cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases.

The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 75
* elevated serum Insulin-like growth factor-1 (IGF-1) level above age- and sex-based normal values and failure of growth hormone(GH) suppression to \< 1.0 ng/ml after a 75 gm oral glucose tolerance test (OGTT) American Association of Clinical Endocrinolgists (AACE) Acromegaly Clinical Guidelines 2004
* visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI without and with gadolinium
* prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry

Exclusion Criteria:

* Age \< 18 or \> 75 years
* acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant
* patients who have received prior radiotherapy or radiosurgery
* patients with adenoma-related visual acuity or visual field deficit from optic nerve and/or chiasm compression or severe optic nerve/chiasm compression in the setting of normal visual fields and acuity
* patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction on MRI with associated symptoms of new onset visual loss, diplopia and/or adrenal insufficiency
Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy

The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which strategy offers the highest detection rate for prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than MRI-guided prostate biopsies alone.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional systematic 12-core TRUS-guided prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* At least one prior negative prostate biopsy
* Prostate-specific antigen (PSA) \> 4 ng/ml

Exclusion Criteria:

* Known prostate cancer
* Contraindications against MRI
* Contraindications against prostate biopsy
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.

In this study the investigators evaluate the side effect of multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.

In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature \> 40 degrees) Children must be seizure-free or seizure controlled

Exclusion Criteria:

* Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.

Children who have a metallic or electrical implants
Impact of Prevnar 13 on Ear Infections in Children

Prevnar (7 valent pneumococcal conjugate vaccine \[7vPnC\]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.


Eligibility Criteria:
Inclusion Criteria:

* Case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database.
* S pneumoniae identified from middle ear fluid or mastoiditis sample.
* Specimen obtained from children aged up to 18 years.

Exclusion Criteria:

* As this is an observational, laboratory based database study, there are no exclusion criteria
Smart Phone App Intervention In Young Adults With Cancer

This research study aims to explore the feasibility and acceptability of a smartphone application intervention, called iaya, among young adults with cancer.

The iaya app was developed by clinicians from the Young Adult Program at the Dana-Farber Cancer Institute. The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.

The investigators are conducting this study to see if the iaya app, specifically developed for young adults with cancer, is practical, to determine patient satisfaction with the iaya app, and to test study procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-39 years
* Able to speak/read English
* Have a smart phone
* Receiving cancer treatment
* Active cancer care from an oncologist at Dana-Farber Cancer Institute

Exclusion Criteria:

* Neurological/cognitive condition interfering with the ability to understand and adhere to study procedures
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.


Eligibility Criteria:
Inclusion Criteria:

1. patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
2. The patient or his/her guardian or immediate family members gave informed consent;
3. American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.

Exclusion Criteria:

1. Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
2. Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
3. Intravenous nutritional support within 8 hours prior to the examination;
4. Patients diagnosed with type I or type II diabetes.
A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects

This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects.

The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg

Exclusion Criteria:

* with personal or family history of hypercoagulability or thromboembolic disease
* has had treatment with any incretin therapy
* has FPG \< 70 or \> 110 mg/dL
Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..


Eligibility Criteria:
Inclusion Criteria:

* All patients treated for type II endoleaks by endovascular therapy

Exclusion Criteria:

* None
Validation of the Arabic Version of the Caries Questionnaire

Arabic is one of the most spoken languages in the world; however, the CARIES-QC questionnaire which evaluate the effect of oral diseases and disorders on children's oral health-related quality of life has not yet been validated in Arabic speaking children. So the purpose of this study was to translate the CARIES-QC into Arabic and test the measurement properties of the Arabic version of the CARIES-QC for use in children with dental caries who speaks Arabic .

Dental caries is a major public health problem. It has been estimated that 621 million children in the world have untreated dental caries . Dental caries always manifests with significant pain, affecting oral health-related quality of life (OHRQoL) and well-being. Several measures were widely used to comprehensively evaluate the effect of oral diseases and disorders on children's OHRQoL. However, most of these measures were 'generic' measures, and they may fail to detect small, clinically important changes related to specific oral diseases. Gilchrist et al recently developed the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) in order to address this issue. Preliminary findings have confirmed that Caries Impacts and Experiences Questionnaire for Children measure had good reliability, validity, and responsiveness. However, The original CARIES-QC was an English measure; so appropriate translation and cultural adaptation should be done in order to be used in other culture and language.

Arabic is one of the most spoken languages in the world; however, the CARIES-QC has not yet been validated in Arabic speaking children. So the purpose of this study was to translate the CARIES-QC into Arabic and test the measurement properties of the Arabic version of the CARIES-QC for use in children with dental caries who speaks Arabic .

Eligibility Criteria:
Inclusion Criteria:

1. Child in age from 5-16 years .
2. Child with active caries
3. Child speaks Arabic.

Exclusion Criteria:

1. Child with dental traumatic injuries .
2. Child has oral mucosal diseases.
3. Child has cleft lip and or palate .
4. Child having severe medical or mental conditions.
5. Child who cannot understand the question even with help
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

This is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-C-1401 (REVEAL) study. To be considered for expanded access, a Principal Investigator from the REVEAL trial should submit a request to Reata Pharmaceuticals on behalf of the individual patient.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Assessment of Skill Retention in Clinical Practice

Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day - Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding of written English used in the questionnaires

Stage 1 - training The aims and requirements of the teaching program will be explained to the participants at the start of the workshop. All participants will be given a sticker with a number and a questionnaire numbered about current ultrasound practice which is numbered according to participant number to allow for blinding. Anyone not wishing to participate can either remove their sticker or not return the questionnaire at the end of the session. The number on the questionnaire correlated to participant number. This will be recorded against the participant name to allow for further follow up. All participants will rotate normally throughout the sessions. At the end of the neuraxial session participants will be scored by the session leader according to their ability to adequately carry out the procedure. Scores will be correlated to participant number.

Stage 2 - assessment of skill retention

Following the training day participants will randomly be allocated into two groups. One group will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new tool to assist them in performing neuraxial ultrasound. The other group with be allowed to continue with their regular practice and will not receive reminders to use ultrasound for neuraxial anesthesia insertion. Two months after the initial training day all participants with be observed performing neuraxial anesthesia and re-assesed according to the original scoring system. Each participant will be assessed 3 times over a 6 month period.


Eligibility Criteria:
Inclusion Criteria:

* Practicing anesthesiologists of all levels at Hadassah Ein Kerem hospital

Exclusion Criteria:

* Unwillingness to complete questionnaire, poor English comprehension
Assessment of the Safety and Performance of a Lumbar Belt

Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Lumbar belt range of products to demonstrate safety and performance of these devices in a real-world setting.

Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon lumbar belt Soft 300/ Mid 500 devices and support peer-reviewed publications on products performance and safety.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has a medically-confirmed common subacute or chronic low back pain
* Subject performs regular physical activity
* The current condition of his/her back allows the subject to pursue a usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
* Subject is affiliated to the French social security regime

Exclusion Criteria:

* Subject has undergone a surgical treatment for his/her back
* Subject presents associated neurologic signs (equina syndrome, radiculopathy, sciatica...)
* Subject presents signs of specific low back pain (i.e. low back pain is a symptom of an underlying condition): presence of red flags
* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (lumbar or sacroiliac hip belt) during sports sessions in the last month
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the devices (elastodiene, elastane, polyamide, polyethersulfone \[PES\])
* Adult subject to a legal protection measure
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.

The study will also involve monitoring serum and urine bone turnover markers.

Eligibility Criteria:
Inclusion Criteria:

* patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)

Exclusion Criteria:

* patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
Fluoridated Milk and Enamel Caries in Adolescents

The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. The main questions it aims to answer are:

* Does fluoridated milk lower the number of caries lesions in teeth over time?
* Does fluoridated milk lower the number of enamel caries lesions over time? Researchers will compare an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk.

The 12-13 year participants will:

* be examined at a baseline and once yearly up to 2 years
* be provided directly with the doses every second month at their dental clinic
* take the fluid daily

During the study, the participants were asked to continue with their usual oral hygiene regimes, including tooth-brushing twice a day with toothpaste containing fluorides as recommended by the Swedish National Board of Health and Welfare.

At their yearly visit to their dental clinic the participants were asked about their health status, use of antibiotics, lactose intolerance, daily consumption of milk, tooth brushing frequency, type of toothpaste and use of other fluoride additives. Information on adverse effects (dental pain, visit to other dental clinic, and antibiotics due to dental infection) was collected.

Caries registration was performed by visual-tactile and radiographic examinations at baseline and 1 and 2 years. Visual-tactile examination was performed by a dental practitioner under lighting with a mirror and occasionally with a probe. Caries status was classified for the occlusal/incisal, buccal and lingual surfaces and the proximal surfaces of incisors and cuspids according to the ICDAS criteria with code 0 (for sound), 1-3 (for enamel caries) and 4-6 (for dentine caries). ICDAS is an internationally applied system for caries detection used clinically (The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries (reference). Radiographic examination of the proximal surfaces of premolars and molars with one bitewing radiograph on each side of the mouth took place in the same session.

Eligibility Criteria:
Inclusion Criteria:

* adolescents of both sexes, aged 12-¬13
* healthy (no oral disease or systemic disease possibly affecting the oral cavity). Health declaration used in the dental clinic was utilized to confirm health status
* adolescents with permanent posterior teeth/no primary molar teeth present and second premolars in contact with the mesial surface of the first molars
* adolescents who, together with their parents or guardians, gave informed written consent to participate. Data confidentiality and the right to withdraw from the study at any time were warranted to the adolescents in writing.

Exclusion Criteria:

None