cyrilzakka/clinical-trials huggingface dataset:
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients

Several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. Little is known about the impact of epidural injection in such patients. The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.


Eligibility Criteria:
Inclusion Criteria:

* diabetes stable for more than ten days
* no contraindication for steroids
* lumbar stenosis
* articular pain

Exclusion Criteria:

* unstable diabetes
* renal insufficiency
Sexual Behavior in Head and Neck Cancer Patients

The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

SCCHN is believed to be caused by different types of viruses being exposed to the mucous membrane on the inside of the mouth, throat, and voice box, over a long period of time. This exposure results in changes in the cells of the mouth, throat, and voice box, which can lead to the development of cancer.

HPV-16 has been linked to SCCHN. Half of all cancers of the oropharynx (the middle part of the throat, the base of the tongue, and tonsils) may be caused by HPV-16. HPV-16 is normally spread sexually, and is one of the main causes of cervical cancer in women. By finding out if the virus is also spread sexually to the throat, doctors may be able to teach patients about risk factors for developing cancer in this area.

Study Procedures:

If you agree to take part in this study, you will be asked to complete a questionnaire about your sexual history, such as specific sexual practices, number of partners, exposure to HPV and other viruses, and any medical history related to HPV-16. The questionnaire will take 10-15 minutes to complete.

None of your personal identifying information will be attached to your questionnaire, and the questionnaire will be assigned a one-of-a-kind study code number.

To check your cancer diagnosis, your medical records will be reviewed.

Length of Study:

Once you have completed the questionnaire, your participation in this study is over.

This is an investigational study.

Up to 1,500 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.
2. Must have the ability to understand and provide informed consent.
3. Patients must be 18 years and older.
4. Ability to read, write, and speak English.
5. Resident of the United States.
6. Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested.

Exclusion Criteria:

1. Previous cancer diagnosis excluding non-melanoma skin cancer.
2. Blood transfusion within the previous 6 months.
3. Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).
Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

A large proportion of patients with Parkinson's disease suffer of chronic pain directly related to the disease. The management of painful symptoms is difficult and currently, there is no commonly admitted guidelines.

Several studies have shown the efficacy of Erickson hypnosis to reduce the perception of chronic pain in different conditions. This efficacy has never been tested in Parkinson's disease.

The objective of this study is to assess the efficacy of Erickson hypnosis protocol, compared to usual care, for the management of Parkinson's disease-related chronic pain.

The study team assume that Erickson hypnosis will be more efficient than usual care to reduce perceived chronic pain. They also assume that regular practice of autohypnosis will contribute to long-term efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* 18 to 80 years old
* idiopathic Parkinson's disease
* without neurological co-morbidity
* Suffering from chronic pain (for at least 3 months), related to Parkinson's disease
* Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain
* antiparkinsonian, analgesic and psychotropic treatments stable for 1-month
* having a health insurance
* signed informed consent form

Exclusion Criteria:

* Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome
* Early untreated patient
* Patient with acute intercurrent pain
* Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.)
* Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) \<24
* Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2\> 1)
* Patient with a apathy (MDS-UPDRS 1.5\> 1)
* Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2\> 1)
* Patient under the protection of adults
* Pregnant or lactating woman
Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).


Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy of the spastic type
* Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.

Exclusion Criteria:

* Children who have undergone surgery on the lower limbs.
* Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.
* Children with ongoing analgesic treatment
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).


Eligibility Criteria:
Inclusion criteria:

* Patients who participated in and completed study CRAD001A2420

Exclusion criteria:

* Premature study or study treatment discontinuation in CRAD001A2420 study.
* Acute rejection within the 3 months prior to inclusion

Other protocol-defined inclusion/exclusion criteria may apply
Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The uncertainty regarding the tradeoffs inherent in the choice of procedure has not been resolved. As such the investigators aim to perform a randomized single blinded trial to evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.

A blinded, randomized, prospective clinical trial is being performed involving Manitoban women over 18 years undergoing unilateral or bilateral breast reconstruction. Women were originally randomized 50/50 to either the DIEP or SIEA group. Due to only about 60-70% of patients randomized to the SIEA group actually receiving the SIEA procedure, the weight of the randomization has now been changed to 70/30 (SIEA/DIEP) for the remainder of the study (approx. 40/110 recruited patients waiting for their OR). Objective isokinetic abdominal strength testing is being done pre-operatively and 3, 6 and 12 months post-operatively. A self-administered validated abdominal wall and breast outcome questionnaire (Breast-Q) is also given preoperatively and at 3 and 12 months postoperatively in . Secondary outcomes measured include: fat necrosis, abdominal wound breakdown, flap loss and seroma rate. Fat necrosis is detected using ultrasonography. Abdominal wound breakdown is measured using calipers. Seroma rates are tabulated and drainage volumes measured. Statistical analyses include a combination of parametric and non-parametric tests.

Eligibility Criteria:
Inclusion Criteria:

* female subject older than 18
* with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
* fluent in English

Exclusion Criteria:

* reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
* suffer from neurological back problems
* suffer form inguinal hernias
Motivation and Nicotine Patch Treatment for Under-served Smokers

The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Currently smoking at least 10 cigarettes/day for past 3 months
* Speak English or Spanish
* Have a telephone or live close to a relative or neighbor with a telephone
* Agree to participate in the study and be available over the next 6 months.

Exclusion Criteria:

* Unable to use nicotine patch due to medical status
* Active skin condition or history of skin allergy
* Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment
* Pregnant or nursing
Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment

Investigating different periodontal surgery techniques to treat gummy smile.

Participants will be subdivided into 3 (three) groups:

1. Patients with upper lip hypermobility - surgery for device implantation in the anterior area of the maxilla;
2. Patients with short teeth and upper lip hypermobility - flap surgery/gingivectomy and device implantation; and
3. Patients who refuse implantation - flap surgery/gingivectomy;

Eligibility Criteria:
Inclusion Criteria:

* Gummy smile due to two etiologies (combined or isolated);
* Short clinical crown of teeth due to the altered passive eruption;
* Upper lip hyperactivity

Exclusion Criteria:

* Smokers;
* Pregnant or breastfeeding patients;
* Patients with systemic diseases that can affect the result of surgical treatment (such as diabetes, heart diseases and taking blood anticoagulant medication, blood diseases, immunodeficiency disease etc.);
* Cleft lip;
* Craniofacial syndrome;
* Facial alteration surgeries during the study;
* Active orto treatment.
ORTHOVISC Shoulder Osteoarthritis Study

A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.

Eligibility Criteria:
Inclusion Criteria:

* A candidate for unilateral treatment of osteoarthritis of the shoulder
* Have failed conservative treatment

Exclusion Criteria:

* Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
* No active instability or acute dislocation episodes within the previous 12 months
* Known allergy to hyaluronate preparations
* Pregnant or breast feeding
* Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
Protein Supplementation In Dialysis Patients

The dialysis population has a strikingly high incidence of mortality. The life expectancy of chronic dialysis patients is 20 years less than that of the general population. Approximately 50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general population. There is also a steady increase of patients with diabetes and the older age groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in ESRD patients. Associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.Therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (PD) patients. This research will also generate basic data about significant health markers critical to the health status of PD patients.

This study is a randomised, open labeled controlled trial where a total of 74 PD patients (37 supplemented; 37 control) were recruited from government and private settings. Subjects were randomised to either the intervention or control group. The intervention group received hydrolysed whey protein supplement and diet counselling for 6 months while the control group received only diet counselling for 6 months.

Patients who consented were first subjected to a screening for identification of eligible subjects. The screening involved basic anthropometry measures (height, weight, BMI), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. About 4ml of pre-dialysis blood was also collected by respective nurses for additional laboratory parameters (hsCRP).

During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline and end of the study (at 6 months) for anthropometry assessment, laboratory results, medical condition, hospitalisations, nutritional status, dietary intake and compliance towards supplementation (intervention group only).

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years old and ≤70 years old
* Undergone dialysis at least for 6 months.
* Categorised as malnourished based on BMI \<24 kg/m² and serum albumin ≤40 g/L criteria
* No incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months.

Exclusion Criteria:

* Patients with high inflammatory diseases, malignancy, cancer
* Vegetarian patients
Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.

This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.

The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset.

The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.

Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement.

All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25.0
* Moderate or severe NAFLD
* 30 \< age \<60

Exclusion Criteria:

* Overt cardiovascular disease and revascularization procedures;
* Stroke;
* Clinical peripheral artery disease;
* Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose \>126 mg/dl, or casual glucose \>200 mg/dl);
* Severe medical condition that may impair the person to participate in a nutritional intervention study;
* Impossibility to follow Mediterranean Diet for religious or other reasons.
A Study of BMS-986195 in Healthy Male Subjects

The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male subjects, if not surgically sterilized, must agree to use adequate contraception
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight \[kg\]/\[height (m)\]2), and total body weight \>50 kg
* All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
* All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator

Exclusion Criteria:

* Previous participation in the current study
* Known previous exposure to BMS-986195
* Employee of PRA or the Sponsor
* History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
* Using tobacco products within 60 days prior to drug administration
* Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies

Other protocol defined inclusion/exclusion criteria could apply
Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

The aim of this study is to establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy and to identify the potential risk factors associated with the development of AKI.

Introduction: Laparoscopic procedure produces adverse effects on splanchnic organs. Pneumoperitoneum is a non-physiologic condition that causes a higher intra-abdominal pressure (IAP) and is associated with significant direct and indirect effects on renal physiology.

Aim of the study:

To establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy.

To identify the potential risk factors associated with the development of AKI. To establish the relationship between the IAP during the procedure and the AKI incidence.

Study Design:

Study population: A single center prospective cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.

Inclusion criteria: age \> 18 years, able to sign the consent form, stable kidney function.

Exclusion criteria: end stage renal disease, acute kidney injury or need of dialysis three months prior the procedure, acute infection, acute inflammation, BMI \> 40, malignancy and pregnancy.

The diagnosis of AKI will be made based on Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline 2012, by comparing the baseline and post-operative serum creatinine and cystatin C and monitoring urine output during the procedure and after the procedure for 24 hours.

Data Analysis: Results will be presented as mean ± standard deviation for quantitative data. A p value of \<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years, able to sign the consent form, stable kidney function.

Exclusion Criteria:

* end stage renal disease
* acute kidney injury or need of dialysis three months prior the procedure
* acute infection
* acute inflammation
* malignancy
* pregnancy
Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE

Use of MRI and DWI to diagnose cardiac scarring after heart attack.

To discover new information about MRI (magnetic resonance imaging) called DWI (diffusion weighted imaging) and its ability to diagnose cardiac scarring.

CMR-DE (cardiac MR with delayed contrast enhancement) evaluates if there has been scarring in the heart muscle following a heart attack.

Subjects are injected with a contrast medication that makes the scarring visible if present. To prove the efficacy of DWI (diffusion weighted imaging) to provide the same images that CMR-DE (cardiac magnetic resonance with delayed contrast enhancement) provides.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 21 years of age and older
* Healthy volunteers
* subjects with a prior history of heart attack and prior CMR-DE imaging.

Exclusion Criteria:

* Women who are pregnant
* Subjects with GFR \< 60 ml/min/1.73m2
* Subjects with ICD
* Subjects with coronary stents incompatible with 3T