cyrilzakka/clinical-trials huggingface dataset:
Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

Remote ischemic preconditioning(RIPC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIPC provides neuro-protection by means of improving dCA.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70,both genders
* Willing to participate in follow-up visits

Exclusion Criteria:

* current or having a history of chronic physical diseases or mental diseases
* suffering from infectious diseases in late one month
* pregnant and lactating women；
* smoking or drinking；
* inability to cooperate sufficiently to complete the dCA examination
Phase III Randomized Controlled Study of Morphine and Nortriptyline in the Management of Postherpetic Neuralgia

OBJECTIVES: I. Determine whether opioid (morphine) treatment results in better management of pain than treatment with tricyclic antidepressant (nortriptyline).

II. Assess the effects the two treatments have on affective and cognitive functions.

III. Determine whether the presence of psychiatric comorbidity, particularly depression, can predict the outcome of the two treatments.

PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are stratified by the duration of pain (greater than 1 year or no greater than 1 year) and the presence or absence of major depression.

Patients are randomized into 6 treatment order groups. Patients start with nortriptyline, morphine, or placebo, taken orally every day. If patients are unable to tolerate nortriptyline or morphine, they will receive desipramine or methadone instead.

A drug titration period lasting 3 weeks is ensued for administration of the first drug treatment. The goal of this titration period is to gradually increase the dose of the drug to obtain maximal analgesic efficacy. Drug dosage is maintained for a period of 3 weeks. The drug dosage is tapered off and followed by a drug free period of 1 week.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnostically confirmed postherpetic neuralgia for at least 3 months following a segmental herpes zoster eruption

--Prior/Concurrent Therapy--

* Other: No concurrent monoamine oxidase inhibitors

--Patient Characteristics--

* Life expectancy: At least 6 months
* Cardiovascular: No second degree or complete heart blockage No myocardial infarction in the last 3 months
* Pulmonary: No severe pulmonary disease
* Other: No history of substance abuse No history of dementia No history of encephalopathy No severe depression that precludes withdrawal from antidepressants Not pregnant No angle-closure glaucoma No AIDS related disease complex No terminal disease with life expectancy of less that 6 months
Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

1. Assessment of Safety
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100

Eligibility Criteria:
Inclusion Criteria:

1. 20 to \<60 years of age
2. able and willing to give written informed consent prior to study entry
3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion Criteria:

1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
2. Immunodeficiency disease
3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
4. thrombocytopenia or Coagulation disorders
5. experienced fever (\>37.5°C) within the past 24 hours or any acute respiratory infection
6. receipt of Immunosuppressants or Immunomodulators within the past 3 months
7. receipt of blood products or immunoglobulin within the past 3 months
8. received influenza vaccine within the past 6 months
9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
10. participation on another clinical trial within 1 month prior to the study vaccination
11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
12. any chronic diseases that interfere with the clinical trial or Malignant tumors
13. pregnant or breastfeeding
14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture

The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.

Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Unfamiliar to acupuncture

Exclusion Criteria:

* Psychotropic medication
* Psychiatric or thyroid disorders
* Pregnancy
Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Temporomandibular joint disorders (TMD) , a musculoskeletal condition , includes a series of clinical problems involving the temporomandibular joint (TMJ), the masticatory muscles, and related structures.This study evaluates the efficacy of integrated traditional Chinese and western medicine in the treatment of TMD.

In this study, 84 patients ranging in age from 18 to 65 years with diagnoses of TMD will be randomly divided into two groups: an experimental group (EG) who will receive the integrated traditional Chinese and western medicine treatment group(with Low-Level Laser Therapy+acupuncture) and a control group who will receive the only western medicine treatment(with Low-Level Laser Therapy).Both approaches will be applied 3times a week for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of TMD according to the Diagnostic Criteria for TMD Research Diagnostic Criteria (DC/TMD）which are manifested as joint pain during mouth opening and chewing, mouth opening limitation (\<40mm), joint clanging, masticatory creatine distension and weakness, which affects normal eating.
2. Aged 18-65;
3. Unilaterally;
4. No any other treatment on TMD in the last 3 months;

Exclusion Criteria:

1. there are tumors, joint degeneration and other serious lesions ;
2. Patients with a history of TMJ trauma or surgery,joint anatomical variation;
3. women pregnant and suckling period;
4. serious systemic diseases of bone and joint, such as rheumatoid arthritis
Real-Life Chronic Rhinosinusitis Outcome Registry

An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.

This real-life chronic rhinosinusitis outcome registry aims at longitudinal data collection from patients attending specialist care centres across Europe.

As primary aim it intends to provide new insights on the burden of uncontrolled disease, the impact on health-related quality of life, productivity loss as well as the effect of disease severity and co-morbid disease on these outcome parameters.

In addition this outcome registry intends to identify patients eligible for type 2 targeted biologic therapy, evaluate treatment effectiveness and markers of treatment response.

Beyond that direct and indirect costs for society related to chronic rhinosinusitis and its' treatment will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of Chronic RhinoSinusitis
* Capable of using a mobile application on a smartphone

Exclusion Criteria:

* Patients with malignancies of the sinonasal cavity
* Patients with inverted papilloma
* Patients with unilateral disease
A Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers Under Fed Conditions

The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) of 18.0kg/m2 to 30.0kg/m2 at screening visit.

  * For men, Those who weigh 55 kg or more
  * For women, Those who weigh 50 kg or more
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have a medical history of gastrointestinal resection (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with histologically proven breast cancer
* 18-76 years old
* Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
* Satisfactory healing of breast and lymph nodes area
* Ability to understand the nature, goal and study methodology
* Consent to cooperate for clinical assessments
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Written informed consent provided before any study specific procedures

Exclusion Criteria:

* HER2 positive or metastatic cancer
* Any other primary tumor
* Contraindication to moderate physical activity
* Contraindication to adjuvant chemotherapy or radiotherapy
* Pregnancy or breast feeding
* Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics

Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.

The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria (Type 1 diabetic subjects):

* Type 1 diabetes treated continuously with insulin from time of diagnosis
* Age 18-55
* Anti-GAD positive
* HIV antibody negative
* Normal CBC
* Negative intermediate PPD test performed and read by study staff
* HCG Negative (females)

Exclusion Criteria Type 1 diabetic subjects):

* History of chronic infectious disease, such as HIV
* History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
* Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
* Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
* Current treatment with aspirin \> 160 mg/day or chronic, daily NSAIDs
* Fasting or stimulated (1 mg glucagon stimulation test) c-peptide \> 0.2 pmol/mL
* History of keloid formation
* HbA1c \> 8.0%
* History or evidence of chronic kidney disease (serum creatinine \> 1.5 mg/dL)
* History of proliferative diabetic retinopathy that has not been treated with laser therapy
* Pregnant or not using acceptable birth control
* Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason).

Inclusion Criteria (Control Non-diabetic Subjects):

* Age 18-45

Exclusion Criteria (Control Non-diabetic Subjects):

* History of autoimmune diseases or diabetes
* History of HIV History of autoimmune disease or type 1 diabetes (use of insulin continuously since diagnosis) in first degree family members
Human Umbilical Cord Stroma MSC in Myocardial Infarction

The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic hearth disease who will experience CABG
* %25\<EF\<%45
* NYHA class II-IV patients
* hemodynamically stable

Exclusion Criteria:

* Patient's in approval
* Acute cardiac decompensation
* Acute myocardial infarction
* Congenital heart disease
* Additional surgical heart disease other than coronary artery disease
* Malign arrhythmia
* All malignancies
* HbA1c level \>%10 (86 mmol/mol) type II diabetes mellitus
* Severe liver dysfunction
* Severe COPD
* Coagulopathy
* Immunosuppressive treatment
* Acute hepatitis, hepatitis B, C and HIV infection
* Chronic liver and renal failure
* Collagen tissue disease
* Stroke
* TB
* Hematological diseases
* Socially and mentally disabilities
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
2. The lower edge of tumor \< 3 cm from the dentate line
3. Clinical T stage ≤ T3

Exclusion Criteria:

1. The lower edge of tumor \< 1 cm from the dentate line
2. Locally advanced stage of tumor
3. Presence of metastatic disease or recurrent rectal tumor
4. Concomitant malignancies
5. Concurrent uncontrolled medical conditions
6. Impaired anal function before surgery
7. Presence of acute bowel obstruction or bowel perforation caused by cancer
8. Pregnancy or breast feeding
Project OASIS: Optimizing Approaches to Select Implementation Strategies

Barriers that prevent healthcare methods supported by science from being adopted in the real world have led to low-quality, inequitable medical care. Implementation science aims to bridge the evidence-to-practice gap but still lacks simple and convenient methods to identify implementation barriers, systematically track which strategies work to improve care, and provide accessible data and expert recommendations to guide implementation strategy selection for use in research and practice. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a hybrid type-III, cluster-randomized trial of a new decision aid tool that matches site variables and barriers to successful implementation strategies.

Implementation science aims to improve the uptake of evidence-based health care practices (EBPs) by defining barriers that prevent their use, offering strategies to overcome these barriers, and developing methods that help clinicians and researchers choose strategies that best address the barriers they encounter. With strategy selection often being inefficient and idiosyncratic, experts have called for methods to make strategy selection scientific, data-driven, and "precise." This "precision implementation" causes a critical need to identify implementation barriers and facilitators quickly and uniformly, track implementation strategy use and effectiveness, and incorporate data and expert knowledge into the process of matching strategies to barriers. Without these improvements, there is a risk of perpetuating implementation failures and health care disparities.

Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a cluster-randomized, hybrid type III trial to compare a machine learning derived decision aid (DA) for selecting implementation strategies with a current expert opinion-based tool in 20 VA medical centers. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework and assess rates of hepatocellular carcinoma screening (an EBP) for Veterans with cirrhosis at these sites. As this is a facility-level intervention, Veterans with cirrhosis will be cluster randomized to the DA vs. Current Tool arms. The investigators anticipate that Veterans at sites in the DA arm will be significantly more likely to receive screening than Veterans at sites in the Current Tool arm.

Eligibility Criteria:
Inclusion Criteria:

Veterans:

* Veterans with two outpatient or one inpatient codes for cirrhosis or its complications who had an encounter in the prior 18 months at a participating VA medical center

VA clinicians:

* Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center

Exclusion Criteria:

* Veterans post-transplant or with active hepatocellular carcinoma