cyrilzakka/clinical-trials huggingface dataset:
Istradefylline for Parkinson Disease With Cognitive Impairment

The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.

Istradefylline has been approved by the U. S. Food and Drug Administration (FDA) to reduce "off" episodes in Parkinson disease. The period when levodopa has a positive effect on Parkinson's symptoms is called on-time. Once the medication stops working, a so called "off" episode starts, where symptoms recur. Usual care for treatment of Parkinson disease with cognitive impairment is use of cognition enhancing medications also called cholinesterase inhibitors. In this study, participants will receive usual care, and in addition, they will be asked to take istradefylline daily for 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for probable Parkinson disease dementia or PD-MCI (mild cognitive impairment)
* Age greater than 50
* Hoehn and Yahr stage \< 4 in "on" state
* Currently taking carbidopa/levodopa
* Antiparkinsonian medications stable for at least 4 weeks prior to baseline visit
* Cholinesterase inhibitor dose stable for 8 weeks prior to baseline visit

Exclusion Criteria:

* Meet criteria for dementia with Lewy bodies, including dementia onset prior to or within 1 year of parkinsonism onset
* Presence of troublesome dyskinesias
* Pregnancy or possibility of becoming pregnant during the study period.
* Moderate or severe hepatic impairment
* dementia too severe to complete study measures or to adhere to medication schedule
CBD in Postmenopausal Women With Osteopenia

This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia.


Eligibility Criteria:
Inclusion Criteria:

* Is a female aged 50-80 years, inclusive, at the time of screening.
* Is postmenopausal, defined as \> or = 12 months amenorrhoea.
* Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research \& Osteoporosis Center up to 6 months prior to the Screening Visit.
* Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit 1.
* Has a body mass index between 18 and 35 kg/m2 (inclusive).
* Is judged by the Investigator to be in generally good health at screening based on participants' medical history.
* Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.

Exclusion Criteria:

* Has a history of epilepsy, hepatitis, or human immunodeficiency virus.
* Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1).
* Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit.
* Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5× the upper limit of normal (ULN), or bilirubin \>2× ULN.
* Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
* Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
* Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit 1.
* Positive urine dipstick results for THC at the Screening Visit.
* Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
* Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
* Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
* History of Osteoporosis diagnosis.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active GPP
* Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
* Must be candidates for systemic therapy or phototherapy

Exclusion Criteria:

* Erythrodermic, guttate psoriasis, drug induced GPP
* Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
* History of recurrent or chronic infection
* ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply
Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD).

The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). Ten subjects with MDD and BPD will receive a single 25 mg oral dose of psilocybin. The hypothesis to be tested is that psilocybin will result significant reduction in symptoms of both MDD and BPD after 1 week and sustained for 4 weeks compared to baseline (improvement in symptoms will be indicated by lower scores on established outcome measures of MDD and BPD symptoms that have been used in prior studies).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diagnosed with current major depressive disorder
* Montgomery-Asberg Depression Rating Scale (MADRS) score of \> 20
* Diagnosed with borderline personality disorder
* Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) score of \> 20
* Ability to understand and sign the consent form

Exclusion Criteria:

* Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
* Illegal substance use based on urine toxicology screening (except cannabis use)
* Current or past history of bipolar I disorder, schizophrenia, or schizoaffective disorder
* Active substance use disorder
Mirror Therapy in Stroke

Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone.


Eligibility Criteria:
Inclusion Criteria:

Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20\< points in MMSE

Exclusion Criteria:

a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.

OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. II. Assess the toxicity of this regimen in this patient population.

OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI At least 2/3 of the tumor in the pons Tumor origin clearly in the pons At least 2 clinical features with less than 6 months duration: Cranial nerve deficit Long tract signs Ataxia No diffuse brain stem enlargement secondary to neurofibromatosis No diffuse leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL ALT no greater than 5 times upper limit of normal Renal: Creatinine or GFR normal for age

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No other concurrent chemotherapy No prior chemotherapy Endocrine therapy: Prior glucocorticoids allowed Radiotherapy: No prior radiotherapy Surgery: No prior surgery Other: No other concurrent investigational drugs
Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia

The goal of this clinical trial is to investigate the effect of video-game on swallowing function in patients with dysphagia through a randomized controlled trial and whether it has additional benefits in improving swallowing function and training compliance compared with conventional training methods. The main questions it aims to answer are:

* How effective is video-game based rehabilitation for dysphagia?
* Whether video-game based has additional benefits in improving swallowing function and training compliance compared with conventional training methods Participants will be divided into two groups, with one group completing video game rehabilitation and one group completing conventional rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

1. first-episode stroke, as confirmed by brain CT or MRI;
2. diagnosis of dysphagia after stroke according to the Toronto Bedside Swallowing Screening Test (TOR-BSST);
3. age between 18 and 80 years;
4. no significant cognitive impairment, able to execute instructions correctly, and with Mini-Mental State Examination (MMSE) score ≥ 24;
5. clear consciousness as assessed by the National Institute of Health stroke scale (NIHSS).

Exclusion Criteria:

1. dysphagia caused by structural lesions (eg, radiotherapy, previous extensive surgery of the head and neck region such as laryngectomy and cordectomy);
2. combined with serious heart, lung, liver, kidney diseases, and hematological disorders;
3. limb deficiency or paralysis, blindness in both eyes, severe visual impairments;
4. motion sickness or vestibular dysfunction;
5. history of epilepsy, malignancy or other neurological diseases;
6. pregnancy or breastfeeding.
Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital

To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.

To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.

Eligibility Criteria:
of patients:

Main inclusion Criteria:

* Patients with lung, prostate breast, prostate or renal cancer;
* Patients with oral cancer drugs;
* Patients accepted to take par in pharmaceutical consultation in hospital.
Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab

Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term.

Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS.

Cognitive impairment may also reduce the ability of patients to comprehend and adhere to treatment concepts (Bobholz 2003). Early detection of cognitive impairment is important to initiate therapeutic intervention, even though the optimal treatment of cognitive decline in MS is at the moment controversial.

Preliminary studies suggest an essential role of disease modifying therapies (DMT) in inhibition of cognitive deterioration in patients with MS (Barak 2002, Flechter 2007). Data about long term cognitive performance of multiple sclerosis patients treated with natalizumab is limited. One study demonstrated in MS patients treated with natalizumab an improvement in SDMT (Symbol Digit Modalities Test) of 16.4% over a period of 2 years (Piehl 2010). SDMT is a screening tool for cognitive impairment in MS patients, mainly measuring working memory and speed processing. As SDMT only covers a part of the neurocognitive impairments seen in MS patients, there is a need for further studies to gain a more complete picture.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 55 years at presentation
* Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
* Patients treated with ntz
* EDSS under 5.5

Exclusion Criteria:

* Brain pathology other than MS
* Known history of head trauma
* Pure spinal manifestation of demyelization
* Neuromyelitis optica
* Primary and secondary progressive MS
* Benzodiazepine intake within the last three months
* Relapse within the last three months
* Steroid intake within the last three months
* History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
* No informed consent
* Insufficient knowledge of German
Mitral Valve Replacement With MValve Dock and Lotus

This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

This study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement.

The surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to provide a structural platform within the mitral annulus so that the Lotus THV can be implanted in a secure fashion in the mitral annulus. The investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. This study is designed to treat subjects with moderate-to-severe MR who are not deemed candidates for mitral valve surgery.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure.
* New York Heart Association (NYHA) Functional Class III or IV.
* High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team.
* Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the procedure.
* Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by echocardiography.
* Left atrial diameter \<5.5 cm by echocardiography

Exclusion Criteria:

* Prior mitral valve replacement or repair surgery.
* Prior transapical surgery.
* Severe aortic or tricuspid valve disease. - Severe symptomatic carotid stenosis (\>70% by ultrasound).
* ACC/AHA Stage D heart failure.
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
* Infiltrative cardiomyopathies (amyloidosis, hemochromatosis, sarcoidosis).
* Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
* Severe mitral annular calcification.
* Glomerular filtration rate (GFR) \< 30.
* Hemodynamic instability defined as systolic pressure \< 90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance.
A Rehabilitative Approach in Patients With Parkinson's Disease

The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi muscle according to the Mézières Method to improve balance and posture and relief pain in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis od idiopathic Parkinson's disease (according to UK Brain Bank Criteria), Hoehn-Yahr stage ≤3 (determined during "on phase"), Mini Mental State Examination (MMSE) \> or = 27, no rehabilitation treatment carried out within 3 months prior to the study, diagnosis of Parkinson's disease by at least 5 years.

Exclusion Criteria:

* Dyskinesias
* Severe fluctuations "on-off"
* Modifications of anti-Parkinsonian drug therapy during the three months prior to the start of the study)
* Sensitivity deficit of the trunk or lower extremities (physical examination)
* Vestibular disorders or paroxysmal vertigo
* Previous thoracic or abdominal surgery
* Other neurological or orthopedic conditions involving the trunk or lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, prosthetic surgery)
* Cardiovascular comorbidities (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)