cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.


Eligibility Criteria:
Inclusion Criteria:

1. Completion of a Cytokinetics trial investigating CK-3773274
2. LVEF ≥55% at the Screening Visit

Exclusion Criteria:

1. Has participated in another investigational device or drug study or received an investigational device or drug \<1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
2. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \<30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) \<100 bpm and/or rhythm is stable \>30 days.
3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
4. Had a confirmed LVEF \<40% with an associated dose interruption during participation in a prior study with aficamten.
5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
6. Has received treatment with mavacamten.
Striving Towards EmPowerment and Medication Adherence R01

This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines


Eligibility Criteria:
Inclusion criteria:

1. Black
2. Living with HIV
3. Cis-gender female
4. Age 18 or older
5. English speaking
6. Viral load non-suppression (\>200 ml) within the past year or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months
7. History of trauma/abuse
8. Capable of completing and fully understanding the informed consent process and study procedures

Exclusion criteria:

1. Unable to completely and fully understand the informed consent process and the study procedures
2. Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
A Study for Patients With Type 2 Diabetes Mellitus

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus for at least 6 months
2. One or more oral antihyperglycemic medications for at least 12 weeks
3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
4. Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
5. Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria:

1. Previously received any form of inhaled insulin
2. Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
3. History or presence of liver disease
4. History or presence of kidney disease
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

The purpose of this study is to determine whether treatment with low dose cyclosporin and methotrexate can inhibit the development of new onset diabetes mellitus

Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1 diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo and mtx therapy could safely induce remission.

Research Design and Methods: In an open pilot study, insulin dose and glycemic control will be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children. After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4 weeks

Exclusion Criteria:

* Ketoacidosis
* Body weight over 110% of ideal weight
* Condition where immunosuppression is contraindicated
* Abnormal liver or renal function tests
Polysaccharide Antibody Response Study

Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency.

Healthy controls (n = 100) and patients with suspected SPAD (n = 100) will be immunized with both Pneumovax 23 and Typhim Vi (age 18 months - 55 years). Analyses of anti-pneumococcal polysaccharide antibodies and anti-Vi antibodies are performed before and 3-4 weeks after vaccination. Also bloodgroup and anti-A/anti-B are assessed. Relevant clinical information (ENT infections, lung infections, bronchiectasis, invasive infections) is obtained from the patient file and history and is noted in a Case Report Form.

The diagnostic performance of Typhim Vi response and allohemagglutinins will be analyzed by calculating sensitivity, specificity, predictive values, likelihood ratios and Receiver Operating Characteristic curves for Typhim Vi and allohemagglutinins using pneumococcal antibody response as the reference standard. The association between low Typhim Vi response or low allohemagglutinins and clinical signs of polysaccharide antibody deficiency will be studied by multiple logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
* Informed consent given

Exclusion Criteria:

* History of serious adverse reaction to a vaccine
* Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
* (Potential) pregnancy
tDCS for Post-Stroke Cognitive Impairment

This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).

The goal of this study is to learn important information about the effects of electrical stimulation (Transcranial direct current stimulation (tDCS) on brain functioning in those with post-stroke cognitive impairment (PSCI). The findings will help determine how stimulation affects the brain's activity, cerebral blood flow, and circulating blood biomarkers of neuroinflammation after stroke. The study will use different forms of non-invasive brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional near-infrared spectroscopy (fNIRS) and electroencephalograph (EEG) will be used, we will also collect blood samples for the biomarkers of inflammation. The study also uses cognitive tests and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1) ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (MoCA \<26);

Exclusion Criteria:

1. clinically significant or unstable medical or psychiatric condition;
2. diagnosis of severe depression;
3. history of relevant neurological diagnosis (e.g., epilepsy);
4. previous neurosurgical procedure with craniectomy;
5. contraindications to tDCS (implanted brain medical devices);
6. severe visual impairment, hearing impairment, aphasia, neglect or dementia.
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
* ECOG performance status 0-1
* Age 18 or older than 18 years
* Measurable disease by RECIST criteria
* Having signed informed consent
* ALT and AST\<2.5 times ULN
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Bilirubin level \< 1.5mg/dL
* Serum creatinine \<1.5 times ULN
* WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous cytotoxic chemotherapy for HNSCC
* Radiotherapy for targeted lesions within six months
* Previous EGFR pathway-targeting therapy
* Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
* Distant metastatic disease
* Heart failure, coronary artery disease, myocardial infarction within the last 6 months
* Known allergy to any study treatment
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
* Legal incapacity
Delaying the Onset of Nearsightedness Until Treatment Study

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Eligibility Criteria:
Inclusion Criteria:

* Age: 6-11 years
* Refractive error measured in spherical equivalent, one eye meets criterion

  * 6 years old: 0.50 to +0.38
  * 7 years old: 0.50 to +0.25
  * 8-11 years old: 0.50 to plano
* Anisometropia: spherical equivalent \<1.50 D
* Astigmatism: \<1.50 in both eyes
* Myopia: Less myopic than -0.74 D, both eyes

Exclusion Criteria:

● Myopic
Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging.

To assess the impact of lifestylel changes upon measures of wellness and aging, in particular weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic exercise would improve mental performance and measures of fitness.

A 10-week, randomized control study conducted in a wellness center in St. Petersburg, Florida. Adults age 21-65, exercising less than 3 days/week. 56 subjects were randomized to a control or an intervention group. Subjects followed a diet with \>30 grams of fiber and \<16 grams of saturated fat daily, and were taught to reach 70-85% of their maximum heart rate 5-6 days/week, and to perform strength training 3 days/week, plus were asked to participate in 10-20 minutes of stress management activities daily. The study was designed to determine body composition, maximal aerobic capacity (VO2 max), total cholesterol/high-density lipoprotein (TC/HDL), and cognition.

Specific aspects ofcognitive performance were noted to increase with increasing levels of aerobic activity, but not with strength training, dietary fiber change, or stress managment.

Having established that the treatment group would exercise at different levels of intensity, additional subjects were recruited, and the cognitive performance of no exercise, moderate aerobic exercise, and frequent aerobic exercise could be compared with specific domains of cognitive performance: memory, psychomotor speed, reaction time, attention, and cognitive flexibility. The St Anthony's Institutional Review Board approved this research project.

Eligibility Criteria:
Inclusion Criteria:

* able to exercise 5-6 days per week

Exclusion Criteria:

* Free of major medical conditions, unable to exercise aerobically 5-6 days per week
Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

The aim of this study is to understand and improve the experience of patients after surgery by comparing two methods of following symptoms while the patient recovers at home.


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years of age who are scheduled for ambulatory cancer surgery at JRSC and their caregivers will be eligible for study participation.

Exclusion Criteria:

* Inability to speak English
* Inability to access a computer, tablet, or mobile phone
* For patients: not interested in/unable to sign up for the MyMSK Patient Portal
* For caregivers: Unable to provide an email address
* Cognitive impairment that prohibits informed consent or understanding of the study protocol
Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen

This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched.

Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.

The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.


Eligibility Criteria:
Inclusion Criteria:

* One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction

  * A dental implant is indicated and treatment planned to replace the missing tooth
  * Have adequate restorative space for a dental implant-retained restoration
  * Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
  * Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
  * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
  * Are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

Exclusion Criteria:

* Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.

  * Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).
  * Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
  * Smokers who smoke \>10 cigarettes per day
  * Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
* Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
* Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
* Participant could be with or without concurrent systemic lupus erythematosus (SLE)
* If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

Exclusion Criteria:

* Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
* Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
* Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
* Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
* History of 3 or more unexplained consecutive pregnancy losses
* Active severe or unstable neuropsychiatric SLE
* Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity

Other protocol-defined inclusion/exclusion criteria apply
Efficacy of a Resources Activation Treatment on Tic-symptoms

The main purpose of this study is to evaluate the efficacy of a resources activation based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.

The main purpose of this study is to evaluate the efficacy of an intervention aimed at the activation of resources for children and adolescents with tic disorders. The activation of resources treatment programme was developed at Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and is currently evaluated in different studies.

Eligibility Criteria:
Inclusion Criteria:

* 8-18 years
* Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
* YGTSS total score F95.2\>13, F95.1\>9
* Tics are the main problems
* IQ\>80
* If medication, then has been stable for at least one months in medicated patients
* No change in medication treatment is planned
* Ability to participate in weekly outpatient treatment
* Acceptance of randomization

Exclusion Criteria:

* Diagnosis of Autism Spectrum Disorder or Psychosis
* Parallel continuous psychotherapy of tics or comorbid
Anorexia Nervosa Inpatient Physiotherapy Adapted Program

Anorexia nervosa (AN) is a psychiatric pathology with several somatics consequences that increase the vital risk. The prevalence in AN is between 0.9-3% and AN has the most elevated mortality in the psychiatric pathologies (10% in the hospitalized patients).

The collateral effects by several undernourishment has been studied but the autonomy and muscle strength research is insufficient.

Physiotherapy research study body image, basic body awareness therapy, relaxation and quality of life.

OBJETIVE: Develop a physiotherapy program to increase muscle strength and quality of life in anorexia nervosa hospitalized patients.

METHOD: 4 weeks of adapted exercises (3 days/week) in anorexia nervosa patients with body max index under 16 in interventional group.

And evaluation program once a week in interventional group and control group.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Hospitalized
* Anorexia nervosa
* Body mass index (kg/m2) \< 16

Exclusion Criteria:

* Men
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures


Eligibility Criteria:
Key Inclusion Criteria:

1. Capable of providing consent and has completed the written informed consent.
2. Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) \< 40 kg/m\^2.
3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
4. History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
5. Treatment with at least 1 but not more than 4 ASMs for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study.
6. Be able to keep accurate seizure diaries.
7. Documented seizure frequency in the baseline seizure diary of ≥8 countable focal seizures during the 8-week seizure baseline period.

Key Exclusion Criteria:

1. History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
2. Presence or previous history of developmental and/or epileptic encephalopathy.
3. Presence of seizure types other than FOS.
4. Status epilepticus within the last 12 months before enrollment.
5. Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
6. Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
7. An implanted responsive neurostimulator system (RNS).
Optical Detection of Intravenous Infiltration:A Pilot Study

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent and/or assent
* Newborn to 17 years of age
* Weight \> 2.5 kg

Exclusion Criteria:

* Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
* Severe scarring of tissue (excessive IV use)
* Tattoo in area of PIV site
* IV site located in antecubital fossa