cyrilzakka/clinical-trials huggingface dataset:
Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population

Participants will complete a survey before an educational session, during the "break" of an educational session, or after the session.

Participants will be recruited from diabetes education sessions at selected locations and at FHMG physician practices. For the diabetes education setting, ta research team member will introduce this study to a group of patients before educational sessions, during "break" of the educational sessions, and after sessions. If the patient is interested, an envelope with the Invitation to Participant letter attached to it and the survey enclosed will be given to them. Also, a NOTE will be attached to the envelope with the instructions: "Please drop your completed survey in the drop-box at ___." The drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally.

For patients at physician practices, an envelope with the Invitation to Participant letter attached to it and survey enclosed will be given by a staff member. Invitation to Participant letter contains all portions of the consent process. A NOTE will be attached to the envelope with the instructions: "Please drop your completed survey in the drop box at____." The drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally. If patient does not meet the inclusion criteria, they will be asked to return the envelope to the staff member who provided it.

Patients will be provided with Invitation to Participate letter along with survey. The Invitation to Participate letter provides patients with study details including inclusion/exclusion criteria, duration of participation, procedures to ensure confidentiality, and an overview of voluntary participation conditions. Implied consent will be used. In addition to the Invitation to Participate letter, there is a statement at the top of the survey "return of completed surveys implies consent to participate in the study"

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Diagnosis of type II diabetes
3. Able to speak and understand English
4. Able to provide informed consent

Exclusion Criteria:

1. Children under 18
2. Does not speak or understand English
3. Not of cognitive capacity to provide valid responses
4. Prisoners
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)

To evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation and/or study areas.
* Prior surgery in the treatment area.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Phase 1/2a Study of ANPD001 in Parkinson Disease

This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells.

Participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with Parkinson Disease. The effect on Parkinson Disease symptoms, safety and tolerability, and cell survival are assessed for 5 years post-transplant (with MRI and PET imaging scans of the brain). Safety and tolerability are assessed annually for an additional 10 years via telephone call (total follow-up of 15 years)

Eligibility Criteria:
Inclusion Criteria:

* Age 50-70 years of age at time of consent in the trial-ready cohort study ANPD001-01
* Met all eligibility requirements for inclusion in the trial-ready cohort in clinical study ANPD001-01
* Diagnosed with Parkinson Disease at least 4 years ago
* Unequivocal motor response to Levodopa

Exclusion Criteria:

* Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001
* History of intracranial therapy for PD, including deep brain stimulation (DBS), focused ultrasound (FUS), gene therapy or other biological therapy
* History of cognitive impairment or dementia
* History of clinically significant Dopa Dysregulation syndrome
* History of epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological disease (other than PD), or poorly controlled cardiovascular disease
* Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks
* History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas
* Contraindication to MRI and/or use of gadolinium
* Weight \> 300 lbs or Body Mass Index (BMI) \> 35
* Uncontrolled diabetes (HbA1c \> 7.0%) or any other acute or chronic medical condition that would significantly increase the risks of a neurosurgical procedure
* Pregnancy or lactation
* Significant drug-induced dyskinesia (\>2 for any body part on the Abnormal Involuntary Movement Scale \[AIMS\])
* Male or female with reproductive capacity who is unwilling to use barrier contraception for 3 months post-administration of the investigational product
* Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments
* Any significant issue raised by the neurologist or neurosurgeon
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* rheumatoid arthritis for \>=6 months;
* methotrexate for \>=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).

Exclusion Criteria:

* history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
* concurrent treatment with any DMARD other than methotrexate;
* prior treatment with tocilizumab.
Cilostazol for HFpEF

Determine if cilostazol improves symptoms and NTproBNP levels (heart failure blood marker) in heart failure with preserved ejection fraction (HFpEF) - a prevalent syndrome without targeted evidence-based treatment.

This will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1 study design with placebo and cilostazol

Heart failure (HF) is the #1 reason for hospital admissions. About half of the patients with HF have a preserved ejection fraction (HFpEF). There is no targeted evidence-based treatment for HFpEF. We recently reported that elevating the heart rate with pacemakers conveys clinical benefits e.g. reduction in heart failure symptoms, lowering filling pressures and an increase in walk distance. Cilostazol is a PDE3 inhibitor that increases the heart rate by about 5-8 beats per minute and has other potentially beneficial HFpEF effects such as peripheral vasodilation, lusitropic effects and dromotropic effects. By activating proteinkinase A, cilostazol may also phosphorylate titin, which may reduce myocardial stiffness.

n-of-1 study design using the standard dose cilostazol formulation of 100mg twice a day approved for peripheral vascular disease. The investigators and patients are blinded. The patients serve as their own controls with two crossovers (Week 1: cilostazol or placebo - Week 2: placebo or cilostazol - Week 3: cilostazol or placebo - Week 4: placebo or cilostazol).

Eligibility Criteria:
Inclusion Criteria:

* \>18 yrs
* LVEF ≥ 50% (on last assessment, \<2 years)
* Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the following:

  1. pulmonary edema on chest imaging or documented on exam or on loop diuretics
  2. NTproBNP \>400 ng/ml in the last 24 months
  3. HFpEF\>50% hospitalization in the last 3 years
  4. Qualitative echo: \> mild diastolic dysfunction on echo report and \> mild left ventricular hypertrophy and left atrial dilation or quantitative echo: left ventricular hypertrophy \[men ≥115 g/m², women ≥95 g/m² or relative wall thickness \>0.42 or any LV wall thickness \>1.2cm and has LA dilation (\>28ml/m2)

Exclusion Criteria:

* \<18yo
* resting heart rate \>100/min
* patients with LVEF \<50%
* advanced end-stage heart failure,
* symptomatic COPD on home O2,
* uncontrolled severe HTN (SBP \>160/100 mmHg)
* patients with life expectancy \<6 months,
* end-stage liver cirrhosis,
* more than moderate valve disease,
* infiltrative myocardial disease
* constrictive pericarditis or myocarditis,
* patients unable to participate in follow up,
* pregnant patients or patients without reliable contraceptive agent for the duration of study participation),
* left ventricular outflow tract obstruction,
* bleeding dyscrasias, blood dyscrasias,
* Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine, fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)

This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection


Eligibility Criteria:
Inclusion criteria:

1. Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy).
2. Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) \>=7.5.
3. Participation in clinical trials voluntarily and signed informed consent form

Exclusion criteria:

1. Pregnancy, preparation for pregnancy or breast-feeding women
2. Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST): 2.0 times more than the upper limit of normal; Creatinine (Cr) 1.5 times above the upper limit of normal.
4. Serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmHg after using antihypertensive drugs)
5. Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
6. Bleeding or bleeding tendency in 2 months
7. Have allergy
8. Noncompliance or cannot meet those
9. Participation in other clinical trials in the last 3 months
10. Participant unsuitable to participate in this test as investigator considering
Effects of Progressive Resistance Exercises Among Athletes With Hamstring Deficit After ACL Reconstruction

The goal of the study is to find out how mild home exercises (similar to usual care) and progressive strength training, which include neuromuscular exercise, affected knee joint function and HS muscle strength in individuals who has persistent HS muscle strength deficits 12-24 months after ACLR.

The objective of the present study is to investigate whether individuals, who perform supervised progressive strength training including elements of neuromuscular exercise intervention (SNG) will achieve greater improvements in leg muscle power and greater improvements in knee function compared with individuals performing a homebased low-intensity weight-bearing exercise protocol. We hypothesize that supervised progressive strength training would be superior to a homebased low-intensity weight-bearing exercise protocol for regaining muscle strength and knee function. This study will impact society by promoting health, reducing healthcare costs, supporting productivity, and contributing to a more active and engaged community. Limited investigation exists regarding the durability of progressive resistance exercises in mitigating hamstring deficits post-ACL reconstruction and the personalized optimization of exercise protocols for individual athletes. Further exploration is needed for sustained benefits and tailored rehabilitation strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 30 years
* 12-24 months post-surgery (ACL reconstruction)
* Persistent maximal isometric knee flexor strength asymmetry (\>10% leg-to-leg the difference, in the isometric testing angle of 90° knee flexion)

Exclusion Criteria:

* Body mass index \[BMI\] more than 35
* known lower limb pathology (including previous and/or concomitant knee injuries requiring surgical intervention to either knee)
Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and aspiration of thrombus material from the infarct related coronary artery will be included. Both cellular and non cellular content of the thrombus will be examined with morphological and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal molecules will be performed. In addition, peripheral venous blood samples will be drawn and analyzed for signalling molecules and corresponding mRNA expression in circulating leukocytes.

Observational, cross-sectional study on 30 patients with STEMI treated with thrombectomy and PCI with stent implantation. Composition and characteristics of the coronary thrombi with respect to cell types, genetic expression and presence of specific markers of inflammation, platelet activity, endothelial activation, coagulation and fibrinolysis will be investigated in relation to the levels of these markers in the general circulation, and specifically related to the time axis from symptom to PCI, as well as to the degree of myocardial necrosis.

Intracoronary thrombus will be retrieved by standard aspiration catheter, washed with saline and stored on formalin as advised by the Department of pathology, OUS Ullevål. A specific protocol for morphological and immunohistochemical methods is prepared and has been shown suitable in a pilot study on 5 patients. Assessment of coronary TIMI flow and peripheral blush grade after thrombus aspiration and PCI will be done. At the same time, peripheral venous blood will be drawn, processed and stored at -80˚C for later analyses. Demographic variables will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* age 18-75 years
* typical symptoms of acute myocardial infarction
* ST-elevation or presumed new left bundle branch block in the ECG
* treated with aspiration of thrombus and primary PCI in the infarct related coronary artery

Exclusion Criteria:

* Signs of infection
* pulmonary embolism
* chronic obstructive pulmonary disease
* arrhythmias, abnormal renal and/or liver function
* autoimmune disease
* malignant disease
Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.The application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.However, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.Therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently.

Dermal loss is the main cause of unsatisfactory scar repair and recurrence.The previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (Brit J Surg, 2015).Furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.Therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.To this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.


Eligibility Criteria:
Inclusion Criteria:

The patient is diagnosed as hypertrophic scar and needs surgical repair; The scar size was 10cm2 to 200cm2, and the site was not limited; Patients with stable vital signs and tolerable operation indicated by routine examination; Patients in good mental state, can follow the doctor's advice, regular return; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past.

Exclusion Criteria:

Those who did not meet the inclusion criteria were found after the selected subjects; The follow-up time after inclusion was less than 2 times, and the objective efficacy could not be evaluated (but the adverse reactions could be evaluated); Subjects who violate protocol requirements.
Bexagliflozin Efficacy and Safety Trial

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.

The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

Approximately 130 investigative sites globally are planned to participate in this study.

An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications.

The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of T2DM
* Subjects who have had a stable treatment regimen for T2DM for the past 3 months
* Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems

Exclusion Criteria:

* Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
* History of genitourinary tract infections
* Evidence of abnormal liver function
* History of MI, stroke or hospitalization for heart failure in the past 3 months
* Prior kidney transplant or evidence of kidney problems
* Prior or planned pace maker implantation
* Pregnant or nursing
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 80 years of age.
2. Stable phosphate control using Calcium-based phosphate-binding medication only.
3. The subject is undergoing regular dialysis treatment.
4. On a stabilised phosphorus diet.
5. If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
6. Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

1. Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
2. Body mass index (BMI) \<=16.0 kg/m2 or =\>40.0 kg/m2.
3. Current or a history of significant gastrointestinal motility problems
4. A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
5. A history of substance or alcohol abuse within the last year.
6. Seizure disorders.
7. Using phosphate binder medication other than calcium based phosphate binders
8. Using colestyramine, colestipol or colesevelam
9. A history of drug or other allergy
10. Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days, prior to signing of the informed consent.