cyrilzakka/clinical-trials huggingface dataset:
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.

This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c \>=7.0% and \<=10.5% at Week -2 are eligible for enrollment in the study.

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
* History of a severe hypoglycemic episode within 6 months before screening
* History of or current illness considered to be clinically significant by the investigator
Intestinal Microbiota Composition After Antibiotic Treatment in Early Life

In this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an important underlying mechanism for impediments in the developing immune system.

Differentiation will be made between a group of neonates who received antibiotics in the first week of life, and control infants who were not exposed to antibiotics in the neonatal period.

Healthy newborns born in the hospital, observed for low probability of neonatal infection will be compared to newborns exposed to antibiotic therapy in early life (first 1-2 weeks).

Infants are recruited from the maternity wards and neonatal wards of four teaching hospitals in the Netherlands. In total 150 infants, treated with antibiotics because of (a high suspicion of) a perinatal infection during the first week of life, will be recruited. The control group comprises 300 healthy newborns, born in the hospital and needing clinical observation for 24-48 hours for several reasons like maternal comorbidity, low probability of neonatal infection, blood sugar monitoring, meconium containing amniotic fluid, or delivery by caesarean section.

Differences in clinical outcomes between antibiotic treated infants and controls are investigated. Incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), gastrointestinal infections (GITI) and excessive crying are evaluated, prospectively assessed by parental reports and retrospectively assessed by doctor's diagnoses. The clinical endpoints will be linked to the developing intestinal microbiota during the first year of life.

Potential differences in intestinal fecal microbiota composition and diversity can be determined at eight time points during the first year of life, as sampling moments include: day one (T1), day two (T2), one week (T3), two weeks (T4), one month (T5), three months (T6), six months (T7), one year (T8).

Eligibility Criteria:
Inclusion Criteria:

1. Term-born babies (≥ 36 weeks gestational age)
2. (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment
3. Signed informed consent by the parents

Exclusion Criteria:

1. Congenital illness or malformations
2. Severe perinatal infections for which transfer to the neonatal intensive care unit is needed
3. Maternal probiotic use ≤ six weeks before delivery
4. Insufficient knowledge of the Dutch language.
Adipose Tissue Response to Overfeeding in Insulin Resistance-Prone vs. Insulin Sensitive Humans

Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate that most of the excess morbidity from obesity is related to insulin resistance (IR). While total adiposity correlates with insulin resistance, not all obese individuals are IR. When obese IR individuals lose weight in response to caloric restriction, even moderate loss of body fat results in improved insulin sensitivity (IS). With massive weight loss, either dietary or surgical, even the most IR individuals can completely reverse their insulin resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There must be differences in the manner in which adipose cells/tissue respond to caloric excess and weight gain. One potentially unifying hypothesis with regard to obesity-associated insulin resistance is that those individuals who fail to respond to caloric excess/obesity with adequate adipocyte differentiation and expanded subcutaneous fat storage capacity develop increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering localized and systemic inflammation and ultimately insulin resistance in skeletal muscle.

Clearly, the best way to examine the human response to obesity is to challenge overweight individuals with the need to store excess triglyceride in adipose tissue. Specific aims are:

1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated with insulin resistance by comparing 1) cell size distribution; 2) gene markers of adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone vs IS individuals subjected to caloric excess.
2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS individuals subjected to caloric excess.
3. Determine whether differences in inflammation and/or innate or adaptive immune response are associated with insulin resistance by comparing differences in resident dendritic cells, macrophages and their activation profiles, changes in T-cell subpopulations, and other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric excess via overfeeding.
4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and insufficient angiogenic response in response to caloric excess.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-35 kg/m2
* Healthy adults
* Age 35-65
* Weight stable
* Nondiabetic

Exclusion Criteria:

* Major organ disease such as heart, kidney, liver
* Malignancy
* Inflammatory conditions (eg. lupus, rheumatoid arthritis, Crohn's disease)
* Eating disorder h/o bariatric surgery or liposuction use of blood thinners such as Coumadin (aspirin is ok)
Comprehensive Magnetic Resonance of Peripheral Arterial Disease

The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.


Eligibility Criteria:
Inclusion Criteria:

Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4\<ABI\<0.9) 96 Normal healthy subjects ages 30-85

Exclusion Criteria:

Age\<30, \>85

GFR less than 45mL/min based on a serum creatinine drawn within 90 days of the MRI:

Pregnancy Contraindications to a magnetic resonance examination

* Intracranial clips
* Implantable pacemaker and defibrillator
* Cochlear or intraocular implants
* Claustrophobia
* Any metallic implant not listed as magnetic resonance compatible in Shellock F.G ---Pocket Guide to Magnetic Resonance Procedures and Metallic Objects, Update 2000. Lippincott, Williams and Wilkins
Transient Thermal Behavior and Diabetic Foot

In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.

Both plants of the patient's feet will be observed by a thermal camera. Static observations (taking a single image), or dynamic (taking a series of images) of the foot, will be made. In the latter case, the observation will be done after a brisk walk of 6 min. The instruction given to patients will be to go the furthest in 3 min and then come back in 3 min, all while walking. The observation will be made by cameras without contact. These thermal cameras are non-invasive and non-ionizing, there is no risk related to their use. The camera will be placed on a tripod, a few tens of centimeters from the foot, and connected to a laptop (for the images acquisition). A wooden box, painted black, will be placed around both feet to protect the scene from parasitic thermal radiation that can disturb temperature variations. Foam will protect the skin / wood interface. Electric resistances, fixed on the box, will be placed in the field of vision of the thermal camera to guarantee the good treatment of the images. These resistors will never be in contact with the patient. The area filmed by the camera will be limited to the sole arch and, sometimes, the hand of patients to see if a thermal anomaly is also present on this member.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic subjects (type 1 and 2)
* age above 18 years old
* able to walk
* affiliate to insurance regimen

Exclusion Criteria:

* unable to stay motionless
* pregnancy
* subjects with feet wound
Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.

Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.

The investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis.

In order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser Doppler recordings. Two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.


Eligibility Criteria:
Inclusion Criteria:

* Type I psoriasis
* Psoriasis plaques on the patient's back

Exclusion Criteria:

* BMI \> 25
* Diabetic patient
* Arteriovenous disease history
* Ongoing anti-inflammatory treatment
* Major cardiovascular history (\<3 months)
* Hypertension
* Topical treatment on the back skin (\<7 days)
* Systemic treatment (steroids, methotrexate, retinoids, cyclosporine) or phototherapy (\<1 month)
* Pregnant women
* Subject within exclusion period following a previous or ongoing biomedical study
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)

Eligibility Criteria:
Inclusion Criteria:

* Healthy females with voiding difficulty with MFR\<12 and post void residual urine\>50cc

Exclusion Criteria:

* History of pelvic floor surgury during last 3 month
* Any contraindication for Tamsolusin or prazosin
HLA-B35 Alleles and AIDS

This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B\*3501 and B\*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.)

HIV disease in people with the B\*3503 allele progresses significantly faster than it does in people with the B\*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine.

Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.

The purpose of this study is to identify variations in the genome of HIV early after infection and following the development of AIDS to determine the location of escape mutations that might provide information about potential B\*35 epitopes. These data will be useful in explaining the difference in disease progression between individuals possessing B\*35 Px alleles and those with B\*35 PY alleles. We have previously shown that individuals with B\*35 Px alleles progress at a significantly faster rate compared to those with B\*35 PY alleles. This study might provide information which is potentially useful in the development of a successful HIV vaccine.

Eligibility Criteria:
* INCLUSION AND EXCLUSION CRITERIA:

Sera and relevant clinical data from properly consented HIV positive seroconverters will be provided to the LGD for analysis. No available subjects will be excluded to maximize power. We will request an accrual ceiling of 100 participants.
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
* Histological confirmation of Breast Cancer with documented ER+ receptor status
* Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
* Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
* Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits

Exclusion Criteria:

* Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
* More than 1 prior regimen of chemotherapy for breast cancer
* ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
* History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
* Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
Wise Practice of Chinese Hemodialysis (WISHES)

The investigators are registering all HD patients at recruited hospitals and developing a HD database in China. Patients will be follow-up every 3 months, and both baseline and follow-up information will be entered into the registration system. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.

The investigators are registering all end stage renal disease (ESRD) patients receiving hemodialysis (HD) treatment, and developing a HD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum, urine, and access patency), complications, drug information and scores of quality of life at the baseline will be collected. Patients will be follow-up every 3 month, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to peritoneal dialysis, hospitalization, access failure，etc. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.

Eligibility Criteria:
Inclusion Criteria:

End stage renal disease patients receiving hemodialysis treatment.

Exclusion Criteria:

No
Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease

Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program in a population of subjects with fibrotic interstitial lung disease. Our hypothesis is that pulmonary rehabilitation will lead to improvements in quality of life, breathlessness, exercise capacity and pulmonary function in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Restriction on pulmonary function testing (TLC \<80%, FEV1/FVC ratio \> predicted or DLCO \< 80%)
2. Evidence of fibrosis on high resolution computed tomography of the chest.
3. Fibrosis on surgical lung biopsy if performed
4. Referral for pulmonary rehabilitation

Exclusion Criteria:

1. Participation in pulmonary rehabilitation in the past 24 months
2. Inability to complete 6 minute walk test or study questionnaires
3. Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation
4. Baseline 6 minute walk distance \> 400 meters
5. Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation
6. Ejection fraction known to be \< 25%
7. Contraindications to pulmonary rehabilitation (clinically unstable, uncontrolled arrhythmia or hypertension, symptomatic or uncontrolled hypotension with systolic blood pressure of \< 95, active angina, unexplained syncope or worsening dizziness, limiting orthopedic or neurological disorders, psychiatric impairment that inhibits cooperation in the program)
8. FEV1/FVC \< 65%
9. Unable to provide informed consent
Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care

The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'.

Hisbeans is a social enterprise where employees are consist of individual with mental disabilities.

'Hisbeans' employees(N = 150 subjects) will be randomly assigned to Group 1 (maro intervention), or Group 2 (control app intervention) by cluster randomization depending on the branch of the company.

* MARO intervention group: MARO (mental health digital application) use
* Control group: sham app use

The intervention period will be 8weeks.

Eligibility Criteria:
Inclusion Criteria:

1. HISBEANS store employees
2. Age: 18 years old or older
3. possessing a smartphone with internet connection
4. subjects agree to participate in the study

Exclusion Criteria:

1. Those who have symptoms of psychotic disorder are acutely active or advanced, making clinical intervention difficult
2. Those who has been started or changed their antidepressant medication within the last 1 month or cannot be maintained stably during the intervention period
3. Those who are non-literate
4. Those who have used the Maro app previously
5. Those who couldn't use Maro app in their own smartphone
6. Those who participate in another intervention study
7. Those who have a serious medical condition that prevents them from participating in the intervention and efficacy evaluation
8. Those who is unable to participate fully and cooperatively by the judgment of the researcher