cyrilzakka/clinical-trials huggingface dataset:
Implication of Metformin Plus Aromatase Inhibitor in Obese Postmenopausal Breast Cancer Women

Metformin is an anti-diabetic oral hypoglycemic agent that considered the gold standard therapy for the treatment of type 2 diabetes. Retrospective analyses show that metformin can offer therapeutic benefits to patients with several forms of cancer. It also has positive weight reducing effect on non-diabetic patient by improving insulin sensitivity (although the exact underlying pathomechanisms remain to be elucidated).

This prospective controlled study aimed to evaluate the effect of combined metformin adjuvant therapy and aromatase inhibitors (letrozole) in postmenopausal obese breast cancer women. In addition, to evaluate the effect of weight reduction on aromatase inhibitor efficacy.

Patients and methods: From February 2014 to June 2015, 75 Post-menopausal breast cancer females' patients were recruited, 53 patients underwent randomization and 45 patients completed six months, treatment. Aromatase inhibitor (letrozole) was administered as once daily in accordance to one of the three groups. Control group: fifteen obese females who received letrozole only; metformin group: fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily, and lean group: fifteen non- obese breast cancer females who received letozole for six months, treatment period. Blood samples were collected at baseline and after six months of aromatase inhibitors treatment for analysis of serum estradiol, osteocalcin, insulin, leptin, lactate and glucose.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, postmenopausal is defined either by:

A. Age ≥ 55 years and one year or more of amenorrhea. B. Age \< 55 years and one year or more of amenorrhea, with an estradiol assay \< 20 pg/ml.

• Patients with breast cancer indicated for hormonal treatment with aromatase inhibitors (overweight 30 \> BMI ≥ 25, obese BMI ≥ 30 kg/m2 and non obese BMI between 18 and 25 kg/m2).

Exclusion Criteria:

* • Diabetic patients.

  * Patients with metabolic syndrome.
  * Patients with last menstrual cycle less than one year ago.
  * Patient with conditions predispose to acidosis (heart failure, renal failure).
  * Ovarian radiation treatment with luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.
Orofacial Pain in Woodwind and Cello Musicians in German Orchestras

Professional musicians in German professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. These factors include environmental noise, irregular working hours, tight schedules, and high demands for quality and discipline, all of which can lead to stress, sleep disturbances, and physical impairments. This prospective, non-interventional survey study aims to assess the health challenges faced by woodwind players (oboe, flute, clarinet, bassoon). It will explore the relationship between the type of instrument played, orofacial pain, sleep problems, and oral health-related quality of life (OHRQoL). Woodwind players, due to their playing techniques, may be more susceptible to orofacial complaints, which could negatively impact their quality of life. A control group of cellists, whose playing techniques put less strain on the orofacial system, will be used for comparison. Participation will be via an online questionnaire targeting musicians who have been employed in a German professional orchestra for at least 12 months.


Eligibility Criteria:
Inclusion Criteria:

* musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello
* at least 12 months of employment or freelance work in the past 5 years with a German professional orchestra

Exclusion Criteria:

* consent not given
The BARCODE 1 Pilot Study

BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. This study forms a pilot of 300 men, with the view to continue to a future study of 5000 men.

The BARCODE 1 study aims to evaluate genetic profiling using the known 170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men will be recruited via participating General Practices (GPs). Men aged 55-69 years who are likely to be eligible for the study will be identified by GPs from medical records. Participants will be contacted via invitation letters from GPs and if interested in the study will be asked to fill in a questionnaire to confirm eligibility to participate. This questionnaire can be completed in hard copy and men will also be given the option to fill in an online version. If eligible, men will then be sent a DNA collection saliva kit. DNA from saliva will be analysed with SNP profiling for the known 170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 30 men in total) will be invited for a transrectal ultrasound (TRUS) prostate biopsy, plus further biological samples. Biopsy results will be correlated with the genetic score. Prostate-specific antigen (PSA) and other biomarkers will be integrated into results to assess combined effects of genetic score and markers.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 55-69 years
* Caucasian ethnicity
* World Health Organisation (WHO) performance status 0-2
* Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule

Exclusion Criteria:

* Non-Caucasian ethnicity (including mixed race or Jewish)
* Previous diagnosis of cancer with a life-expectancy of less than five years
* Prostate biopsy in the past year
* Previous diagnosis of prostate cancer
* Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication like Warfarin or Clopidogrel, poorly controlled diabetes or cardiovascular disease)
Air Pollution and Cardiometabolic Study

The study mainly focuse on examining the subjects living in traffic polluted area and assessing the popuation health risk using disease and risk assessment models.


Eligibility Criteria:
Inclusion Criteria:

* Living in PU community neighborhood，Non smoker and No diseases ,and so on.

Exclusion Criteria:

* Advanced microvascular or neuropathic complications and active cardiovascular disease,and so on.
A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30\~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2\~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed prostate cancer;
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
3. Radiographic evidence of metastasis;
4. Sustained therapy of luteinizing hormone-releasing hormone analogue（LHRHA）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
6. Adequate hepatic, renal, heart, and hematological functions;
7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;
2. Planned to initiate any other anti-tumor therapies during the study;
3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
4. Clinically significant cardiovascular diseases;
5. History of seizure or certain conditions that may predispose to seizure;
6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Alpha-Cell Sensitivity to GLP-1 in Patients With Type 2 Diabetes

Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the alpha-cell.

Type 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses or saline, alpha- and beta-cell responses are measured in blood-samples. During the study plasma-glucose levels are clamped at fasting levels.

With this study we hope to elucidate the pathophysiology behind defect glucose tolerance in type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2 diabetes mellitus.

Background: Glucagon-like peptide-1 (GLP-1) possesses insulinotropic and glucagonostatic properties, and, therefore, GLP-based antidiabetic therapies have been developed. Even though the insulinotropic potency of GLP-1 has been shown to be reduced in patients with type 2 diabetes mellitus (T2DM), a small dose of GLP-1 is capable of normalizing the beta-cell responsiveness to glucose in these patients. The glucagonostatic potency of GLP-1 in patients with T2DM is not known, and, furthermore, the capability of GLP-1 to reestablish normal glucagon secretion in these patients remains to be elucidated.

Objective: To investigate the alpha-cell sensitivity to GLP-1 in patients with T2DM and to establish if GLP-1 is able to reestablish normal glucagon secretion in such patients.

Method: Ten patients with T2DM and ten healthy control subjects are clamped at their fasting blood glucose levels during GLP-1 infusions at increasing doses (0.25, 0.5, 1.0 and 2.0 pmol/kg/min) and placebo, respectively. Furthermore, the patients will be hospitalized overnight while receiving intravenous insulin and thereafter examined under normoglycaemic conditions. Blood are being drawn for analysis of plasma insulin, C-peptide, GLP-1 and glucagon.

Expected results and conclusions: We expect that GLP-1 will inhibit glucagon secretion in a dose dependent manner, leading too an increase in glucose turn-over. The results will potentially elucidate the interaction between GLP-1 and glucagon secretion and thereby broaden our knowledge on the pathophysiology of T2DM. Furthermore, the present study will determine the therapeutic impact of GLP-1 on the alpha-cell deficiency characterizing patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Informed oral and written consent
* Caucasians aged \> 18 years diagnosed with T2DM due to WHO criteria.
* Normal haemoglobin
* HbA1c 6-10%
* BMI 23-35 kg/m2

Exclusion Criteria:

* Hepatic disease, ALAT \> 2 x normal.
* Diabetic nephropathy, (S-creatinine \>130μM or albuminuria).
* Diabetic neuropathy (reported)
* Proliferative diabetic retinopathy (reported)
* Medical treatment that cannot be paused for 12 hours
* Insulin- or glitazon treatment
Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.

Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
* Subjects must have a negative bone scan.
* Subjects must have one of the following risk factors:
* PSA ≥20 and/or
* Gleason score ≥8 and/or
* Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or
* Radiographic pelvic lymph node positive disease and/or
* At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
* Subjects must freely sign informed consent to enroll in the study.
* Subjects must be medically fit to undergo surgery determined by the PI.
* Age ≥ 18
* KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70.
* No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
* Subjects must not have had prior pelvic radiation therapy,
* Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

* Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
* Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
* History of prior pelvic radiation therapy.
* History of androgen deprivation therapy within the past 6 months.
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.


Eligibility Criteria:
Inclusion Criteria:

* Primary care patients
* Able to provide informed consent

Exclusion Criteria:

* inability to comprehend spoken English
* inability to self-administer the instrument on the tablet computer due to physical limitations
* previously enrolled in the study
Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing EGD examination with anaesthesia;
* patients able to give informed consent.

Exclusion Criteria:

* patients with the contraindications to EGD examination;
* patients with a prior EGD examination within 1 year before the trial;
* patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
* a history of upper gastrointestinal cancers;
* allergic to anaesthetic in previous medical history;
* patients refused to participate in the trial;
* the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.
Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

The purpose of this study is to determine whether the peripheral blood marker-based molecular diagnostic method developed in the previous study can differentiate and predict accommodation and antibody-mediated rejection (AMR) in ABO blood type incompatible kidney transplant (ABOiKT) patients who are prospectively recruited.

Our research team retrospectively analyzes biomarkers that distinguish accommodation and acute antibody-mediated rejection through transcriptomic analysis of peripheral blood in patients with ABO blood type incompatibility kidney transplantation at Seoul National University Hospital. Through this, a classification model was developed to distinguish accommodation and antibody-mediated rejection using peripheral blood marker at the time of the protocol biopsy on the 10th day after renal transplantation, and recently reported as a new peripheral blood marker-based molecular diagnostic method. On the 10th day after surgery, transcriptomic analysis through RNA-seq was performed using samples of peripheral blood from 18 patients with accommodation and 10 patients with antibody-mediated rejection confirmed by protocol biopsy. The candidate genes were validated in the discovery set and another independent training set through quantitative real-time polymerase chain reaction (PCR). Finally, a 5-gene classification model including COX7A2L, CD69, CD14, CFD, and FOXJ3 was developed through logistic regression analysis.

To evaluate the diagnostic effectiveness (sensitivity, specificity) for the peripheral blood marker-based molecular diagnostic method by prospectively recruiting patients with ABO blood type incompatible kidney transplantation is needed. And, it is necessary to evaluate the effectiveness of whether the peripheral blood marker-based molecular diagnostic method can predict antibody-mediated rejection or accommodation as a result of protocol biopsy that will be performed on the 10th day after transplantation - peripheral blood samples collected earlier than the 10th day (day 5 and day 7) after ABO blood type incompatible kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* ABO blood group incompatible kidney transplant patients
* Patients who consent to written consent
* Patients over 19 years of age

Exclusion Criteria:

* Pregnant patients
* Patients with a history of drug abuse within the last 6 months
* Psychiatric disease history (major depression, bipolar disorder, schizophrenia, etc.)
* Patients who do not want to participate in this study
An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked an average of at least 15 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular disease in the past 6 months.
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

This is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.

Eligibility Criteria:
Inclusion Criteria:

* current patient in the Helen DeVos Children's Hospital Diabetes Clinic;
* ages 4-11 years;
* prepubertal (Tanner Stage I);
* diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;
* at least six months from date of diagnosis of type 1 diabetes mellitus;
* TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start;
* HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment;
* at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin

Exclusion Criteria:

* pubertal (Tanner stage 2 or greater);
* concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;
* receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;
* intercurrent illnesses such as a fever \> 101 degrees F, infection, or gastroenteritis;
* use of any medication to treat diabetes other than those listed under in inclusion criteria;
* potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study