cyrilzakka/clinical-trials huggingface dataset:
Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for development and regeneration of the nervous system. In earlier studies reduced concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin biopsies have been found in patients with DP.

Purpose: Our purpose is to determine the concentration and biological activity of Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163 (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. We will furthermore relate the findings to peripheral nerve function. In addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.

Hypothesis: We hypothesize that DP develops due to reduced concentration and biological activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients without damage to the nervous system and healthy control subjects.

Methods: Study subjects consists of patients from Department of Neurology and Department of Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark, who are having a lumbar puncture performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic polyneuropathy
* Patients with diabetes without peripheral nerve disorder
* Patients with polyneuropathies not due to diabetes
* Patients not suffering from diabetes or nerve disease (control subjects)
* Patients with unspecified nerve disease

Exclusion Criteria:

* Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
* Cerebral infections
The Effects of Different Modalities of Exercise in Patients With Schizophrenia

Introduction: Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the different problems associated with schizophrenia, reporting that they result in significant improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.

Ethics and dissemination: This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia in Spain (reference number: CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.

The aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.

A multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. The training groups will complete aerobic, strength, or mixed (aerobic + strength) training. The participants will be assessed before, immediately after, and 6 months after the end of the intervention. All the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. The study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form), and quality of life (abbreviated World Health Organization Quality of Life questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia
* Age between 18-65 years

Exclusion Criteria:

* Patients with other mental diseases
* Patients with mental disabilities
* Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU

The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection.

The objectives are as followings:

1. Obtain incidence of three major nosocomial infection in ICU, catheter related blood stream infection(CRBSI), catheter related urinary tract infection (CRUTI), and ventilator associated pneumonia (VAP).
2. Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.

Eligibility Criteria:
Inclusion Criteria:all patients admitted into ICU
The Effect of Yoga Practice on Chronic Back Pain

Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied.

The purpose of this research study is to determine whether a 6 week standardized yoga practice is superior to usual conservative therapies in the treatment of chronic back pain at 6 months. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to and ability to participate in study procedures
* Chronic back pain (pain above the gluteal cleft of at least 3 months duration)

Exclusion Criteria:

* Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
* Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus erythematosus.

Introduction: The systemic lupus erythematosus (SLE) is a disease with a common articular involvement. Approximately 1-2% of patients with SLE have joint inflammation similar to rheumatoid arthritis (RA). There are no well-designed studies of lupus arthropathy.

Primary objectives: To evaluate the ultrasonographic examination of the hands in patients with systemic lupus erythematosus and make its correlation with examination of patients with rheumatoid arthritis (RA) established and with clinical, serological, radiological and functional.

Material and methods: a transversal study will be carried out on patients diagnosed with with SLE and RA.

Clinical Instruments: count of swollen and tender joints, visual analogue scale (VAS) for pain (0-10 cm), edema and for disease activity; disease activity (DAS 28 and SLEDAI), hand grip strength and pinch (Jamar dynamometer and Preston Pinch Gauge); functional questionnaires (HAQ and DASH). It will be observed the presence of "puffy hands", Raynaud's phenomenon and presence of autoantibodies.

Radiographic instruments: evaluation of radiographs of hands and wrists according to the Sharp score modified by van der Heijde. Ultrasonographic Instruments (quantitative and semi-quantitative measures): synovial hyperplasia, synovial blood flow (Power Doppler), bone erosions and cartilage. The joints that will be evaluated: radiocarpal, distal radioulnar, first to fifth metacarpophalangeal and proximal interphalangeal. Ultrasonographic interobserver reproducibility will be carried out in 10% of the patients. All the examinators will be blind for each other findings. Rheumatoid factor and anti-CCP will be investigated in RA patients. Statistical significance will be set at 5%.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years;
* female and male;
* patients with SLE, according to the revised classification criteria of the ACR (Arthritis Rheum, 1997) with current or previous joint activity (arthritis or arthralgia;
* patients with established RA according to ACR classification criteria (Arthritis Rheum, 1988)

Exclusion Criteria:

* changing the dose or drug-based immunosuppression in the last 3 months.
* corticosteroid pulse therapy in the last 30 days;
* infiltration with corticosteroids at hand in the last 3 months;
* previous surgery in the joints studied;
* irreducible deformity of the joints studied;
* overlap with other joint diseases or collagen;
* chiropractic diabetic;
* hypothyroidism
PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers

The objectives of this pilot feasibility study, which is on the use of 68-Ga PSMA PET imaging of salivary gland tumours, are

* to determine the proportion of patients with high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer; and
* to determine if in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers.

The hypotheses of this study are that there is high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers; and that in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging.

The potential participant will be screened and confirmed for eligibility by the appropriate study-team member. A signed IRB approved informed consent will be obtained prior to conducting any study-related procedures.

On the scheduled visit date for the study,

* An intravenous cannula (plug) will be inserted in a vein in the participant's arm, through which the 68-Ga PSMA radiotracer for the scan will be injected. The infusion will take about 1-2 minutes.
* PET imaging will be performed with a dedicated PET/CT scanner. 2.5-6.0 mCi (depending on weight of the patient) of PSMA radiotracer will be injected intravenously.
* A PET scan will be done around 60 minutes after the injection of the 68-Ga PSMA imaging agent.
* During imaging, the participant will be asked to lie still and may be asked to hold his/her breath for a few seconds.
* Imaging will be performed using a PET/CT, which will take 30 to 40 minutes to complete. Imaging of the body from vertex to mid thigh or feet will be obtained.
* After the completion of the scan, the plug will be removed.

A Final Study Visit will take place on that one scheduled day. The participant will not need to visit the doctor's office during the course of the study outside of their usual scheduled doctor's follow up appointments.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, metastatic or locally recurrent salivary gland cancers OR rare cancers (Examples of rare cancers: thyroid ca, cholangio ca, pancreatic ca, gall bladder ca, sarcoma)
* Sample of biopsied tissue available for analysis
* Histologically confirmed diagnoses
* Above 21 years of age
* Able to provide informed consent

Exclusion Criteria:

* Those who do not meet above inclusion criteria
* Diagnosis of haematological malignancies
* Patients with more than one cancer diagnosis
* Contraindication to 68Ga-PSMA PET/CT

  * E.g.: pregnant patients, breast feeding patients, renal impairment, liver impairment, allergy to components of the test
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule
* Ongoing participation in any other clinical trial
A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines

The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.

Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:

Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.

Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.

Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.

An interim analysis is performed after all patients receive the second dose (at 1 month).

Eligibility Criteria:
Patients must:

Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.
Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* patients who require moderate procedural sedation with propofol in the ED

Exclusion Criteria:

* age \> 17 years
* pregnant
* intoxicated
* cannot give informed consent
* allergy to ketamine or propofol
* patient will require deep procedural sedation
* ASA physical status score \> 2
REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)

Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.

Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.

BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be between 19 and 70 years old.
* Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
* Patients are scheduled for coronary intervention
* He/she or his/her legally authorized representative provides written informed consent

Exclusion Criteria:

* Experience of cardiopulmonary resuscitation
* Cardiogenic shock
* Expected survival less than 2 years
* Pregnancy or breast feeding
* Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy

The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are 19 years old or older.
2. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:

   * Didn't take antihypertensive drug

     * 140 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
   * Taking antihypertensive drug

     * 130 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
3. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects with symptomatic orthostatic hypotension
3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \> 9.0%)
4. Subjects with Severe heart failure(NYHA Class 3,4) etc.,
5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
6. Subjects with a history of disability to investigational product ADME at the time of screening
7. Subjects with abnormalities in laboratory test results at the time of screening
8. Subjects with hypersensitivity or history of investigational product and similar drugs
9. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
11. Subjects who received other investigational product within 4 weeks of screening visit
12. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product
13. Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C, Genotype 1
* HCV RNA \>100,000 IU/mL at screening;
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
* Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion Criteria:

* Any evidence of liver disease other than HCV;
* Co-infection with HIV;
* Diagnosed or suspected hepatocellular carcinoma;
* Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass

Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* Patients scheduled for elective cardiac surgery under CPB at the university hospital of Lille, France
* Patients with given written consent
* Patient insured under the French social security system

Exclusion Criteria:

* Pregnant or breastfeeding
* Off pump cardiac surgery
* Lack of DO2 monitoring
* Emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, LVAD implantation) Uncontrolled sepsis
The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis.

The therapeutic alliance (TA) is the working relationship or positive social bond between the patient and the therapist. TA is based on collaboration, communication, empathy of the therapist and mutual respect. Fostering an enhanced therapeutic alliance is a low-cost, therapist-dependent strategy that can accompany any clinical intervention. Growing evidence suggests that the TA plays a pivotal role in clinical outcomes in psychotherapy, medicine and physiotherapy interventions for chronic low back pain. On the other hand, therapeutic exercise is an economic, accessible and simple intervention strategy that has proven to be effective and safe to decrease pain and improve physical function in people with knee osteoarthritis (OA). To date, the role of TA in the management of knee OA is unknown. We hypothesized that a therapeutic exercise protocol accompanied by an enhanced TA could reduce the severity of symptoms and improve function in patients with symptomatic knee OA.

The objective of this randomized clinical trial will be to determine the effects of different levels of TA during the application of a therapeutic exercise program on pain intensity, pressure pain thresholds and function in patients with symptomatic knee OA.

Eligibility Criteria:
Inclusion Criteria:

- People aged 45 to 65 years with a clinical and radiographic diagnosis of knee osteoarthritis (grade I-III according to Kellgren and Lawrance), symptomatic with pain intensity between 3 and 8 points in the PI-NRS with at least 3 months duration, resulting in a mild to moderate level of disability (WOMAC).

Exclusion Criteria:

- People with other musculoskeletal, neurological, or immune conditions that cause pain or functional limitation in the lower extremities (hip osteoarthritis, patellar tendinopathy, sprains, radiculopathies, rheumatoid arthritis, systemic lupus erythematosus), history of trauma less than a year ago ( knee fractures, meniscal or ligament tears) or surgery of any kind on the lower extremity. Knee mobility less than 90º flexion. People in treatment with oral or intra-articular corticosteroids, antibiotics or exogenous opioids of any kind, with unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow physical exercise.