cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants

This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.


Eligibility Criteria:
Inclusion Criteria

* With a body mass index range of 18.5 to 29.9 kilograms per meter square (kg/m\^2)
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory
* Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in
* Negative hepatitis panel (including hepatitis B virus surface antigen \[HBsAg\] and hepatitis C virus antibody \[anti-HCV\]) and negative human immunodeficiency virus (HIV) antibody screens
* Healthy males and females of nonchildbearing potential who agree to use effective contraception

Exclusion Criteria

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
* Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in
* Use of any prescription medications/products within 14 days prior to Period 1 Check-in
* Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in
* Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in
* Poor peripheral venous access
* Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study
* Female participant is pregnant, lactating, or breastfeeding
* Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in
* Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles
* Predisposing factors to retinal vein occlusion (RVO)
Prospective Functional Outcome Study of the Knee

The purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness, and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a male or non-pregnant female age 18 years or older at time of study
* Patient is a candidate for a total knee arthroplasty
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon
* Patients who have had any previous lower extremity procedure
* Patients with a BMI greater than or equal to 40
* Patients with an active infection within the affected knee joint Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
* Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)
* Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
* Patient has a known sensitivity to device materials
* Non-English speaking patients
* Patient is a prisoner
Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytological proved locally advanced esophagogastric junction cancer
* ECOG performance status ≦2
* Stage IIa-IIIc
* No distant metastasis (M0)
* Sign in Informed Consent Form

Exclusion Criteria:

* History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
* Pregnancy or lactation women,
* Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
* Inadequate organ function which is defined as below:

Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);

* Symptomatic peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidines
* Fluoropyrimidines (DPD) congenital absence
Effect of Inhalation Aromatherapy on Anxiety and Depressive Symptoms of Geriatric Patients With Parkinson's Disease

The present study aims to:

Investigate the effect of inhalation aromatherapy on anxiety and depressive symptoms of geriatric patients with Parkinson's disease.

Research Hypothesis:

Patients with Parkinson's disease who inhale aromatherapy will exhibit lower anxiety and depressive symptoms than those who didn't inhale it

A sample of 60 randomly selected patients with patients Parkinson's disease was included in this study. The study subjects were divided equally into two groups; study (30 patients) and a control group (30 patients) matched as much as possible. Exclusion criteria included patients diagnosed for Parkinson's by a specialist, no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. Patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

patients diagnosed for Parkinson's by a specialist

Exclusion Criteria:

no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. Patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender will be excluded from the study.
Cladribine Tablets as an Exit Therapy Strategy

The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland). Patients included must meet the inclusion criteria: RRMS diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new MRI lesion, no EDSS progression) for more than 5 years under a DMT, age≥ 45-year-old.

Analyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing / stopping current treatments but took CladT as exit therapy. Patients with a minimum of 24 months follow up will be included.

We will ensure that CladT provide disease stability compared to treatment continuation / discontinuation in ageing MS patients by measuring:

* the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever.
* the percentage of patients free of EDSS progression confirmed for at least 6 months and until the end of patient follow up.
* the percentage of patients free of MRI activity, defined as new or enlarged T2 lesions compared with the previous brain MRI scan or gadolinium enhancing T1 lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥45-year-old with RRMS
* Disease duration ≥10 years
* No evidence of disease activity ≥5 years under DMT
* EDSS score between 0 and 6.0 included

Exclusion Criteria:

* Progressive form of MS
* Patients without DMT
* EDSS score ≥6.5
The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence

This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI

This is a randomized interventional parallel study to evaluate the effect of PFMT with stabilization exercises of high and low intensity in women with SUI

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide written informed consent
2. Over 18 years old and experiencing uncomplicated SUI
3. Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
4. Symptoms of urinary incontinence for at least three consecutive months
5. Degree of pelvic organ prolapse, stage ≤ 2
6. Willingness to accept the randomization process and fully participate in tests

Exclusion Criteria:

1. History of anti-incontinence surgery in the past 12 months
2. History of pelvic prolapse repair or urethral surgery in the past 12 months
3. History of PFMT in the past 12 months
4. History of interstitial cystitis or bladder-related pain
5. Chronic severe constipation
6. Clinically significant renal or hepatic impairment
7. Clinically significant heart impairment
8. Pregnant, lactating or actively trying to become pregnant
9. Positive urinary tract infection
10. Use of rehabilitation aids (pessaries, urethral plugs, vaginal beads, etc.)
11. Insufficient understanding of pelvic floor exercises and/or omitting exercises
12. Incomplete questionnaire
13. Refusal to participate in the study
Effects of Isometric Conditioning Activity on Subsequent Jumping Performance in Volleyball Players

The pairing of high-effort exercise, called conditioning activity, with a biomechanically similar high-velocity power movement is considered a valid method to effectively facilitate muscle power adaptations. Research has mainly focused on using this method in exercises performed by both limbs, even though sports tasks are often executed through motion sequences produced by a single limb alternately. However, available studies have focused solely on the dominant leg, leaving it unclear if the effectiveness is similar in both legs and how it transfers between them. Therefore, this study aims to evaluate the immediate effects of the isometric split squat exercise on single-leg drop jump performance in volleyball players, considering their training status.


Eligibility Criteria:
Inclusion Criteria:

* no lower-limb serious injury, including tendon or muscle tear,
* participation in regular resistance training and competition.
* for the elite group participants competed at the highest national volleyball league for at least two consecutive seasons.
* for the amateur group participants competed in junior groups outside the highest league level.

Exclusion Criteria:

-
A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer

Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, aged between 18 and 75 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;
4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10\*9/L, neutrophil ≥1.5 × 10\*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
6. Expected survival of ≥ 12 weeks.

Exclusion Criteria:

1. Subjects with poor-controlled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
3. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
7. Associated with CNS (central nervous system) metastases;
8. Active bacterial infections;
9. Pregnant or breast-feeding women;
10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Simulation-based Training Improves Competency in Communicating Bad News

Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families.

Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.

The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.

Eligibility Criteria:
Inclusion Criteria:

* Residents working at the Intensive Care Unit.

Exclusion Criteria:

* Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors

The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.

Patients who meet the inclusion and exclusion criteria will be offered the study and those who consent will undergo Endoscopic Ultrasound (EUS) evaluation. All patients who consent to the study will undergo Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) and EUS guided EchoBrush. All patients will receive the recommended standard antibiotic prophylaxis (Ciprofloxacin 400 mg IV given 30 minutes prior to EUS) that is used prior to EUS-FNA of cystic pancreatic lesions and a prescription for oral Ciprofloxacin for 5 days post procedure (standard of care).

Participants with pancreatic cysts that are \>10 mm but under 25 mm: These patients will undergo standard EUS-FNA of cyst fluid. From the first 19 participants, 0.5cc of aspirated cyst fluid will be sent for Proteomic analysis and the rest for cytology. EUS guided EchoBrush of the cyst wall will not be performed in this group of patients.

Participants with pancreatic cysts that are \> 25 mm will undergo EUS guided Echobrush sampling of the cyst wall at the same time they undergo EUS-FNA. This will be done using the standard technique that is described below.

EUS guided cyst wall brushing and residual fluid aspirated after lavage with 2 cc of sterile normal saline The tip of the Echobrush and the saline used to lavage the cyst will be placed in the same specimen jar (Specimen 2) based on the discussion with published experts on the EchoBrush technique. It should be noted that the pancreatic cyst will be punctured with the 19G FNA needle only once to obtain the specimens mentioned above. A single pass with EUS-FNA is the standard of care for pancreatic cysts and this study does not alter standard of care. It should be noted that the two groups represent two samples from the same patient and same cystic lesion. Therefore each patient will serve as their own internal control. All patients will be considered for surgical resection. Patients who do not undergo surgical resection will be followed up per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* All patients must meet clinical criteria to undergo an Endoscopic Ultrasound (EUS) with fine needle aspiration (FNA).
* Pancreatic cystic lesion with a minimum diameter of 10 mm noted on a previous cross-sectional imaging modality
* All races will be eligible

Exclusion Criteria:

* Coagulopathy defined as an prothrombin time (PT) \> 13.5 seconds or partial thromboplastin time (PTT) \> 35 seconds
* Thrombocytopenia defined as a platelet count \< 50, 000
* Known pancreatic cancer
* Recent pancreatitis defined as an episode of pancreatitis within 4 weeks of study enrollment
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study

FORCE is a randomized home-based resistance training/strength training (RT) intervention study for Stage II and III colon cancer patients undergoing chemotherapy.

Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of adjuvant chemotherapy and continue exercise through the completion of post-operative chemotherapy. Specifically, the investigators will examine between group differences for RT versus waitlist control for chemotherapy outcomes including dose delays, dose reductions, early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as potential markers of change in response to RT. To determine effects of change of MM on chemotherapy-specific drug clearance, the investigators will examine the impact body composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most commonly used drugs for colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years
* Newly diagnosed with histologically confirmed stage II-Ill colon cancer
* Completed curative-intent surgical resection
* Currently prescribed one of the following adjuvant chemotherapy regimens: (IV 5-fluorouracil \[5-FU\] / leucovorin \[LV\], capecitabine, FOLFOX \[5-FU, LV, oxaliplatin\], CAPOX \[capecitabine and oxaliplatin\]
* Patients must have started chemotherapy or plan to start with receipt of the first exercise visit by 3rd infusion visit. Patients enrolled at the Dana-Farber Cancer Institute and who are receiving FOLFOX chemotherapy are eligible to enroll in the pharmacokinetics sub-study.
* No planned major surgery anticipated in the intervention period
* Sufficient time to heal from any major surgery to start of intervention, including colostomy reversal (port-a-cath removal excluded)
* Approval by either oncologist or surgeon to participate in trial
* Readiness as determined by the Physical Activity Readiness Questionnaire
* Ability to understand and the willingness to sign a written informed consent document in English
* Willingness to be randomized

Exclusion Criteria:

* Concurrent actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)
* Patients with untreated hypertension (\>180 mm Hg systolic or \>100 mm Hg diastolic) appearing in the patient's medical record in the two weeks prior to screening
* Presence of metastatic disease
* Current strength training \>2x week for the past 3 or more months
* Patients enrolled in other clinical trials of weight loss, physical activity or dietary interventions are ineligible.