cyrilzakka/clinical-trials huggingface dataset:
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
4. Adequate organ function ≤ 7 days prior to randomization

Key Exclusion Criteria:

1. Has squamous cell or undifferentiated or other histological type GC
2. Active leptomeningeal disease or uncontrolled brain metastasis
3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
4. Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Iressa Versus Docetaxel (Taxotere)

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
* Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
* WHO performance status (PS) 0-2
* Absolute Neutrophil Count (ANC) \>1.5 x 109/liter (L) and platelets \>100 x 109/L
* Life expectancy of at least 8 weeks

Exclusion Criteria:

* Prior ZD1839 therapy
* Prior docetaxel treatment for NSCLC
* Less than 14 days since completion of prior radiotherapy
* Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
* Evidence of clinically active Interstitial Lung Disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
* Patients with pre existing peripheral neuropathy \>= grade 2 (NCI CTC criteria)
Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment

The purpose of this study is to determine whether simple, evidence-based clinical screening be quickly and feasibly implemented (\>85% of patients in an average of \<6 minutes) in large-volume urgent transient ischemic attack (TIA)/stroke clinics to identify individuals at high risk for the three most common and devastating post-stroke co-morbidities (depression, obstructive sleep apnea and cognitive disorders).

We have created a simple screening tool (the "DOC" Screen) that will be routinely applied to all patients at a high-volume Regional Stroke Prevention Clinic. Consenting patients will also undergo "gold standard" research assessments in order to determine the diagnostic characteristics of the screen compared to gold standard research assessments.The proportion of eligible patients who complete DOC screening and the time for completion (mean, range, standard deviations) will be calculated from aggregated data for all new consults in the stroke prevention clinic. For patients who consented to undergo gold standard testing, sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the DOC screen will be calculated. Screening cut-points will be optimized using Receiver Operating Characteristic (ROC) and area under the curve analysis, and logistic regression will be applied to this ROC Curve analysis to control for variables such as age, sex, BMI and education. We hope to develop a pragmatic approach to screening the large, high-risk stroke prevention clinic population, allowing broad screening for these important health conditions. This could change routine standard of care across stroke prevention clinics and facilitate early identification and appropriate assessment of patients.

Eligibility Criteria:
Inclusion Criteria:

* Attending outpatient TIA and Stroke Prevention Clinics at any of the three regional stroke centres.

Exclusion Criteria:

* Those who are unable to complete the screen complete the screen due to severe aphasia, severe motor dysfunction and those who are not fluent in English without translation available.
The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability

The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.

The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination.

The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking patients with no systemic or local diseases were qualified.

Additional inclusion criteria were as follows:

* minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
* minimal width of the alveolar ridge of 6-7 mm in the region of interest
* HKT (height of the keratinized tissue) higher than 2 mm
* API ≤ 35 (Approximal Plaque Index)
* PI ≤ 25. (Plaque Index)
* Bone Type III or D2 were included in the study
* No graft procedures in the area of interest,

Exclusion Criteria:

-
Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC)

The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.

The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.

This will be a pilot study with a pragmatic trial design wherein all hepatology providers at the Mayo Clinic in Rochester, MN and Scottsdale, AZ will be invited to participate in the study. Consented providers will be randomized to the Digital ALD/AUD Clinic (DALC) arm or standard of care. Provides randomized to standard of care arm will continue to enroll their patients with ALD in the Interactive Care Plan (ICP), a nursing led program started at Mayo in 2021 for longitudinal remote care of patients with compensated and decompensated cirrhosis. All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state). Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care.

The target sample size will be 40 providers (20 providers per arm) and the investigators anticipate 150 patients with ALD will be seen during the study period across both arms. The number of ICP eligible patients seen versus the number of ICP referred patients will be recorded for all providers. Clinically relevant outcomes including hepatic decompensation, MELD 3.0 score, liver chemistries, alcohol use or relapse, liver-related hospitalizations, medication compliance, and mortality will be recorded as part of current ICP program, in both arms. Data will be collected retrospectively from the available medical records at the end of the study period, and no research contact will be made with the patients after initial consent for those patients being offered the DALC. The study duration will be 6 months after the initial Hepatology appointment. At study enrollment and completion, providers will be asked to fill out a survey regarding their satisfaction with ALD/AUD treatment. Consented providers will be informed that they may drop out of the study at any time.

Eligibility Criteria:
Inclusion Criteria:

* Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
* Patient-Age ≥ 18 y.o.
* Patient-Alcohol-associated liver disease

Exclusion Criteria:

* Provider-Providers in other divisions
* Patient-Inability to provide consent
Dabigatran in an Interaction Probe Drug Cocktail

Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Weight at least 50 kg and body mass index 19 - 30 kg m-2
* Normal clinical laboratory profiles
* No childbearing potential or use of adequate contraceptive measures

Exclusion Criteria:

* Blood loss \>300 ml within 2 months prior to the first dosing day
* Pregnancy, breastfeeding
* Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
* Infection with HIV, HBV or HCV
* Participation in the preceding 3 months or concomitantly in any clinical drug study
* Suspected current drug or alcohol abuse
* History of drug or alcohol abuse.
* Concomitant medication with the exception of hormonal contraception.
* Positive result in urine test for drug abuse.
* Nicotine consumption equivalent to \>5 cigarettes per day
Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors

Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.

Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month.

The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response.

This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of pancreatic adenocarcinoma
* Patient \> 18 years old
* Social Security affiliation
* Signed informed consent

Exclusion Criteria:

* Patient in emergency situation
* Major person being the object of a legal protective measure or unable to express its consent
"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin

The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.

Researches will break the method of this investigation into two steps:

First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.

The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent form
* Age more than 18 years old
* Able to understand the purpose of the experiment, voluntarily participate, willing to complete follow-up according to the requirement of the experimental protocol.

Exclusion Criteria:

* Severe cardiopulmonary, liver and kidney dysfunction, and inability to tolerate surgery due to coagulation dysfunction
* Viral myocarditis, myocardial infarction or stroke with a course of less than six months
* Simultaneously accompanied by malignant tumours, with an expected lifespan of less than or equal to 1 year
* Severe thoracic deformity
* Advanced age (more than 90 years old)
* Other situations that the researcher deems unsuitable for participation in the study
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Normal history and physical exam.
* Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
* T4 count \>= 800 cells/mm3.
* Normal chest x-ray and urinalysis.
* Negative hepatitis B surface antigen.
* Negative HIV p24 antigen test.
* Normal skin reactivity by Merieux test.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

* Positive PPD.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Treatment:

Excluded:

* Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

* Any history of IV drug use.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
* More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma

RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.

PURPOSE: Phase II trial to study the effectiveness of dexamethasone in preventing side effects following treatment with denileukin diftitox in treating patients who have persistent or recurrent T-cell lymphoma.

OBJECTIVES: I. Evaluate the potential benefit of dexamethasone administered prior to denileukin diftitox in terms of avoidance and/or reduction of hypersensitivity type reactions, flu-like symptom complex, and vascular leak syndrome side effects (adverse events) in patients with persistent or recurrent cutaneous T-cell lymphoma. II. Assess the response rate in terms of tumor burden reduction in these patients treated with this regimen. III. Determine the rate of patient withdrawal from the study due to adverse effects.

OUTLINE: This is an open label, multicenter study. Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5. Patients also receive oral dexamethasone twice daily beginning 24 hours prior to and concomitantly with denileukin diftitox. Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 or 4 weeks.

PROJECTED ACCRUAL: Approximately 15-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of persistent or recurrent cutaneous T-cell lymphoma (CTCL) and suitable for denileukin diftitox therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Albumin at least 3.0 mg/dL Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 28 days prior to and during study No known hypersensitivity to denileukin diftitox or its components (e.g., diphtheria toxin, interleukin-2, or its excipients) or to dexamethasone No concurrent serious, uncontrolled infection that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior denileukin diftitox (DAB389-interleukin-2) or DAB486-interleukin-2 No concurrent interferon Chemotherapy: No concurrent chemotherapy\* No concurrent extracorporeal photochemotherapy\* No concurrent systemic or combination cytotoxic chemotherapy No concurrent topical chemotherapy \*For remission induction of CTCL Endocrine therapy: No other concurrent corticosteroids Radiotherapy: No concurrent electron beam radiotherapy and/or photophoresis Surgery: Not specified Other: At least 21 days since any prior anticancer therapy and recovered No other concurrent anticancer therapy for CTCL No concurrent experimental drugs or approved drugs tested in an investigational setting No concurrent topical therapy\* No concurrent phototherapy\* No concurrent cyclosporine No concurrent systemic retinoids \*For remission induction of CTCL
Simulated Home Therapy Program for the Hand After Stroke

The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.

Stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. Participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the Rehabilitation Institute of Chicago by Dr. Mary Ellen Stoykov. Over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. The skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. Difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill.

Subjects were assigned to one of two groups by casting lots. One group (VAEDA Glove) performed all tasks while wearing a custom Voice And EMG-Driven Actuated glove, the VAEDA Glove. The other group (No-Glove) performed the same types of tasks without use of the VAEDA Glove. The VAEDA Glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. The glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. Forces are transmitted through the cables from a servomotor located remotely to the digits. The servomotor controls torque or displacement in the cable. Along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension.

The VAEDA Glove can be controlled with up to 3 channels of electromyography (EMG). For this study, electrodes were placed above flexor digitorum superficialis (FDS) and extensor digitorum communis (EDC). The group using the J-Glove could receive assistance during hand opening, but only if appropriate EMG activity was detected. The EDC EMG activity had to reach a prescribed threshold before extension assistance would be provided. Similarly, FDS EMG activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. Feedback of muscle activity was available to the user through a custom graphical user interface.

Eligibility Criteria:
Inclusion Criteria:

* chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
* moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment

Exclusion Criteria:

* anti-spasticity medications/injections taken less than 6 month prior to enrollment
* contractures greater than 20 degrees
* inability to follow single-step commands
* significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)