cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living
2. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening
3. Participant has normal premorbid intelligence quotient (IQ) at Screening
4. Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed

Exclusion Criteria:

1. Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
2. Participant has a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury
3. Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology)
4. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
5. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood
6. Participant has current or recent suicidality
HER2-directed Biosimilar in Breast Cancer: Real World ePRO

This project will engage anti-HER2 directed Trastuzumab biosimilar with a novel quality of ePRO and enable comparison of reliable reference real world patient data, thereby creating a basis for analytic research in order to promote the quality and efficiency of treatment

Comprehensive data on patient history and follow-up modalities, AEs and outcome will be collected as ePRO to provide high-quality reports and quantitatively abundant data provided by patients. In particular, prospectively collected data shall be compared to previously collected ePRO from women treated for HER2-positive BC in a variety of indications and settings . Since a large number of data entries for wellbeing and symptom reporting (according to CTCAE) is available from these patients, the investigators will refer to this as a historic registry data warehouse. Accordingly, the ePRO from these patients treated for HER2 positive BC are available for planned comparative analysis and shall be applied to indicate differences in anti-HER2 directed medication between Ogivri and Herceptin.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Patients ≥ 18 years
* Patients with HER2-positive breast cancer (IHC-FISH/SISH)
* Undergoing Anti-HER2 treatment during the observational period containing OgivriTM (Trastuzumab) +/- Pertuzumab +/- Chemotherapy
* Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions

Exclusion Criteria:

* Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted
* Patients with insufficient knowledge about the use of a smartphone
Evaluate the Performance of Large Language Models in Ophthalmologic Patient Consultation

The intelligent image models lack an understanding of diagnostic and treatment logic, and have not considered textual information such as symptoms and signs. Large language models like ChatGPT, can learn medical knowledge, understand, and generate human natural language, offering new technologies for medical knowledge-based intelligent question answering and the creation of smart medical documents. Therefore, our team plan to verify large language models' feasibility and effectiveness in ophthalmology clinics for medical history collection and examination recommendations during consultations, comparing its performance with traditional methods.


Eligibility Criteria:
Inclusion Criteria:

* No age or gender restrictions for patients.
* Non-emergency ocular diseases including corneal diseases, lens disorders, and vitreoretinal diseases.
* Voluntary participation with signed informed consent.

Exclusion Criteria:

* Top 10 Ocular Emergencies: globe perforation, ocular chemical injury, corneal ulcer perforation, Pseudomonas aeruginosa keratitis, acute angle-closure glaucoma, acute panophthalmitis, central retinal artery occlusion, acute optic neuritis, endophthalmitis, and orbital cellulitis.
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer

The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is \[Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.\] The main questions it aims to answer are:

* probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery
* surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules.

The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for total or partial gastrectomy;
* Ages from 18 years old.

Exclusion Criteria:

* Palliative patients
* Use of probiotics and prebiotics in the last 15 days;
* Patients who are unable to complete all monitoring steps;
* AIDS patients;
* Diabetic patients;
* Pregnant patients;
* Patients with Autoimmune Diseases;
* Patients with Liver Diseases;
* Patients with Kidney Disease;
* Patients with Inflammatory Bowel Diseases.
* Patients who have MCP (pacemaker),
* Patients with severe Edema,
* Patients with titanium plates in any limb of the body
* Patients who for some reason had their surgeries suspended during follow-up.
* Patients undergoing mechanical colon preparation in the last 30 days.
* Patients not resident/domiciled in Amazonas.
A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis

This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female 18 years of age or older.
* Subject has provided written informed consent.
* Females must be post-menopausal , surgically sterile or use an effective method of birth control. , Women of childbearing potential must have a negative urine pregnancy test at Visit 1/Baseline.
* Subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp.
* Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
* Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of scalp psoriasis or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has spontaneously improving or rapidly deteriorating scalp psoriasis.
* Subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis.
* Subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome), or which exposes the subject to an unacceptable risk by study participation.
* Subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study.
* Subject has a history of psoriasis unresponsive to topical treatments.
* Subject has any hair on their scalp of a length that extends beyond the subject's chin.
* Subject has any open sores, lesions, cuts, or infections, etc. on the scalp or has had a scalp surgical procedure within the past 30 days.
* Subject is currently enrolled in an investigational drug or device study.

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.

The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years
* Patient provides study specific informed consent prior to study entry.
* Documented history and physical exam within 90 days prior to registration.
* ECOG PS 0, 1, or 2 within 90 days prior to registration

Exclusion Criteria:

* Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
* Prior invasive non study malignancy unless disease free for ≥ 3 years

  * Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
* History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
A Study of GLWL-01 in Patients With Prader-Willi Syndrome

The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the treatment of patients with Prader-Willi Syndrome (PWS).

Participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or Placebo/GLWL-01), with each sequence consisting of two treatment periods separated by a washout period

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PWS based on genetic confirmation using DNA method
* Body mass index (BMI) of 27 to 60 kg/m2
* No evidence of weight excursion beyond 10% of baseline weight
* Patients must provide assent and have a reliable caregiver (must have been caring for the patient for at least 6 months) who provides a separate written informed consent to participate. The caregiver is expected to be the primary caregiver throughout the study and must be in frequent contact with the patient (defined as at least 4 awake hours per day). The caregiver must be able to communicate with site personnel and in the investigator's opinion must have adequate literacy to complete questionnaires. If a caregiver cannot continue, 1 caregiver replacement is allowed
* Are on a stable diet and exercise regimen for \>2 months prior

Exclusion Criteria:

* Current enrollment in or discontinuation within the last 30 days from a clinical trial involving any investigational drug or device
* Are currently living in a group home for more than 50% of the time
* A history or presence of other medical illness that indicates a medical problem that would preclude study participation
* Have an estimated glomerular filtration rate \<60 mL/minute/1.73 m2. Have macroalbuminuria (defined as spot urine albumin to creatinine ratio of \>300 μg/mg) or hematuria
* Are hypertensive (defined as sitting systolic blood pressure (BP) greater than or equal to (≥)140 millimeters of mercury (mmHg) and diastolic BP ≥90 mmHg)
* Patients on weight loss medications within 30 days of dosing, or with a history of bariatric surgery
* Unable to refrain from or anticipates the use of:

  1. Any drugs known to be significant inhibitors of Cytochrome P450, family 3, subfamily A (CYP)3A enzymes and/or P-glycoprotein (P-gp) including regular consumption of grapefruit or grapefruit juice for 14 days prior to the first dose. Acetaminophen (up to 2 grams per 24-hour period) may be permitted
  2. Any drugs known to be significant inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzymes and/or P-gp, including St. John's Wort
  3. Any medications that prolong the QT/QTc interval, unless the participant has been stable on the medication for at least 3 months and has a corrected QT interval (QTc) \<450 msec
* Currently taking simvastatin \>10 mg per day, atorvastatin \>20 mg per day, or lovastatin \>20 mg per day, or have a history of statin-induced myopathy/rhabdomyolysis
* Unsuitable for inclusion in the study in the opinion of the investigator
Changes in Tactile Perception in People With Segmental Exclusion Syndrome

Segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. This syndrome has an important negative impact on the daily life of affected subjects; however, it remains poorly studied, particularly in terms of pathophysiology, and its management is still not specific. Currently, the main pathophysiological hypothesis is an alteration of the afferences related to a dysfunction of the sensorimotor loop. An hypothesis is that this dysfunction could concern the level of tactile perception and that the damage to the distal light touch receptors could play a role in the pathophysiology. The protocol is based on the performance of tests that explore different aspects of light touch: passive, active, dynamic and static sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* No history of upper limb involvement
* Confirmed diagnosis of segmental exclusion \> 3 months after injury (2 items assigned to 400 points)
* Able to understand simple orders

Exclusion Criteria:

* Central neurological involvement after the initial or pre-existing injury
* Truncal nerve damage
* Presence of psychiatric pathology
* Communication and/or comprehension disorders
* Presence of other pathology that may lead to sensory disorders (complicated diabetes, ductal syndrome, ...)
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)

This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have been 18-65 years of age, of either sex and any race.
* Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of \<6 but \>2; congestion must have been \<2.
* Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
* Subject must have understood and been able to adhere to the dosing and visit schedule.

Exclusion Criteria:

* Subject had used any investigational product within 30 days prior to enrollment.
* Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
* Subject was participating in any other clinical study(ies).
* Subject was using any nasal lavage fluid or spray.
* Subject was using any perfume during the study day.
* Subject was using any oral rinse during the study day.
* Subject had used topical or oral nasal decongestants in the past 1 week.
* Subject had used a nasal corticosteroid in the previous 2 weeks.
* Subject had anosmia or ageusia (absence of the sense of smell or taste).
* Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
* Subject had a respiratory infection in the 2 weeks prior to testing.
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness.

There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.

This study is designed as a single blind prospective randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grade II and III acute lateral ankle ligament injuries. The patients will be randomly allocated into one of the three groups. Randomization will be performed by computer. Blinding of patients is not possible, but the observer will be blinded at eight weeks and six months.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Grade II or III ankle sprains
* Presentation \< 72 hours after the acute injury

Exclusion Criteria:

* Patients with a history of chronic instability
* Who had a fracture on X-ray investigation
* Other injuries or disabilities on the same limb
* Alcoholism, serious psychiatric and neurological illness
* Patients with bilaterally sprained ankles
* Patients with previous surgery on the lateral ankle ligaments
* Skin diseases where taping is not practicable
* Patients who are unable to give informed consent
* Patients who are unable to fill out questionnaires
* Neuromuscular disorders of the lower extremities
* Active rheumatoid arthritis
* Gait disturbances
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)

The purpose of this study is to assess the safety and biological activity of ATYR1940 in participants with LGMD2B and FSHD.


Eligibility Criteria:
Inclusion Criteria:

* Provided informed consent.
* Investigator's opinion, participant is willing and able to complete all study procedures and comply with the study visit schedule.

Participant with LGMD2B:

* Established, genetically confirmed diagnosis of LGMD2B.
* Either the presence of a short tau inversion recovery (STIR) positive muscle on lower extremity skeletal muscle magnetic resonance imaging (MRI), or, if no STIR positive muscles, meets muscle biomarker criteria.

Participant with FSHD:

* Established, genetically confirmed diagnosis of FSHD.
* The presence of a STIR positive muscle on lower extremity skeletal muscle MRI.

Exclusion Criteria:

* Currently receiving treatment with an immunomodulatory agent, including targeted biological therapies within the 3 months before baseline; corticosteroids within 3 months before baseline; or high-dose non-steroidal anti-inflammatory agents within 2 weeks before baseline.
* Currently receiving curcumin or albuterol; use of a product that putatively enhances muscle growth on a chronic basis within 30 days before baseline; statin treatment initiation or significant adjustment to statin regimen within 3 months before baseline (stable, chronic statin use is permissible).
* Use of an investigational product or device within 30 days before baseline.
* Evidence of an alternative diagnosis other than LGMD2B or FSHD or a coexisting myopathy or dystrophy, based on prior muscle biopsy or other available investigations.
* History of severe restrictive or obstructive lung disease or evidence for interstitial lung disease on screening chest radiograph.
* History of anti-synthetase syndrome, prior Jo-1 Ab-positivity, or a positive or equivocally positive Jo-1 Ab test result during screening.
* Chronic infection, such as hepatitis B, hepatitis C, or human immunodeficiency virus or a history of tuberculosis.
* Vaccination within 8 weeks before baseline or vaccination is planned during study participation.
* Symptomatic cardiomyopathy or severe cardiac arrhythmia that may in the Investigator's opinion, limit the participant's ability to complete the study protocol.
* Muscle biopsy within 30 days before baseline.