cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft

The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under Protocol BMTI-2006-01.

Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2006-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study


Eligibility Criteria:
Inclusion Criteria:

Subjects who meet the following criteria may be included in the study:

1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).

Exclusion Criteria:

1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.
Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT

Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation (SCT) from matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease and other severe toxicity.

The use of non-selected donor lymphocyte infusions (DLIs) (to help early immune recovery and induce antitumor response) following nonmyeloablative allogeneic stem cell transplantation (ASCT) is also complicated by the risk of acute graft versus host disease (aGVHD) with 30-40% of patients experiencing grade III-IV aGVHD. Data suggests that the use of natural killer (NK) cells (instead of nonselected DLIs) in this setting may mediate a graft versus tumor (GVT) effect independently of aGVHD.

This pilot study is designed to evaluate the efficacy and toxicity of donor natural killer (NK) cell selection and infusion following nonmyeloablative allogeneic stem cell transplantation (ASCT) from matched donors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with who have undergone a non-myeloablative allogeneic transplant, using a 6/6 human leukocyte antigen (HLA) matched sibling donor. Measureable disease is not needed at study entry.
* Performance status must be Karnofsky 50-100%.
* Donor cellular engraftment of at least 2.5% from the non-myeloablative procedure.
* ≤ Grade 2 acute Graft versus Host Disease (aGvHD) at time of infusion of natural killer (NK) cell infusion. Patients with treated aGVHD must be on a stable dose of therapy (no increase in immunosuppressive therapy for the 2 weeks before planned natural killer cell infusion \[NKI\]). The dosage/level of immunosuppressive therapy at the time of NKI should be no greater than 1 mg/kg of prednisone daily or mycophenolate 1000 mg bid daily or cyclosporine with a target level of 200 or equivalent.
* Estimated survival at least 8 weeks.
* Age \> or equal to 18 years of age.

Exclusion Criteria:

* Pregnant or lactating women,
* Patients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocol.
* Patients who had biopsy proven overall Grade 4 GVHD lasting longer than 7 days, from the non-myeloablative therapy, are not eligible
The Effect of CRT on the Hypercapnic Ventilatory Response

Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.

Sleep disordered Breathing is common in heart failure, affecting around half of patients. This may be Obstructive Sleep Apnoea due to loss of pharyngeal muscle tone (OSA, associated with obesity and snoring and predisposing to hypertension, heart attack and stroke) or Central Sleep Apnoea (CSA). CSA is particularly prevalent in severe heart failure and associated with an adverse prognosis. The mechanism involves reflex hyperventilation due to pulmonary oedema, exaggerated chemosensor response to hypercapnoea associated with increased sympathetic nervous system activation and a prolonged circulation time.

It is known that CRT improved CSA in 'responders' but the mechanism is unknown. We hypothesis that CRT normalizes the respiratory response to carbon dioxide (the hypercapnic ventilatory response - HCVR).

We will screen patients undergoing CRT with an Embletta sleep study to identify a group with moderate to severe CSA and a group with no sleep apnoea (controls). Patients will undergo assessment of the hypercapnic ventilatory response with a Read Re-Breathe test prior to device implantation and 6 weeks and 6 months afterwards. The gradient of minute ventilation vs PaCO2 will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with reduced ejection fraction (\<40%)
* Either no significant sleep disordered breathing or moderate to severe CSA
* Able to consent to the study
* Ambulatory
* Aged 18-100 years

Exclusion Criteria:

* Patients on Non-Invasive Ventilation
* Predominant OSA
* Unable to consent or attend for the study
Midazolam Sedation for Neonatal Lumbar Puncture

Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I, II
* Post natal age ≤ 30 days
* Fasting of at least 2 hours before the procedure

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) score III or greater
* Gestational age of 37 weeks or younger
* Congenital disease or defect
* Any medication provided by the caregiver prior ED admission
* Fasting of less than 2 hours
The Effects of Pain and Pain Relief on Peripheral Nerve Excitability

This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.

The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Participants able to give informed consent.

Exclusion Criteria:

* Chronic pain conditions
* Neurological or Psychiatric disease
* Other major diseases
* Pain medication within the last 24 hours
Blood Glucose Management in Intensive Care Units

The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.


Eligibility Criteria:
Inclusion Criteria:

* Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission
* Insulin therapy started less than 12 hours before inclusion of the patient in the study
* Expected duration of hospitalization greater than or equal to 48 hours

Exclusion Criteria:

* Moribund patients
* Patients admitted for ketoacidosis or hyperosmolar coma
* Patients admitted for symptomatic hypoglycaemia
* Patient requiring insulin for serum potassium correction
* Severe acute hepatocellular insufficiency
* Age \< 18 years old
* Pregnant or breastfeeding women
* Patients under legal protection measures
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.


Eligibility Criteria:
Inclusion Criteria:

Following eligibility criteria are defined to select relevant studies from the literature

* Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \[over 12 months\]))
* Participants have received either Dronedarone or Sotalol
* controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies

Exclusion Criteria:

Exclusion criteria for potential participants are:

* Children/adolescents
* Permanent atrial fibrillation (AFib)
Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion

the PowerScope appliance is found to be efficient for the treatment of class II malocclusion. Accordingly, it appears valuable to investigate the efficiency of skeletally anchored powerScope in the treatment of class III malocclusion

The PowerScope is the latest innovation in the treatment of Class II malocclusion which is a direct derivative of the Herbst Type II appliance. Dr. Andy Hayes worked in conjunction with American Orthodontics to develop PowerScope in 2016. This appliance supports intermaxillary wire-to-wire installation via a nut and hexagonal screw. A ball and socket joint is used to maximize lateral movement while improving patient comfort. The appliance is made up of a telescopic mechanism made up of an inner shaft/push rod, middle and outer tubing, and a spacer between the middle and outer tubing. A nickel-titanium (NiTi) spring provides a constant 260 g force. According to the present knowledge no studies regarding treatment outcomes of comprehensive fixed appliance treatment combined with the PowerScope in Class ΙII patients have been reported.

The introduction of temporary anchorage devices (TADs) has made it possible to achieve absolute anchorage control in daily clinical orthodontic practice when used in conjunction with fixed functional appliances. However, it appears that there is no evidence in the literature supporting the clinical effectiveness of miniscrew- anchored fixed functional appliances for the treatment of Class III malocclusion.

According to the current available literature, the PowerScope appliance is found to be efficient for the treatment of class II malocclusion. Accordingly, it appears valuable to investigate the efficiency of skeletally anchored powerScope in the treatment of class III malocclusion.

Eligibility Criteria:
Inclusion Criteria :

1. Mild to moderate Class III malocclusion adolescent patients with ANB (-3 - 0).
2. All permanent teeth are erupted (3rd molar not included).
3. An age of patients range from 14 to 18 years.
4. Good oral and general health.
5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
6. No previous orthodontic treatment.

Exclusion Criteria:

1. Orthodontic cases with severe crowding of upper and lower anterior segment that require extraction treatment approach.
2. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
What Are the Main Themes Concerned by the Second-line SMUR 67, Known as Reinforcements, in the Bas-Rhin Sector

In this study the investigators wish to evaluate the possibility of anticipating the requests for SMUR reinforcement within the SAMU67.

The studied population concerns each patient having benefited from an SMUR at the time of his pre-hospital care. The investigators expect from this study an improvement of the assumption of responsibility of the patients in the future with optimization of the delay of sending of an SMUR when this one is necessary.


Eligibility Criteria:
Inclusion criteria:

* Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020.
* No opposition from the patient or his parental authority to the re-use of his medical data for scientific research.

Exclusion criteria:

- Presence of opposition from the patient or his parental authority to the re-use of his medical data for scientific research purposes.
Evaluation of Quality of Life and Period of Hospitalization by Education

Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.

The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B

Eligibility Criteria:
Inclusion Criteria:

* Planned stoma
* colorectal cancer, from resection of left hemi-colon aboral A. colica media
* Patients speaking german and living in Germany
* ECOG ≤ 3
* Informed Consent
* standard education program

Exclusion Criteria:

* Patients treated with stoma by emergency
* patients with dementia
* status post stoma
* Patients in contact with a stoma-therapist
* recurrence of colorectal cancer
Istria County CPR Survival 2011-2017

Analysis of factors that influence CPR survival of 1440 patients that were resuscitated in Istria County, Croatia between 2011-2017.

Survival status, duration to EMS arrival, level of education of initial CPR provider, initial monitored rhythm, cause of cardiac arrest, age, gender and time of year will be recorded and analyzed to determine which factors influence CPR survival.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients that were resuscitated in Istria county because of out of hospital cardiac arrest (OHCA)

Exclusion Criteria:

* minors
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients should satisfy all the following criteria to be considered eligible for randomization:

  1. Be age 18 or above
  2. Able to provide written informed consent
  3. Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.

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  1. Septal deviation must be present on direct or endoscopic examination
  2. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
  3. Collapse of external nasal valve and/or lateral motion instability must be documented

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  1. The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.

In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.

Exclusion Criteria:

1. Septal perforation
2. History of previous functional rhinoplasty or sinus or septal surgery
3. Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
4. Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
5. Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19

The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. The study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. The aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Previously admitted to a hospital for Covid-19
* Discharged from hospital for at least 30 days
* Previously treated for cancer at MSK
* Interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed)
* Space to house a treadmill at personal residence
* Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+)
* Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report
* If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.

  * Women \<50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment.

Exclusion Criteria:

* Currently receiving home oxygen after discharge
* Enrollment onto any other interventional investigational study
* Current treatment for any other diagnosis of invasive cancer of any kind
* Distant metastatic malignancy of any kind
* Receiving non-hormonal anticancer therapy
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance

The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac stratum).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Patients scheduled for open heart surgery or spinal column surgery
* Offered patient information and written informed consent
* Mini Mental State \> 23
* American Society of Anesthesiologists physical status classification system (ASA) 1-3

Exclusion Criteria:

* No informed consent
* Patients aged \<18 years
* Patients living outside Berlin/Potsdam and surrounding area
* Less than 5 points in Stanford Scale of Hypnotic Susceptibility: Form C; German version (SHSS:C -Weitzenhoffer \& Hilgard, 1962; Bongartz, 1999 a)in the screening/recruiting phase
* Lacking consent capability or accommodation in an institution due to an official or judicial order
* Emergency patients or ambulant patients
* Pregnancy and lactation
* Coworkers at Charité
* Lacking willingness to save and hand out data within the study
* Insufficient knowledge of the German language
* Participation in another trial according to the German Drug Law the week before inclusion (in the study) and the parallel participation in another trial according to the German Drug Law within the first 3 months after surgery
* Acute, severe psychic disease (acute psychotic disorder, severe drug dependency, withdrawal symptoms)
* Conditions which make a sufficient information and consequent consent impossible
* The patient is under juridical supervision
* acute risk of suicide
* dementia
* patients who suffer from insulin dependent Diabetes mellitus and who have been diagnosed with Diabetes mellitus within the last year
* patients who have suffered allergic shock in the past
* hardness of hearing, deafness, blindness
* cardiac function: ejection fraction (EF) \< 30%
* Patients undergoing psychotherapeutic treatment
* Patients taking awareness-modulating drugs (antipsychotic drugs)
* Boozed/primed patients or patients under drug influence
* Patients having had an epileptic seizure within the last four weeks
* Patients suffering from productive cough
* Patients having a chronic low blood pressure (systolic \<90mmHg)
* Allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment)