cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.

Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae.

Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
* Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous treatment/procedure in or near the treatment area:

  1. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.
  2. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.
  3. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.
  4. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.
  5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.
  6. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.
Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)

Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory
* Beginning of symptoms in the past 7 days
* Mild disease
* Informed consent

Exclusion Criteria:

* Preexisting liver disease
* Hypersensitivity to ivermectin
* Participants in other clinical trials for therapies against COVID-19
* Severe pneumonia
* Pregnant or breastfeeding women
* Concomitant use of warfarin, erdafitinib or quinidine
* Use of ivermectin in the 5 days prior to randomization
* Inability to obtain a blood sample needed to assess liver transaminases
* Elevation of transaminases \>1.5 times the normal level
* Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms
Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema

The DRAGONS study is a non-interventional, prospective study that will

1. characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and
2. correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.

The DRAGONS study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of DR, DME and other retinal pathologies.

Subjects will be included in the study if at least one eye meets any of the following criteria:

Group 1 - eyes with treatment naive DR with or without DME Group 2 - eyes with DME that are incompletely responsive to anti-VEGF therapy Group 3 - eyes with various retinal conditions including eyes with DR and DME that are anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole

The study will consist of a single visit and a retrospective chart review. The study visit will consist of:

1. Screening for eligibility;
2. Aqueous humor collection;
3. Blood collection;
4. Optical coherence tomography;
5. Optical coherence tomography angiography;
6. Fundus photography; and
7. Fluorescein angiography.

Approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. Plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with at least one of the following retinal conditions in at least one eye:

* Treatment naive diabetic retinopathy (group 1 only);
* Diabetic retinopathy with DME that is incompletely responsive to anti-VEGF therapy at principal investigators discretion with retinal thickening documented on OCT (group 2 only);
* Various retinal disease including but not limited to diabetic retinopathy without DME which has previously been treated, DME which has responded to anti-VEGF therapy, neovascular age-related macular degeneration, branch or central retinal vein occlusions, epiretinal membrane, or macular hole (group 3 only)

Exclusion Criteria:

1. Prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent;
2. Prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent;
3. Prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent;
4. Intraocular or refractive surgery in the study eye within 90 days of signing informed consent;
5. Systemic anti-VEGF treatment within 90 days of signing informed consent
Parameters of Cerebral Perfusion

The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiopulmonary bypass for CABG a
* having an appropriate temporal bone window for reliable TCD monitoring
* needing pharmacological intervention because of hypotension before going on CPB.

Exclusion Criteria:

* requiring hypothermia during surgery
* requiring emergency surgery
* contraindication for phenylephrine,
* having known brain pathology (e.g. Cerebral Vascular Accident (CVA) or increased intracranial pressure
* having a history of severe carotid artery stenosis.
Postpartum Contraception Counseling on the Rate of Unintended Pregnancy

Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies


Eligibility Criteria:
Inclusion Criteria:

1. Age: above 18 years
2. Primigravida
3. Women who will accept to participate in

Exclusion Criteria:

1. Women who are not intended to use contraception
2. Multiparous
3. Women who refuse to participate in the study
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U

This usability study is to test the basic functionality of the BrightArm Compact (BAC) system. The BAC is a motorized rehabilitation platform to offer gravity bearing for weak upper extremity. It has a medical grade PC which hosts numerous interactive, adaptable computer games, played using BrightBrainer Grasp (BBG) controllers. The device is passive, in that no actuators apply forces on the patient. Further, the patient is free to lift that arm, nothing restricts the arms movement away from the BAC table.

Healthy, age matched participants are invited to test the BAC at Bright Cloud Int Corporate Labs (675 US Hwy 1 south, B203, North Brunswick, NJ 08902, USA).

At the beginning of the usability training, participants will be required to sign a consent form, and BCI research staff will go over the details of the study and check inclusion criteria (generally healthy individual, age 50 \~ 85, English speaker, cognitively normal).

Subjects participate in 4 study sessions over approximately 1 month, each session lasting about an hour. The BAC table will have a different configuration each session. In the first session the table will have 0 tilt (flat). In session 2 it will be tilted 10 degrees downwards, in session 3 the table will be tilted up 10 degrees and in Session 4 the BAC table will be tilted up 20 degrees.

The difficulty of the games will also vary from session to session, progressing from the lowest difficulty in Session 1 to the highest difficulty in Session 4. Thus a given game will not be exactly the same, when played in a subsequent session, so to allow varying interaction scenarios.

At the end of each session, participants will be asked to fill up a custom feedback form. The custom form has questions on the system, the rehabilitation table, the controller, the therapeutic games they tested, and their overall impression of the experimental device. Each question on the custom form is answered on a 5-point Liker Scale.

At the end of the last session they will fill a standardized USE form, with questions rated on a 7-point Likert scale.

Feedback from participant will be used to improve the device as well as the therapeutic games.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* age 50\~80;
* good or corrected vision;
* good or corrected hearing

Exclusion Criteria:

* motor or cognitively impaired;
* outside 50\~80 age bracket;
* inability to speak English;
* history of violence or drug abuse.
Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis

The impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

To study the mechanisms underlying inactivity-induced muscle atrophy, the impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18-40

Exclusion Criteria:

* Smoker
* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension)
* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
* A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
* Any known disorders in muscle metabolism
* Regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month)
* Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
* Allergy to lidocaine
* Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)
Effects of Unblocking the Full Potential of Percept PC IPG

Population Size and Eligible Patients: The study will enroll patients with Parkinson's disease (n=30) who had an IPG replacement from Activa PC (older generation of neurostimulator) to Medtronic PerceptTM PC (newer generation of neurostimulator) as a part of their standard-of-care. No patient will be receiving the system for research purposes only.

Study Design: This is a prospective, double-blinded, randomized, cross-over clinical investigation to further investigate the efficiency of Medtronic PerceptTM PC neurostimulator. This study involves three in clinic visits. During the first study visit, the patients' neurostimulator will be reprogrammed using all the additional features the Percept PC has to offer. At the end of the visit, the patients will be randomized between their baseline program, ((Activa PC group) and the newly defined programming settings (Percept Group). During the second visit (1-month follow-up) the effect will be clinically assessed, and a crossover of the condition will happen. The third visit (2-month follow-up) will be a follow-up visit with no programming but only clinical assessment.

Study Duration: Expected study duration is 1 year with the possibility for renewals.

Objectives and outcome measures: The goal is the study is to define whether or what the benefit is of the Percept PC neurostimulator compared to the older Activa PC neurostimulator. The primary outcome is patient-reported global impression of change (PGIC). The secondary outcome measures are clinical scales assessing symptoms of Parkinson's disease (UPDRS-III and -IV) and quality of life (PDQ-39), the active problems list and amount of medication intake.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with idiopathic Parkinson's disease who previously underwent DBS surgery.
* Individuals who had IPG replacement from Activa PC to Medtronic PerceptTM PC Neurostimulator as standard-of-care
* Individuals should be able to provide their informed consent

Exclusion Criteria:

* Cognition impairment (MoCA \< 20/30)
* Patients with severe PD symptoms who are unable to come to the clinic three times within three months (e.g. bedridden patients)
Acute Effects of Low and High-Speed Resistance Training on Blood Pressure in Older Adults: A Crossover Study

The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Participants performed three experimental sessions (i.e., HSRE, TRE, and a control session \[CS\]) in a random order and separated from one another by seven days (standard deviation \[±\] 1 day). Food consumption was maintained constant during 48 h prior to the exercise session and a standard breakfast was offered 60-90 min before the beginning of the experimental sessions. The pharmacological therapy was kept constant during the whole study, and participants took their anti-hypertensive medication at the same time in all experimental days as prescribed by their physician.


Eligibility Criteria:
Inclusion Criteria:

- Aged ≥60 years; Frail according to Fried's criteria (Fried et al., 2009); Possessed sufficient physical and cognitive abilities to perform all exercises required by the protocol; Had a physician authorization to participate of exercise programs.

Exclusion Criteria:

Participation in a structured physical exercise training program in the past six months; Prescription of hormone replacement therapy and/or psychotropic drugs; Presence of any acute cardiovascular event (e.g., myocardial infarction) or complication in the past six months.
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.


Eligibility Criteria:
Inclusion Criteria:

1. Patients included in the CORIMUNO-19 cohort
2. Patients belonging to one of the 2 following groups:

   * Group 1: Cases meeting all of the following criteria

     * Requiring more than 3L/min of oxygen
     * OMS/WHO progression scale = 5
     * No NIV or High flow
   * Group 2: Cases meeting all of the following criteria

     * Respiratory failure AND (requiring mechanical ventilation OR NIV OR High flow)
     * WHO progression scale \>=6
     * No do-not-resuscitate order (DNR order)

Exclusion Criteria:

* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Known hypersensitivity to Tocilizumab or to any of their excipients.
* Pregnancy
* Current documented bacterial infection
* Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
* Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
* Haemoglobin level: no limitation
* Platelets (PLT) \< 50 G /L
* SGOT or SGPT \> 5N
Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain

This study aims to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain.

Neck pain is a common musculoskeletal disease. In chronic pain clinics, neck pain ranks second in frequency after low back pain. Lifetime prevalence is higher in workers. 51-80% of workers experience at least one episode of neck and arm pain. Neck pain symptoms may disappear spontaneously within a few weeks, while 30% of them continue as chronic neck pain. Today, studies are planned with the theory that pathology leads to deficiencies, deficiencies lead to functional limitations, and functional limitations lead to disability. Chronic neck pain increases the cost of treatment and reduces work capacity. In addition, neck pain in industrial workplaces causes loss of work days as much as low back pain. The aim of this study is to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain. In addition, it is aimed to examine the relationship of these parameters with quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Complaining of neck pain for more than three months,
* With any chronic disease diagnosed,
* No past or present mental illness,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.
A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis

Currently, no standard of care exists to prevent incisional hernias (IH). This study will compare how frequently IH develop in standard abdominal closures vs. abdominal closures with dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of IH.

If patients decide to participate in this study, they will be randomly assigned to one of two study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The assignment will be made by computer program and is completely random. Patients are not informed of which arm they are assigned.

Arm A (Treatment Arm): dHACM Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA-registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns.

Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure.

Data collection will be performed at routine follow-up outpatient clinic visits with the primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will see a surgeon who is blinded to the randomization. This surgeon will perform a painless handheld ultrasound examination of the incision site.

Two million laparotomies are performed annually in the United States (US). Following these surgeries, the incidence of new incisional hernias (IH) is estimated at 400,000 cases per year. These hernias are a major source of morbidity and mortality for patients, and they result in $6-10 billion per year in healthcare costs. Our multidisciplinary hernia prevention group has identified a novel IH prevention strategy in the form of dehydrated human amniotic-chorionic membrane (dHACM). We previously showed that dHACM prevents IH in animal models, and subsequently in a prospective cohort of high-risk patients.

The purpose of this trial is to quantify the efficacy of dHACM in IH prophylaxis by performing a prospective, double-blinded randomized controlled trial. Our specific aim is to test the hypothesis that augmentation of standard abdominal fascia closures with prophylactic, onlay dHACM sheets without fixation will reduce IH formation in a high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years
* Written informed consent
* Non-emergent operation
* Predicted incisional herna (IH) risk ≥150% of the average IH risk, as calculated by the University of Pennsylvania Hernia Risk Calculator, which accounts for 18 IH risk factors
* BMI \> 27 yields IH risk \> 150% of the average IH risk; this can be used as a shortcut for screening potential subjects

Exclusion Criteria:

* Previous intraperitoneal mesh placement
* Previous abdominal incisional hernia
* Emergency procedures
* Patients with inflammatory bowel disease