cyrilzakka/clinical-trials huggingface dataset:
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw

Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to removable prosthesis. However, for patients with a severely atrophic maxilla or mandible, cranial bone grafting of the jaw is required to increase bone width and height necessary for implant insertion. An active collaboration between the surgeons from the Oral and Maxillofacial Department and the prosthodontist from the Department of Dentistry has been established for continuous quality improvement of the concept of (immediate/delayed) implant loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.

The investigators aim to develop a prospective database registering (immediate/delayed) implant loading data of all patients eligible according to the protocol. Patient demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected during consecutive visits within the framework of routine practice.

Development of a database registering immediate functional loading data secondary to cranial bone-grafting of a severely atrophic jaw, will provide more information about potential patient, surgical and prosthetic factors influencing long-term biological and mechanical stability, as well as patient satisfaction. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of all genders
* Patients with moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood \& Howell, 1988), caused by terminal periodontitis or edentulism
* Patients requiring bone augmentation procedures through cranial bone grafting for jaw reconstruction
* Patients ineligible for conventional removable prosthetic rehabilitation

Exclusion Criteria:

* Patients not eligible according to abovementioned criteria
* Patients with severe uncontrolled diabetes
* Patients with cranial vault without diploe and/or cranial vault thickness \<3mm, as defined with cone-beam CT (De Ceulaer, et al., 2012)
Walking in the HIBBOT: is Gait Improved?

The aim of the study is to assess the impact of the innovative walking aid HIBBOT on the functions, activity and participation of young children with Cerebral Palsy, in comparison with conventional walking aids.


Eligibility Criteria:
Inclusion Criteria:

* At risk of or diagnosed with cerebral palsy, based on MRI (uCP 86 - 89 % sensitivity) or HINE (uCP 98% ) or standard motor assessment
* age 18 months - 6 years
* GMFCS level II - IV =with potential (=able to stand and walk when supported by a therapist at the level of the pelvis and lower trunk)
* Sufficient cooperation to complete the tests.

Exclusion Criteria:

* Hip dysplasia
* Fixed contractures in the lower limb
* Botox infiltration \< 6 months prior to inclusion
* Surgery \< 12 months prior to inclusion
* Insufficient understanding of the interventon and tests (based on mental level assessment)
* Refractary epilepsia
Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients

This Early Feasibility Study (EFS) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (AIS) patients treated with VitalFlow-IS stimulation within 6 hours of symptom onset. The purpose of the EFS is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited Premarket Approval (PMA) pathway).


Eligibility Criteria:
Inclusion Criteria:

* Time last known normal within 4.5 hours of presentation for enrollment

  * Allows 1.5 hours for pre-stimulation study procedures to maintain a 6-hour therapeutic window
  * IV rtPA and Endovascular Treatment (EVT) permissible if not inappropriately delayed by study procedures
* Age 18-85 years
* Diagnosis of ischemic stroke in the anterior circulation
* NIHSS at baseline 4-20
* Creatinine \< 1.7 mg/dL
* Signed informed consent by patient/Legally Authorized Representative (LAR)

Exclusion Criteria:

* Pre-stroke disability Modified Rankin Score (mRS) between 2-6
* Inability to communicate sufficiently to participate in study procedures
* Neuroimaging with intracranial hemorrhage, severe brain edema, or ASPECTS \<5
* Known or newly-discovered aneurysm or arteriovenous malformation (AVM)
* Intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure
* Metallic foreign bodies or implanted devices in the head or neck, including tattoos
* Cardiac, vagal nerve, or intracranial neural stimulation device
* Cochlear implant or implanted hearing aid
* Potential for delay in intravenous rtPA or endovascular therapy due to study procedures

  * Intravenous (IV) rtPA: Stimulation might be delivered during the rtPA infusion period
  * EVT: Stimulation might be performed while EVT team is mobilized
* Seizure concurrent to stroke, or history of seizures, epilepsy, or recurrent syncopal events.
* History of neuropathy (including facial nerve injury), carotid surgery, or vagotomy.
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Locally advanced disease or at high risk for relapse
* No clinically or radiologically suspected metastases
* Prior lymphadenectomy required
* Meets at least 1 of the following criteria for poor prognosis:

  * Gleason score greater than 7
  * T3 or T4 disease
  * Prostate-specific antigen greater than 20 ng/mL
  * N1 disease

PATIENT CHARACTERISTICS:

Age

* Under 80

Performance status

* ECOG 0-2

Life expectancy

* More than 10 years

Hematopoietic

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* AST and ALT no greater than 1.5 times upper limit of normal (ULN)
* Bilirubin no greater than ULN

Renal

* Creatinine less than 1.6 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular

* No uncontrolled or severe cardiovascular disease
* No prior thrombosis

Pulmonary

* No prior pulmonary embolus

Other

* No active infection
* No intolerance to aspirin
* No other prior malignancy except basal cell skin cancer
* No physical or psychological condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy

Chemotherapy

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy

* No prior hormonal therapy
* No other concurrent hormonal therapy

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics

Other

* No other concurrent anticancer therapy
PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery

To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic renal or adrenal surgery.

30 patients undergoing retroperitoneoscopic renal or adrenal surgery were included in this study.Their PaCO2, PetCO2, and PTCCO2values were measured at 3 time points before and 30min, 60min after pneumoperitoneum and calculated the different between each measure(PetCO2 and PTCCO2) and PaCO2. Agreement among measures was assessed by the Bland-Altman method.

Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing retroperitoneoscopic renal or adrenal surgery
2. Age more than 16 years.

Exclusion Criteria:

1. Care taker unable or unwilling to give oral informed consent
2. Patients with history of severe trauma, operations, smoking, and severe cardiovascular or respiratory diseases, such as coronary heart disease, congestive heart failure, or chronic obstructive pulmonary disease

4.Subject has a condition or allergy which would prohibit placing the probe 5.Subject has participated in a trial with any experimental drug or device trial within 30 days prior to enrollment in the study
Mono Antiplatelet and Colchicine Therapy

The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.

After successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. For those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and C-reactive protein are measured. Aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. C-reactive protein is remeasured 30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
* Provision of written informed consent

Exclusion Criteria:

* Cardiac arrest or cardiogenic shock
* Age \<19 or \>90 years old
* Severe liver impairment
* Severe renal impairment (eGFR \<30 mL/min/1.73 m2)
* Atrial fibrillation requiring anticoagulation therapy
* Intolerance of prasugrel, ticagrelor, or colchicine
* History of intracranial hemorrhage
* Active bleeding
Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID)

This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.

Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MIxed Connective Tissue Disease

Exclusion Criteria:

-
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis urothelial carcinoma of the bladder (Recurrence of prior NMIBC biopsy or pathology must be obtained within 12 months prior to enrollment. First time NMIBC biopsy within 6 months of screening. MIBC allowed if demonstrated pathologically)
2. Have no evidence of metastatic disease
3. Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

1. Any additional malignancy that requires active treatment. Exceptions include:

   1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.
   2. In situ cervical cancer treated and with at least 1 year without recurrence.
   3. Any other subject felt appropriate by the Investigator upon discussion with trial's Medical Monitor.
2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
4. Chronic active hepatitis B or C and HIV.
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors

Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.

We posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. They must be comprehensive (addressing multiple behaviors and the "5 As"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the Chronic Care Model. We will test the effectiveness and implementation of an innovative "packaged" intervention with these features. Six ACORN-affiliated practices will adopt a brief (3 minute) routine to deliver A1-3 (Ask, Advise, Agree) in the office and to offer patients four options for intensive assistance (Assist \[A4\], Arrange \[A5\]) outside the office. Patients can select 9 months of online, telephone, or group counseling; or usual care. An electronic health record (EHR) will expedite the in-office intervention and referrals. Outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from EHR data, "counselee" surveys, and patient/staff interviews). We hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the Common Measures for physical activity, diet, smoking, and alcohol use). EHR-captured data will measure RE-AIM parameters, including Reach (14 sub-measures), Adoption, and Maintenance. Surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore Implementation issues and suggested improvements. We hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. Accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. We strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. If our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.

Eligibility Criteria:
Inclusion Criteria:

All individuals over the age of 8 years presenting for care in 9 primary care practices

Exclusion Criteria:

None
Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease

Psychological difficulties, especially depression and anxiety are the most prevalent non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as effective in PD. Mindfulness courses have received increased popularity and recognition as an effective way to manage emotional states, and there is ever growing findings of the effectiveness of mindfulness courses for people with long-term medical conditions. Two small pilot studies have indicated that mindfulness courses can be helpful for people with PD in improving symptoms of depression, language functioning and motor symptoms. The investigators propose to deliver these courses remotely, through Skype video conferences, to make it more accessible for people with mobility limitations and people who live in rural areas.

This study will employ a mixed-methods design, with an experimental randomised control trial followed by a qualitative design. Sixty participants will be randomly assigned to the 8-week mindfulness course (n=30) or a wait-list control group (n=30). Block randomisation will be used and the randomisation scheme will be generated using the randomisation.com website. One-hour sessions will be delivered to groups of 5 people using Skype video-conferencing. As this is a pilot study analyses will largely be descriptive. Further, inferential analyses using mixed modelling will be conducted by intention-to-treat. At the end of the intervention, the investigators will interview the participants of the mindfulness group about their experiences of the course.

Eligibility Criteria:
Inclusion Criteria:

* be diagnosed with PD according to PD Brain Bank criteria by a neurologist or geriatrician
* have a computer and internet access at home, since the course will be delivered via Skype
* be able to communicate in English fluently
* be stabilised on mood altering medication and/or Parkinson's medication for a month

Exclusion Criteria:

* have severe cognitive impairment that would make participation in the mindfulness sessions and home practice of mindful meditation problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993).
* have severe psychiatric conditions (e.g. psychosis, drug/ alcohol addiction) that can potentially risk failure in the treatment or limit participation in the course
* have severe hearing impairment
* are currently participating in other psychological therapies
* have prior formal training in mindfulness methods or current meditation practice
Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery

This study evaluates the ability of a belladonna and opium suppository given prior to surgery to improve bladder comfort after surgery for patients who are having elective ureteroscopy surgery.

Belladonna and opium suppositories are administered postoperatively to relieve bladder discomfort usually caused by bladder spasms. The onset of action of the suppository is 30-60 minutes. Bladder spasms are more likely to occur following uteroscopy procedures. The spasms result in a felt desire to void, even when there is no urine in the bladder. The spasms can produce pain or a sense of severe urgency.

By administering a belladonna and opium suppository at the beginning of surgery, it is hoped that there will be a decrease in the incidence of bladder spasms, increased comfort and less need for additional medications.

Eligibility Criteria:
Inclusion Criteria:

* Patients from one urology practice schedule for elective uteroscopy.

Exclusion Criteria:

* Patients with pre-operative indwelling catheter or urinary stent.
* Patients who report any allergy to belladonna or opium.
Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle

Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery. We conducted a previous study that showed our treatment bundle is highly effective.

Our current study planned to examine patterns/rate of S. aureus transmission to improve feedback widespread implementation of the perioperative infection prevention program at Iowa.

The purpose of this study is to assess the fidelity of the set of interventions in controlling perioperative S. aureus and to provide data feedback via surveillance involving epidemiology of transmission for system optimization.

The operating room schedule will be reviewed each day by the research assistant.

At the start of each case, the technician will obtain an OR PathTrac kit and will fill out required card indicating the OR number, the surgery date, and the type of surgery. The cards will be placed back into the kit. Sample collection will be directed via use of the kit. The first sample is the adjustable pressure-limiting valve and agent dial of the machine before patient entry (measures terminal cleaning), then provider (attending and assistant) hands after they enter but before patient interaction, then the provider nose and mouth after induction of anesthesia and patient stabilization, then provider hands, then same environmental sites, then provider sites again, then stopcock.

A transmission event will be defined as detection of S. aureus pathogens among 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The software platform will process transmission dynamics in order to continually summarize the epidemiology of S. aureus transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistant will use the reports to continually optimize the interventions during the observational period.

Eligibility Criteria:
Inclusion Criteria:

* Adult (at least 18 years old) patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.

Exclusion Criteria:

* \<18 years old, Shellfish, iodine, chlorhexidine allergies, no anesthesia and/or placement of peripheral and/or central intravenous catheter required
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia


Eligibility Criteria:
Inclusion Criteria:

* Member of managed care plan for hypercholesterolemia
* Fasting blood lipid levels as defined by the protocol
* Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse