cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

Recent advances in treatment have increased the cure of childhood ALL to 75% or better. However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in particular on the Disease Free Survival (DFS).

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 1 to 17 years at diagnostic
* Documented Ph+ ALL
* Eligibility for the current local prospective therapeutic study of childhood ALL
* Informed consent given by the parents or by legal guardian

Exclusion Criteria:

* Abnormal hepatic functions
* Abnormal renal functions
* Active systemic bacterial, fungal or viral infection
13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12 months of age. We intend to recruit all interested participants who completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those that recruited the majority of the children in the original study). The study will start in March 2010, at which time the eldest participants in the 6096A1-007 study will be approximately 42 months of age. There will be two visits per participant, 1 month apart from each other. At visit one, all participants will have a blood test and receive a dose of PCV13. At visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.


Eligibility Criteria:
Inclusion Criteria:

1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study.
2. Aged 39-46 months (inclusive) at time of enrolment.
3. Available for entire study period and whose parent/legal guardian can be reached by telephone.
4. Healthy children as determined by medical history, physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator.
5. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

1. Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007).
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal conjugate vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorder.
8. Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, synagisB).
10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable.
11. Child who is a direct descendant (child, grandchild) of the study site personnel.
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis

The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.

Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases.

Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.

Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.

We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.

Eligibility Criteria:
Inclusion Criteria:

* indication for anterior cervical discectomy
* monoradicular syndrome caused by compression at C5-6 or C6-7
* monosegmental disease on MRI
* able to actively perform flexion/extension movement
* segmental mobility on the afflicted level \>2 degrees of rotation
* informed consent

Exclusion Criteria:

* previous operative interventions on the cervical spine
* multiple segments afflicted
* positive L'Hermittes sing
* Active infection
* Immature bone
* Tumorous processes in the cervical region
* Previous radiation therapy in the cervical region
* Pregnancy
* Cervical myelopathy
* not able to speak Dutch
Real Zero Fluoroscopy Catheter Ablation.

A Retrospective Propensity Matched Study comparing:

* real zero fluoroscopy catheter ablation
* conventional fluoroscopy catheter ablation without 3D system
* conventional fluoroscopy catheter ablation with 3D system

Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.

The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:

* underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
* underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support

Covariates for matching will be:

* arrhythmia type
* age of a patient
* number of diagnostic catheters used during a procedure
* type of a diagnostic catheter used during a procedure\]

Eligibility Criteria:
Inclusion Criteria:

* right atrial tachycardia
* right atrial premature complexes
* AVNRT
* right atrial AVRT/WPW
* right ventricle tachycardia / right ventricle premature complexes

Exclusion Criteria:

* left atrium arrhythmia
* left ventricle arrhythmia
Effects of Plasmalogen on Obese Subjects

This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to provide informed consent to participate in the study
* BMI ≥ 25 ㎏/㎡
* HbA1C ≺ 8% without antidiabetic medication in the previous 3 months
* Stable medication for 3 months prior to the enrollment, and expectedly throughout the course of study

Exclusion Criteria:

* Scallop allergy
* Symptomatic obesity, i.e., endocrinal, hypothalamic or drug-induced obesity
* Hypertension under medication with 4 or more drugs
* Hepatic disorder with AST ≥ 5 times upper limit of the normal range
* Mental disorder including schizophrenia and neurosis
* Alcohol dependence
* History of malignancy for which treatment completed in the past 5 years
* Inflammatory disease
* Use of plasmalogen supplement in the past 3 months
* Ineligible condition as determined by study physician
Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-III
2. 18-85 years of age, inclusive
3. Weight 50kg+
4. Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG

Exclusion Criteria:

1. Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
2. Pregnancy
3. History of alcohol or drug dependency/abuse
4. History of long term opioid intake or chronic pain disorder
5. History of significant psychiatric conditions that may affect patient assessment
6. Failure of upper extremity block
7. Previous iliac crest bone grafting
8. History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
9. Inability to understand the informed consent and demands of the study.
Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment

The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients

Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80,
* ASA I-III level;
* BMI 18.5\~23.9;

Exclusion Criteria:

* Patients with full stomach and high risk of reflux aspiration;
* Allergic to benzodiazepines, opioids, rocuronium bromide;
* Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
* Pregnant and lactating women;
* severe liver and kidney dysfunction;
* Patients with severe anemia and hypoproteinemia;
* Previous drug use history;
* Recently participated in other clinical studies;
* Patients who cannot cooperate with communication.
Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer

The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer.

Background Prostate cancer is the most common malignancy in men and the second leading cause of cancer death among males in the Western World. When tumors become refractory to androgen withdrawal therapy, chemotherapy represent a palliative treatment with an improvement on quality of life, particularly the combination of mitoxantrone and prednisone . This observation has led to numerous studies evaluating the potential use of new chemotherapeutic agents as Docetaxel in patients with metastatic androgen independent prostate cancer. Recently Docetaxel based regimens have shown an improvement in survival when compared with mitoxantrone in a phase III trial .

However the prognosis of these patients remains very poor and new effective tolerated approaches are needed to improve the results of chemotherapy.

Rationale In a recent study a Raf kinase inhibitor protein (RKIP) encoded by a suppressor gene was found to be responsible of the metastatic process; in fact the decreased RKIP expression was associated with increased invasive capability of prostate cancer cells, presumably though the activation of MEK and ERK by phosphorilation .

Sorafenib, a novel signal transduction inhibitor, prevents tumor cell proliferation and angiogenesis blocking Raf/Mek/Erk pathway at the level of Raf kinase and tyrosine kinase receptors VEGFR-2 and PDGFR.

In a phase I study the combination of docetaxel and Sorafenib was evaluated in prostate and other tumors . The treatment was well tolerated and one partial response (4%) and 12 stable disease (50%) were reported.

According to these data we designed a phase II study to evaluate the association of Sorafenib and Docetaxel in metastatic prostate cancer

Simon's Optimal two-stage design for phase II clinical trial will be applied to calculate the sample size that minimizes the expected number of patients to be accrued. The sample size will be calculated on the following assumptions: alpha error =0.05, beta error =0.20; PD (clinically uninteresting true no progressive disease rate) and P1 (sufficiently promising true no progressive disease rate) will be set at 60% and 80%. 11 patients will be enrolled in the first stage: if no progressive diseases are \< 7 the accrual will be stopped and the drug's combination rejected. In the case of \>= 7 no progressive diseases 32 more patients will be accrued at the second stage. The treatment will be accepted if \>= 30 no progressive diseases out of 43 patients will be observed

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic hormone refractory prostate cancer
Physiologic Elasticity Changes During Pregnancy and After Labor.

Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging in addition to elasticity evaluation during the 3rd trimester and 6 weeks postpartum.

Female pregnant patients in their 2nd trimester will be evaluated for vaginal elasticity using vaginal tactile imaging. Vaginal elasticity will also be evaluated during the 3rd trimester and 6 weeks postpartum.

Patients will be recruited and sign a consent form. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* During the 2nd trimester.
* During the 3rd trimester.
* 6 weeks postpartum. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients in their 2nd trimester.

Exclusion Criteria:

* Pregnant patients presenting after their 2nd trimester.
Effects of Strength Training on Knee Osteoarthritis

To understand the effects of leg strengthening exercise, we will study the effects of strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly with no OA or knee pain. In each of the first three groups, we will look at whether people who do strength training have less pain and/or slower progression of x-ray signs of OA over 30 months than people who perform nonstrengthening, range-of-motion exercises. We are including the fourth group to find out whether people with OA (groups 1 \& 2) have the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain.

Several studies have confirmed that weak leg muscles are associated with osteoarthritis (OA) of the knee. Studies of body composition in these people have also shown that, despite being weaker, people with OA have significantly greater muscle mass than those without OA, suggesting that those with OA may have the potential to greatly increase their strength. However, research has not clearly shown whether exercises designed to improve leg strength will decrease the severity of pain or slow the progression of OA based on radiographic (x-ray) analysis. To understand the effects of leg strengthening exercise, we will perform a randomized clinical trial of lower extremity strength training using four subgroups of people: (1) OA with knee pain; (2) OA without knee pain; (3) no OA with knee pain; and (4) normal elderly with no OA or knee pain.

In each of the first three groups, we will determine whether people assigned to strength training have lower pain scores and/or slower progression of radiographic changes of OA over 30 months than controls who perform nonstrengthening exercises (i.e., range-of-motion exercises). We are including the fourth group to determine whether those with OA (groups 1 \& 2) exhibit the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain. We will also prospectively monitor changes in body composition and bone mass, quality of life, and symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 60 to 100 years of age

Exclusion Criteria:

* Knee joint replacement surgery
* Diabetes mellitus
* Uncontrollable hypertension
* Neuropathies of the lower extremity
* Poor mental cognition (i.e., inability to follow instructions)
Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies

This study seeks to achieve two aims:

* To assess the implementation of Noona software for continuous symptom monitoring for a diverse population of patients with thoracic malignancies who are undergoing radiation and
* To validate remote collection of standardized PRO measures using Noona software.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed cancer. Radiographically apparent (i.e. not histologically or cytologically confirmed) malignancy of the thorax is allowed.
* Currently planning to receive radiotherapy with or without chemotherapy for greater than one fraction.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
* Age 18 years or older

Exclusion Criteria:

-Unable to reliably access and use a device compatible with Noona software.
Mobile Medically Supervised Patient Management in Rheumatoid Arthritis

The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years, owner of App capable device, RA, informed consent

Exclusion Criteria:

* non German speaking, no App capable device available
Pediatric Sleep Questionnaire: Normalization and Validation Study

The information gathered from normal pediatric patients seen at the Pediatric Neurology Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate the information gathered from pediatric patients with sleep disorders. This will serve as the information source for a pediatric sleep database.

A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and LaRabida Children's Hospital. The questions asked are those routinely obtained in the clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the Pediatric Neurology Clinic and at LaRabida Children's Hospital

Exclusion Criteria:

* Adults
Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.

Eligibility Criteria:
Inclusion Criteria:

* The inflammatory bowel disease patients

Exclusion Criteria:

* Liver and renal disease
* Hypercalcemia
* Hyperparathyreoidism
* Chronic pancreatitis
* Concomitant vitamin D medication
* Pregnancy
* Sarcoidosis
* Malignancy
* Inability to obtain valid data from subject
Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

a) Compare between Nonabsorbable Polymeric Clips and Endoloop ligatures regarding:

1. technical difficulties.
2. operation time.
3. cost effectiveness.
4. postoperative complications.
5. inpatient stay.

Laparoscopic appendectomy is gradually evolving as the 'gold standard' in the treatment of acute appendicitis, especially in the obese, elderly, and in cases where the diagnosis is uncertain . There are clear benefits with the laparoscopic approach in terms of decreased pain and faster recovery than the open approach . However, disadvantages like a higher incidence of intra-abdominal collection, longer operating time, and higher costs have been documented. These may be dependent on the technique of appendicular stump closure. Therefore, the technique for appendiceal stump closure is crucial in laparoscopic appendectomy.

Laparoscopic appendectomy was first described by Semm in 1983 and is currently preferred approach for an appendectomy for many surgeons. Numerous methods of stump closure have been used, like intracorporeal suturing of the stump endoloop application, endostapler application LigaSure customized titanium clip application, and, more recently, using nonabsorbable plastic clips . Many of these techniques are either time consuming or expensive, or not available universally.

Eligibility Criteria:
Inclusion Criteria:

* . Able to give informed consent for inclusion in the study
* Age of the patient : Any age

Exclusion Criteria:

* • Intraoperative decision to convert to open appendicectomy

  * Primary open appendicectomy
  * Unable to give informed consent for participation in the study