cyrilzakka/clinical-trials huggingface dataset:
Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)

The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties.

There is a need of validated scale for correct assessment for patients with disorders of consciousness (DOC) in Russia. One of the most detailed scales that provides robust results in these patients is the Coma Recovery Scale - Revised (CRS-r). The validated Russian version of CRS-r will be very helpful in clinical work and scientific research for making correct assessment of patients status and its changes over time in Russia and Russian-speaking countries.

The purpose of this study is to validate Russian version of CRS-R and to assess its psychometric properties.

The first step of the study was to perform translation of CRS-r from English into Russian according to the validation protocol:

1. Double direct translation by independent translators;
2. Combination of two Russian translations;
3. Reverse translation by native English speaker.

Final Russian version and back-translated version of the Scale were approved by the original author, Dr. J. Giacino. He approved the original validation study protocol as well.

To validate Russian version of CRS-r and to assess its psychometric properties the investigators will perform an observational study on 60 adults with disorders of consciousness of different etiology on different period of recovery after coma. It is planned to include patients with various states of consciousness (e.g., vegetative state, minimally conscious state "minus" and minimally conscious state "plus") in balanced proportions.

Every patient will be examined by two independent researchers on the same day. The patients will be examined twice with a week interval between examinations for evaluation of sensitivity of CRS-r. Test-retest reliability will be applied to investigate interrater reliability. This method will be applied as well to assess the consistency of patients' scores over time. The internal consistency of the test will be investigated by inter-rater method. For this item two researchers will conduct patient assessment with CRS-R on the same day with a small period of time between the examinations. Content validity of the test will be used for assessment of validity of CRS-R. It will be performed with expert evaluation of the content of CRS-R by the investigators. Сriterion validity will be examined by assessing the correlations of CRS-R with the scales of other questionnaires with proven high psychometric properties for consciousness disorders: the Glasgow Coma Scale and Full Outline of UnResponsiveness (FOUR) score.

Eligibility Criteria:
Inclusion Criteria:

* Adults recovering after coma in any period (persistent, permanent);
* Vegetative state or minimal conscious state;
* Locked-in syndrome.

Exclusion Criteria:

* Coma, brain death.
Bone Response to Enzyme Replacement in Gaucher's Disease

The purpose of this study is to examine how the skeleton responds to repeated doses of enzyme replacement therapy in patients with type I Gaucher's disease who have had their spleens removed.

Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons. Patients with Gaucher's disease experience enlargement of the liver and spleen and bone destruction. The condition is passed from generation to generation through autosomal recessive inheritance.

Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect nerve cells. The symptoms of type I can appear at any age.

In this study patients will be divided into three groups. Each group will receive different doses of enzyme replacement (Ceredase). In addition, two of the three groups will also receive doses of a form of vitamin D (calcitriol). Researchers believe the groups receiving vitamin D will have an improved response as compared to those patients only receiving enzyme replacement.

Patients in each group who respond to enzyme replacement with increases in bone density will be compared to the other treatment groups.

The purpose of this study is to examine the response of the skeleton to repeated infusions of macrophage-targeted glucocerebrosidase (CEREDASE (Trademark) ) in splenectomized patients with type I Gaucher's disease. The magnitude and rate of development of the skeletal response will be monitored non-invasively. Theoretically, an enhanced response should occur in patients supplemented with pharmacologic doses of 1, 25-dihydroxyvitamin D3 (calcitriol), since calcium absorption and enzyme delivery to bone marrow macrophages should be increased in this setting. These issues will be addressed in a clinical trial that uses a modified factorial design. A total of 57 patients will be assigned to three treatment groups by block randomization.

Group 1: CEREDASE (Trademark) (60 IU/kg q2wks; 0-6 months)

CEREDASE (Trademark) (30 IU/kg q2wks; 7-24 months)

Group 2: Calcitriol (0.25-3.0 micrograms/day; 0-24 months)

CEREDASE (Trademark) (60 IU/kg q2wks; 7-12 months)

CEREDASE (Trademark) (30 IU/kg q2wks; 13-24 months)

Group 3: Calcitriol (0.25-3.0 micrograms/day; 0-24 months)

CEREDASE (Trademark) (60 IU/kg q2wks; 0-6 months)

CEREDASE (Trademark) (30 IU/kg q2wks; 7-24 months)

The number of patients responding to enzyme replacement with a significant decrease in hepatic volume and a significant increase in trabecular bone density of the lumbar spine will be compared between the treatment groups.

Eligibility Criteria:
Splenectomized Gaucher patients.

Aged 18-45 who have not received enzyme therapy for at least 1 year.

No patients with other illnesses (pulmonary, liver, kidney, bone, hematologic).
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects

Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 55 years
* BMI \>= 18.5 and \<= 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells or blackouts
* Any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Seasonal rhinitis
* Thrombocytes \< 150000/μl
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 2 months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco \< 5 days prior to administration of study drug or during trial
* Blood donation or loss \> 400 ml, \< 1 month prior to administration or during the trial
* Excessive physical activities \< 5 days prior to administration of study drug or during trial
* Clinically relevant laboratory abnormalities
* Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery

The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Euroscore ≥ 5

Exclusion Criteria:

* Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery
Trial of pRehospital Intervention With trAditional Chinese Medicine for Acute strokE

The main purpose of this trial is to observe whether Xingnaojing, intravenously administered within 24 hours of symptom onset on pre-hospital emergency ambulance, improves the Early neurological deterioration of acute stroke at 3 days.

The TRACE is a multicenter, registry observational study. Xingnaojing injection is the only essential traditional chinese medicine on emergency ambulance used for acute stroke.The primary hypothesis of this trial is that Xingnaojing used for acute stroke within 24 hours of symptom onset on ambulance will improve the Early neurological deterioration of acute stroke at 3 days. All suspected acute stroke participants will be registered once they are taken on the ambulance. The primary outcome will be determined at 3 days.Besides, there will be a quantitative interview with emergency doctors about their knowledge and attitude on Xingnaojing for acute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of suspected acute stroke；
* Symptom onset within 24 hours；
* Age ≥ 18 .

Exclusion Criteria:

* Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
* Other conditions that render outcomes or follow-up unlikely to be assessed; Known to be pregnant or breastfeeding;
* Non-acute stroke (result from Computed Tomography(CT) or Magnetic Resonance Imaging(MRI)).
Phase Ib Study of SC Milatuzumab in SLE

Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).

Milatuzumab or placebo will be given subcutaneously once weekly for 4 weeks to determine if milatuzumab helps to control lupus (SLE). The treatment portion of the study lasts 4 weeks. Then patients are followed for disease activity for at least 12 weeks. If patients respond to the study drug, they may be eligible for one course of retreatment, again followed by 12 weeks of follow-up. Patients who showed a response will continue to be followed at timepoints up to one year after treatment to assess how long the response lasts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old
* Signed written informed consent before study entry
* Diagnosis of SLE by American College of Rheumatology revised criteria (meets ≥ 4 criteria)
* Positive ANA (titer ≥ 1:80) at study entry
* At least 1 BILAG A or 2 BILAG B scores in any organ/body system and ≥ 6 SELENA-SLEDAI score
* Receiving at least 5.0 mg/day oral prednisone (or equivalent) at stable doses for at least 4 weeks prior to study entry
* If receiving immunosuppressives or antimalarial agents, at stable doses for at least 4 weeks prior to study entry

Exclusion Criteria:

* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test.
* Women of childbearing potential and fertile men not practicing or unwilling to practice birth control during the study
* Rituximab, belimumab, other prior antibody, investigational or experimental therapy within 6 months
* Allergic to murine, chimeric, humanized or human antibodies
* Hematologic abnormalities not attributed to lupus: hemoglobin \< 8.0 mg/dL, WBC \< 2000/L, ANC \< 1500/L, platelets \< 50,000/L,
* AST, ALT or alkaline phosphatase \> 3 times upper limit of normal and not attributed to lupus
* Serum creatinine \> 2.5 mg/dL, proteinuria \> 3.5 g/day
* Received live vaccine within 4 weeks
* Thrombosis, spontaneous or induced abortion, stillbirth or live birth within 4 weeks
* Antiphospholipid antibodies AND a history of thromboembolic events
* On oral anticoagulants (not including NSAIDs) within 4 weeks
* Active infection with antibiotics within 7 days
* Infection requiring hospitalization or herpes zoster treatment within 4 weeks
* Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years
* Malignancy (except squamous or basal cell carcinoma, cervical CIS) within 3 years (unless approved by the medical monitor)
* History of recurrent abortions (2 or more)
* Known HIV, hepatitis B or C, other immunosuppressive states
* Other concurrent medical conditions that, in the investigator's opinion, could affect the patient's ability to tolerate or complete the study will not be eligible for the study.
Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation

the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation

The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.

Exclusion Criteria:

1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase \> 2.5 times of the upper normal limit, serum creatinine \> 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction \< 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score \> 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.
How Exercise Signals Health Responses

The purpose of this research is to determine the blood signals that promote health and well-being in response to exercise at different intensities.

Most studies find a dose-response relationship between exercise participation and all-cause mortality. In contrast, physical inactivity and consequent overweight or obese status is associated with a cadre of health consequences. Frequently, comorbidities of obesity are mechanistically linked via chronic low grade inflammation stemming from increases in adiposity. Although exercise is known to combat obesity and obesity related disease states, the mechanisms of action are not fully understood. Therefore, the investigators propose the following study in an attempt to elucidate anti- and pro-inflammatory endocrine responses to exercise. Initial studies in animal models have provided evidence that exercise induces long-term anti-inflammatory effects, potentially via myokine signaling following skeletal muscle activation. Humans are an ideal study population as the investigators can prescribe multiple exercise protocols that mimic human behavior, and control exercise intensity to meet recommendations. Also, humans allow the investigators to collect larger plasma samples and therefore measure more circulating proteins of interest over multiple time-points. Finally, the investigators can select individuals that exercise at different frequencies, allowing the investigators to analyze the differences in endocrine responses to exercise over differing levels of fitness. In summary, a human model will allow for a much better understanding of the human condition.

Eligibility Criteria:
Inclusion Criteria:

* No tobacco use
* Not pregnant, lactating, or planning to become pregnant in the next 6 months
* Regular menses for the past 6 months
* No use of hormone replacement for metabolic conditions (use of hormonal contraceptives are not exclusionary)
* No physical limitations
* Has the ability to safely perform exercise

Exclusion Criteria:

* Has no major health problems
* Cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease
Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods.

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.

In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major surgery during anesthesia and muscle relaxation

Exclusion Criteria:

* Patient with chronic obstructive lung disease
An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 or older)
* admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
* have a physician's order for an IV
* are able to speak, read and understand English
* referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization

Exclusion Criteria:

* admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
* history of a psychological disorder, as determined from the patient's chart;
* history of peripheral neuropathy, as determined by patient's chart;
* history of IV drug abuse, as determined from the patient's chart;
* decreased sensation in the arm or hands, as reported in the chart or by the patient;
* patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale);
* a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;
* veins that cannot be palpated and are difficult to visualize by VAST nurses;
* pregnancy;
* an order for the emergency insertion of an IV by the patient's doctor or assigned nurse;
* an IV insertion that requires the use of a catheter gauged 18 or larger
* severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale
Amisulpride Treatment for BPSD in AD Patients

Currently, olanzapine is the most widely used and studied drug for the treatment of behavioral and psychological symptoms in patients with Alzheimer's disease, but there are significant side effects. Amisulpride is a new antipsychotic that not only controls mental symptoms but also improves cognitive function. Therefore, the aim of this study was to evaluate the effectiveness and tolerability of both amisulpride and Olanzapine for treating the behavioral and psychological symptoms of dementia in patients with dementia of the Alzheimer type.

This study was a randomized, open-label, prospective clinical study in which patients were randomized to receive amisulpride and olanzapine for 8 weeks. Drug efficacy and safety assessments were assessed at baseline, 2 weekends, 4 weekends, and 8 weekends.

Eligibility Criteria:
Inclusion Criteria:

1. It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
2. a total score of MMSE\<24
3. The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
4. Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised

Exclusion Criteria:

1. People with vascular dementia, frontotemporal dementia, dementia with Lewy bodies or other neurocognitive disorders;
2. Patients with severe brain organic diseases or brain trauma;
3. Physical illnesses associated with severe respiratory, circulatory, immune, and endocrine systems;
4. History of other mental disorders;
5. Those who are allergic to amisulpride or olanzapine;
6. Patients who are contraindicated with amisulpride and olanzapine: pheochromocytoma, prolactin-dependent tumors and narrow-angle glaucoma;