cyrilzakka/clinical-trials huggingface dataset:
LOTUS: Global Acute Stroke Study Utilizing Penumbra System

The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 and ≤ 85
* Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
* Planned frontline treatment with aspiration utilizing Penumbra System
* Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
* National Institute of Health Stroke Scale (NIHSS) ≥ 6
* Signed informed consent per Institution Review Board/Ethics Committee
* CT ASPECT score from 6 to 10 (≥ 6) or according to MR DWI ASPECT score from 5 to 10 (≥ 5)
* Pre-stroke mRS 0-1

Exclusion Criteria:

* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
* Associated myocardial infarction or severe infection (endocarditis or sepsis)
* Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) or \> 3.0 or platelets count \< 40 x 10\^9/L or PTT/APTT \> 50 sec
* Uncontrolled hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg)
* Baseline glucose \< 2.7 or \> 22.2 mmol/L
* Seizure at the onset of stroke
* Time of stroke symptom onset unknown
* Females who are pregnant
* Known serious sensitivity to radiographic contrast media that cannot be pre-treated
* Renal failure as defined by serum creatinine \> 3.0mg/dl (264 µmol/L)
* Currently participating in an investigational (drug, device, etc.) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
* CT/MRI evidence of the following conditions at screening: significant mass effect with midline shift, evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM), or intracranial tumor
* . Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
* Angiographic evidence of occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
* Excessive arterial tortuosity that would prevent the device from reaching the target vessel
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)

The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
* Patients diagnosed as left ventricular hypertrophy by electrocardiogram

Exclusion Criteria:

* Secondary hypertension
* History of myocardial infarction
* Stroke within the previous 6 months
Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen

The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).

Eligibility Criteria:
Inclusion Criteria:

* presenting with unstable angina
* presenting with acute myocardial infarction
* eligibility for percutaneous coronary intervention

Exclusion Criteria:

* presenting with cardiogenic shock
Manual Therapy in Metabolic Liver Disease

Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver.

Chronic liver diseases such as metabolic disease associated with nonalcoholic fatty liver lead to a stiff liver due to activation of hepatic stellate cells or portal fibroblasts into matrix-producing myofibroblasts. Congested livers tend to fibrosis, while the physiological forces that the liver receives during physical activity and deep breathing could have a beneficial effect on it, favoring physiological remodeling.

The importance of the mobility of the viscera for their proper functioning is known. Likewise, the beneficial effect of physical activity on the liver is known. This physical activity includes a component of applying pressure on the liver. These pressures are also exerted during the techniques described for manual liver treatment. Although there is some evidence about the effectiveness of these manual techniques for the treatment of pain situations, the effect they could have on liver parameters is unknown.

For all these reasons, we aim to know the effect of manual liver techniques on biochemical and mechanical sensitivity parameters in subjects with Metabolic Disease Associated with Non-Alcoholic Fatty Liver (NAFLD).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI \> 36

Exclusion Criteria:

* Fibrosis defined by FIB-4 \> 2.67
* Hepatic cirrhosis
* Geographic dispersion to avoid losses
* Contraindication to manual therapy
* Diabetes mellitus tiype 1
* Severe hypertriglyceridemia with TG \> 500 mg/dl at the time of recruitment
* Life expectancy less than one year
* Advanced chronic kidney disease (stage G4)
Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial

Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* surgeon determined need for inguinal hernia repair

Exclusion Criteria:

* \< 18 years of age
* \> 99 years of age
* medical indication for open repair
Work-Related Fibromyalgia

The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.

4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* working at least 3 months in same working place

Exclusion Criteria:

* Diagnosed with the other musculoskeletal diseases
Coronary Disease and the Effect of High-intensity Interval Training

The primary purpose of this study is to investigate if systematic, high intensity, interval-based aerobic exercise training results in regression of lipid content of atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with stable coronary heart disease. Composition and morphologic characteristics of plaques will be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* stable coronary artery disease
* will undergo cardiac catheterization
* will be treated with percutaneous coronary intervention (PCI)
* signed written informed consent
* able to execute the intervention

Exclusion Criteria:

* earlier bypass surgery
* known inflammatory disease other than atherosclerosis
* planned surgery within 4 months
* included in another randomized controlled study
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-100
* Indicated for primary total knee arthroplasty
* Possess a smartphone with capabilities to use the FocusMotion app and FM2 Knee Brace
* Home discharge post-operatively

Exclusion Criteria:

* Prior ipsilateral knee surgery
* Prior manipulation under anesthesia of either knee
* BMI \> 40
A 1-year Clinical Investigation on the On1 Concept

A 1-year Clinical Investigation on the On1 Concept.

This open, prospective, multi-center clinical trial evaluates the On1 Concept for the treatment of patients in need for single tooth replacement or 3-unit bridges in the mandible or maxilla.

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.
* Obtained informed consent from the subject.
* The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
* The subject shall be healthy and compliant with good oral hygiene.
* Full-mouth bleeding score (FMBS) lower than 25% \[10\].
* Full-mouth plaque score (FMPI) lower than 20% \[11\].
* Suitable for implant treatment in the posterior, pre-molar and canine area in the mandible or maxilla.
* The subject shall have a favorable and stable occlusal relationship.
* In need of one or multiple single tooth replacements or 3-unit bridges.
* Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).
* The implant sites are free from infection and extraction remnants.
* The subject is suitable for a 1-stage surgical procedure.
* Sufficient amount of buccal and lingual keratinized mucosa.
* The subject has a sufficient amount of bone for placing NobelActive implants with a length of at least 8 mm.
* Primary implant stability as assessed by manual hand testing.

Exclusion Criteria:

* The subject is not able to give her/his informed consent of participating.
* Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
* Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.
* Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.
* Infections in the planned implantation site or adjacent tissue.
* Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
* Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).
* Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
* Alcohol or drug abuse as noted in subject records or in subject history.
* Smoking of \>10 cigarettes/day.
* Fresh extraction sites (up to 6 weeks).
* Severe bruxism or other destructive habits.
* Pregnant or lactating women at the time of implant insertion.
* Previous bone augmentation (lateral and/or vertical).
* Soft tissue augmentation less than 2 months before implant placement.
Effect of Vitamin D Deficiency on the Structure of Titanium Platelet-Rich Fibrin

ABSTRACT The aim of the study was to compare the macroscopic properties, chemical degradation levels, and fibrin network structures of T-PRF membranes obtained from systemically healthy individuals with optimal vitamin D levels, with vitamin D-deficient individuals who reached optimal levels after three months of vitamin D supplementation.

A total of 48 participants, 24 with vitamin D deficiency and 24 with optimal vitamin D levels, were included in the study. The macroscopic properties (weight, width, length, density), chemical degradation levels and fibrin network structures of the obtained T-PRF membranes were evaluated using scanning electron microscopy (SEM) and light microscopy.

Blood samples taken from individuals with the help of a 20 ml syringe were immediately transferred to 2 10 ml titanium tubes and placed opposite each other to ensure balance in the tabletop centrifuge device in order to be properly separated in the centrifuge process. To obtain T-PRF, it was centrifuged in the IntraSpin™ device at 2700 rpm centrifugal force for 12 minutes.

After centrifugation, the fibrin in the middle of the 3 layers formed in the titanium tube was held and pulled with the help of a press. Then, the red layer in the lower layer, where erythrocytes were dense, was separated from the fibrin layer with the help of scissors and the membrane was obtained by pressing for 2 minutes using the own weight of the PRF box.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 20-55
* Being systemically healthy
* Not using any medication regularly
* Not taking additional vitamin D from outside
* Patients who met the conditions of not having used antibiotics for the last three months were included in the study.

Exclusion Criteria:

* People who use cigarettes (tobacco) and alcohol
* Those with platelet function and clotting disorders
* Those who are pregnant or breastfeeding
* Those who use medications that affect the natural clotting process
* Those with a history of infection in the last three months
* Those receiving immunosuppressive therapy
* Those who do not consent to volunteer
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and \< 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and \< 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
* Either:

  * Age ≥ 18 years (at all sites) or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
  * Or aged ≥ 60 years
* Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
* Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
* Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)

Key Exclusion Criteria:

* Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
* Prior hospitalization for COVID-19
* Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
* Requiring oxygen supplementation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)

Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.

The proposed study is designed as a pilot study to evaluate the usefulness of MSOT for the evaluation of disease activity in IBD patients. As current methods for the evaluation of intestinal inflammation in IBD have relevant restrictions, new, non-invasive, quantitative, and accurate modalities are urgently needed. In comparison to other techniques, MSOT provides relevant advantages such as non-invasive imaging, high spatial resolution (this is of special importance for the evaluation of the intestine, which can be only a few millimeters thick), and highly sensitive detection of specific molecules such as total hemoglobin or oxy- /deoxygenated hemoglobin. These advantages suggest MSOT as an outstanding technique for evaluating disease activity in IBD.

The proposed study incorporates nearly no risk for participating patients and might provide relevant data for more a more in depth analysis of MSOT for IBD diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Histological verified Crohn's disease or ulcerative colitis
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* Mental retardation of the patient with restriction of general judgment and awareness
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.


Eligibility Criteria:
Inclusion Criteria:

* 18 years +

Exclusion Criteria:

* Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
* Previous treatment with PPI og H2RA
* Previous contact to doctor or hospital because of dyspepsia or reflux
* Pregnancy or breast feeding
Internet-based CBIT for Children With Chronic Tics

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders. children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL).

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders, children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL) condition in a cross over design.

Participants will be randomized to ICBIT, or to wait list, and half will cross over from wait list to ICBT. Two blind independent clinical evaluators will rate tic severity and comorbidity. The primary outcome measure is the Yale Global Tic Severity Scale (YGTSS). Assessments will be performed at baseline, post-ICBT or post wait list, 3-months and 6-months (post-treatment for those originally assigned to ICBT) and post-ICBT, 3-months and 6-months (post-treatment for those originally assigned to wait list condition). All assessments were conducted by 2 PhD level independent child psychologists.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Tourette Syndrome or Chronic Tic Disorder.
* Yale Global Tic Severity Scale tic severity score ≥14.

Exclusion Criteria:

* Change in psychotropic medication regimen during the past 6 weeks.
* Current diagnosis of substance abuse/dependence.
* Lifetime diagnosis of pervasive developmental disorder, mania or psychosis.
* Previous sessions of CBIT.
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers

The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.


Eligibility Criteria:
Inclusion Criteria:

* Wound size greater than 1x1 cm
* Wounds must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant must be candidate for negative pressure wound therapy
* Participant agrees to participate in follow-up evaluations
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
* Participant is to receive Silver granufoam for their wound
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Participant undergoing active cancer chemotherapy
* Chronic steroid use