cyrilzakka/clinical-trials huggingface dataset:
Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders

An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.

Medical data (demographic and clinical characteristics - diagnosis, MoCA test results) are collected from patients to whom Divaza is prescribed to be taken according to the following regimen: 2 tablets 3 times per day for 12 weeks.

Neurologists assess the patients' cognitive functions with MoCA scale before starting therapy with Divaza (visit 1) and 12 weeks after the treatment (visit 2).

The efficacy of Divaza for the treatment of cognitive impairment in patients with chronic cerebral ischemia (CCI) is evaluated.

Safety is assessed based on the frequency and severity of adverse events. In addition, the relationship between MoCA test performance and gender or regional social and economic factors is evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender aged 18+ years.
2. Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs.
3. Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month.
4. Signed informed consent form.

Exclusion Criteria:

1. Other neurological diseases.
2. Any known allergy to/intolerance of any constituent of the medication.
3. Pregnancy, breast-feeding.
4. Participation in other clinical trials for 3 months prior to enrollment in this study.
5. The patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of OOO NPF Materia Medica Holding.
Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity

The world lacks a gold standard treatment for treating dentin hypersensitivity. Fluoride varnish is most commonly used as a treatment but it causes temporary discoloration of tooth structure and may cause irritation or burning of gums when it comes in contact with gums. Seventh generation bonding agents are less technique sensitive and are easy to use. The present study aims to find out the better seventh generation bonding agent as a treatment option for sensitivity.

A total of 105 patients with dentin hypersensitivity are randomized into three groups. Scaling and root debridement are performed for all the groups. This study compares two seventh generation bonding agents and taking fluoride varnish as control group.

Dentin hypersensitivity is a painful condition resulting from external stimulation of exposed vital dentin. Dentin gets exposed to the oral environment by multiple factors like gingival recession, erosion, attrition, abrasion, fractures, caries, and many more. The intra-tubular fluid movement of exposed tubules is believed to be the mechanism of hypersensitivity. Dentin bonding agents acts by occluding patent tubules, thus reducing hypersensitivity. Seventh generation combines etchant, primer and bonding agent into one solution and makes it easy to use.

After diagnosis of dentin hypersensitivity, the patients signed a consent form stating their voluntary participation in the research. The discomfort internal scale score and Schiff cold air sensitivity scale scores are recorded at baseline, immediately after the intervention, after 01 week and after 01 month. Discomfort internal scale score are recorded for every participant using dental explorer in the mesial and distal direction on the exposed surface of the affected teeth for tactile stimulation. For schiff cold air sensitivity scale scores an air syringe system was used to check the evaporative response on the affected teeth of the participants and the scores are recorded.

All the patients received scaling and root debridement as a standard protocol treatment. Dentin bonding agents and fluoride varnish are applied to the participants. All the participants are instructed to fast for two hours after the treatment. All the records are made on subjective response of patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of 18 to 45 years of age
* Hypersensitive teeth to air and tactile stimultaion
* Gingival recession of Miller Class I and II
* Score 1 of Silness and Loe Plaque index
* Participants who have no sysytemic illness
* Patients who agree to give consent were included in the study.

Exclusion Criteria:

* Carious teeth
* Fractured restoration or cracked teeth
* Teeth undergoing orthodontic or periodontal treatment at sensitive site
* Patients who had dental bleaching in last 03 months
* Patients taking pain killers
* Smokers
* Pregnant and nursing females were excluded from the study
A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Available tissue for central laboratory evaluation of HER2 status
* Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)
* Life expectancy \>6 months
* Female, age \>=18 years
* ECOG performance status of 0, 1, or 2
* Adequate bone marrow function as indicated by the following: \*ANC \>1500/uL, \*Platelet count \>=100,000/uL
* Adequate renal function, as indicated by creatinine \<=1.5× upper limit of normal (ULN)
* Adequate liver function, as indicated by bilirubin \<=1.5× ULN and AST or ALT \<2× ULN unless related to primary disease
* Use of an adequate means of birth control (women of childbearing potential)

Exclusion Criteria:

* Initiation of Herceptin \>=4 weeks after beginning taxane chemotherapy
* Prior chemotherapy for metastatic disease
* Prior cumulative anthracycline dose of \>360 mg/m2
* History of significant cardiac disease or uncontrolled arrhythmias
* Ejection fraction of \<50% or below the lower limit of normal
* Active infection
* Symptomatic or untreated brain metastases
* Pregnancy or lactation
* Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
* Hypersensitivity to study medications
* Major organ failure or systemic disease precluding the safe administration of study medications
Comparison of PRP & DFDBA vs. DFDBA in Intrabony Periodontal Defects

The purpose of this clinical trial is to compare the results in subjects with periodontitis using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material, namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment of bone defects around the teeth.

After being informed about the study and potential risks, 13 patients giving written informed consent and who meet the eligibility requirements were randomly allocated in a single blind manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).

33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and radiographic outcomes obtained in test and control groups,12 months post - operatively.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* with chronic periodontitis
* who were free of local or systemic disease
* who had not received any type of periodontal therapy in the last six months
* radiograph showing at least one angular defect in any quadrant
* the involved teeth were vital and asymptomatic
* the site of interest had at least 2 mm of keratinized gingiva on the facial aspect of the selected teeth

Exclusion Criteria:

* Patients with abnormal platelet count
* allergic to chlorhexidine or any other medicine used in the study
* showing unacceptable oral hygiene compliance during / after the phase I therapy;
* pregnant or lactating mothers;
* smokers
* endodontically involved teeth
* patients under any medication known to interfere with periodontal healing. e.g., corticosteroids
* on anticoagulant therapy
* patients with transferable jobs or who were uncooperative
* patients participating in other dental clinical trials.
Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls

Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are damaged following an outbreak of shingles.

The purpose of this study is to identify and study abnormalities in the nerves and cells in the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be responsible for causing nerve pain. This data will be compared to the tissue of healthy volunteers. Our goal is that this information will lead to the development of better treatment options for people with painful nerve conditions.


Eligibility Criteria:
Inclusion Criteria:

Group 1: 5 Caucasian males \>50 years of age with PHN of greater than 6 months duration since rash healed and clinically meaningful pain (Visual Analog Scale (VAS) \>40mm at Baseline) Group 2: 5 Caucasian males \>50 years of age, non-diabetic with no nervous system disease (healthy control groups)

Exclusion Criteria:

1. History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
2. Allergy to lidocaine
3. Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
4. History of slow-healing diabetic foot ulcers
5. HgA1c \>11% within the last three months
6. Active cancer within the previous two years, except treated basal cell carcinoma of the skin
7. Co-morbidities that can produce neuropathy
8. Subjects taking sodium channel blockers within one week of study treatment and throughout the study
9. Subjects taking any other experimental drugs within 30 days prior to enrollment
10. Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment
The CARMA Technique Study

Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.


Eligibility Criteria:
Patients with colonic polyps will be considered following below criteria

Inclusion Criteria:

- any polypectomy (though only a maximum of two polyps from one individual participant)

Exclusion Criteria:

* polyps less than 10mm which were resected under endoscopic view with a definite \> 1mm clear margin
* scar site recurrence polyps
* polyps with endoscopic evidence of invasion
* pedunculated polyps
* pseudopolyps
* participants who will not be available for follow up endoscopy
Computerized Cognitive Bias Intervention for Intolerance of Uncertainty

This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology.


Eligibility Criteria:
Inclusion Criteria:

* Elevated IU interpretation bias at pre-intervention.

Exclusion Criteria:

* None.
Exercise Training on Brain Insulin Responsiveness

The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity continuous training (MICT) and high-intensity-interval-training (HIIT), which will be performed in a randomized order. This will be compared to a waiting control condition.

Investigate one acute bout of exercise on the brain insulin responsiveness using functional magnetic resonance imaging in combination with intranasal insulin in healthy participants of normal-weight and overweight/obesity. Two single endurance exercise sessions with different intensities will be evaluated, namely moderate intensity continuous training (MICT) and high-intensity interval training (HIIT). This will be compared to a waiting control condition. In a cross-over design, investigators will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise. Cerebral response is defined as the cerebral blood flow and resting state functional connectivity in response to intranasal insulin. Secondary outcomes include changes in blood metabolites and proteins and changes in eating behavior.

Eligibility Criteria:
Inclusion Criteria:

* BMI between ≥ 19.5 to 39 kg/m2-
* Less than 150 min/week for moderate-intensity physical activity
* Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for regular physical activity of adults)
* Written consent to participate in the study
* Written consent to be informed about incidental findings

Exclusion Criteria

* Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
* Limitations to participate in ergometer-based exercise (balance and coordination disorders, orthopedic problems, ...)
* Insufficient knowledge of the German language
* Persons who cannot legally give consent
* Pregnancy or lactation
* History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures and migraines)
* Taking psychotropic drugs
* Taking medications that influence glucose metabolism
* Regular use of analgesic drugs
* Taking anticoagulant agents
* Previous bariatric surgery
* Acute infection within the last 4 weeks
* Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
* Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
* Current participation in a lifestyle intervention study or a pharmaceutical study
* Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery
* Persons with claustrophobia
* Temperature-sensitive person
* Persons with tinnitus or increased sensitivity to loud sounds
18750-Sun Protection Factor Assay

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male or female
* Aged between 18-70 years old.
* Good health
* Signed and dated Informed Consent Form
* Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* PRe-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.


Eligibility Criteria:
Inclusion Criteria:

* All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)

Exclusion Criteria:

* Age \< 18years
Russian Severe Asthma Registry

The Russian Severe Asthma Registry is a Russian initiative to collect anonymous long-term evidence for patients with severe asthma in Russia

The Russian Severe Asthma Registry is a Russian initiative to collect anonymous long-term evidence for patients with severe asthma in Russia. The RSAR initiative is realized under the efforts of the Interregional Public Organization "Russian Respiratory Society" and LLC "RSMI" with the sponsorship of "AstraZeneca Pharmaceuticals" LLC.

The developed RSAR electronic database is a Russian software product that meets the current requirements of the Russian legislation in the field of working with personal data and the implementation of similar observational studies.

Participating researchers also agree to grant access and share anonymous data at the patient level as part of the work to implement the RSAR initiative. Participants will provide high-quality data for the development of data sets for research, approved by the Russian Respiratory Society (RPO), which has priority in owning and implementation in scientific field of the gained data. Based on ethical, legal and regulatory authorizations, anonymous data will be collected in the Central Database (CDB) on respiratory diseases (referred to here as the RSAR database) to create sets of important data and the necessary analysis. CDB is part of the software "Medical online platform ROSMED.INFO".

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 years or older.

  * Patients with confirmed diagnosis of severe asthma.
  * Patients receiving treatment according to GINA step 5 or uncontrolled for 4 step. Uncontrolled patients are defined as having symptoms of severe asthma or frequent exacerbations .
  * Signed informed consent.

Exclusion Criteria:

* Patients currently participating in clinical trials at the time of enrolment

  * Intermittent, mild, moderate BA, before verification of the diagnosis.
  * COPD.
  * Diseases of the respiratory system, such as tuberculosis, sarcoidosis, IPF, lung cancer.
  * Vasculitis, systemic connective tissue diseases.
  * Neoplasm.
  * Written refusal of the patient to participate in the study after signing an informed consent.
Transfusion Requirements During Spinal Surgery for Severe Scoliosis

Corrective surgery for scoliosis can result in prolonged operating room time and significant blood loss. The investigators goal is to determine what the transfusion requirements are for young adults undergoing spinal surgery for scoliosis and what other intra-operative factors influence the amount of blood and blood products used. The investigators will used the information obtained to improve the management of patients undergoing corrective surgery for scoliosis.

Data collected prior to surgery will include patients' past medical history, hemoglobin concentration, INR, MCV, gender, age and weight.

Immediately prior to surgery, but after induction of anesthesia, subjects will have another complete blood count drawn to assess preoperative hemoglobin/hematocrit concentrations. This is customarily done to establish a baseline. During surgery patient's core temperature, hemoglobin, hematocrit levels, estimated blood loss, Central Venous Pressure, blood pressure, heart rate, cell saver, the amount of irrigation fluid, colloid, crystalloid, blood and blood products will be recorded hourly throughout surgery. All of the data collection described is standard in these types of cases.

Patients will be transfused allogenic blood if hemoglobin levels fall below 8.0 g/dL or patients present with clinical signs/symptoms of hypovolemia (hypotension, tachycardia). Data collection concerning allogenic blood transfusion will include intraoperative transfusion rate, volume of transfused units per patient and transfusion index. Surgical intervention data regarding the extent of the surgical procedure will be collected: the number of curves, the curve magnitude, type of instrumentation required, the number of levels fused and the fluoroscopy time. The placement and type of wound drains and their .respective outputs will be noted. Preoperative and postoperative curve magnitude will be documented as well as instrumentation used to facilitate curve correction. The number of levels fused will be documented.

Hemoglobin and hematocrit levels will be noted at several intervals post operatively (24 hours, 48 hours and last result prior to discharge) and further transfusion requirement will be recorded. The length of Intensive Care Unit stay and the length of hospital stay will be noted. Regarding surgical procedure all patients will be operated on by the same surgical team, under standardized anesthesia, total intravenous anesthesia (TIVA), and postoperative analgesia. Data will be expressed as percentages or as a mean +/- SD. T-test analysis will be used for comparison for quantitative variables and a p value \< 0.05 will be considered statistically significant

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing surgical correction of scoliosis