cyrilzakka/clinical-trials huggingface dataset:
Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue

This study aims to evaluating inflammatory and apoptotic activity in rat's endometriosis lesion treated by Propolis compared to Dienogest

Propolis has known of having various efficacy. The main benefits are as antimicrobial, antioxidant, anti-inflammatory, immunomodulatory and antiapoptotic.Propolis has even been shown to have an antibacterial effect in vitro, without requiring human immunological reactions.

The immunological effect of propolis is generated through immune suppression directly and decreasing cytokine production which stimulates immune process. Although proven to have a various efficacy, propolis can't be used as a therapeutic drug due to the difficulty of obtaining standard chemical composition as a requirement to be the drug's substances. Therefore, it is necessary to have biological composition in each propolis prepartions written down before comparing the efficacy.

Anti tumor activity by propolis, which has been tested in animal previously, showed that propolis can inhibit DNA synthesis in tumor cells, induce cell apoptosis and activate macrophage to produce factors which regulate the function of B, T, as well as NK cell.

Dienogest, is the next choice of progestin drug class. It has high selectivity binding in progesterone receptors, inhibits cytokine secretion in endometriosis stroma cell and induces apoptosis in endometriosis cell. Dienogest also has slight inhibitory effect against estradiol, so it can deminisce the symptoms due to hypoestrogenic such as decresing in bone mass density.

Eligibility Criteria:
Inclusion Criteria:

* female ratus rat type
* having normal estrus cycle

Exclusion Criteria:

* nothing
Study on Exercise Safety of Patients With Cardiovascular Diseases

To retrospectively observe the cardiovascular safety during exercise in patients with cardiovascular diseases


Eligibility Criteria:
Inclusion Criteria:

Patients with confirmed or suspected cardiovascular disease who completed the trial

Exclusion Criteria:

Refusing to participate in the study
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)

1. To evaluate feasibility of using multiparametric Magnetic resonance(MR) imaging to predict nonalcoholic steatohepatitis(NASH)
2. To develop non-invasive diagnosis tool using multiparametric Magnetic resonance(MR) imaging for nonalcoholic steatohepatitis(NASH)

Nonalcoholic steatohepatitis(NASH) is a severe form of nonalcoholic fatty liver disease(NAFLD). The causes are known to be associated with metabolic diseases such as obesity, insulin resistance type 2 diabetes, and hypercholesterolemia. Histologically, it is characterized by steatosis, hepatocellular injury, and inflammation and fibrosis of the liver parenchyma. Nonalcoholic steatohepatitis (NASH) may progress to cirrhosis and hepatocellular carcinoma(HCC) may develop even in patients without viral hepatitis, therefore there have been much interest and many researches in causation and diagnosis for nonalcoholic steatohepatitis(NASH).

Liver biopsy remains the gold standard for the diagnosis of nonalcoholic fatty liver disease(NAFLD) and is the only reliable method for differentiating nonalcoholic steatohepatitis(NASH) from simple steatosis. However, liver biopsy has several drawbacks, including invasiveness, potential complications such as excessive bleeding and death, sampling error, and inter- and intra-observer variability.

Magnetic resonance(MR) imaging has been used as a multiparametric imaging tool with which to evaluate steatosis by chemical shift imaging andm magnetic resonance(MR) spectroscopy, and fibrosis by magnetic resonance(MR) elastography and T1 mapping. To the best of our knowledge, there is no accurate imaging diagnostic tool for nonalcoholic steatohepatitis(NASH), therefore the investigators aimed to develop non-invasive imaging diagnostic model using multiparametric magnetic resonance imager(MRI).

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>19 years age
2. Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) and fatty liver on abdominal ultrasonography
3. Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH)

   * Clinically suspected nonalcoholic steatohepatitis(NASH): \>40 years age, metabolic syndrome, fibrosis on transient elastography(TE, Fibroscan), or elevated Fibrosis-4(FIB-4), Aspartate aminotransferase-to-platelet ratio index(APRI), nonalcoholic fatty liver disease fibrosis score(NFS) on blood tests
4. Patients who underwent (\<6 months) or will undergo US-guided liver biopsy

Exclusion Criteria:

1. Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary sclerosis)
2. Alcohol abuse (men, \>140g/week; women, \>70g/week)
3. Fatty liver due to medication
4. Contraindication to magnetic resonance imager(MRI)
5. Hepatocellular carcinoma
6. Pregnancy
A Pilot Study for the Determination of Allergenicity of Cat Dander Samples Obtained by Different Methods

Measurement of skin reactivity of cat dander samples obtained by different methods.

Subjects will be assessed for the study by of a conventional skin prick test with a positive (histamine), a positive (standardized cat dander extract) and a negative allergen control (a diluent) if they fulfil all other in- and exclusion criteria, too.

A screening prick test will be performed in order to confirm positivity (cat dander allergy).

A scratch test will be performed in participants after a positive screening prick test, in order to measure skin reactivity to cat dander, originating of three different body areas of the cat. For this purpose, a small amount of cat fur in solution with distilled water will be placed onto the volar aspect of both forearms after the skin has been scratched with a scratch lancet. The distilled water in which the cat hair was solved before will serve as negative control.

This procedure will be repeated with fur of the three different areas of the cat, always using triplicates (nine samples per cat).

From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female between 18 years to 65 years
* A positive clinical history with inhalant allergy presumably due to cat allergen.
* Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract.
* Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml.

Exclusion Criteria:

* Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent,
* Participation in another clinical trial within the last 30 days and during the present study,
* Pregnant or lactating women,
* Positive skin reaction in the screening prick test to negative control,
* Currently suffering from allergy symptoms,
* History of systemic reactions to allergens,
* Severe diseases influencing the results of the present study by discretion of the investigator,
* Immunotherapy with the allergen preparation during the past two years,
* Skin lesions and excessive hair-growth in the skin test areas,
* Treatment with prohibited concomitant medications according to section 9.3 (protocol) with the exception of medications with local effects which will not influence the results of the skin tests,
* Alcohol or drug abuse.
Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy

To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients.

72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.


Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++);
* Basically normal hepatic and renal functions as well as results for blood routine examinations;
* Karnofsky score ≥ 60;
* Anticipated life span for more than three months;
* They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin;
* The therapeutic efficacy was objectively evaluated with reference to the criteria from WHO;
* All of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.
The Effect of Oxygen Flow Rate on End-tidal CO2 During Deep Sedation

This study aims to detect the effect of different O2 flow rates on end tidal carbon dioxide level in patients scheduled for minor gynaecological procedures under deep sedation using laryngeal mask airway.

* Primary outcome was measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.
* Secondary outcomes included peripheral O2 saturation, hemodynamics, time to recovery, total propofol dose, patients' satisfaction, sedation score, and complications.

Procedural sedation (PS) is generally considered to include the stages of moderate and deep sedation of the continuum of anaesthesia . The clinical goals of procedural sedation are to alleviate apprehension, ameliorate the examination, findings, minimize the patients' memories of the incident and to control pain and distress during diagnostic and interventional medical procedures a lot of minor gynaecological procedures can be performed under moderate to deep sedation as ( D\&C Biopsy, hysteroscopic polypectomy and diagnostic hysteroscopies ) The greatest threat to the safety of sedated patient is airway compromise and or respiratory depression . To decrease the risk of airway and respiratory complications, careful attention must be directed toward the appropriate selection of medications, adherence to dosing recommendations, and most importantly the identification of the high-risk patient.

Regardless of the clinical scenario or the medications used, appropriate monitoring of the patient's respiratory and physiologic functions is mandatory to rapidly identify respiratory compromise.

Respiratory function is usually evaluated by observation of qualitative clinical signs (respiratory rate, depth and effort) and oxygen saturation monitoring. Oxygen desaturation in pulse oximetry usually occurs as a delayed sign , so if the capnograph monitor is used, any increase in EtCO2 during hypoventilation can alert the observing anesthetist to avoid hypoxemia. Capnography is a respiratory monitoring device that has become an accepted standard of care for PS in many circumstances. So, the American Society of Anesthesiology standards for Basic Anesthetic Monitoring require the use of capnography for both moderate and deep sedation.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18-45 years
2. ASA physical status l : ll
3. Minor elective gynaecological procedures lasting less than 30 minutes ( D\&C biopsy, hysteroscopic polypectomy and diagnostic hysteroscopy )

Exclusion Criteria:

* We will exclude from the study patients with the following:

  1. Patient refusal to participate in this study.
  2. ASA lll or more.
  3. Lengthy procedures taking more than 30 minutes
  4. Contraindication for the use of laryngeal mask airway as ( pharyngeal pathology, risk of aspiration and airway obstruction below larynx)
  5. BMI more than 35
Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique.

Vertical bone height reduction after extraction in the posterior maxilla is inevitable and complicates the treatment plan. Crestal sinus elevation, using implants and different grafting procedures are considered some of the proposed treatment protocols. Ever since the introduction of implant dentistry and implant placement in the posterior maxilla has been a dilemma. The choice of the type of bone, anatomical landmarks and reduced remaining bone height are all obstacles faced when placing implants in this area. Vertical bone height reduction occurs post extraction of the maxillary molars and premolars by maxillary sinus pneumatization. Many protocols were suggested to overcome this phenomenon; placing short implants, 2nd premolar occlusion and finally maxillary sinus elevation.

A recent systematic review evaluated osteotomes mediated sinus floor elevation with or without grafting material. It concluded a high long term survival rate in both procedures, however only one comparative study was used in the analysis that involved 12 participants only. Another systematic review assessed the survival of implants placed with lateral versus crestal sinus approach in 4-8 mm ridge height. It concluded that the ability of the less invasive crestal sinus approach to replace one-stage lateral approach, however, only one randomized control trial was presented that involved 4o patients, and were followed-up for 5 years. This emphasizes the gap of knowledge in literature with high quality evidence concerning these approaches.

The purpose of the present study is to evaluate the radiographic vertical gain in bone height as well as the implant stability after implant placement without the use of bone grafts in posterior maxilla following sinus elevation using the crestal implant approach technique.


Eligibility Criteria:
Eligibility criteria:

Inclusion criteria:

1. Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
2. Adults above the age of 18.
3. Residual Bone height from 5mm to 7mm under the maxillary sinus assessed in CBCT.
4. Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
5. Good oral hygiene.
6. Patient accepts to provide an informed consent.

Exclusion criteria:

1. Smokers.
2. Pregnant and lactating females.
3. Medically compromised patients.
4. Patients with active infection related at the site of implant/bone graft placement.
5. Patients with untreated active periodontal diseases.
6. Patients with parafunctional habits.
7. Acute or chronic sinusitis.
Low Glycemic Diet Intervention and Community Diabetic Patients

The purpose of this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients.

Design: Randomized clinical trial.

Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）

Low glycemic diet can help to control Blood glucose levels，this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients,and to improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and diet controlling.

Eligibility Criteria:
Inclusion Criteria:

* subject has a fasting blood glucose between 6.1 and 6.9mmol/L or diagnosed of type 2 diabetes
* glycosylated hemoglobin(A1C) between 6 and 11%.
* subject's age≥18 years.

Exclusion Criteria:

* subject has kidney disease (defined as creatinine\>1.3 mg/dl)
* active liver or gallbladder disease
* significant heart disease
* a history of severe hypoglycemia, or use of weight loss medications.
* subject that is pregnant.
Tear Based Sample Collection Breast Cancer Detection

This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individual is an adult woman and has recently been diagnosed with breast cancer.

Exclusion Criteria:

* Individual is excluded if they have already started treatment for the breast cancer diagnosis.
* Age less than 18 or more than 100 years.
Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control

A multi-center, randomized, open, non-inferiority, Phase 4 study

A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients with Partly Controlled Asthma

Eligibility Criteria:
Inclusion Criteria:

1. Adult at the age of 19 or older.
2. Patient with partially controlled asthma (Asthma Control Test score 16\~24)
3. Written informed consent to study participation.

Exclusion Criteria:

1. History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.
2. Cardiac tachyarrhythmia.
3. contreated respiratory fungal, bacterial, or tuberculous infection.
4. Moderate to severe bronchiectasis
5. Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis\*, or patients with chronic obstructive pulmonary disease requiring intensive treatment.

   * Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings.
   * Asthma related emergency room visit or hospitalization within 2 weeks prior to screening.
   * Administration of systemic steroids within 2 weeks prior to screening.
   * Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening.
6. Administration of systemic steroids within 2 weeks prior to screening.
7. Hypersensitivity reactions to lactose and milk.
8. Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study.
9. Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
10. Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study.
11. Individual considered by the he investigator to be inappropriate for study participation due to other reasons.
Rational-emotional Behavioral Therapy (REBT) in Patients With Osteoarthritis and Concomitant Diseases Before Arthroplasty

The objective of this study was evaluation of the effectiveness of REBT on the emotional state of orthopedic patients with comorbidities before and after arthroplasty.

The studies assessed depression or anxiety in orthopedic patients by using Spielberger State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before and after athroplasty. The comorbid background studied. The orthopedic patients with comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia, other diseases. Patients with high levels of anxiety and depression underwent Rational Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with comorbidities but without exposure considered as a control.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before operation.

Exclusion Criteria:

* Other types of psychiatric pathology
* Reluctance to undergo psychological correction
* Failure to pass pre-test
* Ongoing follow-up with a psychologist or psychiatrist
Analysis of the Efficacy and Stability of a Wearable ECG Monitor

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring. After the data collection is completed, a satisfaction survey will be conducted with the medical staff. The data obtained simultaneously from HiCardi+ and MX40 will be analyzed, and the satisfaction survey responses from the medical staff will be reviewed to confirm the clinical convenience of the patch-type ECG monitoring device.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 years or older
2. Patients admitted to Chonnam National University Hospital who require ECG monitoring
3. Individuals who have expressed their intention to participate in this study or have obtained written consent from a proxy

Exclusion Criteria:

1. Individuals who are unable to provide consent themselves or through a legally designated representative
2. Individuals deemed unsuitable for participation in the clinical trial based on the researcher's judgment