cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy for Patients With Cancer of the Stomach

The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.

The primary aim of this dose-finding study is to determine the maximum tolerated doses of docetaxel, oxaliplatin and S1 given every second (DOS2w) or third (DOS3w) week as first-line treatment in patients with advanced gastro-esophageal cancer. Secondary end points are to evaluate toxicities according to NCI-CTCAE v. 4, response rate, progression-free survival and overall survival

Primary Outcome Measure:

To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).

The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).

Methods:

This dose-finding study is planned to include a total of 24 patients with advanced gastro-esophageal cancer, adenocarcinoma.

12 patients will be included in (DOS2w) at four at progressively higher dose levels.

Chemotherapy will be repeated day 1 every second week to a maximum of nine courses.

12 patients will be included in (DOS3w) at three progressively higher dose levels.

Chemotherapy will be repeated day 1 every third week to a maximum of six courses.

In both (DOS2w) and (DOS3w) dose-limiting toxicity (DLT) will be evaluated after the first course. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continues if 0/3 or 1/6 patients experience DLT.

Patients will be evaluated with a ct-scan at baseline and after every three or four cycles to exclude progression and evaluate response. Response is assessed by the investigator according to RECIST version 1.1.

Eligibility Criteria:
Inclusion Criteria:

1. Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
2. Age ≥ 18 years.
3. WHO performance status 0-1.
4. Neutrophils ≥ 1,5 x 109/L and platelets ≥ 100 x 109/L.
5. Bilirubin ≤ 1,5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.
6. Creatinine-clearance ≥ 60 ml/min.
7. Planned first day of treatment within 8 days after inclusion in the study.
8. Signed consent form.

Exclusion Criteria:

1. No previous treatment with chemotherapy, except for (neo)-adjuvant chemotherapy for adenocarcinoma - treatment should have been completed at least 6 months before entrance in this study.
2. No sensory neuropathy.
3. No previously treatment with docetaxel, oxaliplatin or S1.
4. No clinical suspicion of brain metastases.
5. No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
6. Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
7. No pregnant women or women who are lactating. Patients who are not using contraception.
8. No known DPD-deficiency or known allergy to taxanes or platinum.
9. No signs of physical or mental illness that would prevent absorption of oral treatment.
Falls Prevention Clinic

At the Falls Prevention Clinic, each subject receives a comprehensive assessment of his or her individual risk factors for falling in addition to a comprehensive medical examination. Recommendations and appropriate followup tests and referrals are ordered for patients on an individual basis.

Essential for medical advancement is the inquiry into information collected from medical records of older adults at high risk of falls and fracture. On such example is a retrospective chart review we conducted among patients who sustained a hip fracture \[14\]. The database we propose will provide novel insight into the identification of individuals at high risk for falls, key predictors of falls and associated mortality, morbidity, health related quality of life and healthcare resource utilization. In summary, our database will enable us to assess and improve quality of care, service delivery, patient outcomes, patient reported outcomes and track economic burden.

Purpose: In community-dwelling seniors aged 70 years and older who attend the Vancouver Falls Prevention Clinic and who consent to allowing their data to form part of the Falls Prevention Clinic Database, we will audit charts to answer the following questions: 1) In terms of mobility and functional status, what characterizes the patient population that is referred to the Falls Prevention Clinic? 2) What is the physiological profile assessment (PPA) of individuals at the Falls Prevention Clinic? 3) What are the demographic characteristics? 4) What are factors that explain differences in health related quality of life and healthcare resource utilization? and 5) For individuals who have a high falls risk profile, what are their specific clinical outcome measures that indicate better or worse health related quality of life?

Objective: To develop a Falls Prevention Clinic Database for subjects who attend the Falls Prevention Clinic at Vancouver General Hospital and Lion's Gate Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥70 years attending a Falls Prevention Clinic Service;
* Understands, speaks, and reads English proficiently;
* MMSE \[11\] score \> 24/30;
* A Physiological Profile Assessment (PPA) © \[15\] score of at least 2 SD above normal OR Timed Up and Go Test (TUG) 68 performance of greater than 15 seconds OR history of at least 2 falls in the previous 12 months;
* Expected to live greater than12 months;
* Living in the Metropolitan Vancouver area;
* Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
* Able to walk 3 meters with or without an assistive device; and
* Able to provide written informed consent.

Exclusion Criteria:

* Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
* Diagnosed with dementia (of any type);
* Had a stroke;
* Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
* Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema

To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser

Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.

Focal to Mas+ confluent burns to areas of diffuse leakage

Eligibility Criteria:
Inclusion Criteria:

* Eyes with DME (center or non-center involving) with \<350 microns central retinal thickness

Exclusion Criteria:

* Subfoveal exudates, history of VR surgery, history of macular laser
Randomized, Controlled Evaluation of a Virtual Human Patient for Provider Training in Motivational Interviewing

The purpose of this study is to evaluate the efficacy of training with a virtual standardized patient on the acquisition and maintenance of motivational interviewing skills compared with traditional academic study.

Motivational interviewing is an evidence-based counseling approach that aims to increase a patient's motivation to make positive health changes in their lives. A common training method for medical professionals is the use of human standardized patients, who are actors who pretend to be patients for educational interviews. Standardized patients are expensive and it is challenging to maintain an adequate pool of patient actors. Accordingly, after licensure or medical boards, health professionals typically adopt new evidence-based practices, like motivational interviewing, without human standardized patient training experiences. Given the established importance of post-training coaching and feedback to the acquisition of motivational interviewing, innovative training methods are needed. Computer virtual patients may provide a cost-effective alternative that is scalable and supports dissemination of evidence-based practices. This study will evaluate the efficacy of a virtual standardized patient, relative to academic study, for training motivational interviewing among health care professionals from the Department of Veterans Affairs and Department of Defense.

Eligibility Criteria:
Inclusion Criteria:

* All health care staff (e.g., physicians, nurses, social workers, psychologists) from supporting service lines are eligible to participate in the study.

Exclusion Criteria:

* 8 hours or more of formal training in MI in the year prior to baseline assessment.
* Successfully completed participation in the VA Evidence Based Practice roll-out of MI.
* Served as MI trainers or have conducted research on MI at any time
* Do not anticipate being available for the full duration of the training study (according to their verbal self-report)
Corneal Incisions With the IntraLase iFS Femtosecond Laser System

The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
* Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
* Clear intraocular media other than cataract
* Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
* Signed informed consent

Exclusion Criteria:

* Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
* History of active or recurrent ophthalmic disease
* Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
* White to white measurement less than 10 mm or greater than 14 mm
* Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
* Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
* Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
* Subjects with conditions associated with increased risk of IOL/capsule instability
* Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities
* Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)
* History of any ocular or medical conditions that could affect corneal wound healing
* Poorly-controlled diabetes or subjects with diabetic retinopathy
* Concurrent use of topical or systemic medications that may impair corneal wound healing
* Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
* Ocular hypertension (\> 21 mm Hg)
* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course
* Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit
Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis

THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis


Eligibility Criteria:
Inclusion Criteria:

* Male of female of at least 19 years old
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy

Exclusion Criteria:

* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients with previous gastrointestinal surgery
* Patients with history of gastrointestinal cancer
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.

The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine.

Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic restless legs syndrome

Exclusion Criteria:

* History of sleep disturbances
Safety Study of the VEGA UV-A System to Treat Ectasia

The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years of age or older
* Diagnosis of Ectasia
* Presence of central or inferior steepening
* Topography consistent with ectasia
* BSCVA 20/20 or worse
* If contact lens wearer; removal of contact lenses for required period of time
* Signed informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
* History of chemical injury or delayed epithelial healing
* A known sensitivity to study medications
* Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
* A condition that would interfere with or prolong epithelial healing
* Presence or history of any other condition or finding that makes the patient unsuitable for treatment
Shape of the Sagittal Curvatures of the Spine in Youthful Female Volleyball Players

The goal of this study is to assess the formation of the sagittal curvatures of the spine in healthy girls practicing volleyball versus their untrained peers.

Research questions:

1. Is there a differentiation in values of thoracic kyphosis, lumbar lordosis angles, and compensation ratio among girls practicing volleyball and their untrained peers?
2. Does practicing volleyball determine the frequency of correctness in the lumbosacral inclination, the shape of the curvature of the thoracic kyphosis and lumbar lordosis?
3. Does practicing volleyball determine the frequency of types and subtypes of body posture?

The investigators compared 30 healthy girls aged 10-13 (attending training regularly, three times a week), with 30 healthy peers who did not train in any sports and did not regularly participate in any physical exercises apart from attending obligatory physical education classes. The Baseline Bubble inclinometer was applied as the research tool of choice. The study protocol entailed the measuring of the sagittal curvatures of the spine.

Eligibility Criteria:
Inclusion Criteria:

* age range of 10-13 years,
* dominating right hand and right leg,
* a written informed consent to participate in the study.

Exclusion Criteria:

* injuries of the musculoskeletal system,
* pathology of the limbs,
* previous orthopedic surgery,
* neurological disorders,
* refusal to participate in the study.
FRailty WAlking Patterns (FRAP) Study

The aim of this study is to evaluate sit-stand phases and gait speed detection using an externally worn Reveal LINQ (TM) compared to an external reference (3D accelerometer, and/or the Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands

Frailty is a geriatric syndrome characterized by reduced homeostatic reserves, exposing the organism to extreme vulnerability to endogenous and exogenous stressors.

Frailty is prevalent in older people and involves a progressive physiological decline of multiple body systems, typical signs and symptoms include weight loss, fatigue, muscle weakness, slow or unsteady gait declines in activity.

Frailty is increasingly recognized as an important prognostic indicator in heart failure (HF) and is more prevalent in HF than the general population.

The identification of frailty in its early stage is important because interventions may potentially prevent, or delay the clinical consequences of frailty.

Of particular focus in this study will be walking speed as prior research has demonstrated that slow gait speed has the strongest prognostic ability of the traditional components used to assess frailty, and has been reported as one of the strongest to predict adverse outcomes, such as mobility disability, falls, or hospitalization.

Also of interest is the detection of posture changes as this may have implications for detecting changes in sleeping habits and could also provide context for other biomarker signals collected by the LINQ device.

The literature has been reviewed and the scientific soundness of the proposed analytical techniques evaluated. The rationale for this study design is to evaluate the feasibility of using the Reveal LINQ™ to monitoring walking patterns.

HF patients (the target population for the study in discussion) would make it possible to test the sensitivity of the accelerometer embedded in the LINQ device in a small cohort of subjects with reduced mobility and for which frailty is more prevalent than the general population, as well as recognized as an important prognostic indicator.

No risk to the subjects is expected with this study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Heart Failure in New York Heart Association (NHYA) class II and class III
* Willing to sign the informed consent form.
* At least 18 years of age.

Exclusion Criteria:

* • Not able to walk continuously for a period of 6 minutes and perform the walking exercises as necessary for the study protocol.

  * Any known allergy to Titanium
  * Any concomitant conditions which in the opinion of the investigator would not allow accurate measurement of gait and frailty parameters with an externally worn device.
  * Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
  * Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m\^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
* Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
* Measurable disease (by Response Evaluation Criteria In Solid Tumors \[RECIST\])
* No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

Exclusion Criteria:

* Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
* Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
* History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
* Known distant metastases
* Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
Phase 2 Open-label Extension Study of AOC 1020 in Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

This study will continue to evaluate the safety, tolerability, and efficacy of AOC 1020 in participants who were treated in the randomized, placebo-controlled, Phase 1/2 AOC 1020-CS1 clinical study.

Participants from AOC 1020-CS1 are eligible to enroll in AOC 1020-CS2 if they have satisfactorily completed AOC 1020-CS1. All participants who enroll in AOC 1020-CS2 will receive AOC 1020 regardless of whether they received AOC 1020 or placebo in AOC 1020-CS1. Dosing will occur every 6 to 7 weeks (twice quarterly).

The total duration of active treatment in AOC 1020-CS2 is approximately 22 months. Once participants have completed active treatment, they will be followed through a 12-week safety follow-up period to monitor for adverse events (AEs), concomitant medications, and pregnancy status (as applicable). Total duration on study is up to approximately 25 months (2 years 1 month), excluding the potential 8-week screening period.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent (signed and dated) and any authorizations required by local law and be willing and able to comply with all study requirements. When enrolling participants who are minors, it is necessary to also obtain consent from a legally designated representative and the participant will receive information in a way adapted to their age and mental maturity.
2. Completion of AOC 1020-CS1 with the following as judged by the Investigator and Sponsor:

   1. No significant tolerability issues
   2. Satisfactory compliance with the AOC 1020-CS1 protocol requirements

Exclusion Criteria:

1. Pregnancy, intent to become pregnant during the clinical study, or active breastfeeding.
2. Unwilling or unable to continue to comply with contraceptive requirements for the length of AOC 1020-CS2.
3. Any new conditions or worsening of existing condition(s) that in the opinion of the Investigator or Sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study. (Note: FSHD progression is not exclusionary, even if the participant no longer has the ability to walk 10 meters without a walker or two canes.)