cyrilzakka/clinical-trials huggingface dataset:
Adult Stem Cell Response to Burn Injury

This study is designed to determine the response of adult stems cells, also referred to as mesenchymal stem cells (MSCs), to tissue injury resulting from thermal burns. The study will consist of a one time collection of a patient's blood, about one teaspoon, on the third day following the initial burn. MSCs in the blood will then be quantitated and identified using according to unique proteins found on their cell surface using flow cytometry. The results of flow cytometry analysis will then be compared to the patients characteristics (age, sex, race, etc.), their past medical history (hx of diabetes, hypertension, heart disease, etc.) and to the patient outcome (length of hospital stay, mortality, etc.).

Traumatic and non-traumatic disease processes result in varying tissue injury that can culminate in organ failure and death. Current literature has demonstrated that adult stem cells (ASCs) are mobilized into peripheral circulation as a heterogeneous population of cells following tissue injury. The significance of this heterogeneity has not yet been defined. Other studies have shown ASCs augment tissue repair under appropriate conditions. This proposal will begin to elucidate the mechanism of ASC activation, mobilization and localization to sites of injury. This study will use flow cytometry to identify subsets of ASCs mobilized in response to tissue injury and compare this response to the patient's demographics, comorbidities, in hospital morbidities, and mortality. Patients with thermal burns will be used as a model of tissue injury given the quantity of tissue injured and the robust signal generated from this injury. ASCs are currently being investigated as adjuncts to tissue repair involving a host of tissues, including cardiac, neural, and renal. The identification of a specific subset of ASCs selectively mobilized in response to tissue injury would alter all studies involving ASCs in tissue repair and necessitate the identification and targeting of subsets selectively mobilized in response to injury to each particular tissue.

Eligibility Criteria:
Inclusion Criteria:

* Any consentable patient presenting to the Ohio State University Emergency Department or directly admitted to the Ohio State University Burn Unit within three days of a thermal burn

Exclusion Criteria:

* Prisoners
* Pregnant patients and nonconsentable patients.
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

The overall aim of this study is to assess if patients with persistent gastroesophageal reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking omeprazole 30 minutes prior to the first meal of the day.

GERD remains a common gastrointestinal complaint, resulting in 6% of outpatient visits. The economic burden is significant with direct costs exceeding $12 billion/year and indirect cost as high as $75 billion/year. The primary aim of this study was determine whether a brief educational intervention optimizing proton pump inhibitor (PPI) dosing would reduce GERD symptoms using the gastroesophageal reflux disease symptom assessment scale (GSAS) questionnaire. Further, secondary analysis would utilize the results of the trial and combine them with costs related to uncontrolled GERD to estimated the potential economic impact.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* taking omeprazole 20 mg
* episodic heartburn at least 3 times per week
* provides consent and be willing to complete study questionnaires
* read, speak and write English

Exclusion Criteria:

* weight loss (alarm symptom)
* normal esophagogastroduodenoscopy (EGD) in last one year
* pregnant or women planning on becoming pregnant at any time during the study
* history of Barrett's esophagus
* prior esophageal strictures
* intolerance/allergy to study medications
* patients on plavix or a history of upper gastrointestinal surgery
* investigators or their immediate family (spouse, children, sibling)
Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics

The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.

Many coronary heart patients have diabetes. For this reason, it is thought that patients need education in order to gain healthy lifestyle behaviors and to provide self-management of diabetes, which is a major risk factor for coronary artery disease. When the literature was examined, no study could be found that focused on diabetes patients with myocardial infarction and emphasized the importance of patient education. It is thought that this study will make an important contribution in terms of patient education to be given to individuals with diabetes mellitus who have had myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* No advanced hearing and vision problems,
* Able to speak and understand Turkish,
* Easy to communicate,
* Literate,
* Agreeing to participate in the research voluntarily,
* Hospitalized due to myocardial infarction in the last month,
* Have stayed in the intensive care unit for at least 24 hours,
* No chest pain
* Patients who have been diagnosed with Type 2 Diabetes Mellitus for at least one year

Exclusion Criteria:

* Sedative or narcotic analgesic drug treatment,
* Use of antipsychotic medication
* Patients receiving Continous Positive Airway Pressure treatment,
* Patients with cognitive dysfunction
Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans

The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms.

The main question\[s\] it aims to answer is:

• Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.

This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in consecutive acute Code Stroke activations at the emergency department.

Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)

Informed consent forms (ICF) will be waived, as approved by the IRB.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of ﬁnal Stroke diagnosis.
* Subjects aged 22 years or older.
* NCCT performed for Code Stroke screening.
* If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
* NCCT and CTA have been processed by Methinks AI software.

Exclusion Criteria:

● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients

The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.

Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.

Eligibility Criteria:
Inclusion Criteria:

* more than twenty years of age
* paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
* more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
* persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
* a pain score of 40mm or more on the visual analogue scale

Exclusion Criteria:

* neuropathic pain caused by confounding factors other than spinal cord injury
* contraindicated for botulinum toxin type A
* a change in pain medication one month prior to study enrollment
* a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
* person who received botulinum toxin type A within three months prior to study enrollment
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals

This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.

Objectives:

* To determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving antiretroviral therapy (ATR) with Doravirine plus Descovy®.
* To evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus Descovy®.

Study Phase:

Phase II

Study Design:

Open label, single arm, single center, prospective study.

Study Disease:

HIV-1 infection

Study Endpoints:

* Concentration of Doravirine in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus Descovy®.
* HIV-1 RNA in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus Descovy®.

Target Population:

Male and female adult HIV-1 infected patients receiving standard ART with tenofovir alafenamide/emtricitabine (TAF/FTC), tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine , plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor during at least 3 months, with plasma HIV-1 RNA suppression (\<40 copies/mL) during at least 6 months.

Number of Subjects Planned:

15 male and 15 female individuals.

Study duration:

16 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
2. Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continuously for at least 3 consecutive months preceding the screening visit.
3. Plasma HIV-1 RNA \<40 copies/mL for at least 6 months at the Screening visit.
4. Signed and dated written informed consent prior to inclusion.
5. Female Subjects of Childbearing Potential must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.

Exclusion Criteria:

1. Severe hepatic impairment (Child-Pugh Class C)
2. Ongoing malignancy
3. Active opportunistic infection
4. Resistance to any of the antiretroviral (ARV) included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
5. Any verified Grade 4 laboratory abnormality
6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
7. Severe renal impairment (Estimated creatinine filtration rate \<50mL/min).
8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
Sickle Cell Anemia Screening and Prevention in Northern Israel

Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others.

In this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.


Eligibility Criteria:
Inclusion Criteria: All pregnant women tested and their husband in those cases that the woman test revealed abnormal hemoglobin.

Exclusion Criteria: No exclusion criteria.
Quality of Life in Patients With Hemorrhagic Telangiectasia

Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.

Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used.


Eligibility Criteria:
Inclusion criteria:

* knowledge of german language
* Age above 17 years
* capable of giving consent
* Diagnosis of HHT (Curaçao criteria or genetic testing)

Exclusion criteria:

-Individuals not meeting the inclusion criteria.
Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.


Eligibility Criteria:
Inclusion Criteria:

* aged 20 to 50 years,
* BMI 18 to 25 kg/m2,
* absence of known or scalable organic or psychiatric disease
* no history of chronic gastrointestinal disease
* having a bowel regularity (1-3 defecation per day, of normal consistency),
* person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women)
* having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine)
* no pregnant nor nursing women
* covered by Social Security
* negative serology for hepatitis B/C and HIV
* who signed the informed consent form

Exclusion Criteria:

* persons abusing drugs (laxatives, anti-diarrheal)
* person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
* person intolerant to gluten and / or allergic to wheat flour
* person in vegetarian or vegan diet
* Inclusion in another clinical study
* subjects receiving over 4,500 Euros in the last 12 months (including the present study)
* subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia

The purpose of this study is to evaluate the changes in various aspects of auditory verbal hallucinations during 24-week antipsychotic treatment in naturalistic condition.

Auditory verbal hallucinations (AVH), meaning the experience of hearing voices, occur in 60-75% of patients with schizophrenia. Patients experiencing persistent AVH tend to be interrupted in their daily routines and have trouble keeping regular jobs due to the intrusiveness or abusive contents of voices. In addition, auditory hallucinations are reported to remain even after disappearance of other psychotic symptoms in many patients with schizophrenia spectrum disorders after treatment with typical antipsychotics.

The study involves detailed phenomenological assessments of AVH and other psychotic symptoms, as well as side effects of atypical antipsychotics.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 15-65 years of age
* Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)\>
* Patients experiencing vivid AVH confirmed by score of 4 or above using hallucinatory behavior item on Positive And Negative Syndrome Scale (PANSS).
* Patients who are drug-naive or drug-free for more than 4 weeks.
* Patients who are scheduled to receive atypical antipsychotic medication.
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
* Subjects who are fluent in Korean.

Exclusion Criteria:

* DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
* Mental retardation (IQ \< 70).
* Neurological disorders including epilepsy, stroke, or severe head trauma.
* Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
* Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline.
* History of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months.
* Subjects who are not fluent in Korean.
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 69 years at Screening
* Hypertriglyceridemia (TG ≥ 200 mg/dL and \< 500 mg/dL and non-HDL-C ≥ 100 mg/dL and \< 220 mg/dL) OR
* Hypercholesterolemia (LDL-C ≥ 100 mg/dL and \< 190 mg/dL and TG value \< 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
* Body mass index (BMI) ≤ 45 kg/m2

Exclusion Criteria:

* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus
* Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
* Any statin at the highest approved dose
* Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
* Active peptic ulcer disease or a history of muscle disease or myopathy
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age or older.
* Diagnosis of UC verified by endoscopy within 60 months prior to consent.
A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea

The purpose of this post marketing surveillance (PMS) study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in participants who are treated for type 2 diabetes mellitus under NesinaAct® tablet therapy (alogliptin/pioglitazone) once daily by physicians in the real-world clinical practice setting over a period of 26 weeks.

The drug being tested in this survey is called NesinaAct® tablet. A surveillance is planned to examine safety and effectiveness of NesinaAct® tablet therapy in participants who are being treated for type 2 diabetes mellitus.

The study will enroll approximately 730 patients.

The study observes percentage of participants with adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) administered a dose of NesinaAct® tablet (alogliptin/pioglitazone) once daily as prescribed by the physician in routine practice over a period of 26 weeks.

This multi-center trial is conducted in a total of 19 sites in Korea.

The data is collected between October 2 2015 to August 30 2019 from the re-examination period up to 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants inadequately controlled on diet and exercise.
* Participants inadequately controlled on metformin alone.
* Participants inadequately controlled on pioglitazone alone.
* Participants inadequately controlled on metformin and pioglitazone combination therapy.
* Participants switching from alogliptin co-administered with pioglitazone.

Exclusion Criteria:

* Participants treated with study drug outside of the locally approved label in Korea.
* Participants with contraindication for the use of study drug (as described in the Korean product label).
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

The purpose of this study is:

* to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
* to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
* to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 years or over
* At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

Exclusion Criteria:

-