cyrilzakka/clinical-trials huggingface dataset:
Sorafenib in Relapsed High Grade Osteosarcoma

Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as single agent, in terms of percentage of patients with high grade advanced osteosarcoma free from progression following 4 months of therapy


Eligibility Criteria:
Inclusion Criteria:

* histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease.
* measurable disease as defined by having at least one lesion that can be accurately measured by means of CT or MRI.
* ECOG PS of 0, 1 and an estimated life expectancy of at least 3 months. ECOG P.S. 2 is acceptable provided that it depends solely on orthopedic problems
* Age ≥15 years.
* Adequate bone marrow, liver and renal function
* Written informed consent

Exclusion Criteria:

* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
* Coexisting malignancies, except for basal or epithelial cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥3 years.
* History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
* History of HIV infection or chronic hepatitis B or C.
* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
* Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
* Patients with seizure disorders requiring medication (such as steroids or anti-epileptics)
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
* Patients with evidence or history of bleeding diathesis
* Patients undergoing renal dialysis
* Patients unable to swallow oral medications
Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

Papillae tunneling techniques (PTT) are a new approach toward regeneration of isolated intrabony defects. Compared to regular papillae preservation techniques, PTT rely on complete preservation of involved interdental papillae, providing optimal healing environment for periodontal wound. Surgical access is therefore gained either by vertical incision in vestibulum, or by short releasing incision on adjacent tooth. Interdental tissue is then carefully raised in a full thickness manner by tunneling instruments, root surface thoroughly cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of choice.

While the success and aesthetic results of non-incised papillae techniques are well documented, no paper so far compared clinical results of papillae preservation techniques with different biomaterials.

Therefore, the aim of our study is to compare gain of clinical attachment level (defined by sum of pocket probing depth and recession) to regular papillae preservation techniques, and to prove non-inferiority of Gel 40® (collagen matrix, loaded with micronized heterologous bone) to Gen-Os® (granulated cortico-cancellous heterologous bone mix).

Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis stage III/IV
* at least one periodontal lesion with pocket probing depth \> 5 mm, limited by 2 or more bone walls and intrabony component \> 3 mm.
* good oral hygiene with plaque index and sulcular bleeding index \< 30%.
* systemically healthy
* smokers and non-smokers

Exclusion Criteria:

* systemic diseases that contraindicate the treatment,
* on medications that affects periodontal healing
* pregnant or lactating women
* one wall intrabony defects
* defects that involve buccal and lingual side of the tooth
* tooth with incorrect endodontic treatment or restoration
The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation

Our aim is to Test the influence of a new multichanel Transcranial Magnetic Stimulation stimulator (Multiway) on motor excitation, in comparision to a wildly used Magstim Super Rapid 2 single channel stimulator.

Each of the 20 Healthy subjects that are inticipated to inrole to the study wiil undergo 6 simple procedures which are designed to compare the motor threshold obtained by diffrent combination of TMs coils (figure 8, double cone coil,H coil array) and stimulators (Multiway, Super Rapid 2).

The entire length of the procedures is about 4 hours and all subjects will be paid for their participation in the study.

Our main hypothesis is that the motor threshold obtained by the multichanel stimulator will be significtly lower then the single chanel stimulator.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the ages of 18-65
2. Right handed individuals
3. Individual provides Negative responses to the questions on the safety questionnaire completed prior to TMS treatment.
4. Individual gave both written and verbal consent to participation in the study.

Exclusion Criteria:

1. Individual suffers from an Axis I disorder, as diagnosed in a Clinical interview with a Psychiatrist.
2. Individual suffers from an Axis II disorder, as diagnosed in a Clinical interview with a Psychiatrist.
3. Individual has a history of high blood pressure.
4. Individual has a history of epilepsy, epileptic seizure, or febrile seizures.
5. Individual has family members with a history of epilepsy, epileptic seizures or febrile seizures.
6. Individual has a history of head injury.
7. Individual has any metal implants in head (except for dental implants)
8. Individual has history of surgery, including metal implants or individual has a known history of metal particals in the eye, heart pumps, neurostimulator use, or any other medical pump.
9. Individual has a history of migrane.
10. Individual has a history of hearing problems or deafness.
11. Individual has a hisotry of hearing aids or implants.
12. Individual has a hisotry of drug or alcohol addiction.
13. Individual is pregnant or is sexually active and not using contraception.
14. Individual is to difficult to contact.
15. Indicidual has a legal gaurdian.
16. Individual is currently enroleld in another medical study.
17. Individual is a soldier, a prisoner or a convict.
Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State

A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occuaptional therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).

A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occupational therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).

The SMART is both an assessment and treatment too. Patients in both groups will have baseline assessments conducted using the SMART, with further assessments conducted every ten days for thrity days. The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness. It is a five point hierarchical scale from level 1 ( no response) to level 5 (discriminating).

Eligibility Criteria:
Inclusion Criteria:

* admitted with severe brain injury
* GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury
* medically stable, as documented by medical staff
* age 18 to 65 years
* controlled intracranial pressure no sedation
* no previous brain injury

Exclusion Criteria

* patient declared brain dead
* next of kin withdraws patient from the study
* withdrawal of consent by patient on waking
* raised uncontrolled intracranial pressure, following discussions with treating medical team
* patient enrolled in DECRA or RSI Trials
Aerobic Interval Training in Cardiac Rehabilitation

The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.

Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* age over 18
* referred to cardiac rehabilitation
* exercise tolerance demonstrated

Exclusion Criteria:

* severe arrhythmia
* heart failure
* drug abuse
* pregnancy
Propofol Effects on Mitral Valve Annular Velocity

The purpose of this study is primarily to determine the effects of propofol at different concentration on the mitral valve annulus by using Tissue Doppler Imaging

The purpose of this study is to evaluate the effects of different concentration of propofol on patients who are undergoing cardiac surgery. The patients will receive infusion remifentanil 0.5mcg/kg/min with different target-site propofol concentration namely 1.0ng/ml, 2.0ng/ml and 3.0ng/ml. Tissue Doppler Imaging by transesophageal echocardiography will be done to assess the changes in cardiac function.

Eligibility Criteria:
Inclusion Criteria:

patients undergoing cardiac surgery

Exclusion Criteria:

low ejection fraction \< 50% on transthoracic echocardiography atrial fibrillation pacemaker pericardial and infiltrative myocardial disease mitral annular calcification, surgical rings, prosthetic mitral valve lateral left ventricular wall motion abnormality oesophageal abnormality history of extensive radiation to the mediastinum upper gastrointestinal bleeding
Effect of Quetiapine on Marijuana Withdrawal and Relapse

The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.

Eligibility Criteria:
Inclusion Criteria:

* Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks
* Able to perform study procedures
* 21-45 years of age
* Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD)
* Normal body weight

Exclusion Criteria:

* Current, repeated illicit drug use (other than marijuana)
* Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities)
* History of heart disease or current conduction system disease as indicated by QRS duration \> 0.11
* Request for drug treatment
* Current parole or probation
* Pregnancy or current lactation
* Recent history of significant violent behavior
* Major current Axis I psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
* Current use of any prescription or over-the-counter medication
* Prior allergic or otherwise serious adverse reaction to quetiapine
Low Dose Computed Tomography for Lung Cancer Screening

This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for LDCT screening
2. Current smoking (every day/some days)
3. At least weekly use of the Internet
4. Current ownership of cell phone with a text messaging plan
5. Willing to receive study text messages.
6. Ability to complete all aspects of the study
7. Ability to provide signed informed consent

Exclusion Criteria:

1. Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.
2. Those with a condition deemed by the investigators to be exclusionary to the study
Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study

Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs with varying degrees of success in different settings. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Participants are included in the study if they satisfy the following criteria:

  * Male or female.
  * Between 18 and 75 years of age inclusive.
  * Able to provide informed consent to study.
  * History of tobacco cigarette smoking for at least 6 months.
  * Confirmed intention of smoking cessation with no more than 2 previous failed attempts in the last 3 year.

Exclusion Criteria:

* Existing pharmacotherapy for smoking cessation.
* History of major psychiatric disorder or chronic pain syndromes.
* More than 2 failed attempts of smoking cessation in the previous 3 years.
* History of other substance abuse.
* History of atopy, or suspected/known allergy to plaster.
First Responder Aphasia Strategy Training

This study aims to determine the impact of a collaborative approach to training law enforcement officers and first responders about aphasia including their knowledge and confidence in communicating with individuals with aphasia that they may encounter in the field. 75 participants from Madison Police Department will be enrolled and can expect to be on study for up to 6 months.

The investigators will partner with the Madison Police Department to provide training and programming to law enforcement officers and first responders. Training will include direct teaching, aphasia simulations, scenario-based training and a panel with persons with aphasia with the goal of increasing confidence for law enforcement officers and first responders providing services to and communicating with persons with aphasia.

Participants will take 3 surveys over 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Employed by Madison Police Department as a first responder or law enforcement officer
* willing and able to provide informed consent
* willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Not employed as a first responder or law enforcement officer with Madison Police Department
A Long Term Safety Extension Study (CHS-0214-05)

An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.


Eligibility Criteria:
Inclusion Criteria:

* Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50

Exclusion Criteria:

* None
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury

Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury.

The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic or non traumatic spinal cord injury
* Minimum age: 18 years
* Minimum time since spinal cord injury: two years
* Lesion: C3-Th10
* American Association of Spinal Cord Injury Impairment Score C and D
* Focal spasticity in the adductor muscles and/ or triceps surae
* Ability to walk 14 meters
* Spasticity/clonus/spasms disturbing the activities of daily living or participation

Exclusion Criteria:

* Changes in spasticity medication during the last 3 months
* Treatment with botulinum toxin during the last 6 months
* Anticoagulant medication
* Thrombosis
* Malignant tumors
* Pregnancy
* Inflammations or skin lesions in the treated area
* Acute urinary tract infection
* Intended change in spasticity medication within 5 days after intervention
In Vitro Diagnostic Device for the Detection of Strep A

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 3 years of age or older
* Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:

  * presence of sore throat, and at least one other symptom from the list below:
  * redness of the posterior pharyngeal wall
  * pharyngeal or tonsillar exudate
  * tonsillar swelling
  * tender cervical lymphadenopathy
  * fever, \>38C at presentation or within the past 24 hours
* Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

Exclusion Criteria:

* Subjects treated with antibiotics currently or within the previous 7 days.
iACT for Eating Disorders in Type 1 Diabetes

This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.


Eligibility Criteria:
Inclusion Criteria:

* 16-50 years of age
* Diagnosis of Type 1 diabetes
* Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
* Independently manages diabetes (not reliant on a caregiver)

Exclusion Criteria:

* Current suicidal ideation or self-harming behavior
* Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
* Hypoglycemic unawareness as assessed by the Gold Method
* Current substance abuse disorder or current or past psychotic disorder
* NonEnglish speaking
Validation of a Contactless Vital Signs Measurement Sensor

The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Informed Consent as documented by signature
* Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
* Ambulatory or stationary patients of Klinik Lengg

Exclusion Criteria:

* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant