cyrilzakka/clinical-trials huggingface dataset:
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab

Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta. Efficacy will be assessed by DXA measurements at the lumbar spine of the areal bone mineral density (BMD) which is the most frequently used parameter in trials investigating osteoporosis.

The hypothesis of the study is:

Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could be increased during a 36 week treatment course with denosumab measured after 48 weeks.


Eligibility Criteria:
Inclusion Criteria

* Male or female subjects between 5 years and 10 years of age with molecular proven Osteogenesis imperfecta (COL1A1/A2 mutation)
* Subjects must have been treated for a minimum of 2 years with bisphosphonates prior to study entry

Exclusion Criteria:

* Hypocalcemia (\<1.03 mmol/l ionized Calcium)
* Subjects with reduced renal function (estimated GFR (Schwartz formula) \<30ml/min/1.73m2)
* Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator that is indicative of a disease that would compromise the safety of the patient when getting denosumab s.c.
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.


Eligibility Criteria:
Inclusion Criteria:

* A displaced transverse or oblique midshaft clavicle fracture with or without comminution
* Must be 12 ± 2 months to 36 ± 2 months post-treatment
* Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture
* Male or female at least 18 years of age
* Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
* Ability to understand and provide written authorization for use and disclosure of personal health information

Exclusion Criteria:

* Open, or segmental clavicle fracture
* Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture
* Removal of the CRx™ device within 8 weeks of the study visit
* History of alcoholism
* Currently on chemotherapy or radiation therapy
* Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain
* Currently on worker's compensation
* History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
* Rheumatoid arthritis or other inflammatory arthropathies.
* History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.
* Women that are pregnant or think that they might be pregnant
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System as compared to the current standard-of-care breast biopsy procedures


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 years of age or older
* Subject has at least one breast imaging finding requiring biopsy for which images are available
* Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her

Exclusion Criteria:

* Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
* Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases

Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.

Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.

Eligibility Criteria:
Inclusion criteria:

* Patients with critical limb ischemia(grade 4,5\&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
* Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
* Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
* If the lesion extends to popliteal artey against knee flexion.

Exclusion criteria:

* Pediatric patients.
* Patients with isolated infra-popliteal occlusion.
* Patients with popliteal blind segment with bad runoff.
* Patients with acute thrombotic occlusions.
* Patients with previous bypass surgery in affected limb.
* Patients with aneurysmal lesion in the affected limb.
Risk Identification of Long-term Complications

The investigators retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe COVID-19, and strengthen follow-up to improve the prognosis of patients.

At present, there is a lack of prediction models for the long-term complications of severe COVID-19. Therefore, the investigators used the hospital big data platform to retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and conducted cohort follow-up of the changes in lung function including FEV1, FVC，FEV1% and DLCO, etc and and high-resolution CT of patients after discharge. COX model and other statistical methods were used to establish a prediction model for long-term complications of severe COVID-19, and early identification and intervention, strengthen follow-up, and improve the prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

The patient met the diagnostic criteria for severe COVID-19

Exclusion Criteria:

* Pregnant women Patients who died of COVID-19 Patients younger than 18 years of age without pulmonary CT
Pediatric Dose Optimization for Seizures in Emergency Medical Services

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.

PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.

One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.

Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.

If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.


Eligibility Criteria:
Inclusion Criteria:

* Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
* Under the care of a paramedic; AND
* Transported by an EMS agency participating in the study

Exclusion Criteria:

* A prior history of a benzodiazepine allergy; OR
* Known or presumed pregnancy; OR
* Severe growth restriction based on the paramedic's subjective assessment
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema

The aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.

Patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled in the study.

Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.

The enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.

Eligibility Criteria:
Inclusion Criteria:

* - Patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and OCT
* Naive patients
* Patients with clinically significant DME who have not been treated for more than 3 months with anti-VEGF therapy and for more than 6 months with intravitreal injection of dexamethasone
* Central retinal thickness (CRT) at OCT\> 300 microns
* Best Corrected Visual Acuity (BCVA) with ETDRS tables at 4 meters not \<20/400
* Ability to provide written informed consent and follow the procedures of the study

Exclusion Criteria:

* Retinal pathologies other than diabetic macular edema
* Proliferative diabetic retinopathy
* Opacities that limit the execution and interpretation of diagnostic tests
* Surgical interventions in the study eye in the 3 months prior to the start of treatment
* Pregnancy
* Feeding time
Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

This is a prospective, twin-center, cohort study in patients discharged from the hospital after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral anticoagulant apixaban on the background of historical data from the investigator's center on low-molecular-weight heparin (LMWH) substandard adherence in the same setting.

All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more complicated than orally available prophylaxis, more expensive and has poor adherence.

The patients will be identified in the pre-operative admission or in post-operative orders as potentially eligible for extended prophylaxis. On the day of discharge a research assistant or a research nurse will approach the patient, provide information about the study and obtain written consent if the patient fulfills the eligibility criteria.

Each patient will be asked to take apixaban until postop day 29±1 and will be followed until postop day 90±3. The total duration of the study from first patient in to last patient out is expected to take 12 months.

At 1 week after discharge there is a telephone contact to ask about any side effects from apixaban or bleeding events or signs of thromboembolism and to answer any questions from the patient.

At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding, signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and estimate of missed doses using a standardized script. If the patient is still taking it, instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact to ask about bleeding events or signs of VTE. The study is complete for the patient. At the time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing record for apixaban, in order to verify that the patient filled the prescription.

Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and considered at increased risk for VTE (e.g. previous history of VTE, residual cancer, slow mobilization, obesity, comorbidities).
* Written informed consent obtained.

Exclusion Criteria:

* Patient unable to take tablets, even if crushed.
* Active bleeding.
* Venous thromboembolism diagnosed during the hospitalization.
* Severe hepatic impairment (Child Pugh class C).
* Severe renal failure on dialysis or with calculated creatinine clearance \<15 mL/min.
* Platelet count \<50·109/L.
* Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole, voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.
Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function

Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration results in similar increases in muscle mass and strength than those observed after resistance exercise and is feasible for special populations such as the obese and the elderly.

The investigators hypothesis is that weight loss via diet combined with whole body vibration training would additively reduce arterial stiffness and blood pressure in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.

The purpose of the study is to examine the effects of 12 weeks of whole body vibration training (WBVT) and diet on arterial function, autonomic function, and body composition in obese women. Specific aims of the study are to:

To evaluate the extent to which diet and (WBVT) will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.

To investigate that combined diet and (WBVT) are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites \[NOx\], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 \[ET-1\],8-iso PGF2a,vascular endothelium growth factor \[VGEF\]) will be assessed as secondary outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 45 to 65 years of age
* At least 1 year after menopause
* Body mass index of 27-39.9
* Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

* Younger than 45 or older than 65 years of age
* Body mass index lower than 27, or 40 or higher
* Physically active or competitively active
* Smoker
* Use of hormone replacement therapy of less than 1 yr
* Use of calcium channel blocker or beta blockers
* Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants)
* Uncontrolled diabetes
* Any restriction that would significantly interfere with compliance with the diet (e.g., allergy to nuts or dairy, or need to avoid soy)
Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins

The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.

Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old
2. Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
3. No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
4. No neoadjuvant chemotherapy and radiotherapy
5. No digestive obstruction and distant metastasis

Exclusion Criteria:

1. Conversion to open gastrectomy
2. A large amount of bleeding leading(\>500ml)
3. Patients withdrew their consent
Evaluation of Consultation Including Genetic Aspects of Obesity

More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2 consultation types: one including recommendations for eating and physical activity behavior, the other with an additional part on genetic determinants and actions in obesity. It is hypothesized that obese people with obesity-specific genetic mutations, and obese people with a family history of obesity, benefit more if the consultation includes additional elements on genetic determinants.

More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2 consultation types: one including recommendations for eating and physical activity behavior, the other with an additional part on genetic determinants and actions in obesity. Their results are compared to a control group (n\>100). It is hypothesized that obese people with obesity-specific genetic mutations, and obese people with a family history of obesity, benefit more if the consultation includes additional elements on genetic determinants.

The following variables are used: BMI, SCID interview for mental disorders, Stunkard's body silhouttes for participants and their parents and siblings, Restraint Eating Scale, PANAS, Well-being scale, body acceptance, shame and guilt, coping with obesity, participant's satisfaction with consultation.

Assessment Points: before consultation, after consultation, 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

* Brain damage
Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion Criteria:

* Non-malignant ascites or pleural effusion