cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)

This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.

INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.

INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.

This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.

Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.

HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.

Eligibility Criteria:
Inclusion Criteria:

* Existing insulin pump therapy
* Prior participation in a structured diabetes education program
* HbA1c ≥ 7,5% but ≤ 13%
* Ability to understand, speak and write German language
* informed consent (if necessary, informed consent of the parents)

Exclusion Criteria:

* Diabetes duration \< 1 year
* severe organic disease preventing a regular participation in the training course
* pregnancy
* severe cognitive impairment
* current treatment of psychiatric disorder
* renal disease requiring dialysis
Early Treatment With Dexamethasone in Mild Acute Pancreatitis

This pilot trial will evaluate the following in patients with acute pancreatitis:

1. Safety profile of early treatment with intravenous dexamethasone
2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
3. Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years
* Diagnosis of acute pancreatitis confirmed by at least 2 of the following:

  1. Typical epigastric abdominal pain
  2. Elevation amylase/lipase \>3 times upper limit normal and/or
  3. Confirmatory findings on cross-sectional imaging
* Enrollment within 8 hours of presentation

Exclusion Criteria:

* Class II or greater NYHA heart failure
* Oxygen dependent COPD
* Chronic kidney disease\>stage 2
* Cirrhosis
* Existing necrosis on abdominal CT
* Organ dysfunction prior to enrollment
* Sepsis
* Acute respiratory distress syndrome
* Malignancy not in remission for at least 5 years
* Active drug use
* Known allergy to dexamethasone
* Altered mental status
* Insulin-requiring diabetes
* Abdominal surgery within 60 days
Prospective Evaluation of Targeted Axillary Dissection (TAD)

The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.


Eligibility Criteria:
Inclusion Criteria:

* Women or men greater than or equal to 18 years.
* Histologically confirmed invasive adenocarcinoma of the breast.
* Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)

  * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.
  * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
* Patients must have biopsy proven involvement of the axillary lymph nodes.
* Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
* Candidate for surgical management of breast cancer.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
* Pregnancy.
Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg

The proposed exploratory study aims to understand the in vivo skin distribution properties of subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow microperfusion (OFM). The data of this study will help to understand the mode of action of AIN457 in its target tissue.

It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in situ. In addition, the study will further evaluate safety and local tolerability of subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of potential disease relevant biomarkers.

The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the method is completed and Part II with 8 psoriasis patients will start based on the outcome of Part I.


Eligibility Criteria:
For Part I : Healthy male and female subjects 18 to 65 years of age inclusive; For Part II: Chronic plaque-type psoriasis (with or without arthritis) diagnosed for at least 6 months before enrollment including at least one plaque accessible for OFM with at least moderate severity ; Key exclusion criteria for Part I and Part II: Women of child-bearing potential unwilling to use effective contraception; History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive TB-test at screening; For Part I: Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing For Part II: Ongoing use of concomitant psoriasis treatments. Washout periods have to be adhered to.

Other protocol-defined inclusion/exclusion criteria may apply.
A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 years of age and older
* Patients who are eligible and able to participate in the study

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply
Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease

The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.

The ELVIS study is a prospective, randomized, multi-centre open label trial following a non-inferiority design to compare the nasal high-flow (NHF) to non-invasive ventilation (NIV) in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease. Accoring to the randomization the patient is treated with NHF or NIV until discharge. A change of device is possible, if switch criteria are fulfiled OR need for intubation criteria are met before 72h (timepoint for primary endpoint).

Eligibility Criteria:
Inclusion Criteria:

1. acute hypercapnic exacerbation of chronic obstructive pulmonary disease with pH \< 7.35
2. pCO2 \> 45mmHg
3. age ≥ 18 years
4. written informed consent

Exclusion Criteria:

1. immediate need for intubation (acc. to intubation criteria in this protocol)
2. pH \< 7.15
3. BMI ≥ 35 kg/m²
4. established home-NIV or home-CPAP
5. end-stage disease with DNI/DNR order
6. diseases that could influence the primary endpoint: e.g. acute heart infarction, cardiogenic lung edema, acute and massive lung embolism (hypertensive), chronic dialysis with metabolic acidosis, unstable rib fracture influencing ventilation, injury to the face prohibiting use of a face mask
7. acute disease that precludes participation in the trial
8. tracheotomized patients
9. psychological/mental or other inabilities to supply required informed consent
10. participation in other interventional trials
11. suspected lack of compliance
Developing a Childhood Asthma Risk Passive Digital Marker

Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice.

The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.


Eligibility Criteria:
Inclusion Criteria:

• Practicing pediatricians within the IU Health Network

Exclusion Criteria:

• Non-practicing pediatricians within the IU Health Network
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients

A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients

A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable NSCLC
* Patients must have failed one prior line of CT-based therapy for unresectable disease
* Age between 18 and 75 years
* Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1
* Adequate hematological, renal, metabolic and hepatic function
* At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy
* Negative pregnancy test for pre-menopausal women

Exclusion Criteria:

* Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness
* Histological features of neuroendocrine or bronchioalveolar differentiation.
* Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
* Prior or concurrent invasive malignant disease, unless in complete remission for more than three years.
* Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start
* Prior treatment with docetaxel-containing therapy
* Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement
* Paraneoplastic syndromes
Comparison of Wound Integrity for Clear Corneal Cataract Incisions

This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions

Compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. It has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.However, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound Integrity of clear corneal incision is not well.In the poorly closed incision, the risk of infection increased due to the leakage .Especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. Ensuring wound Integrity for clear corneal cataract incision is the key to the success of cataract surgery.

Clinically closed methods include stromal hydration and suture.The effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. Additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. Exploring a safe and effective closed method will benefit for most cataract patients.

This study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.The investigators planned to select 130 cataract patients who met the inclusion criteria. The investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. Wound Integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years old;
2. Nuclear grade is III or IV;
3. Visually significant cataract;
4. The patient is willing and able to complete all necessary follow-ups and examinations.

Exclusion Criteria:

1. Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.;
2. Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
3. History of intraocular surgery;
4. Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
5. Any condition that the study physician considers to be an impediment to the clinical trial.
The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.

Thirty active male and female athletes will be recruited for the study. Subjects will be examined at baseline for VO2max performance. Subjects will then be stratified and randomly divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that baseline VO2max match. Once randomization, subjects will be baseline tested for multiple measures of muscle force capacity, muscle soreness, immune function, and endocrine function. Upon completion of baseline testing, subjects will all complete a one-day, cross-training course in Tampa, Florida. The training course is known to be extremely vigorous and causes significant muscle damage. Subjects will then be retested for muscle function at 24, and 48 hours following the course. At 24- and 48-hours subjects will be asked to repeat a simulated time trial race. In this way, we will measure repeated race performance, recovery from intense exercise, muscle damage from exercise, and immune function during multiple races.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 to 45 years old
* At least one year of cross training experience (i.e. 3 days/week)

Exclusion Criteria:

* BMI of 30 or more kg/m²
* Any allergies to fish, shellfish, algae, or seaweed are excluded from participation
* Have any cardiovascular, metabolic, or endocrine disease
* Undergone surgery that affects digestion and absorption
* Smoking
* Drink heavily (\> 7 and \> 14 drinks per week for women and men, respectively)
* Women who are pregnant or planning to be pregnant
* Taking medication to control blood pressure, lipids, and blood glucose
* Have taken or currently taking anabolic-androgenic steroids
Study of the No-touch Saphenous Vein Graft

Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.

A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease requiring three-vessel myocardial revascularization
* Patient consent to the study

Exclusion Criteria:

* The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
* Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
* Stenosis of the right coronary artery less than 90%
* Concomitant pathology requiring additional simultaneous surgical correction
* Lack of IMA
* COPD with FEV1 \<60%
* BMI \>35
* Prior heart surgery
* Oncological diseases with a life expectancy of less than 5 years
* ACS
* CKD stage 4 and higher
* The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
* CLTI IIb and more
* Atherosclerosis of the brachiocephalic artery more than 50%
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection

The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy).

Hypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in urine cells could be an early molecular markers of acute rejection.

The intention of this investigation is to evaluate a prospective immunosuppressive protocol based on antibodies anti IL-2 (Ac-IL-2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF)and withdrawal steroids in renal transplant and to compare with a steroid-based protocol.

Objectives:

1. To evaluate growth and the impairment in the GH/IGF (growth hormone/insulin like growth factor) axis
2. To determine the impact of steroids on bone metabolism (biochemical parameters, DXA and pQCT)
3. To determine the steroid effect on metabolic factors (dyslipidemia, insulin- sensitivity and arterial hypertension)
4. To determine acute rejection incidence (protocol renal biopsy)
5. To evaluate the expression of IL-17 and mRNA FoxP3 as early markers of acute rejection (blood, urine and renal biopsy).

Two treatment regimes (Arms)will be compared in randomized form in the course of 12 months after transplantation.

Arm A: TAC + MMF + withdrawal of steroids over a six-days following randomization.

Arm B: TAC + MMF + prednisolone (see schedule)/day

Eligibility Criteria:
Inclusion Criteria:

* Age \< 16.0 years
* Bone age of boys \< 15 years, of girls \< 13 years
* Prepuberal Tanner Status I
* First or second kidney transplant, living or deceased kidney donation
* Immunosuppression with Tacrolimus (TAC),Mycophenolate mofetil (MMF)
* Patients and parents, respectively, have given their written consent after enlightenment (informed consent)

Exclusion Criteria:

* Irreversible rejection of former transplant
* Highly reactive (\> 30%) lymphocytotoxic antibodies within 12 months prior to transplantation
* Suspected insufficient medication compliance in dialysis
* Patients receiving a basic immunosuppression other than that prescribed in this protocol
* Simultaneous therapy with growth hormone after renal transplant