cyrilzakka/clinical-trials huggingface dataset:
Maximizing Independence at Home (MIND at Home)

Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish Community Federation of Baltimore, this project seeks to develop effective ways to deliver dementia care to older adults with memory disorders who live in the community. MIND at Home is an 18 month intervention research study whose goals are two-fold: To partner with community organizations to help proactively identify older adults in the Baltimore community who may need help related to memory disorders; To find out if providing person-centered, coordinated care will help older adults with memory disorders remain at home longer, as well other possible benefits. The investigators hypothesize that individuals with memory disorders that receive person-centered, coordinated care will have fewer unmet dementia-related needs, improved quality of life and function, fewer behavioral and depressive symptoms, and will be able to remain in their homes longer compared to individuals who receive augmented usual care.


Eligibility Criteria:
Inclusion Criteria:

* 70+ years old
* Community living (within one of 28 zip codes in Baltimore)
* Has memory disorder
* Has identified study partner willing to participate
* English-speaking

Exclusion Criteria:

* Situation at the time of referral is an emergency with risk of danger to individual or others
* Presence of delirium or other rule outs for memory disorder
Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power

To assess postsurgical visual acuity (distant, intermediate, near), refractive errors, contrast sensitivity, visual function and patient satisfaction after implantation of multifocal IOLs of different add power contralaterally.

Multifocal intraocular lens (MIOL) is considered a prevailing alternative to restore the functional vision from far to near independent of glasses. Many clinical studies on diffractive MIOLs, refractive MIOLs, or hybrid MIOLs in enhancing quality of vision showed promising outcomes. Several studies have confirmed the satisfactory visual outcomes of Tecnis MIOL with +4.00 D add power. The purpose of study is to assess the visual performance after cataract surgery with bilateral implantation of multifocal IOL with two different add power (+2.75 D or +3.25 D) in one patient.

Eligibility Criteria:
Inclusion Criteria:

* • Age-related cataract

  * Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye.
  * A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation.
  * A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
  * Written informed consent to surgery and participation in the study

Exclusion Criteria:

* • Pregnant woman and lactating woman

  * A patient with history of retinal disease
  * A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
  * A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
  * A patient that has been wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery.
  * Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome
  * Those who are not able to read and understand the informed consent (illiterate or foreigners)
Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)

Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.

Exclusion Criteria:

* Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease.
* Procedures that entail the likelihood of blood transfusion will be excluded.
Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology

A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly prevalent in obese populations. This phenomenon is also known as chronotropic incompetence (CI). In adult obese individuals, CI is independently related to elevated risk for major adverse cardiovascular events and premature death. Despite the established association between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents with obesity has however deserved no attention, but is important. CI during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. However, whether CI during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. In addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. In this project, we examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between CI and changes in CPET parameters, lactate, catecholamine and potassium concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG recording). In addition, the relation between CI and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.


Eligibility Criteria:
Inclusion Criteria:

* aged 12-16 years
* obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
* Parental permission

Exclusion Criteria:

- Chronic cardiovascular, renal, pulmonary and orthopedic disease
Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.

Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100 mcg in Adolescent and Adult Subjects (=12 years of age) With Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber

Eligibility Criteria:
Inclusion criteria:

* Informed consent
* Outpatient
* Females must use appropriate contraception
* Diagnosis of seasonal allergic rhinitis
* Able to comply with study procedures
* Literate

Exclusion criteria:

* Significant concomitant medical condition
* Use of corticosteroids, allergy medications, or tobacco
* Clinically significant abnormal ECG
* Laboratory abnormality
* Positive pregnancy test
* Allergy to any component of investigational product
Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)

To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Must have participated on a deforolimus (ridaforolimus) parent trial
* Must have derived a clinical benefit from the parent trial
* Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
* Participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
* Signed informed consent

Exclusion Criteria:

* Has not participated on a parent trial
* Women who are to receive study drug who are pregnant or lactating
* Any condition in the Investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol
Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease

In this study, we apply brain MR imaging techniques at 3 Tesla to assess pain-relevant processing in patients with disc degenerative disease (DDD) scheduled for back surgery and age- and gender-matched controls without back pain. Data collection pre-surgery is performed over two days: On the first day, all participants undergo a battery of questionnaires relevant for individuals with chronic pain and pain sensitivity testing, including temporal summation and pressure pain thresholds. On the second day, participants undergo a MRI protocol, which includes functional MRI (fMRI) and diffusion tensor imaging to assess microstructural properties and structural connectivity. During fMRI, an experimental pressure pain paradigm is performed at the calf i.e. a location not connected to patients' chronic pain condition. Instead, the experimental pain paradigm serves as a condition to test processing of noxious stimulation unrelated to patients' experienced chronic pain. The noxious input pressure is individually calibrated to 50 on a 0-100 VAS scale to ensure that individual pain perceptions, despite different pressure intensities, are comparable across participants. The sensory stimulation will consist of a low standardized pressure intensity (150kPa). In an additional fMRI paradigm, participants do not receive stimulation but are instructed to continuously rate fluctuating spontaneous ongoing back pain (DDD) or perceived unpleasantness (controls).

This project aims at investigating measures of brain architecture, neural response connected with evoked pain, connectivity (structural and functional) and pain-relevant psychometrics and questionnaire data in disc degenerative disease patients scheduled for back surgery. Specifically, MRI is performed to test whether i) patients display differences in properties of the mesolimbic circuit compared to healthy individuals and ii) behavioural as well as clinical characteristics related to the acquired MRI markers. This study is intended to serve as a baseline in a longitudinal project testing associations with between findings at baseline and following surgery (fusion/disc implants).


Eligibility Criteria:
Inclusion Criteria:Inclusion criteria:

* 30-60 year
* Right-handed
* DDD patients: Radiologically verified DDD and DDD pain as their main pain complaint

Exclusion Criteria:

* previous spine surgery
* significant pain problems due to other causes and/or other chronic pain syndromes
* inflammatory rheumatic diseases
* neurological/psychiatric disorders
* severe cardiovascular disease
* substance abuse
* BMI\>40
* Contraindication to MRI
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants


Eligibility Criteria:
Inclusion Criteria:

United States of America (USA) specific inclusion criterion:

- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation.

Rest of World (ROW) specific inclusion criterion:

- Participant must be ≥ 2 years of age at the time of signing the Informed Consent/Assent according to local regulation.

Global specific inclusion criteria:

* Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion
* Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care

Exclusion Criteria:

* Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP
* Participant has known positive serology for muscle-specific kinase
* Participant has known hypersensitivity to any components of the IMP
* Participant has a prior history of meningococcal disease
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* histological diagnosis of primary central nervous system lymphoma;
* B-cell proliferation verified by positive staining for CD20;
* \>=1 measurable lesion.

Exclusion Criteria:

* prior chemotherapy, other than corticosteroids, \>=6 weeks before and after diagnosis or surgery;
* history of prior cranial irradiation;
* evidence of plurisystemic non-Hodgkin's lymphoma;
* other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix;
* uncontrolled active infection.
Extension Study for Patients Entered Into Study Infacort 003

A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to take part in Infacort 004.

A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with AI who had completed study Infacort 003 (EudraCT number 2014-002265-30). All subjects who had satisfactorily completed study Infacort 003 wiere offered the opportunity to participate in study Infacort 004 at or after their final visit of study Infacort 003. Subjects received the usual clinically-appropriate dose (since bioequivalence has been demonstrated with conventional hydrocortisone), as determined by the Investigator, which was administered according to usual clinical practice - generally 3 or 4 times a day. Subjects could continue to be treated in this study until they met the study withdrawal criteria, until Infacort® was commercially available locally (which has now been achieved), or until the Sponsor decided to discontinue the study.

Eligibility Criteria:
Inclusion Criteria:

Subjects successfully completing study Infacort 003, whose inclusion criteria were:

1. Male and female children less than 6 years of age.
2. A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low cortisol usually with other supporting tests.
3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone).
4. Adequately hydrated and nourished. In addition, the parents/carers must be able to understand and give written Informed Consent for this extension study.

Exclusion Criteria:

1. Clinically evident acute AI (adrenal crisis) (Note: the subject can be re-evaluated for eligibility once the episode is over)
2. Inability of the child to take oral therapy
3. Subjects with clinical signs of acute infection or fever on inclusion (Note: the subject can be re-evaluated for eligibility once the episode is over)
4. Any surgical or medical condition that in the opinion of the Investigator may place the subject at higher risk from his/her participation in the study
5. Parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons
6. Subjects who are in a dependent relationship with the Investigator or the Sponsor
[C-11]NOP-1A and Alcohol Use Disorder

The goal of this study is to compare \[C-11\]NOP-1A binding in recently abstinent alcohol use disorders and controls

This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Eligibility Criteria:
\[A\] Alcohol use disorders (AUD)

Inclusion Criteria:

1. Males or Females
2. Fulfill DSM5 diagnosis for alcohol use disorder
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy or lactation
2. Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
4. Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain

\[B\]Healthy controls

Inclusion Criteria:

1. Males or females
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy of lactation
2. Medical, psychiatric or comorbid drug/alcohol use disorders
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain
6. Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
Breast Ultrasonography and Polycystic Ovary Syndrome

The results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated.

Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day after the end of menstrual breast ultrasonography. The aim of this study is to show the association of polycystic ovary syndrome and fibrocystic breast.


Eligibility Criteria:
Inclusion Criteria:

* Over 30 years
* diagnosed with polycystic ovary syndrome according to rotterdam criteria
* no previous history of breast disease
* female patients

Exclusion Criteria:

* Under 30 years
* polycystic ovary syndrome
* patients with a previously known history of breast disease
Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.

To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

Exclusion Criteria:

* Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy