cyrilzakka/clinical-trials huggingface dataset:
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.

Specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria:

* Previous Head and Neck Radiotherapy
MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study

The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by evaluating the difference between planned and actual implant positions on pre- and post-operative CBCTs.

Patients, attending the Department of Periodontology at the Rambam School of Graduate Dentistry, who are scheduled for implant therapy, will be screened for the study. Patients will be referred for CBCT of the upper/lower jaw as appropriate. DICOM data of the patient will be uploaded to MGUIDE software and used for diagnosis and treatment planning of the case. Surgery will be performed using MGUIDE MORE template and MGUIDE MORE surgical kit. Pre-operative and post-operative CBCT will be used for assessment of the difference between planned and actual implant positions.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated inform consent form.
* Age between 18+.
* Patient expresses his wish to restore the missing tooth/teeth with dental implants.
* Patient is examined and found suitable for implant therapy
* Patient can open mouth sufficiently for preparation and placement of dental implants using the contra-angle handpiece and drills.
* CBCT is required for proper diagnosis and treatment planning.

Exclusion Criteria:

-
Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption

In the present study the design of the vitamin B12 absorption test, CobaSorb, is further optimised. We investigate which test - measurement of holotranscobalamin or cobalamins - could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration of vitamin B12 administration in order to determine the final duration of the vitamin B12 absorption test CobaSorb.

Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9 microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8. Cobalamins and holotranscobalamin are measured on day 1-5 and 8. The performance of the vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than 2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused by absorption of the administered vitamin B12.

In the present study the design of the vitamin B12 absorption test, CobaSorb, is further optimised. We investigate which test - measurement of holotranscobalamin or cobalamins - could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration of vitamin B12 administration in order to determine the final duration of the vitamin B12 absorption test CobaSorb.

Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9 microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8. Cobalamins and holotranscobalamin are measured on day 1-5 and 8. The performance of the vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than 2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused by absorption of the administered vitamin B12.

Eligibility Criteria:
Inclusion Criteria:

Above 18 years North european origin Read and understand Danish

Exclusion Criteria:

Vitamin B12 treatment within the past 5 years Use of vitamin pills containing \>1 microgram vitamin B12 with in the past 3 weeks Infectious disease Pregnancy Lactation Giving birth within the past 9 months Use of hormones Known systemic disease
Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts

The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.

The secondary objectives of this study are to assess the efficacy of CBGT on:

A. parameters describing the incidence of suicide and repeat suicide attempts, as well as suicide re-attempt free follow-up time,

B. long-term changes in suicidal ideation,

C. long-term changes in psychiatric symptoms (depression, hope for the future, hospitalization).

Eligibility Criteria:
Inclusion Criteria:

* The patient has been correctly informed
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* French speaking adults (18 years or older) freely hospitalized (in centres or via emergency services) for prevention of suicide and who have a medium or high suicide risk score according to a Mini International Neuropsychiatric Interview structured interview
* Presence of suicidal ideation according to the Beck Suicide Ideation Scale (score \> 3)
* Prior (or recent) suicide attempt within the last three month
* The patient is able to understand the study and capable of giving his/her informed consent
* The patient is available during the weekly time slots proposed by the investigator

Exclusion Criteria:

* The patient is participating in another study that may interfere with the results or conclusions of this study
* Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or is an adult under guardianship
* The patient refuses to sign the consent, or it is impossible to correctly inform the patient
* Emergency situations preventing proper study conduct
* History of schizophrenia or other psychotic troubles
* Presence of psychotic symptoms at initial interview
* Serious cognitive impairment
* Medical incapacity to participate
Xenon-129 Magnetic Resonance Imaging of Healthy Subjects: Hardware and Software Development and Reproducibility

Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe MRI and pulmonary function testing for the development of tools to assess image signal to noise and reproducibility of spin-density and diffusion-weighted imaging.

Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo: 1) brief medical history and vital signs, 2) full pulmonary function tests, 3) proton MRI, 4) spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI.

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Multiple Breath Nitrogen Washout (MBNW) to measure Lung Clearance Index (LCI), and Forced Oscillation Technique (FOT) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

Subjects will be placed in the 3T MR scanner with one of three 129-Xe chest coils fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient RF coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.

Eligibility Criteria:
Inclusion Criteria:

* able to perform a breath hold for up to 16 sec
* BMI between 18 and 40
* stable health on the basis of medical history
* smoking history \< 1 pack/year

Exclusion Criteria:

Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.

* Subject has a daytime room air oxygen saturation \<90% while lying supine.
* Patient is unable to perform spirometry or plethysmography maneuvers
* Patient is pregnant
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
* Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)
Which is a Better Breakfast? Egg or Cereal?

Which is a better breakfast? Egg or cereal?

Which breakfast has the most beneficial effect on blood glucose and insulin, blood hormones and blood pressure, egg or cereal breakfast? Over a seven week period the participant will take part in eating breakfast of either egg breakfast or cereal breakfast which will be monitored. Blood samples will be taken before participants eat and different times throughout until after Lunch on day 1 and day 7. Questionnaires will be given to determine satiety (feeling of fullness) and hunger before and after breakfast and lunch. After a two week period participants will return for another week of the same procedure and tests that was followed from Day 1 though day 7 listed. However, this time participants will be eating the second of the two breakfasts whichever one they did not have for the first test period.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* not lost more than 5% of body wight in the past 3 months, or not trying to actively lose weight at the moment.
* are not suffering from disease such as major heart conditions, cancer, type 1 diabetes, eating disorders, very high cholesterol or triglycerides levels, or any serious illness that requires intensive and long term medical treatment.

are not allergic to or sensitive to eggs, soy or wheat, and do not dislike these foods.

* have a BMI of equal to or \>30 to equal to or \<60
Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study

Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.


Eligibility Criteria:
Inclusion Criteria:

* Pre-capillary PH (PAMP ≥25 mmHg; PAWP ≤15 mmHg) or combined post- a pre-capillary PH (PAMP ≥25 mmHg; PAWP \>15 mmHg; DPG ≥7 mmHg and/or PVR \>3 W.u.) of any etiology.

Exclusion Criteria:

* Complex congenital heart defects (corrected or uncorrected)
* Isolated post-capillary PH (PAMP ≥25 mmHg; PAWP \>15 mmHg; DPG \<7 mmHg and/or PVR ≤ 3W.u.)
* Previous catheter ablation for AF / AT / AFL
* Previous or scheduled cardiac surgery-
* NYHA Class IV, cardiogenic shock
* Life expectancy \<1 year
* Non-compliance
The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "

20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

After signing the consent form, 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured with mass spectrometer. Oxygen saturation, Pulse rate, and minute ventilation will also be monitored. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

Eligibility Criteria:
Inclusion Criteria:

Healthy females and males, with no respiratory, cardio vascular diseases, high blood pressure, psychiatric problem, degenerative nervous system problem, and chronic head ache, muscular disease, or severe acute disease within the two weeks before the study. age 18 and 25, and 55 and 70 years old. Who volunteer to the study

-

Exclusion Criteria:

Did not pass the Inclusion criteria, pregnant women, O2 saturation lower then 95%, pathological sound from the heart or lungs. Claustrophobia, smoking history more then 2.5 packs years.
NGS for HLA Typing of Donors and récipients oh Hematopoietic Stem Cells

The objective of this study is to realize the typing of all HLA loci and validate this technique with continued optimization of next-generation sequencing technology (NGS).

The number of patients waiting allograft of hematopoietic stem cells is constantly evolving. Similarly, the number of voluntary donors of hematopoietic stem cells on all global file has exceeded the threshold of 22 million donors since the end of 2013. Despite this, the search for a matched unrelated donor HLA for a patient remains sometimes a long and difficult, especially for patients with rare HLA alleles. It is important to increase the number of donors in the global file, increase HLA diversity of registrants and resolution HLA typing. More HLA typing of a donor registered on the file will be accurate, more research and the recruitment of a donor in order to achieve an allograft in a patient waiting will be fast.

The constant evolution of the number of HLA alleles and the number of ambiguities quickly demonstrates the limits of current typing techniques. The study of exons and introns that would significantly refine the level of resolution HLA typing, reaching a level of allelic resolution. That level of resolution would also identify all null alleles (alleles from which the protein is not expressed). The search for an HLA with a patient will be made easier by reducing the financial impact and time of the search. In addition, numerous studies have shown that tissue compatibility narrowest possible between the donor and recipient of an allogeneic haematopoietic stem cells can improve patient survival by reducing the incidence and severity of disease graft against the host and to improve engraftment.

In addition, analysis capability of the many sample using this technique should induce the decrease in HLA typing costs and thus facilitate the registration of anonymous bone marrow donors on the national register of the Biomedicine Agency .

Eligibility Criteria:
Inclusion Criteria:

* Bone marrow donors from Brest University Hospital
* Bone marrow recipients of Brest University Hospital

Exclusion Criteria:

* No bone marrow donors from Brest University Hospital
* No bone marrow recipients of Brest University Hospital
HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus lenvatinib and PD-1 antibody with HAIC plus lenvatinib. Thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
The REACH Intervention for Caregivers of Veterans and Service Members With TBI

This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, the participant must:

* identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
* identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
* provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
* believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
* endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.

Exclusion Criteria:

* no telephone;
* current diagnosis of schizophrenia or other major mental illness;
* auditory impairment that would make telephone use difficult; or
* the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.