cyrilzakka/clinical-trials huggingface dataset:
Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System Atrophy

Multiple system atrophy (MSA) is a fetal, rare neurodegenerative disease presenting with parksinonism, autonomic dysfunction, and cerebellar ataxia. Numerous anti-parkinsonism agents have been developed. However, no medication has yet been proven effective for the symptomatic or even causative treatment in cerebellar ataxia. To our knowledge, cerebellar N-methyl-D- aspartic acid (NMDA) receptors play a special role in the modulation of motor learning and coordination. Tllsh2910, a NMDA modulator, has been found to attenuate the ataxic gait in the mouse model. Here, we designed a large-scale double-blind randomized controlled, cross-over phase III trial to investigate the efficacy of Tllsh2910 in neurodegenerative ataxic patients and the association of gut microbiota change.

The study is terminated prematurely due to project replanning and difficulty in recruitment during the pandemic. The overall sample size is not adequate to meet the requirement of estimated power. The statistical results will be investigated. No severe drug-related adverse events were reported during the study period.

Eligibility Criteria:
Inclusion Criteria:

* 1. Clinically confirmed cerebellar ataxia with a SARA total score ≥ 3 (range 0-40).
* 2. Clinical diagnosis of probable or possible MSA-C.
* 3. Patients older than 18 years old and younger than 80 years old.

Exclusion Criteria:

* 1. Major systemic diseases such as hepatic, renal or heart failure, malignancy, stroke.
* 2. Concomitant medication which inhibit CYP2C19 enzyme such as Clopidogrel, cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, fluoxetine, fluvoxamine, ticlopidine.
* 3. Pregnancy and/or breastfeeding.
* 4. Acute diseases that might interfere with the trial.
A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)

This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with Good Clinical Practices. This study will evaluate the safety, tolerability and dose-finding of robatumumab when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C).

The primary study hypothesis is that robatumumab can be safely administered in combination with chemotherapy regimens in pediatric participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must be \<= 21 years of age (older participants may be allowed on study on a case-by-case basis); may be of either sex, and of any race/ethnicity.
* Must have histologic confirmation of the advanced solid tumor, except for brainstem tumors.
* Must have Karnofsky performance score of \>=50 (if participant is \>16 years of age) or a Lansky score of \>50 (if participant is \<=16 years of age).
* Must have adequate organ function during Screening.
* Must be able to adhere to dose and visit schedules.

Exclusion Criteria:

* Must not have a history of another malignancy.
* Must not have uncontrolled diabetes mellitus.
* Must not have persistent, unresolved common terminology criteria for adverse events (CTCAE) Grade \>=2 drug-related toxicity associated with previous treatment.
* Must not have known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications.
* If female, must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at Screening.
* Must not be known to have human immunodeficiency virus (HIV) infection or known HIV-related malignancy.
* Must not be known to have active Hepatitis B, or Hepatitis C.
* Must not have any serious or uncontrolled infection.
AuraOnce Performance Observation

This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.

This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 years
* Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.

Exclusion Criteria:

- Subjects where use of AuraOnce cannot be clinically justified
Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB

Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.

Acronyms:

Tuberculosis (TB) Receiver Operating Curve (ROC) Common Terminology Criteria for Adverse Effects (CTCAE)

The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose' for Pulmonary Tuberculosis. Prospective, Open, Three - Arm Controlled trial Study. Validation of the E-nose in urban settings to estimate the diagnostic accuracy of the E-nose using exhaled air in patients with Pulmonary TB in adults.

The patients who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in Netherlands.

During and after the use of the device, we determine the adverse effects of the intervention, according to the CTCEA.

The researchers use the sputum culture, which is the gold standard, to determine the diagnostic utility of the test. And, will compare the results with other tests currently perform as the regular diagnostic routine, such as Chest X-ray, sputum smear, and symptom based diagnosis.

The patients in the experimental group are invited to come during the treatment phase, and will be asses the progress of the treatment, as well as another use of the device, at 5, 15, 30, 60 days after initiation of treatment, and will be compared the results of the device, with symptoms, x-ray changes, improvement of anthropometric findings, to determine the utility of the device to measure the response to treatment.

Patient Registries will be keep in an electronic database, as well as handwriting history, with the backup copy in the records of the hospital in which the patient was admitted.

auditoriae will be realised by the Ethics Comite in different time frames.

Eligibility Criteria:
Inclusion Criteria:

* Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
* More than 15 years old.
* People with a culture positive for pulmonary TB

Exclusion Criteria:

* Severe compromise of the general condition.
* Not capable to exhaled through the E-nose.
* No possibility to follow-up.
* By discretion of the research team.
McGrath vs. C-MAC Video Laryngoscopy Comparison in Endotracheal Tube Insertion

Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult airway anatomy.

Various studies showed different results regarding the effectiveness of both C-MAC® and McGrath®, by assessing the comparison of the effectiveness, valuable information will be obtained for further consideration by experts in choosing the best tools in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Elective surgery patients without neck and face trauma
2. Undergo surgery requiring general anesthesia with endotracheal intubation
3. Patients with physical status ASA I-III
4. Patients aged 18-65 years
5. Nutritional status (BMI \< 35 Kg/m2)

Exclusion Criteria:

1. Patients refusal to be included in the study
2. Patients with cervical spine instability
3. Anatomical and structural abnormalities of the maxillary teeth
4. Thyromental distance \<6 cm and inter-incisor distance \<3.5 cm
5. History of difficult intubation
6. LEMON criteria ≥ 3
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF) when compared to VT ablation after the third appropriate implantable cardioverter-defibrillator (ICD) shock.


Eligibility Criteria:
Inclusion Criteria:

1. History of remote myocardial infarction
2. Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
3. Documentation of sustained ventricular tachycardia (VT) by any kind of Electrocardiography (ECG) including 12 lead ECG, holter ECG, rhythm strip, event monitoring, event recorder or pacemaker within 30 days before enrollment
4. Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
5. Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
6. Patient has provided written informed consent
7. Patient accepts activation of Home Monitoring®

Exclusion Criteria:

1. Age \< 18 years or \> 80 years
2. Known arterial or venous thrombosis
3. Class IV New York Heart Association (NYHA) heart failure
4. Valvular heart disease or mechanical heart valve precluding access to the left ventricle
5. Acute myocardial reinfarction or acute coronary syndrome
6. Cardiac surgery involving cardiotomy within the past 2 months
7. Patients requiring chronic renal dialysis
8. Thrombocytopenia or coagulopathy
9. Incessant VT or electrical storm
10. Bundle branch reentry tachycardia as the presenting VT
11. Pre-existing implantable cardioverter-defibrillator (ICD)
12. Pregnancy or breast feeding women
13. Acute illness or active systemic infection
14. Other disease process likely to limit survival to less than 12 months
15. Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
16. Unwillingness to participate or lack of availability for follow-up
17. Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.
Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI 18-30 kg/m2

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse
Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People with Pancreatic Cancer

The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically-confirmed (confirmed at MSKCC) PDAC
* Patients must be ≥ 18 years old
* Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
* Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
* Karnofsky Performance Status ≥70%.
* Life expectancy ≥3 months.
* A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.

Exclusion Criteria:

* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
* Women who are pregnant or breast-feeding.
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers

The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy volunteers.

The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC relative to PIC, and lack of an effect of food on the PK of crizotinib in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days.
Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly

The widespread availability of screening coupled with high risks of over diagnosis, over treatment, and a rising risk of dying from competing causes of deaths pose a major challenge for prostate cancer patients and our health care system. Data on outcomes and identification of patients who are likely to benefit from therapies are urgently needed to empower patients and health professionals and to allocate limited health resources wisely. The long-term goal of this population-based study is to improve prostate cancer care for elderly patients. In 2004, approximately thirty percent of the 230,110 new prostate cancer cases diagnosed will be in men over age 75. Elderly men have a high risk of being diagnosed with prostate cancer, but a relatively low risk of dying of this disease, and are often excluded from cancer trials. While the value of primary androgen deprivation for localized prostate cancer remains questionable, this treatment is widely used among elderly patients. Currently, there is insufficient outcomes data to guide treatment choices for elderly patients.The following are the key background considerations that provide the rationale for this proposed project:· Prostate cancer is prevalent among elderly men. · Over diagnosis and competing causes of death are important issues for elderly men with prostate cancer.· Androgen deprivation therapy (ADT) is being increasingly used as primary therapy among elderly patients with localized disease· There are insufficient outcomes data to support the use of primary androgen deprivation for non metastatic prostate cancer· Preliminary dataThe study population in this sub-project is a sub-sample of the large study (IRB # 5177 ) and the research methods are identical in both studies.


Eligibility Criteria:
Inclusion criteria:

* Diagnosed at age 75 or older.
* Diagnosed with non-metastatic prostate cancer in 1992-1999.
* Enrolled in Medicare for the 12 months before diagnosis for an adequate assessment of baseline comorbidity.
* Enrolled in Medicare Part A and Part B through death or the end of the study period to have an adequate claim history of cancer treatment over the follow-up period.
* Alive for at least 6 months after cancer diagnosis. This criterion will remove men who are diagnosed at death or who are dying and have severe comorbidities, and are therefore poor candidates for 'aggressive' cancer interventions.

Exclusion criteria:

* Enrolled in Medicare managed care plans during the study period since no Medicare claims are available during the period of enrollment.
* Have other types of cancer. This criterion will ensure that all cancer therapies identified from the Medicare claims are for prostate cancer exclusively.
The Effect of Nursing Support Program for Women in Surgical Menopause on Their Life Quality

Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause.

Design: The study was a single-center, randomized, controlled trial. Setting: This study was carried out in the gynecology clinic of a training and research hospital in Türkiye.

Method: The participants were randomized into two equal groups: intervention and control. The nursing support program developed in addition to routine nursing care was applied to the intervention group. Routine nursing care was given to the women in the control group. Data were collected with "Personal Information Form", "Menopause-Specific Quality of Life Questionnare", "Pittsburgh Sleep Quality Index" and "Perimenopausal Depression Scale".

Hypothesis:

H0-a: Nursing support program developed in line with the Roy Adaptation Model has no effect on the quality of life of women who have undergone surgical menopause.

H0-b: Nursing support program developed in line with the Roy Adaptation Model has no effect on the sleep quality of women who have undergone surgical menopause.

H0-c: Nursing support program developed in line with the Roy Adaptation Model has no effect on the depressive symptom status of women who have undergone surgical menopause.


Eligibility Criteria:
Inclusion Criteria:

* To have undergone surgical menopause
* To be literate
* To agree to participate in the study

Exclusion Criteria:

* To have natural menopause before the operation
* To have an oncological disease
* To have a psychiatric disease
* To use sleeping pills
* To use hormonal therapy
* To have physical and mental disability
* To have barrier to communication
Production of Vitamin D Metabolites by UV-radiation From Solar Bed

Background:

Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements.

Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system-including autoimmune diseases-and the cardiovascular system.

Purpose:

The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation.

Study Course:

Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.

Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours.

Day 1,2,3 and 7 after solar bed exposure:

Blood samples are drawn and adverse events are registered.


Eligibility Criteria:
Inclusion Criteria:

Healthy adults

Exclusion Criteria:

Abnormal ALT or Creatinine Pregnancy
Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature

The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.

This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 1. 22-70 years.
* 2. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.

  3. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.

  4. Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.

  6. Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.

  7. Subject provides written consent to take part in the study.

Exclusion Criteria:

* 1. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.

  2. Physician intends to treat the subject with an off-label TMS Therapy or indication.

  3. Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.

  6. Known or suspected pregnancy.