cyrilzakka/clinical-trials huggingface dataset:
Vitality Acupunch Exercise Program for Sarcopenia Older Adults

This project was aimed to test the effects of a six-month VA program on the activities of daily living (ADL) and functional fitness of institutional older adults with sarcopenia.

A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's motion, and muscle endurance) of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for six months; the control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years old
* have been living in the facility for at least three months
* intact cognitive function with the Short Portable Mental Status Questionnaire (SPMSQ) score ≥ 8
* hand-grip strength \< 28 kg for men and \< 18 kg for women
* calf circumference \< 34 cm for men and \< 33 cm for women

Exclusion Criteria:

* have spinal cord injury
* have severe cardiovascular or pulmonary diseases
* have musculoskeletal diseases
Clinical Performance of Resin-modified Glass Ionomer and Composite Restorations in Permanent Teeth

The aim of this randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients.

Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the carious lesions for patients in the treatment group while a sub-micron hybrid resin composite (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two calibrated examiners according to the Modified-USPHS criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with two comparable occlusal carious lesions on both mandibular first permanent molars.
2. Neutral occlusion with a natural antagonist tooth
3. Patients that are able to come to recalls
4. Patients with a good oral hygiene

Exclusion Criteria:

1. Patients suffering systemic diseases or allergies
2. Patients with gastrointestinal problems
3. Mandibular first molar teeth with restorations
4. Patients with oral habits
5. Patients receiving orthodontic treatment
6. Hypomineralized or Hypoplastic first molars
Rapid Administration of Carnitine in sEpsis

Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed infection (examples include but are not limited to: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in clinical symptoms; a syndrome associated with a high risk of infection e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever of unknown origin with high suspicion of infectious etiology)
2. Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;
3. Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;
4. Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine \> 0.05mcg/kg/min; dopamine \>10mcg/kg/min; Phenylephrine \>0.4 mcg/kg/min; epinephrine \> 0.05 mcg/kg/min;
5. Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;
6. Blood lactate level of \>2.0 mMol/L.

Exclusion Criteria:

1. Age \<18 years;
2. Pregnancy or breastfeeding;
3. Any primary diagnosis other than sepsis;
4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
5. Any history of seizures or a known seizure disorder;
6. Any known inborn error of metabolism;
7. Anticipated requirement for surgery that would interfere with the 12 hour infusion time;
8. Active participation in another interventional study;
9. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
10. Known systemic allergy to L-carnitine.
11. Severe immunocompromised state (e.g. subject has neutropenia \[receiving cytotoxic chemotherapy with absolute neutrophil count \<500/uL or expected to decline to \< 500 uL within the next three days).
12. Active Treatment with Coumadin
Minipterional Versus Pterional Craniotomy

This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms

This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms. Overall, 60 eligible patients admitted with ruptured and unruptured anterior circulation aneurysms will enrolled in the study.

The aesthetic results will be analyzed with 2 methods. In the first, the patients will be showed to a rule, with a scale from 0 to 100, in which 0 mean the best result and 100 the worst result. Photos will be taken and showed to two independent observers, the results will be classified as excellent, good, regular or poor. The degree of atrophy will be measured with three methods. In the first one, the authors wiil observes the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle will be measured and the third the volumetric analysis of the temporal muscle, subcutaneous tissue and skin will be calculated from the superior edge of zygomatic arch to superior temporal line. The functional results wiil be compared using the Modified Rankin Score. Others variables such frontal facial palsy, post-operative hemorrhage, cerebrospinal fistulas, hydrocephalus and mortality will be also analyzed

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas
Impact of Journal Program on Wellbeing of NICU Parents

The purpose of this study is to investigate the impact of a journaling program on rates of anxiety and depression in neonatal intensive care unit (NICU) parents.


Eligibility Criteria:
Inclusion Criteria:

* Mother, father, and/or legal guardian of infant
* \> 28 weeks gestation
* At least 5 days anticipated admission in Vanderbilt NICU

Exclusion Criteria:

* \< 28 weeks gestation
* Expected death or discharge within 5 days of admission
* Primary medical team feels that participation would be disruptive or detrimental to infant's care
Pain and Symptom Management in Rural Communities

Patients in isolated rural settings often lack easy access to pain care and specialist services. Yet rural residents are more likely than their urban counterparts to be older; be in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health care delivery that has been found useful and effective in many clinical settings and specialties. Telehealth technologies can bridge geographic distance and increase access to specialist care in rural settings. The investigators propose a cluster randomized clinical trial design to test the effects of a telehealth-enhanced palliative care pain-management program for 240 patients and 40 providers in rural health care settings. The proposed program will provide services to both patients and providers: Patients will conduct self-assessments and report pain and other symptoms via telehealth. Health care providers will receive telehealth-delivered case consultations that will include case management, evidence-based practice resources, and peer support. Providers and their patients will be randomly assigned to intervention groups, which receive the telehealth-enhanced palliative care pain-management intervention, or to control groups. The investigators primary aim is to compare patient self-reports of pain and quality of life in the intervention and control groups over 2 months. Aim 2 is to examine, in the intervention and control groups over 2 months, providers' knowledge and attitudes regarding pain and perceived competence in treating pain. Aim 3 is to evaluate the cost-effectiveness of the telehealth intervention. The investigators will use mixed effects models with patients nested within providers to evaluate the effect of the intervention on study outcomes. Findings from this study will be instrumental in advancing telehealth and improving pain management and palliative care among underserved rural populations.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* diagnosed with pain
* completion of an outpatient visit in the past 2 months
* functional fluency in English
* no cognitive impairment
* no problems with regular phone lines

Exclusion Criteria:

-
Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight

The purpose of this study is to test whether peripherally inserted central catheters can be safely placed on patients by intravenous team nurses at the bedside.

We have developed a new device for guiding invasive procedures with ultrasound (US), which we call the Sonic Flashlight (SF). We attach a half-silvered mirror and a small flat-panel monitor directly to an ultrasound transducer to project a virtual image of the US scan into its actual location within the patient. This permits the operator to guide a needle through the skin by aiming directly at the image, using natural hand-eye coordination rather than looking away from the patient at a conventional display. We believe the SF will increase accuracy, safety, and speed for a wide variety of invasive procedures and yield a faster learning of these procedures than conventional US displays.

The research proposed here would bring the application of guided needle insertion to its clinical implementation, specifically addressing the placement of the Peripherally Inserted Central Catheter (PICC) line. The PICC line is increasingly viewed as a safe alternative to direct central line placement in the jugular, subclavian, and femoral veins, while being easier to maintain than a peripheral intravenous line. This study will test the hypothesis that PICC lines can be placed by experienced intravenous (IV) team nurses using the SF for real-time US guidance.

Thirty nurse participants (ages 18-65) will be recruited from the IV team at UPMC Presbyterian Hospital to participate in the study. 200 patient subjects will be recruited from the adult (18 years and older) population of patients already scheduled to receive the PICC placement procedure; patients will have the lines placed by experienced IV team nurses using ultrasound guidance with either the SF or conventional ultrasound (CUS). Investigators will observe each procedure, using audio and video recording, ultrasound image data, and other characteristics of the procedure to monitor the success of each procedure. A set of feasibility trials will be conducted in the interventional radiology (IR) suite to assess the level of training the nurses have received prior to the start of the comparison trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Undergoing peripherally inserted central catheter placement as standard of care.

Exclusion Criteria:

* None
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies

This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured.

Gallium maltolate is an orally bioavailable form of gallium. This is a safety, pharmacokinetic and preliminary efficacy study. The primary objective of the study is to assess the safety profile in patients after oral administration of different doses of gallium maltolate for up to six 42-day cycles (28 days of gallium maltolate, followed by 14 days off treatment). In addition, serum concentrations of gallium and associated pharmacokinetic variables will be measured. From this information, an optimal dose will be selected for assessment of anti-tumor efficacy. The study assesses the effects of oral administration of gallium maltolate on pain resulting from bony metastasis, on biochemical measures of bone turnover, and on disease progression and overall survival in patients with various refractory malignancies. Patients may receive up to 6 cycles of the investigational agent.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hormone refractory prostate cancer, refractory multiple myeloma, refractory bladder cancer, or malignant lymphoma;
* life expectancy of ≥6 months,
* Zubrod Performance Status of ≤2,
* adequate bone marrow function, renal function, liver function and pulmonary function;
* age ≥ 18 years;
* willing and able to give informed consent; and
* effective contraceptive use or non child-bearing potential.

Exclusion Criteria:

* 10% weight loss in the previous 3 months;
* active serious infection not controlled by antibiotics;
* initiation of bisphosphonates treatment within 30 days;
* participation in other research study within 30 days;
* uncontrolled brain metastasis,
* prior intrathecal chemotherapy or whole-brain radiotherapy,
* inability to comply with protocol or undergo specified tests;
* other active malignancy;
* optic neuritis, and
* routine use of diuretics (for initial phase of study only).
Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than or equal to (\>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:

  * Radiosensitizing doses of 5-fluorouracil;
  * Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  * Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
  * Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Subjects may have measurable or non-measurable disease according to RECIST 1.1.
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Acceptable hematological status, liver and renal function as defined in the protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Significant cardiac or peripheral vascular arterial disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
* Other protocol defined exclusion criteria could apply
Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI

The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.

This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.

Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.

The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.

Sensitivity and Specificity of delayed enhancement \>50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Major patient
* Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (\>24 hours)
* Creatinine clearance (calculated using the Cockcroft (\<age 65) or MDRD (\> 65 years))formula \> 30 ml / min.
* Affiliation to the french social security scheme.
* Women of childbearing age: Negative pregnancy test (urine test).
* Postmenopausal women, menopause confirmation of diagnosis
* Patient able to understand the spoken and written French.
* Signature of informed consent

Exclusion Criteria:

* Collapsus or organ failure requiring urgent care in intensive care unit
* Arrhythmia and/or non-reducible tachycardia.
* History of allergic reaction after iodinated contrast medium injection.
* History of nephrogenic systemic fibrosis.
* History of claustrophobia
* Unbalanced asthma.
* Acute pulmonary edema.
* Pregnant or breastfeeding women.
* Clinical signs of thyrotoxicosis.
* Person placed under judicial protection,
* Patient suffering from serious psychiatric disease.
* Patients participating in another clinical trial.
* Contraindication to MRI
DNS-3379 vs. Placebo in Stroke Rehabilitation

This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic stroke.


Eligibility Criteria:
Main Inclusion Criteria:

* Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in upper extremity deficit that warrants the need for rehabilitation therapy.
* Medically stable subjects, with expected survival \> 12 months, who are able to be randomized to study drug beginning between 1 and 52 weeks (i.e., 7 to 365 days) post-stroke.
* Mild to moderately severe upper extremity motor impairment.
* mRS score of 1 to 4 from index stroke.
* Mini Mental State Examination (MMSE) score of ≥ 22.

Main Exclusion Criteria:

* Residual motor deficit from any prior stroke
* Hemorrhagic stroke. Ischemic stroke with limited hemorrhagic conversion (i.e., petechial hemorrhage or micro-hemorrhage) is acceptable.
* Severe or total sensory loss
* Moderate to severe aphasia and/or severe language deficits
* Excessive spasticity in the affected elbow or change in oral spasticity treatment drugs within 2 weeks before the Screening Visit
* Prior botulinum toxin injection to any portion of the affected arm in the prior 3 months before the Screening Visit
* Major and active neurological, psychiatric, or medical diagnosis that is not adequately controlled and would likely reduce the safety of study participation or impact the subject's ability to comply with study protocol procedures in the opinion of the Investigator
* Any suicidal ideation during the subject's lifetime at any time prior to randomization including childhood (based on subject history), equivalent to type 2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Received an investigational pharmacotherapy therapy within the past 3 months
* Heavy use of any tobacco-smoke emitting products (including but not limited to cigarettes, pipes, and cigars) within 30 days of Baseline.
* Pregnant or lactating females
A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery

To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.

Eligibility Criteria:
Inclusion Criteria:

* aged⩾40years; intraocular pressure (IOP) \< 21 mm Hg in both eyes, spherical refractive error\<6 diopters spherical equivalent.

Exclusion Criteria:

* previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.
The Neuropsychiatric Evaluation of HIV-Positive and Negative Drug Using Individuals: Study 215

The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures....

The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures.

Eligibility Criteria:
* Data analysis protocol