cyrilzakka/clinical-trials huggingface dataset:
Design and Evaluation of a Novel Methodology for SABR for Lung Cancer

Aims: To increase the number of patients that benefit from Stereotactic Ablative Radiotherapy (SABR) for lung cancer using new treatment methods that reduce the amount of non-cancer tissue receiving a high radiation dose without affecting tumour dose coverage.

Background: SABR is a treatment for lung cancer which offers major advantages over conventional radiotherapy. It is a more precise highly effective treatment with significantly improved treatment outcomes (greater elimination of cancer cells).

SABR requires high doses per treatment so extreme accuracy is required to minimise healthy tissue damage. Normal breathing results in significant tumour movement, therefore to avoid missing the tumour, larger volumes need to be treated, resulting in more good tissue damage.

UK Standard practice requires the tumour to be irradiated in all positions during breathing whilst the new approach targets the tumours at the position it spends most time to minimise normal tissue affected by radiation.

Current practice for SABR patients would be improved (fewer severe radiation side-effects) and potentially could become a viable treatment for high risk patients.

Methods: 30 SABR patients receiving current standard SABR treatment will be recruited. This is an observation study in which patients will continue to receive standard of care but in addition:

* A camera will be used to make videos of how the patient's chest moves in 3D at CT and treatment. I will build a complex mathematical model that infers movement of the tumour from movement of the chest.
* Their breathing patterns, corresponding tumour motions and treatments plans will be utilised to develop a method for safely implementing the new treatment approach.


Eligibility Criteria:
Inclusion Criteria:

All patients eligible for and who have consented to receive Lung SABR at the Royal Surrey County Hospital will be eligible for entry into this study.

• Over 18 years old (radiotherapy is not delivered to 16-18yr olds at RSFT). No upper age limit.

Exclusion Criteria:

Patients with irregular breathing motion resulting in failed 4DCT

* Patients with unusual chest surface deformities
* Patients who lack the capacity to consent
* Patients unable to read and communicate in English
Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.


Eligibility Criteria:
Inclusion Criteria:

* 19≤ age ≤ 75
* Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Patients who cannot perform endoscopy
* Active gastric or duodenal ulcer
* Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
* Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
* History of gastrointestinal surgery
* History of malignancy tumor, especially in the upper gastrointestinal tract
* Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
* Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
* Bleeding disorder
* Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
* Patients who have taken anticoagulants within a week before endoscopy
* Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
* History of allergic reaction to the medications used in this study
* Use of other investigational drugs within 30 days prior to the study
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with other reason
Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients

This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.

The subjects will undergo uneventful phacoemulsification and implantation of IOL.

The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral or bilateral age related cataracts
* Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter

Exclusion Criteria:

* Pregnant or nursing women
* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* postoperative visual acuity of worse than 0.2 logMAR in any eye
* Patients using systemic or ocular medication that affect visual acuity.
* Patients participating in other clinical trials during the study.
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

* Patients who have undergone pituitary surgery less than 3 months before selection
* Patients previously treated with radiotherapy
* Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
PHARMO Institute Seroquel Safety Study

The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.

Exclusion Criteria:

* less than a year of recorded history before the cohort entry date
* use of multiple antipsychotics concomitantly
* duration and dose of the antipsychotic drug cannot be determined
Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients

All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .

Chronic Obstructive pulmonary disease is known to escalate the consumption of Inhalation Agents in General Anesthesia. Hence the Data to Collect the Official Record

Eligibility Criteria:
Inclusion Criteria:

* Both Sex All Age Group Patient willing to give consent COPD patient

Exclusion Criteria:

* Not willing to give consent Cancerous Lung Lung Lobectomy
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).


Eligibility Criteria:
Inclusion Criteria:

* Males and Females, at least 18 years of age
* Documented symptoms of idiopathic overactive bladder for at least 3 months
* Failure on primary OAB treatment, such as behavior modification or fluid/diet management
* Patients can remain on stable medication
* Willing and capable of understanding and complying with all requirements of the protocol
* Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

* Urinary retention or post voiding residual greater than 100 ml
* Clinically significant bladder outlet obstruction
* Stress predominant mixed urinary incontinence
* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
* Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
* Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
* Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
* Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
* Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
* Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
* History of pelvic radiation therapy
* Any skin conditions affecting treatment sites
* Lacking dexterity to properly utilize the components of the stimulator system.
* Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
* Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
* Recurrent Urinary Tract Infections UTI (\>3 UTI's in the past year)
* History of, or current, lower tract genitourinary malignancies
* Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study
* Any other clinical trial within 6 months
TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study

Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a cross-sectional nationwide database to define clinical and polysomnographic characteristics of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients with metabolic and cardiovascular diseases as well as risk for traffic accidents will be explored as secondary aims. Impact of treatment of sleep apnea on metabolic and cardiovascular complications as well as compliance with positive airway pressure treatment will be further explored longitudinally.

All subjects undergoing sleep study for suspicion of obstructive sleep apnea will be registered in a web-based national database regarding:

* Anthropometric data, educational status, driving licence,
* Smoking and alcohol use
* Comorbidities, and drug use
* Questionnaires, excessive daytime sleepiness
* Polygraphic and polysomnographic findings
* Blood pressure measurements
* If taken, blood glucose, lipids and other biochemical markers
* If measured, lung function test results
* If measured, echocardiography findings
* Follow-up data regarding treatment modality and compliance

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea
* Ability to read and speak
* Signed informed consent.

Exclusion Criteria:

* subjects who use positive airway pressure
* subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
* subjects with alcohol dependency
The Multicenter Cardiology Monitoring Platform Registry

The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional).

It's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.

Rationale: Heart failure (HF) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. A better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies.

Objective: To optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.

Study design: The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional).

Study population: All subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion.

Main study parameters/endpoints: This is a prospective registry from which multiple research questions can be answered. In general, two main approaches will be used: (A) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (B) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.

Eligibility Criteria:
Inclusion Criteria:

* Referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac/cardiogenetic screening;
* Age ≥16 years.

Exclusion Criteria:

* Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.

Biphentin methylphenidate hydrochloride (HCl) extended release (ER) capsules is provided in multiple strengths of 10, 15, 20, 30, 40, 50, and 60 mg to be administered once daily. Once daily dosing is intended to provide treatment for the substantial day.

For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or 40 mg in a timeframe of five weekly periods. In the sixth week each subject will be randomized double-blind to receive either active comparator at the optimized dose or placebo comparator treatment. The first classroom session will be held at the end of the week, when efficacy measurements including Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) and Permanent Product Measure of Performance (PERMP) tests will be administered. At the beginning of the following week, the subjects will be crossed-over to the corresponding active comparator or placebo comparator treatment. The second classroom session will be held at the end of the second double-blind week, when the same efficacy measurements will be administered.

Various safety and tolerability, and quality of life assessments will be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 6 to 12.
2. ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile.
3. In need of treatment for ADHD and able to have 2-day washout from previous medication.
4. Females of child-bearing potential not pregnant and practice birth control.
5. Subject and parent/guardian willing to comply with protocol.
6. Signed consent and assent.

Exclusion Criteria:

1. Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence.
2. Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.
3. Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
4. Use of psychotropic CNS meds having effect exceeding 14 days from screening.
5. Planned use of prohibited drugs.
6. Is pregnant or breast-feeding.
7. Significant ECG or laboratory abnormalities.
8. Experimental drug or medical device within 30 days prior to screening.
9. Hypersensitivity to methylphenidate.
10. Inability or unwillingness to comply with protocol.
11. Well controlled on current ADHD treatment.
12. Inability to take oral capsules.
Intranasal Insulin for Prevention of Type 1 Diabetes

Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for HLA alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-12-month intervals for development of diabetes-associated autoantibodies. Children having at least two types of autoantibodies (of the four measured) in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial. Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes. The primary outcome measure is development of clinical diabetes.

Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for the HLA-DQB1 and DQA1 alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-month intervals until 2 years of age and then at 6-12-month intervals until,15 years of age for development of diabetes-associated autoantibodies (autoantibodies against islet cells, insulin, glutamic acid decarboxylase and IA-2 protein). Children having at least two types of autoantibodies of the four measured in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial. Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes. The primary outcome measure is development of clinical diabetes, but serum concentrations of autoantibodies, responses to intravenous glucose tolerance test and possible side effects of therapy are also closely monitored.

Eligibility Criteria:
Inclusion Criteria:

* children carrying HLA-conferred genetic risk for developing type 1 diabetes
* have had at least two types of autoantibodies of ICA, IAA, GADA and IA-2A in at least two consecutive blood samples drawn at least 3 months apart
* age at least one year

Exclusion Criteria:

* severe other disease
* age above 15 years
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists
* Patients must be 18 years of age or older
* Karnofsky Performance Status ≥ 70
* Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or \< 2
* Adequate organ and marrow function
* Using adequate contraceptive measures, be surgically sterile or post-menopausal

Exclusion Criteria:

* Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study
* Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617
* Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
* Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
* Known bleeding diathesis
* Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
* Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment