cyrilzakka/clinical-trials huggingface dataset:
RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress

Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).

The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.

This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.


Eligibility Criteria:
Inclusion Criteria:

* Norton score \< 14
* Bed and/or chairfast
* no pressure ulcers or at least pressure ulcer category I

Exclusion Criteria:

* Norton Score \>/=14
* Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer
* Expected length of hospital stay \< 2 days
* Medical contraindication for use of reactive static air support surfaces
* End of life care (or Do Not Reanimate (DNR) code IV)
* Age \< 18 years
GIP and GLP-1 in Type 1 Diabetes

Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria:

* HbA1c \> 9 %
* Liver disease (ALAT/ASAT \> 2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \> 130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III or IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* C-peptide increase after 50 g iv arginine
A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.

Eligibility Criteria:
Inclusion Criteria:

* High risk patient to Coronary Heart Disease
* At visit 1(Screening)

  1. If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C\<100mg/dL and 150mg/dL≤TG\<500mg/dL, randomize without run-in period
  2. If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG\<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period)
* LDL-C\<100mg/dL and 150mg/dL≤TG\<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy

Exclusion Criteria:

* Subject with acute artery disease
* Subject with congestive heart failure(NYHA class III\~IV) or uncontrolled arrhythmia
* Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc.
* AST or ALT \> 2XULN, Serum Creatinine \> 2.5mg/dL, Creatinine phosphokinase \> 2XULN
* Subject with gall bladder disease or pancreatitis
* Uncontrolled hypertension
* Endocrine or metabolic disease affected on serum lipid or liprotein
* Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history
* Not eligible to participate for the study at the discretion of investigator
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children

This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.

This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusion criteria.

For individuals who have received DBV712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of DBV712 will occur at 6-month intervals. There will be no other scheduled study visits. For individuals who have been on blinded treatment, a safety assessment will be conducted at Months 1 and 3. Visits for safety assessment and resupply of DBV712 will occur at 3-month intervals during the first 12 months. After a year, visits will occur at 6-month intervals. DBV712 will be supplied to participants at study visits to suffice until the next visit. For individuals who have been on blinded treatment, or off DBV712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day.

Treatment with DBV712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, DBV712 is approved and available by prescription, or the study is terminated.

Eligibility Criteria:
Inclusion Criteria:

* Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022
* Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.
* Negative urine pregnancy test for female participants of childbearing potential.

Exclusion Criteria:

* Early withdrawal from a DBV712 clinical study.
* History of non-compliance during the primary clinical study or unable to follow the protocol requirements.
* Generalized dermatologic disease extending widely on the skin.
* History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

* Trial with immunodulatory product / biological


Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* History of allergic rhino-conjunctivitis in spring and summer
* Age 18 years to 65 years
* Positive skin prick test to grass pollen

Exclusion criteria:

* Blood donation within previous 30 days
* Surgery within the previous 30 days
* Use of investigational drugs within previous 90 days
* Pregnancy or nursing
* Mastocytosis
* Significant cardiovascular disease
* Hypertension
* Active infectious disease
* Significant hepatic disease
* Significant renal disease
* Significant hematological disorder
* Significant pulmonary disease
* Moderate or severe asthma
* Autoimmune disease
* History of malignancy.
* Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
Effects of a 3D Printing Technology Learning Program

3D printing technology helps rehabilitation professionals make an order-made assistive device (AD). However, most have not learned how to use the technology for clinical practice. The study is aimed to evaluate a 3D printing technology learning program for rehabilitation professionals. Eligible participants who have a licence for physical, occupational or speech-language therapy and have not experienced learning any 3D printing technology. The learning program was conducted in accordance with Kolb's Experiential Learning Theory (Morris TH, 2020). The program was conducted over eight weeks. The outcome measure included the Japanese version of the modified Technology Acceptance Model questionnaire (TAM-J). It consists of 13 items and four scales; Perception of usefulness (28 points total), Perception of ease of use (35 points total), Attitude toward use (14 points total) and Intention to use (14 points total). Within-group analyses were performed using the Wilcoxon signed-rank test for the TAM-J between different time points.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants who have a licence for physical, occupational or speech-language therapy

Exclusion Criteria:

* Participants who have experienced learning any 3D printing technology.
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).

In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.

* Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).
* In these, ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
* Either goserelin acetate or leuprorelin Acetate is allowed.
* These patients are able to choose bilateral salpingo-oophorectomy instead of OFS.
* Chemotherapy is omitted in these patients.

Eligibility Criteria:
Inclusion Criteria:

* ER+HER2- breast cancer
* Premenopausal and age \<=50
* T1 or T2
* N1 including micrometastasis
* Genomic Low Risk by OncoFREE test® (1-20)

Exclusion Criteria:

* Postmenopausal women
* ER-negative breast cancer
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30
* Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion Criteria:

* History of seizures or other central nervous system disorders (including migraine headaches)
* history of diagnosed mental illness or suicidal tendencies
* positive screening for Hep B surface antigen
* Hep C antibody
* HIV-1, -2
Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring


Eligibility Criteria:
Inclusion Criteria

1. Patient's aged 18-65
2. Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring

Exclusion Criteria

1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
2. Patients undergoing exercise or drug induced cardiac stress test
3. Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).
mFLOT Chemotherapy as First-line Treatment in GC

A single center phase 1b/2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients. This trial is designed to identified recommended phase II dose (RP2D) of modified FLOT in Chinese patients, and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer.

This trial is in 2 stages: the first stage will establish the maximum tolerated dose (MTD) and RP2D of docetaxel and oxaliplatin in FLOT regime. In the second stage, the efficacy of modified FLOT will be assessed by response rate.

The RP2D of FLOT regime will be established with a standard 3+3 design, starting with the dose of 40mg/m2 docetaxel (dose level 1) and 65mg/m2 oxaliplatin (dose level 1). The plan of dose escalation will be found in following table. Chemotherapy will be administered two-weekly (maximum 12 cycles) until progression of disease, intolerable toxicity or withdraw of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged from 18 to 75 years.
2. Histologically confirmed gastric adenocarcinoma.
3. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
4. At least one measurable lesion should be confirmed by imaging examination.
5. ECOG performance status 0 or 1
6. Adequate bone marrow function:

   Absolute neutrophil count (ANC) ≥1.5x109/L White blood count ≥3.5x109/L Platelets ≥80x109/L Hemoglobin (Hb) ≥90g/L (can be post-transfusion)
7. Adequate renal function: Creatinine Clearance of \>50ml/min
8. Adequate liver function:

Serum bilirubin \<22 umol/L ALT/AST ≤2.5x ULN, for patient with liver metastasis ALT/AST ≤5x ULN 10. Adequate coagulation profile International Normalised Ratio (INR) \< 1.5 Activated Prothrombin Time (APTT) \< 1.5xULN 11. Without brain metastasis and peripheral nerve diseases 12. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. With second primary malignant diseases
2. Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of leucovorin, oxaliplatin, 5-FU or docetaxel
3. With uncontrollable complications
4. Inadequate organ function
5. Pregnancy or of child bearing potential.
International Social Network Intervention

This grant involves 24 social networks of young men who have sex with men, Roma, and young high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.

For over 4 years, our international collaborative research team has carried out a social network HIV prevention intervention trial with community populations of young men who have sex with men (YMSM), disadvantaged ethnic minority Roma (Gypsies), and high-risk heterosexual adult (YHA) women and men in Hungary, Bulgaria and Russia. Eastern Europe has seen a sharp increase in HIV incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. Across the three countries represented in our research during the past funding period, we enrolled social networks of YMSM, Roma, and YHAs. This study will renew our international collaboration to extend this network intervention approach. Our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as "egocentric" social networks.

Eligibility Criteria:
Inclusion Criteria:Members of a friendship group will be eligible for enrollment if they are of legal age to independently consent to participate in this study. In its review and approval of this protocol, the IRB at BotkinHospital, St. Petersburg, Russia verified and confirmed in writing to us that the age of research participation consent is 15. In its review and approval of this protocol, the IRB at the Health and Social Development Foundation determined that the age of research participation consent in Bulgaria is 16. In Hungary, the IRB at the Institute of Sociology at the Hungarian Academy of Sciences determined that the age of independent consent to participate in this study is 14.

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Exclusion Criteria:Individuals will be excluded from enrollment into the study if they are below the age for providing independent consent or are not capable of providing informed consent based on impairment due to the presence of sever psychopatology, substance use, or similar conditions observed at the time of informed consent. Social networks will be excluded from the study if: (1) more than 33% of named network members do not agree to participate; (2) fewer than 50% of members report occurrence of unprotected intercourse during the past 3 months at baseline; or (3) more than 10% of a network's members are also members of another network enrolled in the study.

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Validation of Multiparametric Models and Circulating and Imaging Biomarkers to Improve Lung Cancer EARLY Detection.

CLEARLY will focus on validation of a multifactorial "bio-radiomic" protocol for early diagnosis of lung cancer that combines circulating biomarkers and radiomic analysis. It will (a) assess the role of molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) and radiomic signature, as complementary to assist early detection of lung cancer by low dose computed tomography-LDCT, using bioinformatics techniques; (b) assess the prognostic role of CTCs including the role of cells epithelial mesenchymal transition (EMT) and (c) standardize a method for genomic analysis of CTCs for early detection of treatment resistance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
* Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
* Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.

Exclusion Criteria:

* Previous diagnosis of lung cancer.
* Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
* Performing a chest CT scan in the last 18 months.
* Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients

In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years with severe postherniorrhaphy pain (numerical rating scale \[NRS\] \> 6) for more than 6 month

Exclusion Criteria:

* known amide local anesthetic drug allergy
* recurrent hernia
Effectiveness Of DN and STM Combined With Self-Stretching for Management of Calf and Heel Pain

To determine the effectiveness of dry needling and soft tissue mobilization with self-stretching for the management of calf and heel pain. In our topic pain and physical dysfunction are our variables


Eligibility Criteria:
Inclusion Criteria:

* Patients will be between the ages of 25 to 60 years.
* Female and males.
* History of heel and calf pain.
* Pain level moderate .
* Trigger point / inactive trigger points.
* Acute stage patients.

Exclusion Criteria:

* Phobias like injections or needles.
* Unwilling patients
* Patients on anticoagulant medicines.
* Patients with RA
* Fibromyalgia syndrome.
* Pateint with recent trauma and surgery.
Stepping Up For Inflammatory Arthritis

This study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.

Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic, systemic inflammatory disorders affecting 1-2% of the US population. Ongoing chronic inflammation and lack of exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss, obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all of which impact physical functioning and quality of life. Increases in physical activity can significantly impact each one of these outcomes and are likely to positively impact a patients experience of their disease. This study will examine the benefits of a monitored physical activity program. This study will use a wearable activity device (e.g. fitbit) to monitor step counts and will incentivize one group to achieve higher step counts than the control group. The primary goal of this pilot study will be to determine whether one incentive (loss aversion) is better than no incentive in increasing step counts and maintaining an increased level of physical activity.

Additional outcomes of interest are patient reported disease activity (using the RAPID3 patient reported outcome) and physician measured disease activity, quality of life assessments and weight loss.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA or PsA by a rheumatologist
* Followed by a Penn rheumatologist
* Age 18-80
* A RAPID3 score of 3
* An active email account
* Owns a smart phone and able to download an application
* Willing to take internet based surveys weekly and allow data from a smart phone application to be uploaded

Exclusion Criteria:

* Inability to walk or regular use of a wheel chair or assistive device (e.g., walker or cane)
* Hospitalization within the past 30 days
* Heart or lung disease that precludes participation in an exercise study