cyrilzakka/clinical-trials huggingface dataset:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder

OBJECTIVES:

I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.

There is a 7- to 14-day washout with a placebo prior to treatment for all patients.

The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.

The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria
* DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units)

--Prior/Concurrent Therapy--

* At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine)
* No failure on prior guanfacine

--Patient Characteristics--

* Hepatic: No liver failure
* Renal: No renal failure
* Cardiovascular: No hypertension No other heart disease
* Pulmonary: No pulmonary disease
* Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women
E-learning: Teaching of Blindness Prevention

E-learning material increases the student knowledge level before the traditional class of blindness prevention and help to fix this information a short period (one month) after the class.


Eligibility Criteria:
Inclusion Criteria:

* being a medical student matriculated in the course of ophthalmology. This course is taught to fourth-year students at State University of Campinas.

Exclusion Criteria:

-
National Tunisian Registry of Cardiac Implantable Electronic Devices

The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.


Eligibility Criteria:
Inclusion Criteria:

* Patients originated from Tunisia
* Signed informed consent
* Patients undergoing a cardiac implantable electronic device procedure

Exclusion Criteria:

* Informed Consent not given
Modeling and Workflow Recognition for the Anterior Approach in Total Hip Arthroplasty

The purpose of this study is to create a systematic and general description of the surgical process for the direct anterior approach (DAA) in total hip arthroplasty (THA). For this purpose a surgical process model with a labeled dataset of THA surgery videos will be segmented into the individual surgical steps and sub-steps using a systematic approach.

BACKGROUND AND PROJECT RATIONALE

In Total Hip Arthroplasty (THA), a degenerated hip joint is replaced with an artificial acetabular and femoral component. In clinical practice, several approaches to accessing bone anatomy are employed. The direct anterior approach (DAA) has been adopted widely in recent years due to smaller incisions, fewer complications, faster recovery, and improved patient outcomes. However, the reduced space and limited access may cause more complexity in the execution of surgical steps.

Primary objective

The first goal of this project is to create a systematic and general description of the surgical process for DAA in THA. For this purpose, surgical process models (SPMs) provide a basis to manage, organize, and optimize the surgical process. For this purpose, a labeled dataset of THA surgery videos will be segmented into individual surgical steps and sub-steps using a systematic approach. SPMs are a simplified network of surgical or surgery-related activities and their relationships. These models can be used to compare several interventions, surgeons, or whole Operating Room teams. In addition, the SPMs can be used as input for workflow management systems.

Eligibility Criteria:
Inclusion Criteria:

* Primary surgery for total hip arthroplasty (THA) at Balgrist University Hospital, Kantonsspital Baden and Kantonsspital Winterthur
* Complete radiological data (CT and Hip/Pelvis x-ray)
* Signed consent

Exclusion Criteria:

* Missing or incomplete consent
* Previous surgery of the hip at the site of the THA
* Fracture of the hip or pelvis at the site of the THA
Perioperative vs Postoperative Chemotherapy + Bevacizumab in Colorectal Cancer, Liver Mets

Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have metastatic disease at the time of diagnosis and 50% of all patients eventually die of the disease. The most frequent site of colorectal metastases is the liver, which accounts for 30% to 60% of cases. In these patients, the extent of liver disease is the main determinant of survival. Hepatectomy is the only potentially curative therapy for colorectal liver metastases (CLM), but when traditional criteria for resectability were used, only 10% of patients were candidates for surgical resection.

Although adjuvant systemic therapy after resection of primary colorectal tumors is well established, there are relatively few data on the use of postoperative therapy vs. surgery alone in patients who have undergone resection of liver metastases. In this trial, the absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving survival in patients with CLM, several studies with biologic agents have been tried. The use of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has resulted in increased response rates in patients with stage IV colorectal cancer and improved OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who were potentially curable through resection of liver metastases, perioperative treatment with capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of 73% with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy significantly correlated with a prolonged PFS (P \< .001).

On the basis of these backgrounds, we designed a phase II study to compare the effectiveness of combination chemotherapy with perioperative or postoperative bevacizumab treatment in patients with CLM.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma
* With hepatic metastasis and no evidence of extrahepatic metastasis (the liver metastases must be determined by a hepatic surgeon to be resectable)
* 20\~80 years
* ECOG performance status 0 - 1
* Adequate laboratory findings

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Prior adjuvant chemotherapy, if administered within 6 months before study entry
* Previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy
* Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
* Chronic active hepatitis or cirrhosis
PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer

The purpose of the first group (Group 1) was to find the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long it stayed in the blood, and to see how well it was tolerated. From what the investigators have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood draws. This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort


Eligibility Criteria:
Inclusion Criteria:

* Registered patient at MSKCC
* Age ≥18 years
* Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer HER2 positive status by FISH or IHC as currently being implemented for patients with esophagogastric cancer. HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (≥2.0)
* Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (CT, MRI, FDG PET or bone scan). Patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present.
* Karnofsky Performance Score ≥ 60
* Ability to understand and willingness to sign informed consent
* Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
* Life expectancy of at least three (3) months.
* Willingness to use birth control while on study.
* The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results.
* Concurrent therapy will be allowed.

Exclusion Criteria:

* Inability to lie still for the duration of the scanning procedure.
* Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
* Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab.
* HIV positive or active hepatitis.
* History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entry
* Hematologic

  * Platelets \<50K/mcL
  * ANC \<1.0 K/mcL
* Hepatic laboratory values

  * Bilirubin \>2 x ULN (institutional upper limits of normal), with exception of patients with Gilberts disease. AST/ALT \>2.5 x ULN (institutional upper limits of normal); \>5 x ULN if liver metastasis
* Renal laboratory values

  * Estimated GFR (eGFR) \< 30mL/min/1.73m2
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)


Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* The informed consent must be signed before any study specific tests or procedures are done
* White/Caucasian men and women aged between 18 to 79 years (inclusive )
* Body mass index (BMI): 18 to 34 kg/m2 (both inclusive)
* Ability to understand and follow study-related instructions
* Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and three months after administration of study drug. Subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active.

This is not required if safe contraception is achieved by a permanent method, such as hysterectomy, bilateral fallopian tube ligation or vasectomy.

For subjects with hepatic impairment:

* Subjects with documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, or ultrasound
* Subjects with hepatic impairment (Child-Pugh A or B)
* Subjects with stable liver disease, i.e. same Child-Pugh class in the last 2 months

Exclusion Criteria:

* Any relevant disease within 4 weeks prior to study drug administration requiring medical treatment
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Use containing sex hormones within 4 weeks to six months before first study drug administration
* Use of CYP3A4 and P-glycoprotein inhibitors or inducers
* Use of drugs which may affect absorption
* Major change of medication \<2 weeks prior study drug administration
* Deviations from normal range in physical examination, gynecological examination, clinical chemistry, hematology, or urinalysis considered to be relevant by the investigator
* Any criteria which, in the opinion of the investigator, make study participation unadvisable for scientific, compliance, safety, or medical reasons
Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:

Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.

Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.

Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.

Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.

Eligibility Criteria:
Inclusion Criteria:ma

* Patients referred for high blood pressure
* Age over 30 years
* Untreated for hypertension or under stable treatment for 4 weeks or more
* Patients physically and mentally capable for self-measurement of blood pressure at home
* Written informed consent to participate in the study

Exclusion Criteria:

* Sustained arrythmia
* Pregnancy
* Symptomatic cardiovascular disease
* Any other serious disease (renal failure, heart failure, malignancy)
Enhancing Antiepileptic Drug Adherence

More than half of patients with epilepsy achieve full control of their seizures with antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational intervention in improving medication adherence in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of epilepsy according to the International League Against Epilepsy criteria
* age equal or higher than 18 years
* independence in daily living activities
* absence of major cognitive impairment or active psychiatric disorders

Exclusion Criteria:

* presence of a rapidly progressing neurological or medical disorder
* patients not receiving anti-epileptic drugs
* a history of significant substance abuse within the past year
* a diagnosis of mental retardation
Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss

This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.

Approximately 30% of the Korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. However, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity.

Preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly.

Therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI ) more than 25 kg/m2 or
* Waist circumference more than 90 cm in men or 85 cm in women

Exclusion Criteria:

* History of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months
* Weight changes more than 3 kg during the 6 months before participation
* Unstable cardiovascular events during the 6 months before participation
* Uncontrolled mood disorder
* History of eating disorder
* History of alcohol use disorder
* History of gallstone
* Chronic renal failure (estimated glomerular filtration less than 30 ml/min)
New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.

Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most frequent muscular dystrophies in the adulthood. Multi-spectral optoacoustic tomography (MSOT) is an innovative imaging technique able to non-invasively characterize the molecular composition of the muscle tissue. With this pilot study we will explore the performance of MSOT imaging in FSHD patients and correlate the findings with clinical and MRI data, with the final aim to identify new disease biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* molecular diagnosis of FSHD
* recent pelvic and lower-limb muscle MRI

Exclusion Criteria:

* presence of conditions that can alter the signal of the muscles under investigation: eg. tattoos, scars or skin abrasions at the site of probe evaluation, recent trauma, decompensated diabetes, symptomatic radiculopathies, acute or chronic inflammatory diseases
* current or presumed pregnancy
* inability to give informed consent
Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

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 vinorelbine plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy.

OBJECTIVES: I. Determine the clinical benefit response (including improvement in quality of life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate cancer. II. Correlate PSA response with clinical benefit response in these patients. III. Determine the objective response rate and duration of remission in patients with measurable disease treated with this regimen. IV. Further assess the toxicity of this combination in a cohort of prostate cancer patients. V. Examine the survival characteristics of these patients undergoing this regimen.

OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate that is hormone refractory Hormone-refractory defined as at least 50% increase in PSA while continuing hormonal therapy Must have received prior hormonal manipulation including either orchiectomy or LHRH agonist Must be symptomatic and on a stable dose of pain medication No documented CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 1-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.8 mg/dL Other: Not HIV positive No concurrent infection No concurrent medical or psychiatric illness that precludes study compliance No prior or concurrent second malignancy in the past 5 years except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior antiandrogens If patients have received prior antiandrogens, PSA levels are reassessed at 4 week intervals until there is no decrease in PSA levels before registration into this study Radiotherapy: Prior radiotherapy allowed Must have recovered from prior radiotherapy Concurrent radiotherapy for symptomatic bone lesion allowed Surgery: Not specified Other: No other concurrent therapeutic study