cyrilzakka/clinical-trials huggingface dataset:
Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.

Full acronym for this study: COMMIT - CLEAN SWITCH


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Patients treated with human soluble insulin, NPH insulin or premixed human insulin
* Patients willing to sign informed consent
* Selection of study participants at the discretion of the physician

Exclusion Criteria:

* Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients
Adherence to Hydroxyurea in Children With Sickle Cell Anemia

Medication non-adherence is a true public health problem. Despite advancements in the molecular understanding of disease and improvements in therapy, patient health outcomes will not improve unless patients take prescribed medications regularly. Decreasing the gap between efficacious and effective therapy for patients with SCD is an essential research agenda. Hydroxyurea has been shown to be safe and efficacious in children and infants. However, the effectiveness of the prophylaxis depends on adherence to the recommended regimen. Medication adherence in SCD has previously been found to be sub-optimal in patients taking penicillin, desferoxamine, and pain medication. Adherence to HU has been studied to some extent in children with SCD. Based on estimates of adherence in other chronic illness we expect approximately 50% of patients to be \>80% adherent with their HU administration. There is no gold standard for improving adherence to treatment. There have been a few attempts in the SCD population to improve adherence. These include a day camp to promote education about desferoxamine and peer support, a combination of a slide-show about SCD and it complications, weekly phone calls by the clinic social worker and a calendar, and a seven-phase educational program. Given the striking improvements in the peripheral blood smear findings of patients with SCD on HU therapy, with reduction in the numbers of sickled cells, we hypothesize that viewing the peripheral blood smear of patients with poor adherence to HU compared to a blood smear of someone on HU can be used to improve adherence in non-adherent patients.

We will conduct a randomized trial between the intervention of regularly showing children and their parents the peripheral blood smear and standard care, including reminders of the importance of compliance and review of complete blood count parameters, including WBC, MCV, and Hgb concentration. The outcome measures will be increase in hemoglobin concentration and %HbF and increase in perceived QOL. QOL will be measured with age-appropriate and parent/proxy PedsQL™. Medication adherence will also be monitored throughout the study with pharmacy prescription refills, physician assessment, and self-report via a visual analogue scale. Adherence estimates, hemoglobin concentration, %HbF and QOL will be measured at baseline, 3 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Sickle cell anemia
* on Hydroxyurea for at least six months
* age 2-17.9 years

Exclusion Criteria:

* none
A Pilot Study: Snacking, Willpower and Glucose Availability

To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).

Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)

Eligibility Criteria:
Inclusion Criteria:

1. Females ages 18 - 65 years.
2. Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
3. Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
4. Generally healthy.

Exclusion Criteria:

1. Pregnant or trying to become pregnant.
2. Diagnosis of type 1 or type 2 diabetes
3. Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
4. Current smoker (or has stopped smoking within the last 6 months)
5. Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
6. Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
7. Current alcohol or drug abuse or dependence
8. Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).
Effects of Sensory Flicker and Electrical Flicker Stimulation

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Clinical trials have explored the modulation of brain circuits to treat several brain disorders, including Parkinson's Disease, Alzheimer's Disease (AD), depression, and Obsessive-Compulsive Disorder (OCD). However, current means to non-invasively modulate brain activity are limited.

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years, regardless of gender, race or ethnicity).
* To be implanted with intracranial depth or grid/strip electrodes for surgical evaluation.
* Patient was not shown, during phase I seizure monitoring, to exhibit abnormal EEG activity in response to photic stimulation, and is not clinically suspected to be susceptible to photic-induced seizures.
* Patient has no pre-existing diagnosis of autism.
* Patient is not considered at risk for psychogenic nonepileptic seizures (PNES) triggered by sensory stimulation.
* Fluent in English.
* Able to understand an informed consent (comprehend potential risks and benefits).
* Give written and verbal informed consent to all experiments patient would participate in.

Exclusion Criteria:

* Failure to meet any one inclusion criteria.
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant.

Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with histologically confirmed multiple myeloma
* Achieving partial response (PR) or very good partial response (VGPR) with systemic chemotherapy
* Received less than 4 lines of anti-myeloma therapy.
* Karnofsky performance status of \>= 70%
* Adequate pulmonary, cardiac, hepatic and renal function as outlined in the protocol
* Signed informed consent form in accordance with institutional policies prior to the initiation of high-dose therapy

Exclusion Criteria:

* Non-secretory multiple myeloma
* Have achieved complete response (CR) prior to autologous hematopoietic cell transplantation (HCT)
* Central nervous system (CNS) involvement
* Uncontrolled bacterial, viral or fungal infections
* Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Prior malignancies within the last 5 years except resected basal cell carcinoma or treated cervical carcinoma in situ.
* Females who are pregnant or breastfeeding
* Have received other investigational drugs within 14 days prior to screening
* Prior autologous or allogeneic HCT
* Prior organ transplant or autoimmune disease requiring immunosuppressive therapy
Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health

IMPRINT strengthens maternal and child health by screening, treating and preventing maternal perinatal depression, the most common complication of pregnancy and the child's first 1000 days. It is associated with poor pregnancy outcome and perinatal mortality and has adverse consequences on physical and mental development of the child. Yet, only 7-28% of women with perinatal depression worldwide receive appropriate evidence-based care. This is astounding given that the need of investing on mental health is widely recognized and low-intensity interventions not requiring costly mental health professionals have been shown to be effective.

IMPRINT improves the effectiveness, reliability, safety, appropriateness, equity and efficiency of routine health care provided for the mother and the child during the child's first 1000 days of life. The investigators 1) have adapted into the gender-, country-, and cultural-context an existing evidence-based, low-intensity pregnancy intervention targeting maternal perinatal depression (online CBT-based therapy) (iloodottaa.fi); 2) test in cluster-randomised trial the short- and long-term efficacy of the intervention in women who report clinically relevant, subthreshold or more severe symptoms in an early pregnancy depression screen; 3) study biological, psychological and social determinants of depressive symptom severity, comorbidities and response to interventions. The study recruits women from 58 antenetal clinics in the cities of Helsinki, Vantaa, Keski-Uusimaa, Kuopio and Lohja and aims at recruiting 500 women to the intervention and 500 women to the control arms.


Eligibility Criteria:
Inclusion Criteria:

* EPDS screen result of 10 or more
* Agreed to be invited for the intervention during the screening phase

Exclusion Criteria:

* Active suicidality
* Presence of severe mental disorder
* Concurrent use of psychotropic medication / concurrently under psychosocial treatment for mental disorder
Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level

The purpose of this study is to identify the treatment outcomes of surgical resection with sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell lung cancer and N2 disease at only the sub- or para-aortic level.

Stage IIIA non-small cell lung cancer (NSCLC) is a very heterogeneous disease and current treatment guidelines recommend concurrent chemoradiation therapy or combined neoadjuvant chemotherapy, surgical resection, and sequential adjuvant therapy. When incidental N2 disease is found despite thorough preoperative staging, adjuvant platinum-based chemotherapy with or without adjuvant radiotherapy is recommended.

Although guidelines suggest preoperative mediastinal staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), this method does not allow approach of the sub- or para-aortic lymph nodes. Therefore, patients with suspected stage IIIA NSCLC and N2 disease only at the sub- or para-aortic level should undergo several processes if combined neoadjuvant chemotherapy and surgical resection is planned. First, video-assisted thoracoscopic surgery (VATS) should be performed to verify whether the sub- or para-aortic lymph nodes are involved. If a frozen-section biopsy reveals no malignant tumor involvement in the sub- and para-aortic lymph nodes, the affected lung can be resected. If there is sub- or para-aortic lymph node involvement, further neoadjuvant chemotherapy is required before surgical resection and adjuvant therapy.

Studies have shown that stage IIIA NSCLC with only sub- or para-aortic lymph node involvement has better outcomes than other stage IIIA NSCLC. Moreover, the five-year survival of patients with stage IIIA NSCLC with only sub- or para-aortic lymph node involvement is similar to that with stage II NSCLC. However, those studies were retrospective with relatively small sample sizes. Therefore, we evaluated the outcomes of combined surgical resection with adjuvant chemotherapy and radiotherapy in patients with stage IIIA NSCLC and N2 disease at only the sub- or para-aortic level.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage IIIA non-small cell lung cancer and suspicious of N2 disease only in the subaortic or paraaortic level, or both on chest CT or PET scan

Exclusion Criteria:

* Patients whose subaortic or paraaortic lymph nodes were revealed as negative by mediastinal lymph node dissection
* Patients whose mediastinal lymph nodes other than subaortic or paraaortic level were confirmed as malignant node by mediastinal lymph node dissection
Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).


Eligibility Criteria:
Inclusion Criteria:

* KPS performance status of \>= 80% ("normal activity with effort")
* Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
* Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
* Measurable disease by RECIST Criteria

Exclusion Criteria:

* Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
* Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
* Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
* Moderately severe dry eye
* Congestive heart failure, or a left ventricular ejection fraction
* Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
* Previous malignancies unless free of recurrence for at least 5 years
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.

From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years
2. admitted to the ICU
3. according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS

Exclusion Criteria:

1. age \<18 years old
2. be expected to die within 24 hours
3. end-stage malignancies
4. be participating in other studies, which may affect the results of this study
5. DNI (do not intubation) and DNR (do not recovery) patients
6. family members do not agree to sign an informed consent
LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
* Unresected tumour prior to chemo-radiotherapy (CRT)
* Concomitant CRT completed prior to randomisation
* After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
* Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

* Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
* Cancer of nasopharynx, sinuses, and/or salivary glands
* Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
* Known pre-existing Interstitial Lung Disease (ILD)
* Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months
China Rural Hypertension Control Project 2014

China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test the effectiveness of a standardized protocol-based treatment program on hypertension control in rural China.


Eligibility Criteria:
Inclusion Criteria:

* Man and women aged 40 years or older.
* Mean systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg; and/or use of antihypertensive medications.Mean blood pressure is based on three measurements at two separate days at least two days apart and within one month.
* Permanent residents in the study villages.
* Do not plan to emigrate in the next 2 years.

Exclusion Criteria:

* Unable to provide consent.
* Treated for malignant tumor and life expectancy\<2 years judged by study physician.
* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.
* Diagnosted psychiatric patients.
Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease

The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.

The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.

The secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Confirmed evaporative dry eye disease

Exclusion Criteria:

* Ocular surgery, trauma, herpes infections
* Unwillingness to comply with study protocol
* Pregnant or nursing women
* Any subject that cannot wear an eye mask
* Participation in another ophthalmic clinical trial within past 30 days
Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia

The investigators aimed to find appropriate biomarkers such as serum neurofilament light chain in reflecting disease severity in hereditary ataxia from a large cohort during long-term follow-up. The disease severity is indicated by clinical scales and brain MRI tests.


Eligibility Criteria:
Inclusion Criteria:

* genetically diagnosed as Spinocerebellar ataxia

Exclusion Criteria:

* deny follow-yp
Pain in Competitive Athletes With Physical Disabilities: Techniques, Support and Perceived Difficulties

Pain in physically disabled athletes affects the sporting career directly or indirectly through psychological consequences. Numerous studies address psychological skills in able-bodied athletes and in able-bodied athletes they are scarce.This information is part of a research project aimed at finding resources to help athletes in their pain management.

The purpose of this study is to determine how competitive athletes perceive how pain can affect their sporting careers; what techniques and/or strategies athletes use for pain management and how useful these are; to determine the extent to which athletes with disabilities have received support for pain management and to what extent they have found it useful; and to determine the difficulties they often face in managing their pain.The aim of this questionnaire is to find out how pain, resulting from injury, can affect the sporting careers of competitive athletes with physical disabilities and what techniques they use to manage it.

Eligibility Criteria:
Inclusion Criteria:

Athletes:

* Competitive athletes.
* Physical disability.
* Age without criteria.

Exclusion Criteria:

* Failure to meet the inclusion criteria.
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy

Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals.

In order to design an effective intervention on the management of epilepsy, the drug management of epilepsy by community health workers was evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
* Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
* Patients must be on at least one anti-epileptic medication.
* Patients must be able to report seizure frequency with either a paper or electronic diary.
* Patients must be able to read and understand either English or Hindi.
* Patients must be able to complete questionnaires and provide informed consent to this study.

Exclusion Criteria:

* A diagnosis of psychogenic nonepileptic seizures
* Severe depression, anxiety, or psychosis
* Recent problem with substance abuse.