cyrilzakka/clinical-trials huggingface dataset:
Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy

The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Pre- and Peri-menopausal woman patient age 18-65 years
* Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
* Normal Pap smear result within one year
* The uterus is larger than 12 weeks of gestation
* The body mass index of the patients is 18.5-27.9kg/m2
* Signed informed consent form

Exclusion Criteria:

* Women with Known or suspected malignancy
* patients during pregnancy and lactation
* Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
* Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
* Patients who are known to have participated in any other clinical trial within 3 months
* Patients who cannot sign informed consent
* Patients with acute stage infection of the reproductive system or other sites
Self-Scored Cardiovascular Disease Risk Appraisal

To develop and test a self-scored cardiovascular disease health risk appraisal.

BACKGROUND:

Health risk appraisals (HRA) are being used increasingly by health centers and worksites to inform people of their personal mortality and morbidity risks. However, recent research suggests that many HRAs have limited reliability and validity with respect to coronary heart disease, the leading cause of death in this country. Self-scored HRAs appear to be considerably less accurate in predicting CHD risk than computerized instruments, chiefly because people do not always know the physiologic values required by these instruments and because they frequently make errors computing their scores.

DESIGN NARRATIVE:

During Phase I, a new appraisal named CardioRisk was developed. The Phase I prototype version contained eight major self-reported risk factors. CardioRisk predicted the risk of developing cardiovascular disease (CVD) in a 12-year period using an equation based on recent accelerated failure time models from the Framingham Heart Study. The purpose of Phase II was to thoroughly test and refine the prototype instrument. The Phase II analyses were designed to assess the psychometric properties of CardioRisk, to evaluate its utility as judged by patients, and to determine whether the instrument changed perceptions of personal CVD risk. These results were compared to data for other appraisals to determine whether CardioRisk outperformed comparable products.

In the proposed commercial application, CardioRisk would be distributed by health promotion organizations to increase awareness of the risk factors for cardiovascular disease. Estimates from the American Heart Association put the demand for these products at 180,000 HRAs per year. The potential market for this product includes worksites, community health centers, managed health care organizations, public health departments, and clinics.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years.
* Chronic hemodialysis.
* Stable supplemental EPO therapy.
* Baseline hemoglobin of ≤ 11.5 g/dl.

Exclusion Criteria:

* Women who are pregnant or who are breast feeding.
* Received another investigational drug or device within 30 days.
* Recent parenteral or oral iron therapy.
* Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia.
* Major surgery within 30 days or anticipated or planned surgery during the study.
* Patients with active infections.
* Recent blood transfusions.
* Patients with known allergies to iron products.
Loving-kindness Meditation for Posttraumatic Stress Disorder (PTSD)

A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.


Eligibility Criteria:
Inclusion Criteria:

* posttraumatic stress disorder

Exclusion Criteria:

* psychosis
* borderline personality disorder
A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body

This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is.

The study is looking at several other research questions, including:

* Whether the study drug lowers extra iron levels in the body
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Clinical diagnosis of NTDT as described in the protocol
2. IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening
3. Serum ferritin ≥ 300 ng/mL as described in the protocol

Key Exclusion Criteria:

1. Hemoglobin ≤ 8 g/dL
2. Any RBC transfusion within 12 weeks of visit 3
3. For Part A only: Any ICT use in approximately 12 weeks prior to screening as described in the protocol
4. For Part B only: If on ICT, any change in Iron chelation therapy (ICT) dose in approximately 12 weeks prior to screening as described in the protocol
5. Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol
6. Absolute contraindication to MRI
7. Diagnosis of cirrhosis of the liver
8. Diagnosis of Chronic kidney disease (CKD) stage 4 or higher

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Clinical Evaluation of Chronic Consciousness Disorders Using Resting-state EEG and ERP

Currently, there are significant challenges in the clinical assessment of patients with consciousness disorders, such as distinguishing between vegetative state (VS) and minimally conscious state (MCS), and predicting patient prognosis. This study aims to utilize different research techniques, such as auditory stimulation, as well as modified microstate methods, to enhance the disease classification and prognosis prediction of patients with chronic consciousness disorders.

The investigators collected resting-state electroencephalograms (EEGs) and EEGs under various event-related potential (ERP) stimuli from patients with chronic consciousness disorders, and performed analyses on these data. The resting-state EEGs were subjected to spectral analysis and microstate analysis. The ERP EEGs were analyzed in the time domain, as well as for phase coupling and other measures.Using these computed indicators, the investigators use machine learning, deep learning, and other methods to predict disease classification and prognosis assessment in patients with chronic consciousness disorders.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with COMA /VS/MCS
2. The course of disease was more than 4 weeks
3. The vital signs were stable and able to tolerate the test process
4. Complete skull
5. Right-handed, no history of ear disease or hearing loss before onset

Exclusion Criteria:

1. History of epilepsy
2. Sedatives
3. Muscle relaxants and epileptic prophylaxis within 24 hours
Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months
* Fasting C-peptide level above 0.1 nmol/l
* Presence of GAD65 antibodies
* Written informed consent (patient and parent/guardian)

Key Exclusion Criteria:

* Secondary diabetes mellitus or MODY
* Treatment with immunosuppressants
* Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
* HIV or hepatitis
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
* Pregnancy (or planned pregnancy within one year after 2nd administration)
Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study

In this study the effects of balneotherapy in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal, mineral water on skin microbiome and Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis

Psoriasis is a chronic inflammatory skin disease. It is associated with several important medical conditions, including psoriatic arthritis, and cardiometabolic syndrome. Its most common form, chronic plaque.The aim of this study is to evaluate how Lake Hévíz sulphur thermal mineral water therapy influences the composition of microbial communities that colonizes skin in patients with psoriasis, and the extent and severity of skin symptoms of psoriasis.

The planned participants number is 16 outpatients between 18 and 70 years of age with mild to moderate psoriasis. The balneotherapy takes place in Lake Hévíz, five times a week for three weeks.

The skin microbiome is collected from two different place by swabbing method from the patient. One sample is collected from the normal skin, which is not affected by psoriasis (crook of the arm), the second sample is collected from psoriatic plaque of the elbow. The samples is processed for a sequence-based microbiome analysis.

The skin microbiome is evaluated by the analysis of the sample metagenome compositions, and the activity of psoriasis is evaluated on The Psoriasis Area and Severity Index (PASI), is taken at week 0., at week 3.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis for at least 6 months before the Baseline Visit
* Subject has stable mild to moderate plaque psoriasis

Exclusion Criteria:

* subject has systemic therapy for plaque psoriasis
* balneotherapy within 3 months prior the enrollement
* systemic/local glucocorticoid therapy within 1 month prior the enrollment
* general contraindications to balneotherapy: decompensated cardiovasculardisease; unstable hypertension, angina pectoris; uncontrolled endocrinedisease (hyperthyroidism, hyperparathyroidism); other uncontrolledand unstable metabolic disorders (diabetes mellitus, hyperuricaemia,hyperlipoproteinaemia); acute febrile infections; cutaneous suppuration;pregnancy; decompensated psychosis/neurosis, malignancy, urine and stool incontinent, unconsciousness, alcoholic influence, and lack of compliance.
Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Solid Tumors

This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) with immune cells (IC01) in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent form must be obtained prior to any research procedures;
2. Age: 18 Years to 70 Years;
3. The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (100-200 ml) for the treatment, and who signs the informed consent form independently;
4. Histologically confirmed diagnosis of solid tumors;
5. Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
6. KPS \> 60 points;
7. expected survival \> 6 months;
8. Adequate organ function defined as: ANC≥1.0×10\^9/L, PLT≥50×10\^9/L, ALB≥25g/L;
9. If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.

Exclusion Criteria:

1. Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
2. Patients who have not recovered from adverse reactions related to above-mentioned procedures;
3. Patients with two types of primary solid tumors;
4. Patients with brain metastases or bone metastases;
5. Patients with poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association ClassⅡ or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on the treatment;
6. Patients with other serious organic diseases or mental disorders;
7. Patients with systemic or active infection;
8. Patients with positive HIV test result;
9. Patients who have received an organ transplant;
10. Patients who are breastfeeding or pregnant.
Efficacy and Safety of Oral Valproic Acid for Retinitis Pigmentosa

The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to slow the progression of visual function and/or to improve the visual function in patients with retinitis pigmentosa (RP).

Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily for 48 weeks. Visual function and safety will be assess before and after treatment (48 weeks) between valproic acid and control groups.

This study is designed as a single-site, interventional, prospective, non-randomized, controlled study of 200 participants. Patients that participate in the study will be assigned to either valproic acid group or control in a 3:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of retinitis pigmentosa (RP) established by night blindness, visual field constriction, marked reduction of electroretinogram, and the clinical signs of RP in fundus examination
* Best corrected visual acuity of 20/200 or more on a Snellen chart in at least one eye
* Intact visual field of 5 or more as measured by the kinetic perimetry
* Understand and sign the IRB-approved informed consent document for the study
* Body weight: male (40 kg to 100 kg), female (40 kg to 80 kg)
* Must be able to swallow tablets
* Female subjects of childbearing potential must commit to practice acceptable methods of contraception

Exclusion Criteria:

* Pregnant women
* Lactating mothers
* Medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, myocardiac infarction, malignancy) or severe systemic disease
* Other ocular disease: retinal disease other than RP or cystoid macular edema, glaucoma, cataract worse than +2PSC or infectious corneal disease
* Coagulation disorder or bleeding-tendency
* Liver dysfunction
* Renal dysfunction
* History of pancreatitis
* History of neurological disorders including epilepsy, history of brain injury or any organic brain disorders
* History of mental disorders including schizophrenia, bipolar disorder, or suicidality
* Currently receiving valproic acid or other anti-convulsants
* Has taken one of the following drugs at least 4 weeks prior to enrollment as these drugs are specifically known to affect the progression of RP: vitamin A, lutein, omega-3 fatty acid, or any antioxidant which affect the blood flow of retina or retinal function.
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.

In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Age at entry at least 18 years.
2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
3. Evidence of hepatic steatosis or liver fat (\>5%) by MRI.
4. Evidence of definite or suspected NASH
5. Written informed consent.

Exclusion criteria:

1. Evidence of another form of liver disease.
2. History of excess alcohol ingestion.
3. Contraindications to liver biopsy.
4. Decompensated liver disease.
5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
6. Recent initiation or change of anti-diabetic drugs.
7. Use of colesevelam or other agents in the same class.
8. Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
9. Positive test for anti-HIV.
10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
11. Pregnancy or inability to practice adequate contraception in women of childbearing potential.
12. Evidence of hepatocellular carcinoma
Airway Inflammation in Children With Allergic Rhinitis and Intervention

The purpose of this study is to determine whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing lower airway inflammation and improving small airway function.

Type of study :

This is a prospective randomized,double-blind, placebo-controlled study , to clarity whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis may bring favors in reducing elevated lower airway inflammation，improving airway reactivity and airway resistance.

Methods :

The children with allergic rhinitis accompanied lower airway inflammation such as elevated percentage of eosinophil in induced sputums and/or higher level of fractional exhaled nitric oxide(FeNO) are recruited.By using a random digit table, eligible subjects were randomized into one of two groups,to receive budesonide nasal spray (BUD group) or nasal placebo(placebo group), 1 spray/nostril, 2 times/day, for three consecutive months observation. The following measurements were performed: skin prick test (SPT), peripheral blood cells five-classification test, serum total immunoglobulin E (IgE) and specific IgE of common inhalant allergens testing, nasal lavage and inflammatory cells classification ，pulmonary function test, bronchial provocation test，airway resistance measured by impulse oscillation technique. Meanwhile,history of all subjects were collected, visual analogue scale，rhinitis symptoms scores and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores were evaluated. Symptom scores and laboratory examinations are performed at baseline,4 w,8w and 12 w after treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of allergic rhinitis without asthma
* sensitized to more than 1 common aeroaller¬gens
* FeNO \>20ppb and/or induced sputum Eosinophil\>2.5%

Exclusion Criteria:

* Respiratory infection 2 weeks prior to initial visit
* children with nasal polyposis
* History of immunotherapy
* unable to complete the test or had limited understanding
* Use of systemic corticosteroids 4 weeks prior to initial visit
* nasal and inhaled corticosteroids 2 weeks prior to initial visit
* leukotriene receptor antagonists 2 weeks prior to initial visit
* Use of antihistamines 7 days prior to initial visit
Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.

Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.

Eligibility Criteria:
Inclusion Criteria:

* 14 years of age or older
* no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients
* The researcher (or principal) signs the informed consent form

Exclusion Criteria:

* Significant head trauma or stroke in the last 3 months
* 3 months to accept intracranial, spinal surgery or other parts of large surgery
* In the last week there is an incurable part of the artery puncture
* Acute bleeding constitution, including platelet count \<100 × 109 / L or other conditions
* within the last 48h heparin treatment, APTT higher than the upper limit of normal range
* Oral anticoagulant: INR\> 1.7 or PT\> 15s
* The presence of intracranial tumors, aneurysms or arteriovenous malformations
* Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator)
* Severe liver and kidney dysfunction
* Life expectancy is less than 1 year
* Pregnant or lactating women
* Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research
* Allergic or intolerant to aspirin or clopidogrel
* There are stomach lesions, such as gastritis, gastric ulcer and so on
* Do not want to follow-up or poor treatment compliance