cyrilzakka/clinical-trials huggingface dataset:
Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function

Obstructive sleep apnea (OSA) may contribute to altered cognitive function in patients suffering from severe OSA. And lifestyle modification program may improve the cognitive function after 6 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25kg/m2
* impaired glucose tolerance which defined as plasma glucose at the range of 7.8 and 11 mmol/l 2 hours after 75g oral glucose solution intake,
* willing to participate in lifestyle modification program
* and capable of using continuous glucose monitoring (CGM) as judged by investigator

Exclusion Criteria:

1. Lactating or pregnant,
2. known diabetes, current or previous use of glucose lowering drug
3. current participation in other weight loss or lifestyle interventions, or use of weight loss drugs,
4. current use of steroids
5. uncontrolled thyrotoxicosis
6. allergy to medical grade adhesives
7. known obstructive sleep apnea on continuous positive airway pressure therapy
8. symptoms of cognitive deterioration (according to the Hong Kong Montreal Cognitive Assessment (HK-MoCA) at the score of \<21)
9. predominant central sleep apnea
10. uncontrolled hypertension (blood pressure \>140/90mmHg) or requiring more than two anti-hypertensive medication
11. history of stroke or brain injury,
12. unstable cardiovascular disease (e.g. recent unstable angina or myocardial infarction within the previous 6 months or severe left ventricular failure; neuromuscular disease affecting or potentially affecting respiratory muscles; moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake SaO2 \<92%)
13. psychiatric disease that limits the ability to give informed consent or complete the study
14. Use of psychoactive medication.
Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography

The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease.

The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease.

Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life.

Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled.

1. 15 children with increased liver stiffness due to the Fontan operation
2. 15 children with increased liver stiffness caused by Biliary Atresia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 2-5 years
* Children who are scheduled to have a Stage 3 Fontan cardiac operation (arm 1) AND Children who have chronic liver disease caused by biliary atresia (arm 2)
* Patient must be receiving care at the University of Michigan CS Mott Children's Hospital
* Parent/guardian must be willing to sign the study consent form

Exclusion Criteria:

* For arm 1 subjects: pre-existing evidence of chronic liver disease (as defined by chronic elevation (over 4 weeks) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or conjugated bilirubin to greater than two times the upper limit of normal
* For arm 1 subjects: evidence of overt liver nodularity by conventional US imaging or evidence of portal vein or hepatic vein thrombosis (clots) by US Doppler exam
A Study of Sweat Testing Using a Quantitative Patch

The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.

All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cystic fibrosis
* patients who require a sweat test

Exclusion Criteria:

* Infants less than 48 hours of age
* Patient is receiving oxygen by open delivery
* collection site has diffuse inflammation or rash
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer

For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.

Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old;
2. Metastatic gastric cancer progressed on first-line treatment;
3. Expected survival time ≥ 3 months;
4. At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
5. ECOG PS 0\~2;
6. Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / L, neutrophil count ≥ 1.5 × 10\*9/ L; platelet count ≥ 100 ×10\*9/ L; hemoglobin ≥ 90 g / L;
7. Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
8. LVEF ≥ 55 %;
9. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.

Exclusion Criteria:

1. Patients known to be allergic to active or other components of chemotherapeutic drugs;
2. Patients who have been treated with PLD or irinotecan in the past;
3. According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
4. Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
5. d-MMR or MSI-H or Her-2 overexpression;
6. Severe or uncontrolled infections or diabetes;
7. History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
8. Participated in other clinical trials within 4 weeks prior to the start of the study;
9. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.
A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment

The purpose of this study is to ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. If relevant the general practitioner (GP) will refer patients to COPD rehabilitation conducted by relevant municipality rehabilitation teams. Secondarily the purpose is to improve collaboration and communication between the local hospital pulmonologist, GPs and the municipality rehabilitation team


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnose, verified by spirometry
* Having given informed consent

Exclusion Criteria:

-
The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial.

Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d\~ 8d, 30 d (if necessary)and 84 d, during 9 d \~ 83 d outpatient follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. 18 \~ 75 years with T2DM in China;
2. HbA1c of 7% to 13%;
3. negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.

Exclusion Criteria:

1. HBsAg, HCV, HIV and syphilis test was positive;
2. any time FBG \<6.1 or\> 14.0 mmol / L in the morning;
3. Renal function: eGFR \<60 mL / min ;
4. TG\> 5mmol / L;
5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;
6. Ischemic heart disease, heart failure, stroke or peripheral vascular disease;
7. Pregnancy and breast-feeding women;
8. Patients requiring insulin treatment;
9. Have medical history of hypoglycemia;
10. Have a clear history of allergic patients;
11. Patients addicted to alcohol and tobacco.
A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe

This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.

This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Patients will have no prior experience using insulin or other self-administered injectable medicine. The study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.

Eligibility Criteria:
Inclusion Criteria:

* Adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. They must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses.

Exclusion Criteria:

* Previously treated with injectable medicine
Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment

Exclusion Criteria:

1. Patients with C class by child-pugh score
2. Patients in the acute phase of severe hepatitis
3. Patients have been diagnosed with cancer of the liver
4. Patients with severe cardiopulmonary cerebral disease, and in the failure state
5. Patients in Highly allergic constitution
6. Patients with moderately severe mental disease
Understanding and Modeling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities

The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Available data on the transmission determinants of ESBL-PE in community settings are scarce, methodologically limited and mostly based on single centre studies. A comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. A consortium of investigators with diverse expertise from countries with high and low endemicity of ESBL-EP has been created. Transmission and persistence of ESBL-PE within households and long-term care facilities will be studied. Individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. Advanced molecular typing techniques and state of the art analytical methods will be used. Data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.


Eligibility Criteria:
Inclusion Criteria:

* Residents of the Bellevaux LTCF (Besançon - France)
* Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members

Exclusion Criteria:

* Participation rejection
Efficacy and Safety Study of Deferiprone in Patients With Pantothenate Kinase-associated Neurodegeneration (PKAN)

A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of 18 months of treatment with deferiprone versus placebo in patients with PKAN.

This investigator-initiated trial was funded by the European Commission's Seventh Framework Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA Office of Orphan Products Development (OOPD) (Dr. Elliott Vichinsky).

This is a multi-center, double-blind, randomized, placebo-controlled, 18-month study in patients with PKAN aged 4 years and older. Participants are randomized in a 2:1 ratio to receive either deferiprone oral solution or placebo, twice a day for 18 months. Efficacy assessments, an MRI scan to measure iron levels in the globus pallidus, pharmacokinetic evaluations, and safety assessments are conducted at specified time points. Following completion of the trial, eligible patients are invited to enroll in an 18-month extension study, TIRCON2012V1-EXT, in which all participants receive deferiprone.

Eligibility Criteria:
Main Inclusion Criteria:

* Males or females 4 years of age and older at screening visit;
* Have PKAN, confirmed by genetic testing (supporting evidence required);
* Barry-Albright Dystonia (BAD) total score ≥ 3 at the screening visit;
* Patients who have Deep Brain Stimulation (DBS) systems or baclofen pumps in place will be eligible for the study, but they must have had a stable setting for at least two months prior to the screening visit and stimulation parameters / pump settings must remain stable for the duration of the trial:

Main Exclusion Criteria:

* Evidence of iron deficiency defined by Fe:TIBC ratio \<15%, or serum ferritin \<12 ng/mL;
* Treatment with deferiprone in the past 12 months;
* Previous failure of treatment with deferiprone, or previous discontinuation of treatment with deferiprone due to adverse events;
* Conditions known to contraindicate the use of deferiprone (history of agranulocytosis or recurrent episodes of neutropenia);
* A serious, unstable chronic illness not related to PKAN condition during the past 3 months before screening visit including but not limited to: hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease;
* Evidence of abnormal liver or renal function (serum liver enzyme level(s) \> 3 times upper limit of normal at screening) or abnormal creatinine levels at screening visit;
* Disorders associated with neutropenia (ANC \< 1.5 x 10\^9/L) or thrombocytopenia (platelet count \< 50 x 10\^9/L) in the 12 months preceding the initiation of the study medication. Exception: for patients whose neutropenia was attributed by the treating physician to episodes of infection or to drugs associated with a decline in the neutrophil count and in whom the ANC has fully recovered at the screening visit;
* History of malignancy;

Other protocol inclusion or exclusion criteria may apply.
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants

The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m\^2) at the Screening Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the Screening Visit for any medication taken.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has had surgery or trauma with significant blood loss \<3 months prior to the first dose of study drug.
* The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.
Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients within the age group of 30-65 years (both male and female)
3. Patients should have ≥ 10 natural teeth.
4. Criteria for selection of generalized chronic periodontitis:

   * Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.
5. Criteria for selection of type II diabetes mellitus:

   * Patients having HbA1C \<7

Exclusion Criteria:

1. Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
2. Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
3. Current smokers, individuals who quit smoking less than 6 months.
4. Patients who had undergone periodontal therapy within the previous 6 months.
5. Pregnant women (which may alter the oral flora).
Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study.

Assessment of pulp inflammation by hemostasis achievement after pulp exposure

The possibility has been raised of diagnosing pulpal pathological status using the cytokines that are released during the inflammation process in healthy as well as infected tooth pulp. Cytokines are small polypeptides secreted by leucocytes and other inflammatory cells and are known to play important roles in the intensity and duration of the immune response

Eligibility Criteria:
Inclusion Criteria:

1. healthy children
2. patients had not used any inflammatory medications
3. primary molar teeth of these children were included based on the following clinical and radiographic criteria:

   1. no clinical symptoms or evidence of pulp degeneration (pain on percussion, history of swelling or sinus tract
   2. no spontaneous pain
   3. no radiographic signs of internal or external resorption, widened periodontal ligament space, or furcal/periapical radiolucency
   4. physiological root resorption of no more than one third the root length
   5. a deep caries lesion with a likelihood of pulp exposure during caries removal

Exclusion Criteria:

* patients used any anti-inflammatory medication