cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of the Treatment of Humerus Fractures

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.


Eligibility Criteria:
Fracture-Specific Inclusion Criteria

1. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2.
2. Fracture is closed, Gustilo Type I or II.

   General Inclusion Criteria
3. Skeletally mature men and women, 50 years of age or older at time of index injury.
4. a) Female patients of child bearing potential agree to use double barrier method of contraception b) Female patients of non-child bearing potential must meet one of the following criteria:

   * Postmenopausal for at least 1 year, or
   * Documented oophorectomy or hysterectomy, or
   * Surgically sterile
5. Willing and able to understand and sign the informed consent.

Fracture-Specific Exclusion Criteria

1. Index treatment is greater than 28 days post fracture
2. Open fractures with severe contamination.
3. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
4. Marked bone loss or bone resorption patients, who due to a prior delayed union or non-union of the bones or other illnesses, may not be able to have their fracture adequately reduced prior to placement of the IlluminOss-device. This could leave bone void spaces that would preclude the device from maintaining alignment of the fractured bone.
5. Previous fracture of affected limb.

   General Exclusion Criteria
6. Pregnant or lactating.
7. Active or incompletely treated infections that could involve the site where the device will be implanted.
8. Distant foci of infections that may spread to the implant site
9. Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder).
10. Concomitant metabolic disorders that may impair bone formation.
11. Osteomalacia.
12. Allergic to implant materials or dental glue.
13. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
14. Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).
15. Life expectancy less than one year due to concurrent illness.
French Hypertrophic Cardiomyopathy Observatory

Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.

The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)

This both retrospective and prospective study is proposed to cardiology services 50 hospitals in France. A cardiologist referral is designated for each facility.

The following data will be collected by the physician during the initial hospitalization

* Demographics
* Geographic origin of patient
* Clinical data: criteria for inclusion and non-inclusion data HCM general, Doppler ultrasound, personal history, family history
* Reviews made: non-organic, biological
* Family Survey,
* Treatments: Medical, Electrical, invasive
* Data from hospital

The follow-up to 18 months, 3 years and 5 years will be conducted by clinical-research-technicians of the French Society of Cardiology, an application will be made to municipalities of birth and mail a letter to physicians and patients.

The following data will be collected:

* Vital status
* Data from hospital
* Reviews made: non-organic, biological
* Treatments: Medical, Electrical, invasive

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 15 years old
* Patient with HCM defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

Exclusion Criteria:

* Expressed refusal to participate in the study
* Significant aortic stenosis (\<1 cm ²)
Risk Factors for COVID-19 Mortality

COVID-19 pandemic has deeply burdened hospitals all over the world. A two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. Predicting clinical worsening could help to address major efforts towards higher risk patients.

During the last year most observational studies, generally retrospective, has been conducted, identifying some risk factors such as age, obesity, male gender, cardiovascular disease, COPD, diabetes etc.

The study goal is to collect systematically a variegate amount of clinical, biometric, laboratory and radiological data from patients admitted to the Emergency Medicine Ward of Piacenza Hospital (Italy), in order to prospectively analyze what characteristics are associated to higher risk of mortality.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Emergency Medicine Ward from the Emergency Department of Piacenza Hospital (Italy)
* Confirmed COVID-19 diagnosis through molecular test obtained from nasal-pharyngeal swabs in the Emergency Department
* Age above 18

Exclusion Criteria:

* inability to obtain an informed consent due to neurological conditions.
* patient's refusal to sign the informed consent
* inability of researchers to recruit the patient in the first 24 hours from the admission.
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years and ≤ 75 years at the time of consent.
2. Hepatocellular carcinoma confirmed by histology/cytology.
3. Lesions with measurable disease at baseline by mRECIST.
4. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
5. Child-Pugh: \<=6
6. Adequate organ and bone marrow function.

Exclusion Criteria:

1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
2. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
3. Potential liver transplant candidates
4. Have a history of hepatic encephalopathy or have a history of liver transplantation.
5. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
Sustiva Levels With Use of a Gel Capsule

We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative, proven by ELISA
* Age: ≥ 18 years old

Exclusion Criteria:

* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.
Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation

Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy

Quantification of the effect of ECC duration on blood coagulation and platelet number and function

* Observational study on 20 patients undergoing prolonged ECC
* Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies
* Blood test to be performed in Rambam Blood Bank Laboratory

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 yo
* scheduled for prolonged cardiac surgery requiring ECC time over 3 hours

Exclusion Criteria:

* documented coagulopathy
* antiplatelet therapy other then aspirin
Impact of Cataract Surgery to Socioeconomic Status in Rural Area

This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.

Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.

In the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.

Exclusion Criteria:

* History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
* Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.
* Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.
* Patients not willing to participate in the study.
Prehabilitation for Patients Undergoing Lung Cancer Surgery

Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.

Patients with lung cancer who are scheduled to undergo lung resection surgery will be provided with a digitally-enabled, remotely-monitored prehablitation program. The intervention will consist of the following components: i) general education; ii) inspiratory muscle training; iii) physical activity coaching; and iv) home-based exercise training. The program will be supported with a mobile app and weekly telehealth sessions with one experienced physiotherapist. Participants will be assessed at baseline and at the end of the intervention, prior to surgery. Participants will be contacted and scheduled to undergo face-to-face assessments on lung function, respiratory muscle strength, and functional capacity both at baseline and after the prehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lung cancer and scheduled for lung resection surgery
* Ability to understand and speak English to follow instructions and complete the intended assessments.
* Age ≥ 18 years at the point of baseline screening
* Provide written informed consent for the trial
* Sufficient digital literacy to use a smartphone and mobile app
* No contraindications for exercise

Exclusion Criteria:

* Other cancer diagnoses than lung cancer
* Surgery scheduled in less than one week
* Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

This study was aimed to to evaluate the efficacy of the new multibending ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC.

Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, the investigators evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, which was defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 min.

Eligibility Criteria:
Inclusion Criteria:

* biliary disease requiring diagnostic and/or therapeutic direct POC
* distal common bile duct (CBD) dilation \> 8 mm
* previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP
* ability to provide informed consent

Exclusion Criteria:

* presence of any contraindication to ERCP
* bleeding tendency (international normalized ratio \> 1.5 or platelet count \< 50,000/ mm3)
* diffuse stricture of the distal CBD
* diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV)
* altered gastrointestinal anatomy or significant duodenal obstruction
Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patients are men or women of age 50 or older.
* Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
* Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
* The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
* Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.
* The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion.
* The CNV is associated with only macular degeneration.
* Patient defers other approved treatments of subfoveal CNV associated with AMD.

Exclusion Criteria:

* Prior treatment for subfoveal choroidal neovascularization (CNV).
* Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
* History of vitrectomy or submacular surgery in the study eye.
* Subretinal fibrosis accounting for more than 50% of the lesion.
* Non-CNV lesion components account for more than 50% of the total lesion components.
* CNV due to causes other than AMD.
* Retinal pigmented epithelial tear involving the center of the macula.
* Geographic atrophy involving the central macula.
* Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract).
* Active intraocular inflammation.
* Vitreous hemorrhage in the eye.
* History of spherical equivalent in the study eye greater than negative 8 diopters.
* Intraocular surgery within 2 months of study enrollment.
* Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication.
* History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication.
* Inability to comply with study or follow-up procedures.
Treatment of Hypoglycemia in Type 1 Diabetes

According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
4. HbA1c ≤ 10%.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Known significant cardiac rhythm abnormality based on investigator judgment.
4. Abnormal blood panel and/or anemia (Hb \< 100g/L).
5. Ongoing pregnancy or breastfeeding.
6. Severe hypoglycemic episode within 1 month of screening.
7. Known uncorrected hypokalemia (potassium \< 3.5 mmol/L; available within the past 3 months).
Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With ASD

It was proposed that in order to teach these children to use a Voice Output Communication Aid (VOCA), it should be introduced through a play-based situation using parents as the primary interventionist.

The research will test the effectiveness of using the communication board to improve the frequency of communication and social engagement for these children, and the level or sophistication of that engagement. The study will test the effectiveness of using the communication board in a variety of settings and a variety of practitioners. The study will have sites in and near Jonesboro, Arkansas.

Eligibility Criteria:
Inclusion Criteria:

Criteria for inclusion included a diagnosis of autism and agreement of the parents to participate and use the VOCA at home.

Exclusion Criteria:

Not diagnosed with Autism Spectrum disorder
Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system.

Study hypothesis: text message reminders increase adherence

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system. Patients were enrolled at clinics and pharmacies upon receipt of ACTs and enrolled in the automated system for 3 days.

Eligibility Criteria:
Inclusion Criteria:

-subjects acquiring ACTs in Tamale, Ghana

Exclusion Criteria:

* subjects acquiring ACTs for non household members
* subjects under the age of 18
* subjects without access to cell phones
* subjects living more than 30 minutes from pickup location
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* Proven, probable or possible invasive aspergillosis
* Patient is 2 years of age or older

Exclusion Criteria:

* The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for \>7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
* The patient has been treated with voriconazole for \> 7 days immediately prior to randomization
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
* Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
* HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion Criteria:

* Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening