cyrilzakka/clinical-trials huggingface dataset:
Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months

Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).

In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.

The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.


Eligibility Criteria:
Inclusion Criteria:

1. Patients will require single tooth extraction and subsequent implant rehabilitation.
2. Patients over 18 years of age.
3. Patients willing to comply with the study requirements (signed consent form)
4. Good oral hygiene and no signs of active periodontal infection
5. No compromising medical status
6. \< 10 cigarettes smoking per day

Exclusion Criteria:

1. acute myocardial infarction within the last two months;
2. Uncontrolled coagulation disorders;
3. uncontrolled diabetes (HBA1c\> 7.5);
4. radiation therapy to the head \\ neck region in the last 24 months;
5. immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
6. past or present treatment with intravenous bisphosphonates;
7. psychological or psychiatric problems;
8. abuse of alcohol or drugs;
Tenofovir in Asian Chronic Hepatitis B Patients

Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus (HBV) in various multiple-centre trials, with no cases of resistance encountered. However, its efficacy and resistance profile in the Asian population, which constitute the majority of chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside analogues, TDF has been associated with relatively high rates of hepatitis B surface antigen (HBsAg) seroclearance. It would be interested to see if this could be reproduced. The investigators plan to report the serologic and virologic results of our 140 nucleoside analogue-experienced patients who were commenced on TDF.

Recent multi-center trials have shown tenofovir disoprovil fumarate (TDF) demonstrating potent antiviral efficacy in both nucleoside-naive and -experienced chronic hepatitis B (CHB) patients. At present, there has been no identifiable amino acid substitutions associated with resistance to TDF.

Since TDF and adefovir (ADV), another licensed drug for CHB, belong to same molecular group, acyclic phosphonate, there had been various studies investigating the efficacy of TDF in ADV-resistant patients. The efficacy of tenofovir in this group of patients is conflicting. While several studies have shown TDF achieving similar viral suppression when compared to CHB patients without ADV-resistance , another study found that patients with the signature ADV mutations of rtA181V/T and /or rtN236T responded suboptimally to TDF. For all published studies, the number of patients with documented genotypic resistance to adefovir is actually small (n = 17-40), and therefore, further studies in this area are required.

Another interesting point to note was the relatively high rate of hepatitis B surface antigen (HBsAg) seroclearance found in patients taking TDF. The cumulative rate of HBsAg seroclearance up in hepatitis B e antigen (HBeAg)-positive was 10% after 4 years . However, the same study did not find any HBeAg-negative patients achieving HBsAg seroclearance. In addition, studies on TDF were mainly performed in Caucasian patients, the majority being genotypes A and D. A preliminary study performed in Asian patients, predominantly genotypes B and C, did not discover any cases of HBsAg seroclearance . Given the majority of the CHB population is found in Asia, further studies are needed to clarify if HBsAg seroclearance by nucleoside / nucleotide analogues is potentially achievable using TDF.

Eligibility Criteria:
Inclusion Criteria:

1. HBsAg-positivity for at least 6 months at presentation
2. Commenced on tenofovir for chronic hepatitis B
3. Exposure to other nucleoside analogues before starting TDF

Exclusion Criteria:

1. Concomitant liver diseases including chronic hepatitis C and/ or D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
2. Significant alcohol intake (\> 20 grams per day)
Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells

CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.

Eligibility Criteria:
Inclusion Criteria:

* expected lifespan \>3 months
* patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
* KPS \>70
* for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
* enough function of heart, liver, kidney and bone marrow
* no history of severy allergy
* no other serious diseases that conflict with this plan
* no other history of malignancy
* no serious mental illness
* patients and their families members agree to participate in this clinical study and sign the Informed Consent Form

Exclusion Criteria:

* pregnant or lactating women
* vevere infectious or viral diseases
* active hepatitis B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
* participated in other clinical studies in the past 3 months or who have been treated with other gene products;
* others that other investigators consider not suitable for this clinical study
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe major depressive disorder

Exclusion Criteria:

* Prior treatment with botulinum toxin of any serotype for any reason
* Use of antidepressant medication for depression within 2 weeks of study
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.

Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.

Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.

Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
* Score of at least 50 on the CAPS-SX at baseline.
* Competent to give informed consent.
* If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
* Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
* Other medications, if any, must have been kept stable for at least one month prior to randomization.

Exclusion Criteria:

* History of sensitivity to quetiapine
* Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
* Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
* Medical disorders that may cause or exacerbate anxiety symptoms.
* Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
* Schizophrenia, schizoaffective disorder, or bipolar disorder.
* Suicidal or homicidal ideation or other clinically significant dangerousness
* Currently seeking compensation or increase in compensation for the effects of the trauma.
* Initiation or change in psychotherapy within 3 months of randomization.
A Study of Evacetrapib in Participants With Abnormal Cholesterol

The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.

This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

  * Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
  * Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
  * Hypercholesterolemia on stable statin therapy for at least 3 month
* Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Have known allergies or intolerance to evacetrapib, related compounds
* Have history of recurrent rashes or chronic skin conditions
* Have significant history of or current chronic, active inflammatory conditions
* Have history or current evidence of significant neurological disorder
* Have long-standing diabetes that is insulin requiring
* Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
Basivertebral Nerve Ablation With the Intracept Procedure

This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.

Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years of age
* Patients who have experienced chronic low back pain for ≥6 months.
* Patients who have not responded to at least 6 months of conservative care.
* Patients with Modic type 1 or 2 changes.

Exclusion Criteria:

* Patients with severe cardiac or pulmonary disease.
* Patients with active systemic infection or localized infection in the treatment area.
Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained routinely in the evaluation of patients prior to kidney or pancreas transplantation.

Although there is an increasing quantity of data demonstrating the value of stress echo in risk stratifying patients for cardiac risk prior to major non-cardiac surgery, the current clinical practice utilized for assessing patients being evaluated for kidney or pancreas transplantation is both a stress echocardiogram and a coronary angiogram. This gap in opinion appears to be a concern on the part of both nephrologists, endocrinologists, and surgeons that the stress echocardiogram may miss significant angiographic disease that could result in major post-operative complications in this high-risk subgroup of patients (unstable angina, non-fatal infarction, or death).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are being evaluated for a kidney and or pancreas transplant and scheduled for a dobutamine stress echocardiogram and a coronary angiogram will be eligible to participate

Exclusion Criteria:

* Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.
A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities

The primary objective of this study is to build a well characterized cohort of patients that will be used to determine the genetic variants associated with obstructive sleep apnea (OSA)and its co-morbidities.

The purpose of building the cohort is to allow the performance of genome-wide association studies with a large sample of patients that have been well-characterized using standardized procedures.

Eligibility Criteria:
Inclusion Criteria:

We will recruit subjects who are:

* 18 years of age and older.
* Willing and able to give informed consent

AND any of the following:

* PSG (polysomnogram)requested by a physician based on clinical grounds
* AHI (Apnea-hypopnea index) ≥ 5 episodes per hour based on a prior PSG.

Exclusion Criteria:

Incapable of giving informed consent

* Under the age of 18
Study of Cyclosporine in Post-LASIK Patients

This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for bilateral LASIK surgery
* Patient is in good general health
* Eye glasses prescription of -1 to -8

Exclusion Criteria:

* Significant Dry Eye
* Presence of eye disease
* Uncontrolled systemic disease
* Previous use of RESTASIS®
Video-stylet for Nasotracheal Intubation

The purpose of this study is to compare conventional laryngoscopy with video-stylet (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.


Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring Nasotracheal Intubation under general anesthesia
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. Ankylosing arthritis patients.
3. BMI≧35 kg/m2
cliniMACs HUD for T Cell Depletion

This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY


Eligibility Criteria:
Inclusion Criteria:

severe combined immune deficiency need for stem cell boost

Exclusion Criteria:

n/a
Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* kidney-only transplant
* renal replacement therapy at time of transplant
* receiving standard immunosuppression regimen post-transplant.
* Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.

Exclusion Criteria:

* pre-emptive at time of transplant
* receive a multi-organ or dual kidney transplant
* age donor or recipient below 18 years
* Maastricht type I and II DCD
* donor kidneys preserved on static cold storage (SCS)
* kidneys retrieved after normothermic regional perfusion (NRP)
* Recipient virtual panel reactive antibodies ≥85%
* Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE marked Device) versus Standard treatment in women with twin pregnancy. The study is in two phases - a SCREENING phase, in which women with a short cervix (cervical length of ( less or equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen in the antenatal clinic setting.

An internal pilot phase will take place, with ten interviews being conducted with pregnant women to explore the acceptability of proposed methods of recruitment, their information requirements, their views of the consent and randomisation processes, and the delivery of the intervention, including the screening component. The interviews will also explore their understanding and expectations of trial participation. The findings of this pilot phase will feed into the next phase of the trial and support the design of the interview guides for the main nested qualitative study.

This pilot phase is separate from the main study. Later on we will ask both women and healthcare professionals about their experiences of the study, via questionnaires and face-to-face interviews.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting with twin pregnancy (monochorionic or dichorionic)
* Women with gestation established by scan at ≤16 weeks according to NICE guidelines.
* Women aged 16 years or older
* Women wishing to participate in both the SCREENING and RANDOMISATION phase of the study

Exclusion Criteria:

* Women unable to give written informed consent
* Women with known significant congenital structural or chromosomal fetal anomaly at the time of inclusion
* Women with existing or planned cervical cerclage in the current pregnancy
* Women who with existing or planned (prior to 20+6 weeks gestation) treatment for twin to twin transfusion syndrome in the current pregnancy
* Women with suspected or proven rupture of the fetal membranes at the time of recruitment
* Women with singleton pregnancy or higher order multiple pregnancies
* Women with known sensitivity, contraindication or intolerance to silicone
* Women involved in a clinical trial of an investigational medicinal product (CTIMP)
Skin Wetting in Burn Survivors

This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns \>40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.


Eligibility Criteria:
Inclusion Criteria: Non-burn survivors

* Healthy male and female subjects
* 18-65 years of age.
* Free of any underlying medical conditions

Exclusion Criteria (non-burned individuals):

* Any burn-related injuries resulting in at least one night of hospitalization.
* Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
* Abnormalities detected on routine screening
* Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
* Current smokers, as well as individuals who regularly smoked within the past 3 years.
* Body mass index of greater than 30 kg/m\^2.
* Pregnant individuals

Inclusion Criteria (burn survivors):

* Healthy male and female subjects
* 18-65 years of age.
* Free of any underlying medical conditions
* Having a burn injury covering 20-40% or \>40% of the participant's body surface area; at least 50% of those burn injuries must be full thickness that required skin grafting.
* Participants must have been hospitalized due to the burn injury for a minimum of 15 days

Exclusion Criteria (burn survivors):

* Any burn-related injuries resulting in at least one night of hospitalization.
* Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
* Abnormalities detected on routine screening
* Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
* Current smokers, as well as individuals who regularly smoked within the past 3 years.
* Body mass index of greater than 30 kg/m\^2.
* Pregnant individuals
* Extensive unhealed injured skin