cyrilzakka/clinical-trials huggingface dataset:
Multilevel Intervention for Physical Activity in Retirement Communities

The purpose of this study was to assess whether a 6-month multilevel physical activity intervention can significantly increase physical activity levels in sedentary adults, 65 and older, living in Continuing Care Retirement Communities (CCRCs).

Sedentary residents (N=307) in 11 CCRCs received the multilevel MIPARC intervention or a control health education program for 6 months. A group randomized control design was employed with site as the unit of randomization. The intervention was delivered through group sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led advocacy efforts.

Objective monitoring of physical activity suggests that fewer than 3% of adults over age 60 meet current physical activity guidelines. Ecological models posit that behavioral interventions are most effective when they operate on multiple levels. The MIPARC study intervenes on four levels: individual (pedometer-based self monitoring, educational materials and monthly counseling calls), interpersonal (monthly group sessions and peer mentoring), environment (walking signage prompts, tailored walking maps, step counts)and policies (review of on-site activity opportunities and walkability, recommendations for change and peer led advocacy)to increase the activity levels of residents. The study promotes walking as the primary means to increase light to moderate PA, with a secondary focus on strength and flexibility and decreased sedentary behavior.

As most Continuing Care Retirement Communities have management structures that provide the opportunity to improve the social and built environments for physical activity and walking, this study also aims to train participants on how to advocate for improvements in the environment that would improve walkability.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 65
* Able to walk 20 meters independently (without human assistance, can use cane/walker)
* Able to speak and read in English
* No cognitive, vision or hearing impairments that would prevent provision of informed consent, comprehension of instructions, completion of surveys and participation in phone conversations
* Able to complete the Timed Up and Go Test to assess falls risk within 30 seconds
* Live within the selected retirement community (facility-dwelling) Able to hold brief conversation over the telephone.
* Will be in San Diego for the duration of the study
* Provision of consent to participate
* Willing to wear a pedometer, accelerometer and GPS device
* Willing to complete all surveys and attend weekly meetings
* No history of falls in previous that resulted in an injury or hospitalization in the past 12 months
* Physician clearance to participate

Exclusion Criteria:

* Inability to give informed, voluntary consent
* Inability to complete assessments
* Lack of written physician consent to participate in unsupervised light-to-moderate intensity walking
* Inability to speak and read English
Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings

pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm.

there is malignant thickening : methoselioma, metastasis and non malignant thickening.

trans thoracic USn is a reliable , safe and gold standard for studying pleura.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed as having pleural thickening with or without pleural effusion.

Exclusion Criteria:

* Emphysema or contraindication to pleural biopsy
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
* Patient must have a serum testosterone \> 180 ng/dl.
* Karnofsky performance status (KPS)\>_70%.
* Patients must have adequate organ function as defined by the following
* laboratory criteria:
* WBC \>_ 3500/mm3
* ANC \>_1500/mm3
* Platelet count \>100,000/mm3
* Hemoglobin \>8.0g/dL
* Creatinine \<1.6mg/dl
* Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
* SGOT and SGPT If alkaline phosphatase is _\< 2.5 x ULN, any elevations in
* AST/ALT; OR if AST/ALT is _\<1.5 x ULN, any elevation in alkaline phos
* Prior hormonal therapy is allowed as:

  1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).
  2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).
* Patients must be at least 18 years of age.
* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment

Exclusion Criteria:

* Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
* Uncontrolled serious active infection.
* Anticipated survival of less than 3 months.
* Active CNS or epiduraltumor
* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
* Peripheral neuropathy \>_ grade 3.
* Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
* Prior chemotherapy
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab

Phase IV, 3-armed, prospective, open-label, single-center, Israeli study, examining the response to SARS-CoV-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated MS patients. Treatments will be administered according to common local practice. Demographic, clinical, treatment-related and COVID-19-related data will be collected. Blood samples will be drawn for each participant at baseline (before COVID-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of COVID-19 vaccine. Humoral, B-cell and T-cell responses will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

(1) Diagnosis of multiple sclerosis (MS) according to 2017 McDonald criteria. (2) Age \>=18 years.

(3) Treatment with Teriflunomide for at least 6 months/or 4 to 18 months after the last course treatment with Alemtuzumab/or untreated.

(4) Signed written informed consent.

Exclusion Criteria:

(1) Cognitive decline that precludes understanding the study procedures.
Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy

Background: Neurobehavioral functions and quality of life (QoL) are the important outcome measurements after radiotherapy in patients with brain tumors and even head/neck cancers. However, few studies have focused on neurobehavioral functions and QoL after anti-cancer treatment particularly brain radiotherapy for pediatric/adolescent patients with brain tumors. This study thus aims to prospectively evaluate those functions in pediatric or adolescent patients with brain or head/neck tumors in order to provide useful information about their clinical outcomes.

Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated using a neuropsychological battery, which includes general cognitive functions, intelligence, memory, executive functions, information processing and emotional/behavioral expressions. The QoL will be evaluated by the health-related QoL questionnaire. All participants will be examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment.

Expected results: Patients'neurobehavioral functions and QoL will show significant improvement after treatment, and the improvement will not be diminished across each post-treatment phase.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients diagnosed with brain tumors or head/neck cancers who are no older than 18 years old
* Patients should be considered indicated for receiving the subsequent course of local radiotherapy

Exclusion Criteria:

* Patients who received radiotherapy once before
* Patients have visual and/or hearing impairments which obviously impede the administration of neurocognitive assessment
* Patients cannot underwent brain MRI examination because of clinical contraindications, such as renal insufficiency (GFR \<30)
Effects of Low/No Calorie Sweeteners on Glucose Tolerance

This study aims to determine the effects of chronic exposure to some low/no calorie sweeteners (LNCS) on glucose tolerance and glucagon like peptide 1 (GLP-1) release in healthy individuals. LNCS examined in this study are saccharin, sucralose and aspartame+acesulfame-K. The amounts of LNCS given to the participants are kept similar to daily life exposure; far less than the Acceptable Daily Intakes (ADIs) levels proposed by Food and Drug Administration (FDA) or European Food Safety Authority (EFSA).

Excessive sugar consumption has been related to chronic metabolic problems, including obesity, type 2 diabetes, neuroinflammatory diseases, etc. Therefore, it is recommended to decrease added sugar intake below 10% of total energy intake. Low/no calorie sweeteners (LNCS) may seem as a good alternative to added sugars because they provide sweetness without adding calories to the diet. Although they may reduce energy intake and prevent weight gain, studies investigating the short and long term effects of these sweeteners on metabolic profile are controversial. Therefore, there is a need for future studies to shed light on metabolic effects of these compounds in humans.

Some observational and clinical studies show that they may cause insulin resistance and type 2 diabetes. There are possible mechanisms that may explain this relationship. One of these possible mechanisms is interaction with sweet taste receptors (STRs). It has been shown that STRs not only found in oral cavity but also in extra-oral tissues, such as gastrointestinal tract, pancreas, brain, etc. In vitro studies with sucralose, it has been shown that it may activate STRs in L-cells and stimulate GLP-1 release in a similar manner with glucose. However, these results were not confirmed in vivo.

There are at least six different LNCS approved for human use worldwide. However, each of them have different biological fate in terms of absorption, metabolism and excretion characteristics in the body. Therefore, result of a study with one of LNCS cannot be extrapolated for all LNCS; each of them should be studied in well-designed studies.

In this study it is hypothesized that LNCS may activate STRs in intestinal L-cells and alter release of GLP-1; as a result impair glucose tolerance. In acute human studies, these effects are tested and there are controversial results in regard to glucose tolerance or incretin release. However, individuals who want to consume fewer calories or to better control their blood glucose use LNCS in place of sugar for longer period of time. For this reason, we wanted to test the effects of regular use of LNCS on glucose tolerance and incretin release.

Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* Normoglycemic,
* Female,
* 19-45 years old,
* Weight-stable past 3 months

Exclusion Criteria:

* Insulin resistance,
* Type 2 diabetes mellitus,
* Presence of acute/chronic infection,
* Use of medication that may affect glucose metabolism (thiazide diuretics, glucocorticoids, estrogen or beta blockers)
* Chronic alcohol intake,
* Regular consumption of diet soda (more than one can of soda per week)
Outcome After Treatment of Pulmonary Aspergilloma

Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.

A retrospective chart analysis, based on the search results from a thoracic surgery database and an interventional radiology database. Outcome analysis of all surgically treated patients for a confirmed invasive aspergilloma. Comparisson with (preoperative) embolisation of the bronchial circulation.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven Aspergilloma of the lung

Exclusion Criteria:

* Treatment limited to the use of systemic antifungal agents
Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study

A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
2. Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
3. At least 18 years of age at screening
4. Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
5. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
6. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
7. Life expectancy of at least 24 months

Exclusion Criteria:

1. Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
2. Presence or history of bypass in the diseased limb
3. Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
4. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
5. History of acute arterial occlusion requiring an emergent intervention
6. Severe chronic renal insufficiency (serum creatinine \>2.5 mg/dL) or undergoing hemodialysis
7. Previous renal transplant
8. Uncontrolled arterial hypertension (BP \>200 mmHg) at 2 successive readings
9. Uncontrolled or poorly controlled diabetes
10. Abnormal blood values that could influence patient recovery and or/ graft hemostasis
11. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
12. Any active local or systemic infection
13. Known heparin-induced thrombocytopenia
14. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
15. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
16. Previous enrolment in this study
17. Subject is participating in another study
18. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
19. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain

MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction.
3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery.
4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.

Exclusion Criteria:

1. Previously dosed with MR-107A-01.
2. Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
5. Use of medications with the potential to interact with MR-107A-01.
6. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

* All adverse events

Efficacy Marker

* Office blood pressure

Eligibility Criteria:
Inclusion Criteria:

* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
* Age ≥18 and ≤80 years old
* Able and willing to provide written informed consent to participate in the study
* Able and willing to comply with the required follow-up schedule

Exclusion Criteria:

* Prior renal artery intervention (balloon angioplasty or stenting)
* Evidence of renal artery atherosclerosis (defined as a stenotic severity of \>30%) in either renal artery
* Multiple main renal arteries in either kidney
* Main renal arteries \<4 mm in diameter or \<20 mm in length
* eGFR of \<45 mL/min per 1.73 m2 using the MDRD formula
* Type 1 diabetes
* Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
* Others
Comparison of Morphological and Radiological Data in Patients With Urolithiasis

The aim of the study was to compare the ultrastructural changes in the renal parenchyma with the results of postprocessing CT analysis with contrast enhancement in patients with urolithiasis.


Eligibility Criteria:
Inclusion Criteria for experimental group:

1. Men and women \>18 years and \<45 years old;
2. Established diagnosis of urolithiasis that does not interfere with the processes of urodynamics (there is no expansion of the overlying urinary tract);
3. Planned surgery - percutaneous nephrolithotripsy;
4. Stone size up to 20 mm., Patients with multiple small two-sided stones;
5. Patients with CT of the kidneys with contrast enhancement performed according to the required protocol.

Exclusion Criteria for experimental group:

1. Age \< 18 years old or ASA\> 3;
2. With single kidney;
3. Patients with coral stones;
4. The presence of concomitant systemic pathology (DM, AH), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma;
5. A history of injuries and surgical interventions on the kidneys, urinary tract, renal vessels;
6. Taking nephrotropic drugs;
7. Systemic intake of nephrotoxic drugs;
8. Severe general somatic condition, making the operation impossible;
9. Pregnancy.

Inclusion Criteria for control group:

1. Men and women \>18 years and \<45 years old;
2. Absence of urolithiasis in the patient's anamnesis and in his family history;
3. Renal tumors which have undergone partial nephrectomy or nephrectomy;
4. Patients with CT renal data with contrast enhancement, performed according to the required protocol.

Exclusion Criteria for control group:

1. Urolithiasis in anamnesis;
2. A history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels;
3. Intercurrent background;
4. Non-informative biopsy.
Bioequivalence Study of Escitalopram Tablets 10 mg

The objective of this study was to confirm if two formulations of escitalopram tablets are bioequivalent.

Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg escitalopram; Lundbeck). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, male adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Males between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram)

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any medication, substance, or food. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study.