cyrilzakka/clinical-trials huggingface dataset:
Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

This is a study aiming to investigate a possible correlation between the parameters affecting the physicians' therapeutic choice with the patients' overall adherence to osteoporosis treatment. Secondary end-points include correlation between the parameters affecting the physicians' therapeutic choice and the patients' quality of life as well as the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).

The study will include 100 orthopedic surgeons from the private sector working in private offices. The selection of this group of physicians resides on the fact that orthopedic surgeons working in private offices hold more than 60% of osteoporosis prescriptions in Greece.

Each physician will fill once a questionnaire regarding the parameters affecting his/her choice of osteoporosis treatment before entering any patient in the study. Following the completion of the questionnaire every physician will recruit up to 10 patients in the study who are eligible for osteoanabolic treatment (teriparatide) according to standard medical practice and the Greek osteoporosis treatment guidelines.

Each patient will receive teriparatide up to 24 months while he/she will fill the Greek EQ5D questionnaire on months: 0,12,24 or at early discontinuation. Adherence to treatment will be evaluated at the same time points as well as on monthly telephone interviews.

Both the adherence to treatment and the possible alteration of patients' quality of life (evaluated through the EQ5D questionnaire) during the study will be correlated with the parameters affecting the initial therapeutic decision of the physician

Eligibility Criteria:
Inclusion Criteria:

* Female patients with postmenopausal osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.
* Male patients ≥ 50 years old with idiopathic osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.
* Male and female patients with steroid-induced osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.

Exclusion Criteria:

* Prior use of teriparatide or PTH(1-84)
* Hypersensitivity to teriparatide regimen.
* Pregnancy and lactation.
* Hypercalcamia.
* Renal deficiency (eGFR \< 30 ml/min).
* Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis .
* Uninterpretable increases of alkaline phosphatase (ALP)
* Prior skeletal radiotherapy.
* Skeletal malignancies or bone metastases
Vitamin D for Critically Traumatic Patients

Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients. The serum levels of calcidiol and PTH will be measured on Day 0, Day 3, Day 10, Day 15, Day 30 and Day 60 before and after vitamin D supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Major trauma adult (\> 20 years old) with Injury Severity Score equal or higher than 9, who is admitted to ICU

Exclusion Criteria:

Patients with the following conditions:

* Chronic liver disease
* Contraindication to enteral feeds
* Hypercalcemia
* Current use of vitamin D, estrogen, or medications for bone disease
* High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma
Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).

After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.

In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).

These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.

The data upraised through this are compared off-line to the MRI findings.

Eligibility Criteria:
Inclusion Criteria:

* left ventricular wall motion abnormalities
* existent myocardial vitality MRI exploration
* reduced LV-function
* steady angina pectoris
* patients which are legally competent and which are mentally able to understand the study staff
* patients give their written consent

Exclusion Criteria:

* pregnancy or lactation
* acute or instable angina pectoris
* acute myocardial infraction in the last 3 month
Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment

This study evaluates the effect of changes in the range of drinks offered in vending machines in schools on the sugar intake of pupils via drinks.

Children and adolescents consume a considerable amount of liquid in the form of sugary drinks. A high sugar diet associated not only with the increase in overweight children, but also with type II diabetes, cardiovascular disease and cancer.

In many schools, cold drink vending machines with different fillings are available offering various sugary drinks.

Participating schools will be randomised in a ratio of 1:1:1 into three groups. In one intervention group, the vending machines will be re-equipped to contain 60% drinks containing a maximum of 6.7g sugar/100ml, 20% drinks containing more than 6.7g sugar/100ml and 20% water. In the second intervention group, the vending machines offer 80% water, 20% products with a maximum of 6.7g sugar/100ml. In the control group, the range of products offered by the vending machines remains unchanged. Information of the students drinking habits, total fluid intake and sugar intake in the form of food and drinks will be collected. In addition, data such as body height, body weight, physical activity and socio-democratic or socio-economic data will be accumulated. The sales figures of the drinks in the vending machines will be recorded and information about the surroundings of the schools (fast food chains, supermarkets, etc.) will be collected.

The survey of students and data collection will be repeated three times. In a sub-study, demographic data and the frequency of consumption of sugared beverages and water are collected from 2 focus groups. In addition, participants will complete a questionnaire on general attitudes towards sugary drinks or water, obstacles to and incentives for reducing sugar consumption by liquids or increasing water consumption.

Eligibility Criteria:
Inclusion Criteria:

* Students in one of the recruited schools
* Appropriate knowledge of the German language

Exclusion Criteria:

* No signed consent of parent and of child
Zirconia and Metal-based Single Crown Posterior Restorations.

The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Male and female patients from 18-70 years of age
* Need for a single crown restoration
* Presence of antagonist
* minimum of 20 teeth
* moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
* low to moderate caries risk, and no active periodontal disease.

Exclusion Criteria:

* Women who are pregnant at the date of inclusion
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Smoking more than 15 cigarettes a day
* Poor oral hygiene (Plaque Index over 30%)
* Bruxism
* vital teeth
* allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material
Development of a Prediction Platform for Neoadjuvant Treatment and Prognosis in Pancreatic Cancer Using Organoid

The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Newly discovered pancreatic cancer and not a relapse
3. Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
4. who is in need of neoadjuvant chemotherapy before surgery
5. Patients who can undergo surgery for pancreatic cancer after neoadjuvant chemotherapy
6. Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery
7. Able to make decisions for oneself for participation
8. Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)

Exclusion Criteria:

• None
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild to moderate dry eye as defined in the protocol.
* Able and willing to follow instructions.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition that may affect the results of the study.
* History or evidence of ocular or intraocular surgery within the past six months.
* History of intolerance or hypersensitivity to any component of the study medications.
* Use of concomitant topical ocular medications during the study period.
* Ocular conditions that may preclude safe administration of the test article.
* Unwilling to discontinue contact lens wear during the study period.
* Participation in an investigational drug or device study within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.
Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.

Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

* Smokers volunteers, minimum age 18 years

Exclusion Criteria:

* no history of acute or chronic organic, metabolic and inflammatory diseases;
* no fever and infections in the last 3 months;
* no history of cardiovascular pathological symptoms;
* no allergies;
* none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD
* women were not menstruating when the experiment was performed.
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery

Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center
* Ability to understand and sign written informed consent by the patient or legal guardian

Exclusion Criteria:

* Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)
* Receiving ongoing treatment of antibiotics for other infections
* Sensitivity or allergy to vancomycin or cefazolin
* Previous spine surgery at the index level within the last 90 days
* Postoperative radiotherapy of the surgical site required (e.g. for tumor)
* Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse
* Undergoing spinal decompression only
* Trauma patients
* Pregnancy
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).


Eligibility Criteria:
Inclusion Criteria:

1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
4. Age ≥ 18 years.
5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

Exclusion Criteria:

1. Evidence of colon/small bowel perforation at the time of study screening
2. Goals of care are directed to comfort rather than curative measures.
3. Moderate (ANC \< 1000 cells/uL) or severe (ANC \< 500 cells/uL) neutropenia.
4. Known food allergy that could lead to anaphylaxis.
5. Pregnancy

   a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration
6. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained \< 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate \> 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate \> 90 beats per minute, respiratory rate \> 20 breaths per minute or PaCO2 \< 32 mmHg, temperature \>38ºC or \<36ºC, WBC \> 12,000 cells/uL, \<4,000 cells/uL, or \>10% immature (band) forms).
7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 54 years
* BMI measurement result is 18.0 kg/m2 to 30 kg/m2
* Written informed consent
* Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

* who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period

  1 administration)
* Other exclusive criteria, as defined in the protocol
Measuring Corneal Cells With Specular Microscopy

Assess changes in the corneal cell count using Specular Microscopy following tretments with Anti-VEGF injections

Patients with active Wet AMD often receive intraocular Anti-VEGF injections such as Macugen, Lucentis and Avastin on a monthly basis for an extended period of time. While these medications are very effective at controlling the Choroidal Neovascularization associated with this disease, the impact of monthly intravigtreal Anti-VEGF injections on the viability of corneal endothelial cells has yet to be fully characterized. The availability of CESM as a diagnostic test that can be performed quickly and painlessly in the clinic offers a method of tracking corneal endothelial cell count in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Wet Age-related Macular Degeneration
* Receiving monthly intraocular injections of Anti-VEGF medication for at least 3 months
* Age greater than 50 years of age

Exclusion Criteria:

* experiences adverse events
Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa

The purpose of this study is to test the feasibility and acceptability of Safe South Africa, an integrated intervention for preventing HIV and Intimate Partner Violence perpetration for male adolescents 15-17 years of age.

This study will investigate the acceptability and feasibility of Safe South Africa, an integrated intervention to prevent adolescent behavioral risk for human immunodeficiency virus (HIV) and perpetration of intimate partner violence (IPV). Safe South Africa is a theory-driven, developmentally-tailored and gender-specific intervention designed for male adolescents 15-17 years of age. The research will be conducted in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV perpetration in the world. Preventive interventions are urgently needed during adolescence when risk for human immunodeficiency virus (HIV) and intimate partner violence (IPV) increases exponentially. Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the unique age and developmental needs of adolescents. We will investigate the acceptability and feasibility of Safe South Africa with three study aims: (1) a development aim - this aim will result in the creation of Safe South Africa, an integrated male adolescent preventive intervention for HIV risk behavior and IPV perpetration; (2) an acceptability aim - this aim will consist of an evaluation of the social ecology of HIV and IPV risk with a survey of N=100 of adolescents, and a test of the acceptability of Safe South Africa through an open pilot trial with N=20 male adolescents; and (3) a feasibility aim - this aim will consist of a randomized controlled pilot trial with 1- and 6-month follow-up in a sample of N=60 male adolescents to assess the feasibility and acceptability for a future fully powered randomized controlled trial to evaluate efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male adolescent
* 15-17 years of age, inclusive of 15 and 17

Exclusion Criteria:

* parent/guardian does not provide consent
* adolescent does not provide assent
Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy

Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?

To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 7 to 11 years old, from both genders.
* Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
* They were able to stand and walk.
* Gross motor function measure scale GMFM (level I \&II). (Russell et al. ,2013).
* Children with good mentality to understand the evaluation steps.

Exclusion Criteria:

* Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
* Children who have any spinal deformities.
* Children with severe muscle contracture.