cyrilzakka/clinical-trials huggingface dataset:
South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus

The primary objective of this study is:

* To investigate whether insulin aspart with meals is better than a standard treatment with insulin NPH at bedtime, evaluated by HbA1c.

The secondary objectives of this study are:

* To study if a combination treatment with metformin and/or rosiglitazone and insulin aspart with meals is better than a standard treatment with insulin NPH combined with one or more of the above oral antidiabetic drugs. According to the hypothesis, special focus will be given to the treatment group with insulin aspart combined with metformin and rosiglitazone. The treatment effect will be evaluated by HbA1c.
* To examine the effects of the treatments on glucose metabolism and beta cell function, evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and lactate.
* To examine the effects of the treatments on cardiovascular risk factors evaluated by serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and electrocardiogram (ECG).
* To quantify and describe the patients' subjective experiences of the two different insulin treatments (quality of life assessment)
* To examine patients with type 2 diabetes for the presence of variability in a series of genes, which are known to or are assumed to:

  * affect the long term outcome;
  * determine the responsiveness to treatment with diet, exercise and drugs targeting the known risk markers for late diabetic complications; and
  * after intervention, to analyse the complex interrelationships between genotypes and clinical endpoints and the responsiveness to actual treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 30 and 70 years
* Fasting C-peptide \>300 pmol/l
* Body mass index (BMI) \> 25 kg/m2
* Diabetes for more than 2 years
* Pharmacological antidiabetic treatment for more than 3 months
* 7.0%\<HbA1c\<12.0% at randomisation
* Patient willing to sign informed consent
* Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.

Exclusion Criteria:

* S-creatinine \> 120 μmol/l
* History of intolerance to metformin or glitazones
* S-ALAT/S-ASAT \> 2.5 x upper normal limit
* Total cholesterol \> 10 mmol/l
* Total triglyceride \> 8 mmol/l
* Hemoglobin (Hb) \< normal range
* Treatment with glitazone preceding 30 days New York Heart Association (NYHA) functional class III or IV
* Night work
* Present or planned pregnancy
* Poor vision impeding insulin administration
* Unawareness of hypoglycaemia (complete or partly)
* Mental illness or alcohol abuse
* Clinically relevant major organ or systemic illness
* Uncontrolled hypertension \>180/110 mmHg, systolic or diastolic
* Steroid treatment
* Severe lung disease
* A history of malign disease
* An expectation that the patient will not be collaborative or will not be able to understand the character of this trial
General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)

To confirm and consider the occurrence of important identified risks described in the Japanese Pharmaceutical Risk Management Plan (J-RMP) under conditions used in routine medical practice. The safety specification include: uterine hypercontractions and associated foetal distress, uterine rupture, cervical laceration, amniotic fluid embolism, and foetal distress.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received the PROPESS in treatment for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation). This prospective survey is an observational (non-interventional) survey for re-examination of the safety profile of PROPESS. It only collects data under conditions of use in routine medical practices.

Exclusion Criteria:

* None
Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors

This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors.

This is an open label trial to assess the safety and tolerability of the adult tolerated dose of Hyperpolarized Pyruvate (HP) for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging. Nine patients will receive a single MR imaging examination that includes the acquisition of hyperpolarized 13C metabolic data in combination with anatomic, diffusion, perfusion and lactate edited 1H spectroscopic imaging data. The data will be processed using custom designed software to estimate changes in levels of lactate/pyruvate and to relate them to abnormalities observed in the data from other MR modalities.

The results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of HP 13C lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* Children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do not require sedation for MR imaging
* Karnofsky ≥ 70 for patients ≥ 16 years of age, and Lansky ≥ 70 for patients \< 16 years of age (See Appendix 1 Performance Status Criteria)
* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent
* Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of starting treatment. Effective contraception (men and women) must be used in subjects of child-bearing potential
* Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent

Exclusion Criteria:

* Patients who are not able to comply with study and/or follow-up procedures
* Patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents. Patients who are enrolled in a clinical trial but are off- therapy and in follow up are eligible.
* Patients with history or evidence of cardiac dysfunction
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention

Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Females must be of non-child-bearing potential.
* Female subjects must have a negative pregnancy test.
* Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.
* Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL \<130 mg/dL (3.4 mmol/L) at Screening visit.
* Must be capable of providing informed consent.
* Have an hsCRP concentration of \>2 mg/L, but \< 10 mg/L at screening.

Exclusion Criteria:

* Women who are pregnant or breast feeding.
* Planned PCI with multi-vessel stenting.
* Planned PCI with additional revascularization procedures staged at different days during the study period.
* Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).
* Planned PCI of any bypass graft.
* History of CABG surgery.
* Planned cardiac or major non-cardiac surgery within the study period.
* Disabling stroke in the past 6 months.
* History of chronic viral hepatitis or other chronic hepatic disorders.
* History of Gilbert's syndrome or elevated bilirubin concentrations at screening.
* History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.
* Renal impairment with serum creatinine \>2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.
* Current inadequately controlled hypertension (blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic) on a stable dose of antihypertensive medication.
* Current poorly controlled diabetes mellitus, defined as HbA1c \>10% at Screening.
* History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF\<30%) regardless of symptomatic status.
* History of malignancy within the past 5 years, other than non-melanoma skin cancer.
* Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
* Alcohol or drug abuse within the past 6 months.
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering hypothermia therapy.

Further, investigators would like to analyse the influence of these perinatal risk factors on the severity of encephalopathy during and after hypothermia therapy.

Encephalopathy of the neonate could have different aetiologies. Perinatal asphyxia leading to hypoxia-ischaemia is frequent ,1-2 per 1000 life born neonates are affected. Hypoxic ischaemic encephalopathy is one of the most important causes for adverse neurodevelopmental outcome, cerebral palsy, epilepsy and hearing and vision deficiencies in term and near term neonates. Til now, hypothermia therapy is the only therapy reducing the risk of adverse neurodevelopmental outcome and is nowadays standard of care. In this study investigators would like to analyse perinatal risk factors causing HIE and their influence on the Sarnat Score on day 1 and 3 of life (during hypothermia therapy) and on day 4 of life (after hypothermia therapy).

Eligibility Criteria:
Inclusion Criteria:

* This study includes data of neonates suffering from hypoxic-ischaemic encephalopathy born with a gestational age \> 35 0/7 weeks, who were admitted to the neonatal and intensive care units in Switzerland between 2011-2013 and were treated with therapeutic hypothermia.

Exclusion Criteria:

* Neonates with hypoxic-ischaemic encephalopathy, born with a gestational age \< 35 0/7 weeks or without hypothermia treatment or syndromal diseases or with malformations were excluded.
* Further, children without consent to research use were excluded.
Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg \[14C\]-radiolabeled GLPG0634.

The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.

Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated.

This study will also provide safety and tolerability information for GLPG0634.


Eligibility Criteria:
Inclusion Criteria:

* male, between 40 and 65 years of age, inclusive
* within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women

The objectives of this study are to:

* Evaluate the effect of visual feedback on the intensity of low back pain, range of motion and function of pregnant and non-pregnant women with chronic low back pain.
* Determine the association between low back pain, catastrophizing, fear of movement and low back perception/image.

It is antecipated that 15 pregnant women with low back pain and 15 non-pregnant women with low back pain will enter the study. Each group will receive two different interventions, one consisting of visual feedback when performing 10 repetitions of low back flexion, extension and right and left side-flexion and another intervention consisting of the same low back movements without visual feedback. Participants will be assessed for pain intensity, pain location, disability, kinesiophobia, catastrophizing, perception of the low back, flexion range of motion and time to perform the sit to stand test both at baseline and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* The sample will consist of 15 pregnant participants (ideally between the 2nd and 3rd trimester of gestation) with chronic idiopathic low back pain and a group of 15 non-pregnant women with chronic idiopathic low back pain.

Exclusion Criteria:

* Pregnant women with risk pregnancy will be excluded as well as low back pain with a known cause (e.g. radiculopathy) and all participants with serious pathologies (e.g. history of trauma, surgery for less than 12 months, neurological pathologies, tumors).
Antibiotic Prophylaxis in Rhinoplasty

This study compares the efficacy of a single intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides), alone versus both intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides) and postoperative oral dose of "cephalexin" or "clindamycin" use in nasal surgery.

The study will consist of 2 treatment arms:

Treatment arm A: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.

Treatment arm B: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (aged 18years and older)

Exclusion Criteria:

* Prior rhinoplasty
* Any exogenous (non-nasal) grafts/implants
* Immune deficiency (DM, meds, other)
* History of radiotherapy to nose
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667

The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. age of 18 to 50 years
3. body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mmHg, or pulse rate outside the range of 50 to 90 mmHg at screening
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings

Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, \>80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.


Eligibility Criteria:
Inclusion Criteria:

* Agrees to be enrolled (or has parent/guardian approval to be enrolled)

Exclusion Criteria:

* Previous sickle cell screening
Evaluation of the Effect of Output on New Adhesives

The study investigates the impanct real output has on the adhesion of a new adhesive


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evalua-tion
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristo-mal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation
The Efficacy of VR and AR on Pruritus

The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.

In this study, there will be three groups: intervention group 1 with autogenic relaxation (AR), intervention group 2 with virtual reality (VR) game application and control group with routine nursing care and kidney functions narration. The number of volunteers to be included in the study was determined by power analysis. Forty patients with itch symptoms will be included in each group. Preliminary application for all three groups will be performed in the patient group registered to the Dialysis Unit of the Nephrology Department of Hacettepe University and Baskent University Hospital. Socio-Demographic Form, 5-D Itch Scale, Dermatology Life Quality Index, State and Trait Anxiety Scale, Pruritus Behavior and SGO / OR Application Log.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis treatment for the last 6 months,
* Receiving four hour hemodialysis treatment three times a week,
* 18-65 years of age,
* experiencing pruritus for the last month.
* Not taking any pharmacological / non-pharmacological treatment for pruritus
* No cognitive and psychiatric diagnosis,
* Do not use hearing aids,
* Open to communication and cooperation,
* Using smart mobile phone,
* Without liver disease and dermatological diseases,
* Patients who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Pregnant in the research process,
* Kidney transplantation,
* Experiencing discomfort due to virtual reality glasses,
* Patients who voluntarily leave the trial will be excluded from the follow-up.
Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations

The primary purpose of this study is to compare the safety and effectiveness of commercially available dietary supplements believed to increase coenzyme Q10 (CoQ10) concentrations.

An 8-week, randomized, placebo-controlled clinical trial will be conducted comparing the effectiveness of four commercially available dietary supplements on increasing CoQ10 concentrations and self-reported health outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males or females age ≥ 40 years
2. Ability to read and speak English

Exclusion Criteria:

1. Daily use within the past 2 months of any dietary supplements containing CoQ10 or geranylgeraniol (GG)
2. Taking a statin medication within the past 6 months
3. Current daily usage of H2 blockers or PPI medications
4. Current daily use of bisphosphonates
5. Current daily tobacco smoker
6. Known allergies to any substance in the study products
7. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
8. Current diagnosis of a chronic health condition (e.g., cancer, Crohn's disease) deemed clinically contraindicated for the study protocol.
9. Participant in a clinical trial in the previous 30 days.
10. Participants unable to provide consent
A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic cancer not amenable to standard therapy;
* any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
* measurable and/or evaluable disease (Part 1), \>=1 measurable lesion (Part 2);
* ECOG performance status 0-1.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
* known past or present CNS metastases;
* acute or chronic infection.
Food and the Brain

The proposed study will examine the role of reward and emotion in women with and without a history of binge eating. It is important to understand how the brain responds to reward and emotion in binge eating in order to identify different pathways toward binge eating and provide individualized targets for treatment. This is particularly important in light of the fact that for many patients, the current treatments for binge eating are not effective.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 18-35
* with or without current binge eating behaviors

Exclusion Criteria:

* Any contraindication for MRI (orthodontia, vascular stents, metallic ear tubes, metal implants, piercings, etc).
* substance abuse
* traumatic brain injury
* BMI \< 18.5
* pregnant women