cyrilzakka/clinical-trials huggingface dataset:
Characterization of the Incretinpathy in Type 2 Diabetes Initiated After Sixty Years Old

Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production, frequently accelerated gastric emptying and obesity. The known effects of the incretin hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in gastric emptying and modulation of the appetite. T2DM have disturbances in this system, providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert trophic effects on the beta-cell.

Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents rests on their ability of to increase active (intact) levels of incretin peptides, including GLP-1 and GIP.

Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.

T2DM in elderly are behaving differently. Elderly patients have no increase in liver production of glucose; when obese, have normal insulin secretion, however, display extreme resistance to its action. In non obese individuals, the concentration of glucose necessary for insulin secretion is increased and the action is standard. These findings suggest therefore that the approach should be differentiated treatment for these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Stable weight (\<5% variation) within the last three months
* Age: 35 to 50 years old for middle-age group, and 65 to 80 y old for elderly group
* Body mass index (BMI): 20 to 29.9kg/m2
* T2DM with diagnosis above 35 years and less than 5 years (Middle-age group)
* T2DM with diagnosis above 65 years and less than 5 years (Elderly group)
* Use of oral antidiabetic drugs (that must at stable dose within the last 3 months)
* Not have participated in any study of intervention with drugs in the last six months.

Exclusion Criteria:

* Use of estrogen, progestogen, active antipsychotics and systemic corticosteroids
* Use of DPP-IV inhibitors and incretin mimetics (current or within 1 month before)
* Continuous use of insulin or glitazone
* Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
* Smoking
* Obesity
* Uncontrolled systemic or disabling diseases
* T2DM treated by non pharmacological methods
* Patients submitted to bariatric surgery
* Latent autoimmune diabetes of the adult (positive anti-GAD antibodies)
The Effects of Different Intensity Training on Strength and Mobility of Elderly

In this study, investigators tried to find a useful and safe way of training for the elderly population which can help this population to improve their fitness factors as fast as possible. investigators have tried to see if different intensity training has different effects on muscle strength and functional mobility of elderly women in different time points (4, 8, and 12 weeks). Investigators hypothesized that Higher intensity would be more effective to improve muscle strength and functional mobility at different time points. The participants were trained twice per week and each session contain 4 exercises ( leg press, leg extension, leg curl, and seated calf raises) and the data have been collected at the pre-test and 4th, 8th, and 12th weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years old and above.
* Orientation to place, time, and person, able to follow the simple instructions, and perform the exercises.
* Without any health problems that would interfere with their safety or ability to complete high and low-intensity training such as the occurrence of myocardial infarction in the past six months, recent heart attack, uncontrolled hypertension (Blood Pressure \>166/96 mm Hg), a broken leg in the past six months, diagnosed osteoporosis, and diagnosed stage three and four of heart failure.

Exclusion Criteria:

* Participation in regular balance or lower body resistance training during the past three months (at least twice per week).
* The health issues that might confound the study results, including lower-body neuropathy, stroke within the past year, Parkinson's disease, diagnosed vestibular disorders, severe vision (self-rated vision as poor or very poor even when wearing glasses or contact lenses), and lower-extremity joint replacements.
* Taking the regular medication's impairing balance ability (Antidepressants, Neuroleptics or Benzodiazepines) or muscle strength (Corticosteroids).
* Elderly with dementia
Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract

The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose was demonstrated in a double-blind, placebo-controlled study. .

Peanut skins, a by-product of peanut processing industry, is usually discarded as a waste in despite of the high content of phenolic compounds. Polyphenol extract from peanut skins has been demonstrated to inhibit α-amylase activity in vitro. Hence, the aim of this study was to evaluate the regulatory effects of the peanut skin extract on blood glucose and body fat by a double-blind, placebo-controlled, clinical study. Subjects with simple obesity (body mass index \[BMI\] ≥ 27 or body fat ≥ 30%) ingested 4 Sugarlock® (n = 16) capsules or placebo (n = 14) a day for a total of 6 weeks. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every three weeks. Also, 5 subjects were randomly selected for MRI scans to examine the distribution and thickness of abdominal fat layers before and after the trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 20-70 years;
* Body mass index (BMI) ≥ 27 or body fat ≥ 30;
* No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
* No drugs consumption.

Exclusion Criteria:

* BMI \>35;
* Alcoholic;
* US-controlled diabetics;
* Stoke in past one year;
* High blood pressure;
* Mental diseases or melancholia;
* Pregency or breast-feeding a child.
Breakfast Nutrition and Inpatient Glycemia

A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital "no concentrated sweets (NCS)" breakfast meals with more balanced meals. The study team hypothesized that a balanced breakfast would improve pre-lunch BG values.

This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD). Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All patients on Ward A (with and without diabetes) were given the intervention breakfast for the first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS meals). After 4 weeks, the standard and intervention wards were switched. Data were collected only on patients with diabetes who were able to consume meals.


Eligibility Criteria:
Inclusion Criteria:

* Adults with cardiovascular disease who were admitted to 2 pre-specified wards at Duke Medical Center during the study period
* Diagnosis of diabetes (type 1 or 2) or newly identified hyperglycemia (blood glucose of \>200 on 2 separate occasions)
* Able to consume food by mouth

Exclusion Criteria:

* Intensive care patients
* No intake by mouth (enteral, parenteral, NPO)
* Taking in nutrition supplements (Ensure, etc)
Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)

The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis.

The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.

Retrospective archive study.

In the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed retrospectively in the Radiology department of Usak Education and Research Hospital. Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler) measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS patient's phenotype will be evaluated according to National Institutes Health (NIH) recommendations.

The ovarian ultrasonographic findings of PCOS women will be compared.

This study approved by Usak University Medical Faculty Ethical Committee April,06,2022.

The Ethical Committee decision number is 57-57-04.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive period According to Rotterdam criteria PCOS women.

Exclusion Criteria:

Women have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.
Meditation and Hypnosis for Chronic Depressed Mood

This study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.


Eligibility Criteria:
Inclusion Criteria:

* Currently meeting DSM-IV criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more.
* Being 18 years of age or older.
* Being sufficiently proficient in English to be able to participate in group therapy.
* Being able to attend weekly meetings at Stanford.

Exclusion Criteria:

* Concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the SCID interviews).
* Presence or history of psychosis.
* A current primary diagnosis of panic disorder, generalized anxiety disorder, or PTSD.
* A current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months).
* Serious suicidal risk, as defined by:
* Current suicidality, i.e., beyond simple ideation (e.g., making threats or attempts; gathering means; has a plan); OR
* Serious prior attempts (bodily harm; gathered means; hospitalization).
* Has a significant medical condition that could interfere with participation in meditation/yoga.
* Current participation in psychotherapy or a meditation group.
* Has started (or changed level or type of) prescribed antidepressant medication or St. John's Wort in the previous 3 months.
Fotemustine in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

* Assess the relationship between MGMT expression and response to fotemustine in patients with metastatic malignant melanoma.

Secondary

* Establish a value for MGMT expression below which fotemustine has a strong probability of effectiveness.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8, and 15. Beginning 5 weeks later, patients achieving stable or objective response receive maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6 courses.

Tissue samples are collected at baseline to assess level of MGMT expression by PCR.

After completion of study treatment, patients are followed every 2 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic malignant melanoma, meeting the following criteria:

  * Metastatic lymph nodes or skin allowing for surgical resection
  * At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)
* Measurable or evaluable disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* ANC \> 2 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Transaminases ≤ 2.5 times normal
* Alkaline phosphate ≤ 2.5 times normal
* Total bilirubin normal
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe uncontrolled infection
* No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* At least 2 weeks since prior adjuvant therapy
* At least 4 weeks since prior radiotherapy
* At least 30 days since prior participation in another clinical trial
* No prior or concurrent prophylactic phenytoin
Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.


Eligibility Criteria:
Inclusion Criteria:

* chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip)
* poor response to medical management that was attempted for at least 4 weeks
* a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion.

Exclusion Criteria:

* active sinusitis
* rhinitis medicamentosa
* recurrent and ongoing epistaxis
* immunodeficiency as defined by an illness or a history of sinus surgery.
Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.

WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. The aim of this trial is to investigate the bactericidal activity of faropenem administered with amoxicillin/clavulanic acid (augmentin) using the WBA model. We will also explore whether there is any additive effect or synergy with rifampicin in this model. The activity of faropenem on WBA by different strains of M. tuberculosis will be compared and the relationship between the host immune profile and WBA will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 21 and above
2. Male or female willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding
2. Signs of active TB
3. Previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems)
4. Current use of any drugs or medications known to have an interaction with any of the study drugs
5. Current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
6. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
7. Known hepatic disease or alcohol abuse
8. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
9. Current participation in other clinical intervention trial or research protocol
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
* Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
* Pregnant or lactating females
Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis

The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.

The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).

The 6minWT is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (MS) patients. The protocol for this test recommends a distance of 30 meters (6minWT30) to perform the test. However, this distance is not always available in practices and patients' homes. The aim of this study is therefore to validate a protocol over a distance of 6 meters (6minWT6) and to evaluate its reliability : intra-evaluator and test-retest.

The project focuses on the population of walking patients with MS. Inclusion: adults, confirmed diagnosis of MS, Expanded Disability Status Scale (EDSS) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of French, have already completed a 6-minute walking test, be able to give consent by signature.

Exclusion: Lung disease, heart disease, co-morbidity preventing 6minWT, relapse in the last 3 months, chronic fatigue ≥ at 8 (Visual Analog Score-Fatigue or Rochester Fatigue Diary).

21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minWT. The alpha was set at 0.01, the power at 0.9 for a correlation of 0.8.

Each patient will enter the study for one week, corresponding to two visits. The participant will perform the 6minWT6 and the 360 Degree Turn Test the first day and the 6minWT30 followed by the 6minWT6 after up to 45 minutes rest, the second day, a week apart.

Eligibility Criteria:
Inclusion Criteria:

* adults
* confirmed diagnosis of MS
* Expanded Disability Status Scale score 3 to 6.5
* to be able to walk 30 meters with or without aids
* good understanding of French
* have already completed a 6-minute walk test
* to be able to give consent by signature

Exclusion Criteria:

* Lung disease
* Heart disease
* co-morbidity preventing 6minWT
* relapse in the last 3 months
* chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.

PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.

ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.

Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.

Study type: RCT, single blind.


Eligibility Criteria:
Inclusion Criteria:

* Mastectomy program with axillary clearence

Exclusion Criteria:

* bilateral surgery
A2 to O Lung Transplants

Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.


Eligibility Criteria:
Inclusion Criteria:

* first lung transplant
* blood group O recipient
* low pre-operative anti-A antibody titers
* consent to study participation

Exclusion Criteria:

* re-transplant
* multiorgan transplant
* positive virtual crossmatch at time of transplant
A Physical Activity Program to Disrupt Sedentary Time in Older Latinos

To test the feasibility of an intervention designed to replace sedentary time with physical activity in older Latinos, delivered in their homes to improve cognitive function and brain connectivity.

After being informed of the study and potential risks, all patients giving informed consent will undergo a focused phone interviews, followed by screening to determine eligibility. Participants that meet inclusion criteria will undergo baseline cognitive function testing via video (following NIH toolbox guidelines for remote cognitive function assessment), followed by a one week measurement of sedentary time using a physical activity monitor (actigraphy). At week 0, participants will be randomized into either a physical activity group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs at 6 weeks using the same measures as baseline.

Eligibility Criteria:
Inclusion Criteria:

* no history of major head trauma
* ownership of a smartphone
* ability to make video calls

Exclusion Criteria:

* Requires assistive ambulation;
* Unstable angina,
* Claudication
* severe arthritis,
* extreme dyspnea on exertion,
* Class III-IV heart failure;
* Current uncontrolled sustained arrhythmias,
* severe/symptomatic aortic or mitral stenosis,
* hypertrophic obstructive cardiomyopathy,
* severe pulmonary hypertension,
* active myocarditis/pericarditis,
* thrombophlebitis,
* recent systemic/pulmonary embolus (within 3 months);
* Revascularization procedures within the previous 6 months;
* Pregnancy