT is still under debate in older patients. Beyond pre-treatment genetics-based risk stratification, measurable residual disease (MRD) during treatment and follow up emerges as an important prognostic factor in first CR. Furthermore, MRD may provide a tool for a read-out of therapeutic efficacy. In this diagnostic meta-study the investigators intend to measure MRD using multiparameter flow cytometry across up-front randomized clinical trials which in total will accrue more than 1000 patients. According to the leukemia-associated phenotype at diagnosis or the different-from-normal approach, MRD will be assessed early (after induction) and late (after consolidation) during treatment. The aim of the study is to show that levels of MRD measured early during treatment are closely related to overall survival and thus may serve as an early surrogate. There is a growing public demand that new, promising drugs are approved for therapy as rapidly as possible. Therefore, it is of great interest to obtain these approvals based on early biomarker endpoints such as MRD rather than on long-term survival endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia according to the WHO classification
* Informed consent in place for a randomized study of the Study Alliance Leukemia (SAL) including the Heidelberg Leukemia Network (HeLeNe) covering assessment of MRD by MPFC in the reference laboratories in Heidelberg and Dresden.

Exclusion Criteria:

* No signed informed consent compliant with the requirements of PERDAM
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).

This protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in CAH.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Congenital Adrenal Hyperplasia (CAH)
* normal ECG during baseline evaluation

Exclusion Criteria:

* history of liver disease, or elevated liver function tests
* history of cardiovascular disease
Antibiotic Prophylaxis for Simple Hand Lacerations

Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?

Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).

Exclusion Criteria:

* Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
* Current or recent (within two weeks) use of any antibiotics
* Allergy to clindamycin or cephalexin
* Bites (e.g. dog, cat, or human)
* Lacerations resulted from crush injury
* Lacerations involving bone, tendon, blood vessel, or nerve
* Lacerations inflicted more than 12 hours prior to ED visit
* Pregnant or breast-feeding women
Evaluating Trends in Anaplastic Thyroid Cancer Patients' Clinical Study Experiences

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in anaplastic thyroid cancer clinical research, as well as the reasons for withdrawal or discontinuation.

Insights gained from this study will ultimately benefit those with anaplastic thyroid cancer who may be invited to participate in clinical research in the years to come.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with anaplastic thyroid cancer
* Willing to comply with all study related procedures and assessments
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

* No documented diagnosis of anaplastic thyroid cancer
* Any serious and/or unstable pre-existing medical disorders
* Pregnant or lactating woman
Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.

In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.

Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.

Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age-18years and above
* Both male and female patients
* BMI-\>18
* Elective Subacute upper extremity fractures

Exclusion Criteria:

* Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
* Patients with drug abuse history in the past 6 months
* ESRD
* Hepatic failure
MVP RCT: Mind and Voice Project Randomized Control Trial

The study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults.


Eligibility Criteria:
Inclusion Criteria:

* Prior Alcohol Use
* Interpersonal Violence

Exclusion Criteria:

* Person does not understand/speak English
* Prisoner or person being taken into custody/under house arrest
* Person or parent/guardian unable to give consent due to insufficient cognitive orientation due to unknown reasons
* Person unable to give consent due to insufficient cognitive orientation due to drug or alcohol use/ accidental overdose; given pain medications (fails MMSE)
* Person diagnosed with schizophrenia
* Person is actively suicidal or being treated for self-harm (includes overdose with the intent to harm self - not accidental)
* Person being treated for child abuse situation
* Deaf or visually impaired/illiterate/can't speak
* Screened within last month or already in study
* Combative
* Patient died
* Too sick in emergency department to approach (e.g. - never stabilizes, in trauma bay, intubated, on ventilator, or a Level 1 trauma)
* Person has already refused 2 times