cyrilzakka/clinical-trials huggingface dataset:
Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have metastatic pancreatic cancer.

OBJECTIVES: I. Assess the antitumor activity of dolastatin 10 in patients with metastatic adenocarcinoma of the pancreas. II. Evaluate the qualitative and quantitative toxic effects of this therapy in these patients. III. Investigate the clinical pharmacology of this treatment.

OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus once every 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: This study will accrue 12-37 patients within 18.5 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the pancreas Bidimensionally measurable lesions with sentinel lesions outside field of any prior radiation therapy No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious infection At least 5 years since prior malignancy except the following: Nonmelanoma skin cancer Carcinoma in situ of the cervix No overt psychosis or mental disability

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior adjuvant chemoradiation to disease At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since prior investigational drug (including analgesics or antiemetics) No other concurrent anticancer therapy
Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone

This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.

Primary objective of the study is to investigate efficacy \[percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)\] and safety of different oral doses of BAY94-8862 given once daily.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital
* Subjects with either type 2 DM or moderate CKD

Exclusion Criteria:

* Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
* Acute coronary syndrome (ACS) (elevated cardiac troponins which are not caused by an ACS are not an exclusion criterion) in the last 30 days prior to the screening visit
* Cardiogenic shock
* Valvular heart disease requiring surgical intervention during the course of the study
* Subjects with left ventricular assistance device or waiting for heart transplantation
* Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
* Addison's disease
Caloric Restriction, Exercise, and Glucoregulation in Humans

Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.

Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* females postmenopausal
* no diabetes, cardiovascular disease, cancer
* no orthopedic problems
* not currently exercising
* BMI between 25 and 29.9
* nonsmokers

Exclusion Criteria:

* current regular exercisers
* premenopausal women
* cardiovascular disease, lung disease, cancer, diabetes
Measuring Head Impacts in Sports

Head impacts in sports can lead to brain injury even when the participant is wearing a helmet. The forces that contribute to brain injury from sports-related head impacts are not well understood. This study will test a new device to measure the speed of head impacts among football players.

Each year, 50 to 70 million people in the United States participate in helmeted and unhelmeted sports with the potential for head impacts. Such sports include football, soccer, hockey, basketball, and boxing. Participating in these sports carries the risk of mild traumatic brain injury (MTBI). The biomechanics of head impacts that result in concussions or other MTBIs are not well understood; however, it is thought that such impacts correlate with head accelerations. Currently, there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play. This is a major obstacle in understanding the mechanism of MTBI and its prevention. This study will evaluate a newly designed miniature device that uses Head Impact Recording Technology (HIRT) to quantify head acceleration during impact in actual sports play.

One hundred college football players will be enrolled in the study. Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season. Data collected will be assessed to determine the incidence, magnitude, and duration of head acceleration during impacts on the sports field.

Eligibility Criteria:
Inclusion Criteria

* College football players
Ultrasound Guided Superior Laryngeal Nerve Block Compared With Blind Block Technique

The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique.

Airway anesthesia is pivotal for successful awake intubation provided either topically or by nerves blocks. Airway blocks are technically harder to perform with more complications possibilities. However, in experienced hands, they can be useful as they provide better intubating conditions.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists ( ASA ) physical status I and II.
2. Age between 40-60 years.
3. Modified Mallampati class III-IV .

Exclusion Criteria:

1. Local pathology of the neck.
2. Bleeding diathesis.
3. Allergy to local anesthetic agent.
4. Intellectual impairment.
5. Psychiatric disease.
6. Body mass index ≥30 kg/m2.
Kynex Versus Refresh Plus Study in Subject With Dry Eye

The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older, of any race and either sex.
* Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
* Criteria for the diagnosis must include the following two characteristics at Visit 1 (Day 1):
* Subjects' assessment of dry eye status (answer of at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?"
* Sodium fluorescein (NaFl) corneal staining score sum of ≥3 in either eye (NEI scoring system).
* Able and willing to follow study instructions.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study:
* History or evidence of ocular or intraocular surgery in either eye within the past three months.
* History of intolerance or hypersensitivity to any component of the study medications.
* History or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
* Use of topical ocular medications during the study period.
* Subjects using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
* Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
* Subjects unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
* Current punctal occlusion of any type (e.g. collagen plugs, silicone plugs).
* Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
* Participation in any investigational drug or device study within 30 days of entering this study.
Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years of age
* Biopsy proven HER2+ early breast cancer
* ECOG performance status 0-1
* Should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease.
* Adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion.
* Women of childbearing potential who are sexually active must agree to use highly effective methods of contraception during treatment and for three weeks after the last dose of chemotherapy or anti-HER2 therapy. The women currently using hormonal contraceptives must agree to change to an alternative highly effective method of contraception
* Willingness and ability to comply with study and follow-up procedures and give written informed consent.

Exclusion Criteria:

* Any evidence of stage IV breast cancer
* Participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved
* Any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer.
* Women who are pregnant or breastfeeding.
Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy

A pilot randomized feasibility trial with a blinded evaluator.

Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. In the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. These interventions have not been explored on patients with CIPN.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
2. Patients who have no prior evidence of peripheral neuropathy of the hands
3. Age 18 years or older
4. Able to sit for minimum of 30 minutes for hand therapy sessions

Exclusion Criteria:

1. Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
2. Patients taking duloxetine or gabapentin
3. History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
4. Inability to sit for minimum of 30 minutes
5. Documented cognitive problems limiting ability to participate in hand therapy
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis

The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA.

The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
* The target lesion starts less than or equal to 30 mm from the venous anastomosis.
* The target lesion has \> 50% stenosis as measured per protocol.
* The patient has a maximum of one secondary stenosis.

Exclusion Criteria:

* The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure.
* The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure.
* The secondary lesion is an occlusion.
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.

BACKGROUND:

The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection.

AIM:

To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection.

METHODS:

We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up.

EXPECTED RESULT:

The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Patient proved with infection of H. pylori in gastric mucosa
* Patient with signed informed consent.

Exclusion Criteria:

* woman in breast feeding or pregnancy.
* allergy or severe adverse effects to drugs used in study.
* severe complications of peptic ulcer disease (like perforation or obstruction).
* patients with history of cancer or failure of major organs.
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
* Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
* Normal intelligence
* Able to swallow capsules

Exclusion Criteria:

* Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
* Prior treatment with atomoxetine
* History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
* History of severe allergies or multiple adverse drug reactions
* Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Home-Based HIT in Obese Individuals

This study aims to investigate the efficacy of a novel home-based high-intensity interval training (Home-HIT) intervention in obese individuals, with elevated cardiovascular disease (CVD) risk. It was hypothesised that Home-HIT would 1) have high adherence to the prescribed exercise intensity (compliance), 2) improve markers of CVD risk, and 3) lead to favourable skeletal muscle adaptations.

The applicability of current high intensity interval training (HIT) protocols to the sedentary obese population has been disputed by public health experts. Existing HIT interventions have been successful only under optimal conditions with high levels of supervision and specialised equipment, creating further barriers to exercise in those most in need. We aimed to eliminate many of these barriers by modifying existing HIT protocols to create a new home-based HIT (Home-HIT) intervention tailored to individuals with low fitness and mobility. It was hypothesised that Home-HIT would 1) have high adherence to the prescribed exercise intensity (compliance) and 2) improve markers of cardiovascular disease (CVD) risk. 32 Obese adults with at least 3 additional CVD risk factors (age 36±2 y; BMI 34.3±0.8 kg∙m-2; VO2peak 24.6±1.0 ml∙kg∙min-1), completed one of three 12-week training programmes 3x/week: Home-HIT (n=9); Laboratory-based supervised HIT (Lab-HIT; n=10) or home-based moderate intensity continuous training (Home-MICT; n=13). Adherence and compliance were monitored online in almost "real time" using a heart rate (HR) monitor and mobile app. The Home-HIT group completed 4 progressing to 8 1min intervals interspersed with 1min of rest in an unsupervised place of their choosing. The intervals were composed of simple bodyweight exercises that required no equipment. Changes in VO2peak, insulin sensitivity, body composition, flow-mediated dilation (FMD) and aortic pulse wave velocity (PWV) were assessed. Muscle biopsies were taken to assess changes in capillarisation, mitochondrial density, intramuscular triglyceride (IMTG) content and eNOS and GLUT4 protein expression using quantitative immunofluorescence microscopy.

Eligibility Criteria:
Inclusion Criteria:

* obesity (BMI \>30 kg/m2)
* age 18-55

Exclusion Criteria:

* diagnosed CVD and other contraindications to participate in an exercise intervention
* BMI \<30 kg/m2
Computer Assisted Cognitive Remediation Program in Schizophrenia

The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.

Schizophrenia can be considered a chronic illness that affects all aspects of daily life. Cognitive deficits seems to play a key role that interferes directly in the functional adaptation.

Cognitive remediation therapy (CRT) emerges as a psychological intervention that target cognitive impairment. But, the use of computerized or papel an pencil procedures for remediation cognitive deficits remains controversial. Nonetheless, computer tasks offer a number of advantages compared to those of paper and pencil. The most noteworthy advantages are to enhance patient's motivation just because the sensory variety that the exercises presented or the possibility to provide immediate feedback. Furthermore, the possibility to present custom-tailored and adapted tasks taking into accounts the patients deficits and their evolution in the process of the psychological therapy is another important feature of computer-assisted cognitive remediation therapy.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV (APA, 1994)criteria for schizophrenia disorder
* Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)
* Patients were considered sufficiently stable if they had a Global Assessment of Functioning Scale (GAF)score of 40 or superior and they maintained a stable dose and type of psychiatric medication for at least 1 moth prior to inclusion.

Exclusion Criteria:

* Non presence of cognitive impairment confirmed by neurocognitive assessment
* Traumatic brain injury or history of neurologic illness.
* Electroconvulsive therapy in the last year.
* Psychiatric comorbidity.
* Plan to change medication during the trial.