cyrilzakka/clinical-trials huggingface dataset:
Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans

Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid oxidation, leading to conversion of fatty acids into triglycerides and its accumulation inside the muscle tissue. Moreover, in adipose tissue mitochondrial dysfunction results in decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle tissue. Lipid accumulation inside muscle tissue interferes with the insulin signaling pathway and causes insulin resistance. Mitochondrial dysfunction in both tissues has therefore been proposed to play an important role in insulin resistance in humans.

Pioglitazone, a thiazolidinedione, is an FDA approved medication for the treatment of type 2 diabetes. It improves muscle insulin sensitivity at least in part by lowering intramuscular lipid concentrations but the mechanism by which this occurs is unclear. In the present study, we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in muscle and adipose tissue in humans who are insulin resistant.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
2. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
3. Subjects must range in age from 18-65.
4. Subjects must have the following laboratory values:

   * 2-hour OGTT plasma glucose 140-250 mg/dl
   * Hematocrit ≥ 35 vol%
   * Serum creatinine ≤ 1.6 mg/dl
   * AST (SGOT) \< 2.5 times upper limit of normal
   * ALT (SGPT) \< 2.5 times upper limit of normal
   * PT, PTT within the normal range

Exclusion Criteria:

1. Subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. Subjects taking systemic glucocorticoids will be excluded. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months.
2. History of clinically significant heart disease, including ischemic heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG) and congestive heart failure
3. History of peripheral vascular disease (history of claudication)
4. History of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
5. History of peripheral edema
6. Uncontrolled hypertension with systolic BP\>160 mmHg, diastolic BP\>100 mmHg
7. Resting heart rate \>100 beats/min
8. Autonomic neuropathy
9. Heavy alcohol consumption (\> 2 drinks/day)
Cortical Processing of Proprioception Related to Pitching Performance in Baseball Players With Glenohumeral Internal Rotation Deficit

The current study aims to characterize the cortical activity and proprioceptive acuity in baseball players with glenohumeral internal rotation deficit (GIRD). Additionally, the correlations between cortical activity, proprioceptive acuity, and pitching performance will be examined. The evaluation of proprioception will be conducted using the active joint reposition sense of the shoulder. Simultaneously, the investigators will record cortical activity by electroencephalography (EEG). To represent pitching performance, the investigators will collect ball velocity and pitching accuracy. This will help the investigators understand the process of proprioception in the central nervous system, as well as factors associated with pitching performance in baseball players with GIRD.


Eligibility Criteria:
Inclusion Criteria:

* playing baseball for at least one year
* still active in training or competition
* frequency of training or games should be at least 3 hours per week

Exclusion Criteria:

* current dominant upper extremities pain
* a history of upper extremities surgical interventions or fractures or dislocation or degenerative joint disease
* cervical radiculopathy within 6 months
* lower extremities injury or surgery within the current 6 months
* Visual analog scale (VAS) \> 5 during movement in the experiment
2nd-line Treatment of Metastatic Colorectal Cancer

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:

* Center
* Number of metastatic sites: 1 versus \> 1
* Bevacizumab-based first-line therapy: Yes versus No

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal cancer
* Resected or asymptomatic primary tumor
* Metastatic colorectal cancer not eligible for curative surgery
* No major surgery within four weeks of the start of study treatment
* At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
* Disease progression after failure of irinotecan-based chemotherapy
* Bone metastases are allowed if there is at least one other measurable metastatic site
* CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
* WHO PS ≤ 2
* Platelet count \>= 100,000 mm3
* Hemoglobin \> 10g/dl
* Bilirubin \< 1.5 ULN, AST/ALT \< 5 ULN
* Serum creatinine \< 1.5 ULN, creatinine clearance \> 60 ml/min (Cockcroft)
* A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
* Negative pregnancy test in women of childbearing potential
* Male or female using an effective contraceptive method
* Absence of known or symptomatic brain metastases
* Life expectancy \> 3 months
* Informed consent signed prior any study specific procedures

Exclusion Criteria:

* Prior raltitrexed-based chemotherapy
* Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
* Uncontrolled arterial hypertension defined as systolic pressure \> 150 mm Hg or diastolic pressure \> 100 mm Hg
* Malignant hypertension or hypertensive encephalopathy
* Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
* Hemorrhagic diathesis or significant pathology of coagulation
* Peripheral neuropathy grade\>2 (NCI-CTC v4.0)
* Hemoptysis \< 1 month
* Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
* Symptomatic brain metastases or carcinomatous meningitis
* History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
* Severe bacterial or fungal infection (Grade \> 2 NCI-CTCAE v.4.0)
* Known or suspected sensitivity to one of the study drugs
* Pregnant or breastfeeding women
* Previous enrollment in an investigational drug study within the last 4 weeks
* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)
Determination of MCG Reference Intervals in Healthy Individuals

Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting cardiac abnormalities. However, the results of MCG cannot be evaluated without defined reference intervals. This is a multicenter cross-sectional study designed to establish reference values for MCG parameters healthy adults in China.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Those with no hospitalization for any reason in the 6 months prior to the study.
3. Those who are not currently taking any prescribed medications.
4. Those with no history of cardiovascular diseases, including coronary artery disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic coarctation, or peripheral arterial disease.
5. Those with no risk factors for cardiovascular diseases, including hypertension, diabetes mellitus, hyperlipidemia.
6. Those with no history of smoking (previous non-smoking or smoking cessation \>6 months).
7. Those with no excessive alcohol consumption (average daily alcohol consumption \<3 drinks, 1 drink = beer 355mL / white wine 44mL / red wine 118mL).
8. Signed informed consent.

Exclusion Criteria:

1. Those with body mass index \>28kg/m2 or \<18kg/m2.
2. Those with resting heart rate \<50 beats/min, or \>110 beats/min.
3. Those with resting systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90 mmHg.
4. Those with fasting blood glucose ≥7 mmol/L, and/or random blood glucose ≥11.1 mmol/L.
5. Those with total cholesterol ≥6.2 mmol/L or low-density lipoprotein cholesterol ≥4.1 mmol/L.
6. Those with abnormal electrocardiograms, such as arrhythmias, ST-T changes, and pathologic electrical axis deflections.
7. Those with cardiac ultrasonographic pathologic findings, such as left ventricular hypertrophy, left ventricular dilatation, abnormal ventricular wall motion, and valvular regurgitation or stenosis of more than mild degree.
8. Those with respiratory diseases, kidney diseases, liver diseases, endocrine diseases, anaemia or other blood diseases, connective tissue diseases, malignant tumors and other diseases.
9. Professional athletes, pregnant or lactating women, psychological or psychiatric disorders such as depression.
10. Those who are unable to perform magnetocardiography due to claustrophobia, etc., or those who are unable to cooperate with the corresponding examinations required by the study for various reasons.
Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC

To investigate the role of racial and socioeconomic disparities in coronary heart disease (CHD) mortality in the United States.

BACKGROUND:

Despite strong decreases in coronary heart disease (CHD) mortality over past decades, there is evidence that racial and socioeconomic disparities in CHD mortality are increasing. CHD surveillance efforts that examine trends within these population subgroups are an important first step in quantifying and reducing disparities. The Atherosclerosis Risk in Communities (ARIC) Study has monitored rates and trends in validated hospitalized myocardial infarction and fatal CHD among black and white adults aged 35 to 74 years in four U.S. communities since 1989.

DESIGN NARRATIVE:

The study will expand the scope of ARIC surveillance by examining variations in the rates and temporal trends in CHD by socioeconomic status (SES), measured at the level of census tract. For CHD events already included in ARIC surveillance (1992-2002), addresses will be obtained from medical records and death certificates and geocoded so that they can be matched with identifiers for census based geographical areas. The ARIC study will contribute yearly updates of abstracted CHD events and addresses for subsequent years (2003-2005). Each event will be linked with census tract level SES indicators available from the 1990 and 2000 censuses. This novel effort will permit an examination of disparities by SES in rates and trends in fatal CHD, hospitalized myocardial infarction, case fatality, use of invasive cardiac procedures and prescription of efficacious medication at time of hospital discharge. In addition, the extent to which racial disparities in CHD and associated treatments are explained by SES will also be explored.

Eligibility Criteria:
hospitalized and fatal coronary heart disease cases eligibility: within 4 defined geographic areas and ages 35 to 74 years of age
Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.

The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Eligibility Criteria:
Inclusion Criteria:

* Woman over 40 years of age
* Has a tomosynthesis examination with comparator
* Has a mammographic finding

Exclusion Criteria:

* Pregnant, breastfeeding or believes she may be pregnant
* Unable or unwilling to give informed consent
I-Smads in Periodontitis

Recently, it has been stated that Smads play an active role in all conditions where transforming growth factor-beta (TGF-β) is involved, including periodontal inflammation. This study aimed to examine the levels of TGF-β and inhibitor Smads in saliva and gingival crevicular fluid (GCF) in patients with Stage 3 Grade B periodontitis before and after non-surgical periodontal treatment. Twenty (20) stage 3 grade B periodontitis and 20 periodontally healthy individuals were included in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and saliva samples were obtained at baseline and one month after treatment. TGF-β, Smad6, and Smad7 were determined by ELISA.


Eligibility Criteria:
Inclusion Criteria:

* Have at least 20 natural teeth, excluding third molars.
* Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.
* Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

* History of systemic disease.
* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
* Periodontal treatment during last 6 months that could affect periodontal status.
* Smoking.
* History of radiotherapy or chemotherapy.
* Current pregnancy, lactation or menopause.
Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters

The aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone.

A chronic condition such as psoriasis requires a high level of self- management and requires for many patients behaviour change to improve health outcome. Changing behaviour is a challenge that requires a commitment by the patient to implement successfully. Motivational interviewing is a patient centered directive counseling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. It is a well-known method of counseling, and is considered to be a useful intervention strategy in the treatment of lifestyle problems.

This study is a randomized controlled trial using telephone motivational interviewing. The counseling intervention comprises 6 telephone calls during a 12 week period, after attending 3 weeks of supervised climate therapy on the Canary Islands

Eligibility Criteria:
Inclusion Criteria:

* Conducted 3 weeks of supervised climate therapy in The Canary Islands
* Able to write and communicate in Norwegian
* PASI more than 7 on application

Exclusion Criteria:

* more than 5 climate therapy treatments during the last 10 years
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between the ages of \>=6 to \<18 years.
* Diagnosis of SCD
* 23vPS vaccination at least 6 months prior to enrollment.

Exclusion Criteria:

* Previous vaccination with pneumococcal conjugate vaccine.
* Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"

"In our study, we aimed to compare the effects of conventional radiofrequency thermocoagulation applied to the articular branches of the femoral and obturator nerves with chemical ablation using phenol on hip pain."

"Our study is designed as a double-blind, prospective randomized controlled trial. Blinding will be ensured by keeping the researcher performing pain diary follow-ups unaware of which procedure was applied to each patient.

Patients will be randomized using computer-assisted methods. Following approval from the hospital ethics committee, clinical trial registration will be conducted. From 2024 to 2025, patients presenting with chronic hip pain to the Department of Algology at ADU Faculty of Medicine will be divided into two groups. In Group 1, chemical ablation of the femoral and obturator nerve branches with phenol under ultrasound guidance will be performed. In Group 2, conventional radiofrequency thermocoagulation of the articular branches of the femoral and obturator nerves under ultrasound guidance will be applied.

During the study, pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, 2 hours post-procedure, and at 1 month and 3 months post-procedure for both Group 1 and Group 2. The WOMAC scale will be used to evaluate their functional capacity."

Eligibility Criteria:
Inclusion Criteria:

Be older than 18 years old. Written consent must be obtained. Have had chronic hip pain for more than 3 weeks. -

Exclusion Criteria:

Major psychiatric illness Presence of lumbar radicular pain or referred pain in the patient Patients using anticoagulant agents Patients with infection in the area where the procedure will be performed Those with allergy to local anesthetics Those allergic to phenol or betamethasone Pregnant women Scheduled for surgery

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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the diagnostic criteria used and the population being studied.

GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S recommendation has failed worldwide for the same reasons: the presently impractical pattern of the testing. A solution is direly needed.

Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically, to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.

We hypothesize that, in GDM women, results of an OGTT performed after delivery, before hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks postpartum (OGTT-2). Our aims are:

1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study.
2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the 2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.
3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum).

If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum OGTT will be avoided. Medical practice will change.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 45 years;
* Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA criteria or patient followed for GDM);
* Treated with diet, insulin or oral hypoglycemic agents;
* Have given birth to a child at term (gestational age ≥ 37 weeks);
* Have signed the consent form.

Exclusion Criteria:

* History of glucose intolerance or diabetes before the pregnancy;
* Have presented another obstetrical pathology during the pregnancy;

  * Severe gestational high blood pressure with proteinuria;
  * Delayed intrauterine development syndrome;
  * Pregnancy with more than a foetus;
  * Drug addiction;
  * Had complications during the delivery such as:
* Moderate to severe postpartum bleeding;
* Surgery in postpartum (curettage, hysterectomy, etc.).
Investigation of KLYX in Patients With Constipation

This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
* Ethnically Chinese
* Males or females aged between 18 and 65 years inclusive
* A history of constipation symptoms for at least 6 months fulfilling, with occurrence of two or more of the following symptoms during the 3 months before screening (the 3 months need not be consecutive):

  i. Very hard (pellet-like) and/or hard stools (Type 1 or 2 of the Bristol Stool Scale) for at least 25% of the time; or ii. Sensation of incomplete evacuation at least 25% of the time; or iii. Straining during defecation at least 25% of the time; or iv. Sensation of anorectal obstruction or blockage often during defecation at least 25% of the time; or v. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation, support of the pelvic floor) at least 25% of the time; or vi. Fewer than 3 defecations per week.
* Patient has had no bowel movement (i.e. still constipated) two days prior randomisation.

Exclusion Criteria:

* Any disorder or laboratory result at Screening that in the judgement of the investigator that will place the subject at excessive risk if participating in a controlled study
* Clinically suspected to have colorectal cancer
* Significant gastroparesis or gastric outlet obstruction
* Hypersensitivity to sodium docusate and/or sorbitol
* Hypersensitivity to glycerine
* Pregnant or lactating women, women who intend to conceive, or women who are sexually active and capable of pregnancy who are not using a method of birth control (e.g. prescription hormonal contraceptives, intrauterine device, double-barrier method, male partner sterilization)
* Diabetic patients currently on insulin therapy
* Having participated in other clinical trial(s) within the 3 (three) months prior screening
* Unable to withdraw medications that may affect gastrointestinal motility such as prokinetics, erythromycin analogues, laxatives, etc.
* Unable to meet or perform study requirements: known or suspected inability to comply with the study protocol