cyrilzakka/clinical-trials huggingface dataset:
ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes

Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor tissue perfusion and function as well as an increased risk of cardiovascular events. ATP, which is released from the red blood cells, contributes to the regulation of the blood flow and studies have shown that red blood cells taken from T2D patients have an impaired ability to release ATP. However, it is not known whether the changes in the ATP system is an underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will normalize ATP release, plasma ATP levels and thereby blood flow.

Furthermore, epidemiological studies show a clear link between regular exercise and a reduced risk of serious cardiovascular disease. The extent to which a physically active lifestyle may improve endothelial function in T2D is unknown. Regular physical activity improves vascularization and induces an anti-inflammatory environment. Both the angiogenic and anti-inflammatory effects of physical activity is in part mediated by substances released from the active muscle. These muscle-derived substances are classified as myokines and have paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The purpose of the project 2 is to investigate whether high intensity interval training may reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In individuals with T2D we will determined blood flow in the muscle tissue using advanced ultrasound. In addition, using intravascular and intramuscular microdialysis we will determine ATP levels in blood and in the muscle interstitium.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics
* BMI \>30
* Non smokers
* Physical Inactive (less than 2 hours per week)

Exclusion Criteria:

* Thyroid disorder
* Known ischemic heart disease (intermittent claudication, angina)
* Diabetic eye disease
* Diabetic kidney disease
* Known heart disease
* Intake of beta-blockers
* Blood Pressure \> 140/90
* Nephropathy and macroalbuminuria GFR measurement
* Acute illness within the last three weeks
* Chronic disease, including cancer, heart (ischemic and claudication), liver, kidney and respiratory disorders (asthma)
* Significant peripheral diabetic neuropathy (severe sensory disturbances)
* Significant peripheral diabetic angiopathy (former or current foot ulcer)
* Rheumatological disorders
* Pregnancy or childbirth within the past three months
* Alcohol abuse
* smokers
* Use of illegal performance-enhancing drugs (see IAAF list)
* Injuries and / or surgery within the last 6 months
Single Case Research Design: Deaf Children's Language Outcomes

Eight deaf children in kindergarten to 3rd grade classes will be randomly selected for single case research. Their language skills will be monitored and assessed daily. Using a noncurrent multiple baseline design (Single Case Research Design or SCRD), Strategic and Interactive Signing Instruction (SISI) will be administered to two children in each of four classes.

A randomized selection method will be employed to select deaf children to participate in single case research. Two children will be selected from each age group between 5 and 10, making a total of eight students. Their language skills will be closely monitored and evaluated over the course of the year. Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 SCRD participants in a class will begin receiving SISI while other children remain in the baseline for 3 weeks. Brainstorming occurs on Monday and the final sign language composition is shared on Friday. At the end of each day's intervention, child participants will independently narrate their expressed message recorded on videos. A score of 1 (applied correctly), 0.5 (applied but incorrectly), or 0 (omitted) will be given to their inclusion of target sign language skills, which is converted into percentages. If a child receives 100% on their target SL skill for 3 consecutive days (3 data points), Teacher 1 will select a new sign language skill to target. If the child receives 0% or 50% on their target sign language skill, Teacher 1 continues to focus on the same sign language skill.

Eligibility Criteria:
Inclusion Criteria:

* Deaf children in kindergarten to 3rd grade class in a school for the deaf

Exclusion Criteria:

* Non-deaf children
Aerobic Training in Patients With Congenital Myopathies

Congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout their life. However, progression of symptoms is rare. There are no specific treatments for congenital myopathies. Training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. The investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. The study starts and ends with a test day, where efficacy based on VO2max, performance in functional tests and a questionnaire will be assessed.

10 weeks of cycle-ergometer training at home. Intensity at 70% of maximal VO2,max.

Eligibility Criteria:
Inclusion Criteria:

* Danish patients with gene verified congenital myopathy

Exclusion Criteria:

* Patients who are to week to train at a cycle-ergometer for 10 weeks
* Patients who have other health issues, which can disturb the interpretation of the efficacy
Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer

Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer.

A randomized study including 200 patients, 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies.

Quality of life (QL) is increasingly being accepted as an important endpoint in clinical studies, however little is known about its diagnostic value in order to optimize the therapy of cancer patients. This project at the Tumorcentre Regensburg aims to integrate QL-diagnostics into the therapy of patients with breast cancer and to evaluate the efficacy of QL-diagnostics in the context of a randomized clinical trial.

The Tumorcentre Regensburg provides the infrastructure of the present project (telemedicine, project groups, quality circle). Breast cancer patients' therapy is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options, such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counseling and rehabilitation, nutrition and sports.

In the course of an implementation phase, a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and sociodemographic information in order to generate a QL-report including a therapy recommendation.

This is a two-arm randomized clinical trial with one test group (communication of the QL-finding to the coordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the coordinating doctors will be included in this randomized study. QL-assessments (EORTC QLQ-C30 plus BR23) will be taken at designated points in time over a 12 months time course. Finally, patients will provide an overall evaluation of the course and the effects of the therapy using an open-ended questionnaire.

We expect that patients in the test group will experience a lower number of QL-deficits at the end of the study period (Median 1 +/- 2) than patients of the control group (Median 2 +/- 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n=100 vs. n=100, alpha = 5% \[two-tailed\], beta = 10%).

This is the first study to evaluate a new form of QL-diagnostics in the complexity of a real patient care environment. This study promises to reveal important new insights into advanced patient care and will make the inclusion of the quality of life concept in the current breast cancer treatment guideline more concrete.

Eligibility Criteria:
Inclusion Criteria:

* All patients with primary breast cancer in the county of Regensburg, Amberg and Sulzbach-Rosenberg from November 2004 to approximately June 2006 submitted by coordinating physicians who were trained in quality of life questionnaires and profiles

Exclusion Criteria:

* Secondary breast cancer, patients who refused to participate, patients incapable of filling out questionnaires, male patients, pregnant patients, age below 18 yrs.
Pre-therapeutic Validation of the Virtual Reality-based Exposure Scenario for CBT "ReVBED" for the Induction of Food Craving in Patients With Bulimia and Binge Eating Disorder (BED)

Food craving is a major therapeutic issue in Eating Disorders with binge eating: the Bulimia Nervosa and the Binge Eating Disorder (BED). Food craving is linked to compulsive eating and its apprehension is currently based on classic Cognitive and Behavioural Therapies (CBT). However, it remains difficult to induce in therapy and a significant number of patients do not respond to classic CBTs. The development of exposure scenarios for CBT in virtual reality (VR) has allowed a gain in efficacy and in particular therapeutic effects lasting longer after treatment. Nevertheless, the stimuli used are often simple food visuals and insufficiently consider the many factors influencing food craving (physical, psychological, socio-environmental...) and VR immersion is still limited by the use of 3D laptops (fixed) rather than wireless headsets.

Eating Disorders-specialized clinicians from Saint-Etienne University Hospital Center (CHU) and VR-specialized engineers from National School of Engineering of Saint-Etienne (ENISE) therefore collaborated in the creation of ReVBED, a VR-based exposure scenario for CBT for the induction of food craving in eating disorders with binge eating. ReVBED offers successive exposures to multimodal stimuli in a coherent scenario and in an immersive virtual environment via a wireless VR headset.

Our first objective is to validate the effectiveness of our scenario in inducing food craving in patients with bulimia and BED.

Eligibility Criteria:
Inclusion Criteria:

* Patients: who meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Bulimia Nervosa or Binge Eating Disorder
* Controls: paired to patients on age and level of education

Exclusion Criteria:

* Patients and controls:
* Under legal protection measure (guardianship, curatorship or safeguard of justice)
* Having a treatment being established and / or not stabilized (declarative) able to alter the physiological data recorded and the answers to the self-questionnaires
* Having one or more sensory deficit(s) or disorder(s) incompatible with the use of VR equipment (declarative)
* Patients: who have already benefited from specific care targeting food craving (declarative) Controls: with a score greater than or equal to 88 on the Bulimia Test (BULIT)
L-Arginine and Erectile Dysfunction

The purpose of the study is to determine whether the treatment with L-arginine leads to an improvement of erectile dysfunction in patients with erectile dysfunction.

Erectile dysfunction (ED) is a common medical disorder often affecting the aging male. Nitric oxide (NO) is a physiological signal essential to penile erection. NO synthase (NOS) catalyzes the production of NO from L-arginine. ADMA, a competitive inhibitor of NO synthase increases with age and many disorders that reduce NO in the erectile tissue are commonly associated with ED. Although new pharmacological strategies have been identified for medical treatment of ED, patients often seek alternative therapies for cost or side effect reasons.

The aim of the present study is to determine the efficacy of orally administered L-arginine on ED not caused by established organic disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 20 and 65 years, an ED for at least 6 months duration and written consent.
* Each patient had to be informed about the study details in written and oral form before the beginning of the drug administration.
* The hormonal status including dehydroepiandrosterone sulfate (DHEAS), Prolactin and Testosteron of each patient had to be within the normal range. -

Exclusion Criteria:

* Patients with primary erectile dysfunction, congenital anomalies, Diabetes mellitus, severe hepatic-and renal insufficiency, severe cardiovascular diseases, cerebrovascular accidents, uncontrolled hypertension, endocrine diseases, psychiatric disorders, and evidence of dementia were excluded.
* Patients were excluded if they had pelvic fractures or prostatectomy and if they had undergone reconstructive or prosthetic surgery on the penis.
* Increased levels of serum potassium, known hypersensitivity to the study medication or any ingredient of the drug.
* Administration of PDE-5-Inhibitors (sildenafil, tadalafil, vardenafil or apomorphine) within four weeks prior to the administration of l-arginine or placebo led to exclusion.
Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

Patients suffering from Thalassemia or another hemoglobinopathies required regular blood transfusions. The complications and adverse effects of blood transfusions can be classified as immediate and late. Among the immediate effects the most common are allergic reactions and fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are mostly related to blood transmitted infections like HIV or Hepatitis C infections.

The purpose of this study is to summarize the data of those complications in a cohort of 100 patients receiving regular blood transfusion.

About 100 patients aged several months to 50 years are treated in the Pediatric Hematology Unit, most of those patients receive blood transfusions monthly. The adverse reactions were routinely recorded during each transfusion. All the patients were also screened annually for the incidence of blood transmitted infections principally HIV and Hepatitis C. All those records will be systematically screened and all the immediate or late adverse reactions and complications related to blood transfusions will be summarized.

A second goal of this study will be to control the staff strictness related to the ministry of health protocol dealing to blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

* Not applicable
Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption.

Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age \> 18 years
3. English-speaking
4. Capability to operate a patient-controlled analgesia (PCA) device

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
2. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
3. History of a seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]
Mechanisms of Immune Tolerance and Inflammation in Patients With Cystic Fibrosis With ABPA

The goal of this study is to identify the immunological factors that influence a patient's response to the presence of the fungus Aspergillus fumigatus (A. fumigatus) in the lungs. In patients with cystic fibrosis (CF), this fungus is not known to cause damage to the lungs, but some patients respond with an allergic reaction that may cause wheeze, cough, or difficulty breathing. Approximately 230 patients will be enrolled with an additional 60 people who do not have CF and who do not have a history of asthma to serve as a comparison group.

In this cohort the investigators will study blood T-cell responses to Aspergillus antigens to determine if patients with ABPA have greater type 2 responses as measured by IL-13 compared to CF or non-CF controls.

Eligibility Criteria:
Inclusion Criteria:

(CF)

* diagnosis of CF
* age 6 years or older
* presence of A. fumigatus in culture of airway flora, or the presence of one or more of the diagnostic criteria for ABPA (Control)
* age and sex matched to CF population

Exclusion Criteria:

(CF)

* uncontrolled CF-related diabetes mellitus
* use of oral steroids at a dose ≥ 0.5 mg/kg/day
* history of lung transplantation
* pulmonary exacerbation as defined by requirement for use of intravenous antibiotics or need for hospitalization within the preceding 14 days.
* patients who have a diagnosis of HIV and have a CD4+ Tcell count below 500 cells/ml will be excluded (control)
* asthma
Anterior vs Posterior Approach in THA

Determining the best approach for a total hip arthroplasty (THA) implies that the procedure is kind on soft tissues, with the lowest complication rates, and easily reproducible. Although there have been several attempts to resolve this issue in the last decade, a definitive answer has not been found. Therefore, the investigators performed a prospective study to compare direct anterior versus posterior approach based on (1) hospital stay, (2) functional outcome, (3) pain, (4) implant position (5) complications and (6) surgical time.

In this multicentric, prospective, randomized clinical trial, 55 total hip arthroplasties were performed on 50 patients between February 2011 and July 2013. Patients meeting the inclusion criteria underwent surgical treatment using the DAA or PA, according to a randomization process. Radiological analysis assessed implant position, limb lengthening, and potential implant related complications. X-rays were performed at subsequent follow-up visits and consisted of an antero-posterior (AP) pelvic X-ray and a lateral projection of the hip. Two independent observers, not involved with patients or surgeries, reviewed all postoperative radiographs independently.Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study.

Patients underwent either the posterior or direct anterior approach.

Eligibility Criteria:
Inclusion Criteria:

* primary total hip replacement due to osteoarthrosis or osteonecrosis
* patients older than 50 years.

Exclusion Criteria:

* inflammatory arthritis,
* any previous ipsilateral hip surgery
* suffering from proximal femoral deformity
* BMI over 40
* active infection
* severe contralateral hip disease, muscle contractures or neuromuscular pathology
* requiring structural bone grafts.
Awake Thoracic Epidural Anaesthesia Versus General Anesthesia for Video Assisted Thoracoscopic Surgery

Thoracic procedures are routinely performed under general anesthesia (GA), with one lung ventilation (OLV)by double lumen tube or (GA) in spontaneously breathing patient by TIVA or LMA are usually combined with thoracic epidural analgesia.

However, GA whether mechanically ventilated or spontaneously breathing may have adverse effects including peri-intubation hypoxia, trauma to the upper airway, mechanical ventilation-induced injuries, impaired cardiac performance, neuromuscular problems in OLV and increased risk of pneumonia, and release of proinflammatory mediators in generally.

Recently, awake thoracic epidural anesthesia (ATEA) has been used alone in thoracic procedures The results achieved in early studies have been encouraging. ATEA may eventually provide an alternative method to GA for thoracic procedures that would not only eliminate the need for GA but also facilitate both surgical reconstruction and eventually patient recovery.

Recent studies suggested better clinical outcomes with ATEA, including less intraoperative bleeding, a better control of postoperative pain, early mobilization and short hospital stay, oral intake tolerance, reduction of surgical stress response, reduction of intraoperative cardiac events, improvement of myocardial flow determinants and left ventricular function, and a reduction of complications including pulmonary, thrombotic and infectious events.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 60 years.
* ASA score equal to or less than III.
* The absence of severe emphysema or clinical signs of active infectious disease.
* The procedure is predicted to be completed within two hours.

Exclusion Criteria:

* Patients with expected difficult airway management
* Haemodynamically unstable patients
* Obesity (body mass index \>30)
* Inexperienced and poorly cooperative surgical team
* Coagulopathy (international normalized ratio \>1.5)
* Persistent cough or high airway secretion
* Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain oedema
* Extensive pleural adhesions or previous pulmonary resections
* Hypoxaemia (PaO2 \<60) or hypercarbia (PCO2 \>50)
* Any contraindications for use of regional anesthesia technique