cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients

The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and Female subjects,12-17 years old
* Receiving CNI-based maintenance immunosuppression since the time of renal transplantation in accordance with local standard of care
* Stable renal function, in the opinion of the investigator, with a cGFR\>45 mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)
* Adolescent Recipients of a renal allograft from a living donor or a deceased donor at least 6 months prior to enrollment
* Subject must be receiving a calcineurin inhibitor (CNI)-based \[cyclosporine (CsA) \[any formulation\] or Tacrolimus (TAC)\] immunosuppressive regimen
* Subject must be receiving adjunctive background maintenance immunosuppression with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS)/mycophenolic acid (MPA)
* Subjects may be receiving maintenance corticosteroids in accordance with the local standard of care
* Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or T-Spot-TB
* FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start of study medication
* Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2 (updated Schwartz formula)

Exclusion Criteria:

* Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and screening
* History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior to enrollment
* Subjects who have experienced more than 1 episode of acute rejection (AR) of the current allograft or any antibody-mediated AR
* Subjects with any active infection \[including, but not limited to, positive cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV retinitis, CMV colitis, etc.\]
* Urine albumin:creatinine ratio \> 56.5 mg/mmol (\> 0.5 mg albumin / mg creatinine) on a random voided urine specimen
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
* Patient meets protocol criteria for CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient demonstrates continued chronic constipation through Pretreatment Period
* Patient is compliant with IVRS

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer

Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.


Eligibility Criteria:
Inclusion Criteria:

* to live in the Ardennes department (France)
* affiliation to a health insurance organism
* 31 to 65 years old

Exclusion Criteria:

* current follow-up for cervical cytological abnormalities
* history of hysterectomy
* reimbursement for a Pap smear in the last 3 years
Clinical Indicators and Brain Image Data: a Study Based on Kailuan Cohort

The investigators will analyze the relationship between the medical history, physiological indicators and the cerebral small vessel disease as well as the structural and functional changes of the brain/head and neck organs in a large sample size of subjects (participants), to identify the influencing factors of the occurrence and development of cerebral small vessel disease as well as the structural and functional changes of the brain/head and neck organs, so as to provide objective clues for early intervention of the disease and improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 90 years old;
2. Comes from the Kailuan Cohort, completed ≥1 visits which the medical history, physiological indicators were measured;
3. Without contraindications of CT and MR scan;
4. Can cooperate with the measurement of the medical history, physiological indicators and brain imaging.

Exclusion Criteria:

1. Known clinical history with congenital or acquired organic diseases (such as aortic stenosis);
2. Known history of drug abuse;
3. Pregnant and lactating women; 4. With clinical history of psychiatric diseases (such as schizophrenia).
The Effect of Vibration Therapy Over Neck Myofascial Trigger Points

The aim of this study was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized that patients receiving vibration therapy would report less perceived neck pain, disability and present higher PPTs after receiving vibration therapy when compared to a control no-treatment group.

Myofascial trigger points (MTrPs) are a common source of (regional) pain in patients presenting with musculoskeletal pain. Mechanical vibration has been suggested as a treatment for pain relief. In this study, the effects of vibration therapy on people with non-specific neck pain and MTrPs were investigated. Seventeen chronic non-specific neck pain patients were randomly assigned to a treatment (vibration group, n = 9) or control group (n = 8). Vibration group received 10 self-administered sessions of vibration therapy (45-50 Hz for 15 minutes with the subject laying in supine). Perceived neck pain and disability and pressure pain thresholds over MTrPs of the upper trapezius and levator scapulae bilateraly were measured at baseline and after the first, five and 10 treatment sessions.

Eligibility Criteria:
Inclusion Criteria:

* a score of ≥ 5/50 in Neck Disability Index
* active or latent myofascial trigger points in upper trapezius or levator scapulae muscles

Exclusion Criteria:

* previous cervical spine surgery
* cervical radiculopathy
* severe systemic disease
* fibromyalgia
* other widespread musculoskeletal pain syndromes
* patients being treated with medication or physiotherapy within the last 4 weeks
Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the cytokine profile and the correlation to clinical parameters of patients undergoing chemotherapy for breast cancer.

Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.

Eligibility Criteria:
Inclusion Criteria:

* All patients were diagnosed with periodontitis (P) The inclusion criteria were:Loss of clinical insertion (CAL) ≥ 5mm and PD probing depth ≥ 6mm in ≥ 30% of sites; ≥20 teeth; radiographic bone loss that extends to the middle level of the root; presence of supragingival and subgingival calculus according to the severity of periodontal damage. Grade B was assessed indirectly, considering radiographic bone loss in the tooth most affected by dentition as a function of age (0.25 to 1.0).

Exclusion Criteria:

* 1) scaling and root planning or antibiotic treatment in the previous 6 months; 2) systemic diseases that could affect the progression of periodontitis (e.g., diabetes, hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4) long-term administration of anti-inﬂammatory medication; 6) smokers and former smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses containing antimicrobials in the preceding 2 months; 10) patients had previously received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients with neoadjuvant chemotherapy.
Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant

Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.

Recent in vivo studies have reported successful use of 1H and 31P MRS in differentiating between benign and malignant tumors in breast tissue. These studies demonstrated an increase in the choline metabolite peak that reflects an increase in choline-containing metabolites in 70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.The objectives would be to determine sensitivity/specificity of MRS in the context of breast CA, We will use normal volunteers to test software and to develop and optimize MR scan sequences prior to or during the testing of target subjects with suspicious breast lesion.

Eligibility Criteria:
Inclusion Criteria:

* subjects should have well defined suspicious breast lesion and that will be biopsied
* subjects are to include; varied volunteers with different breast tissue with characteristics such as dense breasts, fibrocystic breasts, "small" breasted and "large" breasted women.

Exclusion Criteria:

* Women of childbearing potential who are not practicing a medically accepted method of birth control should not participate
* Subjects that are pregnant, breast-feeding, should not be able to participate
* Subjects having any of the following metallic devices, will be ineligible to participate in the study: pacemaker, prosthesis, artificial heart valve, coronary artery stents, TENS (Transcutaneous electric nerve stimulator) or other neurological stimulation units and surgical clips.
Palatability and Perceived Satiety of Oral Nutrition Supplements

The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion.

The study is a single-blind intervention with a within-subjects design. In total 104 apparently healthy and independently living older adults aged 65 will be recruited to participate. Participants will visit the research facilities eight times in a period of one month. On each test-day participants will consume and evaluate a single product.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or over
* Apparently healthy
* Living independently

Exclusion Criteria:

* Allergies to soy, dairy or gluten
* Following a specific diet
* BMI\>30 kg/m2
* Reduced kidney function
* Suffering from Alzheimer's disease, Dementia, Parkinson's Disease, Cancer, Kidney Disease or Diabetes
* Suffering from Dysphagia
* Already using oral nutritional supplements
* Receiving any medical treatment that is known to reduce the taste or sense of smell
* Current smokers
* Participation in another clinical trial at the same time
LBNP Tolerance With Skin Warming After Exercise Cold Stress

Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold.

Individuals who have experienced a hemorrhagic insult are often wrapped in a warm blanket. In individuals who have exercise in a cold environment, it is unknown how this skin warming influence tolerance to simulated blood loss and whether there is an optimal temperature to warm the skin up to in order to lower blood pressure (permissive hypotension).

After an initial study visit to examine exercise capacity (Visit 1), participants will complete four trials (Visits 2 through 5) After exercise in a cold environment, participants will have cold skin temperatures (\~82°F; Visit 2). Researchers will examine how increasing skin temperature to normal (\~90°F; Visit 3), warm (93°F; Visit 4) and hot (95°F; Visit 5) influences arterial blood pressure and tolerance to simulated blood loss compared to when the skin remains cold.

This project will test the hypothesis that skin rewarming to \~95°F lowers arterial blood pressure without impairing tolerance to simulated blood loss (lower body negative pressure; LBNP) relative to when the skin is kept cold (82°F).

Primary data include core and skin temperatures, arterial blood pressure and LBNP tolerance time. Secondary variables include skin blood flow and heart rate. After completing visit 1 first, all participants will complete visits 2 through 5 in a randomized order and participants are blinded. The order will be counterbalanced between participants.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 40 years old
* free of known disease and illness
* Speak English
* Systolic blood pressure \<140mmHg
* Diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Currently pregnant or breast feeding
* Individuals with diagnosed with cardiac, respiratory, neurological and/or metabolic illness or disease.
* Currently taking prescribed or over the counter medications known to influence the cardiovascular, pulmonary, renal and/or central nervous system.
* Current use of tobacco or nicotine products
* Any physical limitations that impede completion of the tests, such as exercise tests will also be an exclusion criteria.
* Body mass\< 80 pounds body weight
* Appendectomy
Genetics of Fibromyalgia

The Fibromyalgia Family Study identifies and collects blood samples from families with two or more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to identify genes that predispose people to FMS and/or symptoms related to FMS; identifying these genes may lead to a better understanding of the disease and more effective treatments.

FMS predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. The pathophysiological mechanisms underlying FMS are not clearly understood, but neuroendocrine factors seem to be of major importance. Studies of familial association suggest that genetic factors play a role in FMS. This study will establish patterns of genetic linkage in families with FMS.

Participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. Measurements of serum serotonin and related compounds will also be obtained. To detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology
* Have at least one living family member who has also been diagnosed with fibromyalgia
* No other major rheumatological disease
The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination

The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF.
* Participant must be a patient of Northwestern Medical Faculty Foundation.
* Participant does not intend to receive the influenza vaccine.

Exclusion Criteria:

* Participant has a diagnosis of Alzheimer's Disease or Dementia
* Participant has received an influenza vaccination during either the last influenza season or the current.
* The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).
A Study to Compare 2 Formulations of LY900014 in Healthy Participants

The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Had blood loss of more than 450 milliliters (mL) within the last 3 months
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
* Smoke more than 10 cigarettes per day
* Are infected with hepatitis B or human immunodeficiency virus (HIV)
* Are taking illegal drugs
Relationship Between Tooth Decay and Trabecular Bone

Chewing, a movement that matures with experiences, has effects on the growth and development of the stomatognathic system. Tooth decay, which is known to have effects on chewing, can affect the jaw bone due to its indirect effect on the mechanical forces transmitted to the jaw bone. This study was aimed to evaluate the relationship between dental caries and jaw bone trabeculation during the growth and development processes in children by fractal dimension analysis method. 40 patients with deep-dentin caries / apical rarefying osteitis on the right or left side, 40 patients with deep-dentin caries / apical rarefying osteitis on either the right and left sides and 40 patients without deep-dentin caries / apical rarefying osteitis between 8-13 ages were randomly selected. Digital panoramic images of the selected patients were analyzed with fractal dimension analysis.


Eligibility Criteria:
Inclusion Criteria:

* Panoramic radiographs of systemically healthy 8-13 years-old patients,
* Who applied to the Clinic between January 2018 and April 2020 were retrospectively scanned.
* Patients with 1st molars whose root development was completed and the 2nd molars not erupted yet were included.

Exclusion Criteria:

* Patients with temporomandibular joint disorders, any systemic disease, exposed to trauma in the area to be measured, received orthodontic treatment for the last 2 years or had an ongoing orthodontic treatment, unilateral / bilateral cross-bite and had parafunctional habits in their anamnesis were excluded.
Role of Colonic Short Chain Fatty Acids in Obesity

The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. The investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test drink.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant
* body mass index \>=20 and \<=35

Exclusion Criteria:

* history of diabetes mellitus
* history of cardiovascular disease
* history of bowel disease
* history of kidney disease
* history of liver disease
* use of antibiotics within 3 months of enrolment
* unusual dietary habits
* fasting glucose \>6.9mmol/L
* hematocrit below normal range for age and sex