cyrilzakka/clinical-trials huggingface dataset:
Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes

Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night in patients with diabetes. The aims of the study are 1) to compare the dynamic characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo during the night and the early morning hours, 2) investigate differences on glucose metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.

Patients with advanced type 2 diabetes like those with type 1 diabetes are at risk for defective glucose counterregulation and hypoglycemia unawareness, the components of hypoglycemia-associated autonomic failure and the resultant vicious cycle of recurrent iatrogenic hypoglycemia. This may explain why iatrogenic hypoglycemia becomes limiting to glycemic control as patients approach the insulin-deficient end of the spectrum of type 2 diabetes. Compared to Neutral Protamin Hagedorn (NPH) insulin glargine is a new long-acting peakless analogue with lower incidence of nocturnal hypoglycemia having the potential to decrease the frequency of hypoglycemia of insulin therapy. Modern type 2 diabetes therapy guidelines recommend insulin for an increasing population of patients. There is no doubt that type 2 diabetic patients suffer from hypoglycemia under insulin therapy, however it is not clear whether the extensive studies on hypoglycemia in type 1 patients apply also for type 2 diabetes. Recent reports indicate that type 2 diabetic patients of long duration react similarly to a hypoglycemic clamp as type 1 diabetic patients while well controlled type 2 diabetics had even more favorable thresholds for counter-regulatory hormone secretion. On the basis of these considerations the aims of this study are to 1) more precisely define the mechanisms of hypoglycemia in type 2 diabetes, 2) to investigate differences on glucose and lactate metabolism of bedtime NPH insulin versus glargine. To address these objectives we will use the hypoglycemic clamping technique combined with infusion of stable isotopes of glucose and lactate and non-invasive measurement of muscle flow characteristics at hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus
* Therapy may be with either insulin alone or in combination with oral anti-diabetic agents
* Metabolic control with HbA1c values \< 10%

Exclusion Criteria:

* Other than type 2 diabetes
* Pregnancy
* Systemic Corticosteroids, Beta-blockers
* Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematological or other major disease making implementation of the protocol or interpretation of the study results difficult
* History of drug or alcohol abuse
* Impaired renal function (serum creatinine \> 1.3 mg/dl)
Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody

to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy


Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer;
* more than 50% tumor tissues positive with PD-L1;
* EGFR and ALK wild type
* no other tumors

Exclusion Criteria:

* with systematic diseases shortening survival
A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)

The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.


Eligibility Criteria:
Inclusion Criteria:

* History of allergic rhinitis/rhinoconjunctivitis to house dust of 1 year duration or more (with or without asthma)
* If female of childbearing potential, has a negative urine pregnancy test at screening and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study.

Exclusion Criteria:

* Sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.)
* Sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen)
* Immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms)
* History of chronic urticaria and/or angioedema within 2 years prior to screening
* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to screening
* Ongoing treatment with any specific immunotherapy
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen
* Unstable uncontrolled/partially controlled or severe asthma, or life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[SABA\]) within 3 months prior to screening
* Asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to screening
* Chronic sinusitis within 2 years prior to screening
* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps)
* Pregnant, breastfeeding or planning to become pregnant during the study
* Participation in a different investigational study at any site during the same time frame of this study
* Direct association with the administration of the study or a family member of the study staff
Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children:

The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:

1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?
2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?
3. Is the MySmile app easy to use by secondary school children?
4. Is the MySmile app acceptable to use from the perspective of secondary school children?

Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours.

The selection of schools into the study will involve three (3) sampling levels. At the first level, acknowledging the division of secondary schools in the district into urban and rural, one matched-pair will be randomly selected from urban area, and another matched pair will be randomly selected from rural area. At the second level, randomisation of the school is carried out. The 2 schools in each of the matched-pair will be randomly allocated to intervention and control group. At the third level, six (6) classrooms from moderate academic performance level will be selected (2 classrooms from Form 3, Form 4, and Form 5, respectively). Students who fulfil the inclusion criteria will be invited to participate in the study. The randomisation sequence will be carried out by the statistician at the Faculty of Dentistry, Universiti Malaya

Eligibility Criteria:
1. Inclusion criteria for school

   * Government-funded secondary school
   * Received SDS from the mobile dental squad/school dental clinic at least once a year.
   * High-risk schools with all indicators not meeting the district's benchmark.
2. Inclusion criteria for the participants:

   * Secondary school children aged 15-17 years old.
   * Medium to high dental plaque level - Plaque score more than 50%
   * Healthy with no chronic medical history and physical disabilities
   * Understand the English language.
   * Own a smartphone// have access to an Android-based smartphone
The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients

Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from infectious complications and even sepsis. Despite tremendous efforts the etiology of this increased susceptibility to infectious pathogens is incompletely understood. Clinical signs and symptoms as well as current diagnostic clinical tests (WBC, CRP, cytokines, interleukines) lack sensitivity or specificity for adequate prediction of the development of infectious complications or sepsis.

Neutrophil granulocytes, cells of the innate immune system, play an important role in the defence against invading bacterial pathogens and are crucial in preventing fulminant infections. For successful eradication of a bacterium neutrophils need to exert specific functions: chemotaxis, migration, phagocytosis, degranulation and production of radical oxygen species. Much research has focused on the effect of trauma on neutrophil's individual capacities to kill bacteria with conflicting interpretations as a result. For adequate determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma patients we developed novel in-vitro assays in which neutrophils are tested for all of these functions combined. This assay allows us to identify dysfunctional neutrophils adequately.

The main focus of this study is the determination of the functionality of aberrant neutrophils circulating in the peripheral blood of severly injured following trauma.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the ICU
* Expected stay of at least 2 days
* Age: 18 - 80 years
* Informed consent (when proxy consent is obtained and the patient leaves the ICU in good mental health, personal informed consent is additionally necessary)

Exclusion Criteria:

* Immunosuppressive medication
* HIV and related diseases
INCAS - Integrated Care of Asthma in Switzerland

The aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to assess asthma control and patients' satisfaction with the health care service they received. Additionally, patients were offered the possibility to participate in a patient education seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year, patients were asked to complete the questionnaires again. Comparisons of intraindividual changes and differences regarding ACT and PACIC 5A between patients with and without patient education were made.


Eligibility Criteria:
Inclusion Criteria:

* patients with clinical asthma diagnosis
* written informed consent

Exclusion Criteria:

* inadequate knowledge of the German language
* subjects with severe diseases with life expectancy under one year
* subjects with known Chronic Obstructive Pulmonary Disease (COPD)
Bioequivalence of Bicalutamide New Formulation in Japan

The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Japanese healthy male subjects aged 20 to 45 years
* Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 17 and 27 kg/m2
* Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

Exclusion Criteria:

* Presence of any disease under medical treatment
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
* Presence of any infectious disease, such as bacteria, virus and fungus
* Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
* Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)

The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with high blood pressure and thickening of the main pumping chamber of the heart. The results showed that after an average treatment time of 4.8 years, treatment that was based on losartan was better than treatment based on atenolol for reducing the risk of having a stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 to 80 years
* Males and females
* Hypertension (160-200/95-115 mm Hg
* ECG evidence of left ventricular hypertrophy

Exclusion Criteria:

* Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers
* Myocardial infarction or stroke within 6 months
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population. One place where children with ADHD have great difficulty is in being accepted by peers and in making friends. It has unfortunately been very difficult for the field to find good treatments for peer relationship problems for this population. Even when children with ADHD do improve their behavior, it is common that peers do not seem to like the child with ADHD any better. This may happen because children often have negative reputations with their classmates that are hard to change. That is, once a class of children get the impression that one child is disliked or the social outcast, even if that child's ADHD symptoms get better, the peer group may not notice any of these improvements. It is hypothesized that the elementary school teacher may be able to help peers notice positive behavior changes in children with ADHD when they do occur. This clinical trial will design and pilot-test an intervention that would train teachers in classroom practices to reduce the peer rejection of students with ADHD. The pilot test will be conducted in a summer program created to be similar to a regular school classroom in structure. If the treatment seems to succeed in the summer program, then it will be tried in regular classrooms in a future study.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 6-8
* Primary diagnosis of ADHD

Exclusion Criteria:

* Pervasive Developmental Disorder
* Verbal IQ below 75
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease

This is an open-labeled, prospective clinical study aims at collecting and analyzing baseline characteristics of autoimmune inflammatory rheumatic disease (AIIRD) patients receiving sulfanilamide for preventive purposes, as well as subsequent follow-up data, in order to assess the efficacy and safety of the medication. Additionally, through a stratified analysis of risk factors, the investigators aim to identify the AIIRD population that would benefit most from preventive medication based on a favorable benefit-risk ratio.


Eligibility Criteria:
Inclusion Criteria:

1. The patient was diagnosed with AIIRD according to the International Classification of Diseases and had received steroids or immunosuppressive therapy;
2. The patient had not received standard PJP treatment before enrollment, including the first-line treatment drug TMP/SMZ, or other second-line treatment drugs (including Pentamidine, Atorvastatin, Caspofungin, etc.);
3. The patient was at least 18 years old at the time of enrollment;

Exclusion Criteria:

1. Serious health problems or diseases, including (but not limited to) the following: severe liver damage (ALT, AST elevated above normal value by more than 5 times), severe renal insufficiency (GFR \< 30mL/min or Scr \> 445umol/L), severe myelosuppression (Hb \< 65g/L, PLT \< 25×10\^9/L or neutrophils \< 0.5×10\^9/L);
2. Screening test indicates infection with human immunodeficiency virus (HIV), history of lymphomatous hyperplasia of the lymphatic tissue or any malignant tumor of any organ system within the past 5 years, or history of organ transplantation;
3. Participants with a history of allergy to sulfonamide drugs, megaloblastic anemia due to folate deficiency;
4. Pregnant and lactating women;
5. Any medical or psychological condition that the investigator believes would interfere with the participant's ability to comply with the protocol or complete the study;
6. Patients who refuse to comply with the requirements of this study and complete the study;
7. Any other situation that the investigator considers unsuitable for participation in the study (for reasons including but not limited to management reasons).
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.

The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* Elective Cesarean section
* Spinal anesthesia
* Singleton
* ASA ( Physical status score) 1 to 3

Exclusion Criteria:

* Age \<18yrs
* BMI ≥ 45 kg/m2 or weight \< 45 kg
* Refusal to consent
* Urgent cesarean section
* Allergy to a medication used in the protocol
* Impaired hemostasis ou current infection
* Contra indication or failure of spinal anesthesia
Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.

1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce high quality mRNA vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.
Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from BPH symptoms
* Preceding treatment with a phytotherapeutic for at least 4 weeks
* IPSS sum score ≥ 8 points prior to treatment start with ALNA®
* Indication for a switch to treatment with ALNA® for a minimum period of 2 months

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
* Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study