cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.

OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to performance status and are randomized to one of two treatment arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate (absence of disease progression or unacceptable toxicity).

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, locally advanced, or metastatic, unresectable non-small cell lung cancer Failed or relapsed after one prior platinum containing regimen (cisplatin or carboplatin) as first line therapy Prior brain metastases allowed if resection and/or radiotherapy completed, no worsening of CNS symptoms, and at least 1 month since prior corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN in patients with liver metastases) Renal: Creatinine clearance at least 50 mL/min Other: Able to swallow intact study capsules No active infection No life threatening illness (other than tumor) No prior malignancy within the past 5 years except well controlled nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than one prior regimen of chemotherapy No prior gemcitabine No prior CI-994 At least 4 weeks since prior maintenance or consolidation therapy (e.g., matrix metalloprotein inhibitors) Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to primary site Surgery: Not specified
Upright Open MRI for Brain Imaging in Children - a Pilot Study

PRIMARY OBJECTIVE To establish feasibility and acceptability of diagnostic brain MRI in young children for specified indications using an upright MRI system without sedation or anaesthesia.

SECONDARY OBJECTIVES To establish how young children who undergo brain MRI using upright MRI view the experience To establish how parents / carers of young children who undergo brain MRI using the upright MRI view the experience for their child and for themselves.

To establish how image quality compares between brain MRI using the upright MRI scanner and the standard MRI scanner used in clinical practice.

Study Design Feasibility study collecting data on image quality and experience of upright open MRI scanning (performed in addition to standard clinical MRI scan), and comparing outcome measures to standard supine MRI scans, in children referred for clinical MRI scanning for (i) symptoms or signs suggestive of brain tumour and (ii) symptoms or signs suggestive of shunt blockage in children with a ventriculoperitoneal (VP) shunt Study Participants Participants that have been referred for brain MRI for symptoms and signs suggestive of brain tumour or who have known VP shunts with a clinical suspicion of shunt dysfunction. 20 participants in total, aiming for an even split between these two groups but will be flexible based on the local clinical case load.

Planned Size of Sample (if applicable) 20 young school-aged children (5 to 10 years) referred for brain MRI at NUH. The child participant's parents will be simultaneously recruited

Eligibility Criteria:
Inclusion Criteria:

* Referred for clinical brain MRI scan for either:

Symptoms and signs suggestive of brain tumour, or Known VP shunts with a clinical suspicion of shunt dysfunction Parental consent and child's agreement to participate

Inclusion criteria for the adult participants:

Parent / carer of a child participant

Exclusion Criteria:

* Contra-indication to MRI scans Programmable VP shunt requiring re-programming after the research MRI Unable to sit upright unsupported Focal intracranial signs such that a targeted MRI protocol would be required (e.g. focal seizures, focal neurology, visual impairment, pituitary dysfunction).

Exclusion criteria for the adult participants:

Contra-indication to being in the scan room
Energy Drinks and Vascular Function

The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Being Male
* 18-30 years of age
* No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
* BMI ≤ 30 kg/m\^2 and blood pressure ≤ 140/90 mmHg
* Consumption of \<400mg of caffeine/day
* Prior history of consumption of energy drinks

Exclusion criteria:

* Being female
* Age \<18 or \>30 years
* BMI\> 30 kg/m\^2 and blood pressure \> 140/90 mmHg
* Use of medication that may affect vascular measures
* Use of tobacco products including smoking
* Vegan or vegetarian diet
* Being energy drink or caffeine naïve or consumption of \>400 mg of caffeine/day
* Consumption of \>1 energy drinks per month
* Being a shift worker
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

Eligibility Criteria:
Inclusion Criteria:

* Body weight: 50.0 kg ≤ weight \< 85.0 kg
* Body mass index:17.6 ≤ BMI \< 26.4
* Those who provided written informed consent themselves

Exclusion Criteria:

* Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
* Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
* Those whose lab-test results are in the abnormal range
* Those who received medical treatment within 14 days prior to the study
* Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
* Those who have received ASP1941 before
* Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
* Those within a fasting plasma glucose level of \< 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%
Impact of Non-intentional Leaks on Noninvasive Ventilation

The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.

The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients.

Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates.

Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.


Eligibility Criteria:
Inclusion Criteria:

* OHS patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months.
* Healthy subjects without known pathology

Exclusion Criteria:

* OHS patients: instable cardio-respiratory status and/or acute cardio-respiratory failure three month before the inclusion. Latex allergy, oesophageal varices.
Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China

This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.

This study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (CODE), The investigator will mine biomarkers of CODE through multi-omics technology. This study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
* Patients with consent from parents or legal guardians

Exclusion Criteria:

* Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
* Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
* Functional diarrhea
* Patients with poor compliance
Impact of a Structured Clinical Assessment MIDSA, Its Feedback and Support for Change on Commitment to Care of Perpetrators of Sexual Offenses

Evaluate the effectiveness of an intervention including the clinical assessment carried out with the (Multidimensional Inventory of Development, Sex, and Aggression) MIDSA and the review of the results with the professional in charge of the subject on the adherence and commitment to the care of the sexual offenders.

The intervention of MIDSA (Multidimensional Inventory of Development, Sex, and Aggression), a multidimensional investigation tool for issues related to sexuality and violence, could be prove very useful by providing AICS patients as well as the professionals who take care of them with a complete clinical assessment which enlightens the patient on his psychopathological functioning and / or his disorders, and which guides the care through the axes of intervention to be implemented in response to the criminological and non-criminological needs of the patient. This should allow the latter a better awareness (awareness) of his difficulties in the relationship with the other, facilitate his adherence to care, obtain a better commitment on his part in the process of change and consequently, bring him change their lifestyle and gradually adopt proactive attitudes and behavior that ultimately reduce the risk of recidivism of sexual and general violence. However, recourse to MIDSA as a "change operator" in a patient's trajectory is only possible if it is accompanied by a resumption of his clinical assessment by a professional who supports the change process by strengthening his motivation to change their criminal behavior.

Eligibility Criteria:
Inclusion Criteria:

* Adult male patients
* Express written consent of the participant after receiving the study information
* Subject making contact or being taken in charge by a psychiatric service (even an addictology service or by liberal practitioners in connection with psychiatry), a CRIAVS or a care unit dedicated to the care of perpetrators of a sexual offense (AICS) ;
* For a problem of sexual violence such as sexual harassment, assault and rape of adult women (including marital rape), incest, pedophilic or hebephilic acts, sexual sadism, exhibition, voyeurism, frotteurism, use and possession of child pornography or addiction sexual.

  * Affiliated to a social security scheme

Exclusion Criteria:

* Maximum stage (maintenance phase) listed on the URICA scale
* Poor understanding of the French language;
* Patient imprisoned, under legal protection, under guardianship or curatorship
A Prospective Epidemiologic Study of ALK-Positive NSCLC in China

This is a post-marketing, observational, non-interventional, multi-central study of patients with non-small cell lung cancer (NSCLC), with data collected prospectively from medical records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.

Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology. ALK positive status will be detected by Ventana immunohistochemistry (IHC) (Ventana Medical Systems, Inc. and Roche Diagnostics International, Inc). When ALK positive patients are detected, crizotinib will be administrated by various solutions based on physician's desecration and patients' willingness.

The secondary objectives include: 1.To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC.2.To describe demographic, socioeconomic \[such as age, gender, race/ethnicity, geographic location (including rural/urban area), pathologic parameters, education, family income, National Reimbursement Drug List (NRDL) or Provincial Reimbursement List (PRDL)\], and clinical characteristics of NSCLC patients with ALK positive.

The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years), both sex.
* Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.
* Written informed consent.

Exclusion Criteria:

* Those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (SCLC) or metastatic disease from other organs.
The Efficacy of Nitric Oxide in Stroke (ENOS) Trial

Nitric oxide is a multimodal candidate treatment for acute stroke having a number of properties which may be beneficial in acute stroke, including lowering blood pressure, causing cerebral vasodilation, and improving central and systemic haemodynamics. Nitric oxide donors are effective in experimental stroke and pilot studies in patients suggest that one, glyceryl trinitrate, can be delivered easily in a transdermal preparation. Around half of all patients admitted with acute stroke are taking antihypertensive therapy immediately prior to their stroke. No data exist as to whether it is beneficial or safe to stop or continue this treatment during the acute phase. ENOS is a prospective, international, multicentre, randomised, parallel-group, blinded, controlled, collaborative, factorial trial designed to test two questions related to the management of blood pressure immediately post-stroke:

1. The safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate.
2. The safety and efficacy of stopping or continuing prior antihypertensive medication.

Previously independent adult patients who are conscious and have residual limb weakness are eligible for enrollment. Central randomisation will be performed via the internet. Treatment is initiated within 48 hours of stroke onset and is given as daily glyceryl trinitrate patches for 7 days. A computed tomography (CT) scan is required within 7 days of randomisation. Early follow-up is performed locally over the 7 days of treatment, including blood pressure, early stroke events, and adverse events. Telephone central follow-up by the trial co-ordinating centre will be performed at 3 months. The primary outcome is combined death or dependency (modified Rankin Score \>2).


Eligibility Criteria:
Inclusion Criteria:

* Adult(\> 18 yrs).
* Clinical stroke syndrome with limb weakness lasting at least 1 hour i.e. not likely to be a transient ischaemic attack).
* Limb weakness (SNSS Arm \<6 and/or Leg \<6).
* Onset \< 48 hours.
* Conscious (Glasgow Coma Scale \> 8).
* Independent prior to stroke (pre-morbid Rankin scale \< 2).
* Meaningful consent, or assent from a relative or carer

Exclusion Criteria:

* Definite need for nitrate therapy
* Contraindication to nitrate therapy
* Definite need for prior antihypertensive or anti-anginal medication
* Definite need for antihypertensive therapy during acute stroke
* Systolic blood pressure \<140 mmHg or \>220 mmHg.
* Patients expected to require surgical intervention
* Known intracerebral pathology other than stroke
* Other serious condition which is likely to prevent outcome assessment at 3 months
* Previous enrollment in ENOS or current involvement in another trial of an experimental drug intervention.
* Not available for follow-up -Females of childbearing potential, pregnancy or breastfeeding. -
Video Colposcopy in Women With Dysplasia

To assess the effect of live video-colposcopy on women´s anxiety.


Eligibility Criteria:
Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* We included women if they attended colposcopy for the first time

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* known anxiety disorder or depression
* history of conization or other treatments
* known oncological disorder
* inadequate colposcopy
Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash

The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.

The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.

At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).

Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.

Subsequently, patients will be randomly divided into two groups:

- the Trial group, in which patients will perform home oral hygiene with Emoform Glic toothpaste + mouthwash twice a day the Control group, in which patients will perform home oral hygiene with Emoform Glic toothpaste twice a day.

Professional debridement will be repeated every 3 months. Periodontal indexes evaluation will be conducted at the baseline (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3).

Eligibility Criteria:
Inclusion Criteria:

* women at the 4th month of pregnancy

Exclusion Criteria:

* presence of cardiac pacemaker
* neurological and psychiatric diseases
* patients taking bisphosphonates during the previous 12 months from the - beginning of the study
* patients undergoing anticancer therapy.
* patients with poor compliance.
Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

Osteoporosis is characterized by decreased bone strength and it is prevalent among postmenopausal women but also occurs in men and women with underlying conditions or major risk factors associated with bone demineralization. Its chief clinical manifestations are vertebral and hip fractures, although fractures can occur at any skeletal site.The World Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5 standard deviations (SD) below the mean for young healthy adults of the same gender-also referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young normal range (a T-score of \>1 SD below the mean) are defined as having low bone density (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures, including hip fractures, among postmenopausal women occur in this group.

Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of teriparatide is prohibitively expensive and in countries like India with limited personal resources of the individuals, its not a feasible option in the majority of the patients with severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide therapy in an open label non inferiority trial and if successful, the investigators anticipate, the cost of treatment could be reduced considerably so that treatment becomes more affordable to a larger number of patients. Also with weekly therapy, number of multiple injections could be brought down.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.

Exclusion Criteria:

* Patients with renal dysfunction (serum creatinine \>1.5)
* Primary and secondary hyperparathyroidism
* Secondary osteoporosis
* Unexplained elevated ALP (alkaline phosphatase)
* History of therapeutic radiation
* Active malignancy and patients having implant
* Patients who have received i.v. or oral bisphosphonates in their disease course
DAILIES TOTAL1® Lubricity Post Wear

The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign Informed Consent document.
* Adapted, current soft contact lens wearer.
* Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
* Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
* Vision correctable to 20/25 or better in each eye at distance with study lenses.
* Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
* Able to be successfully fitted with study lenses.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* Use of artificial tears and rewetting drops during the study.
* Monocular (only one eye with functional vision) or fit with only one lens.
* Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-specified exclusion criteria may apply.