cyrilzakka/clinical-trials huggingface dataset:
A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease


Eligibility Criteria:
Inclusion Criteria:

* For participants 50 years of age or older: any underlying chronic illness must be in stable condition
* For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
* Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

Exclusion Criteria:

* Received prior vaccination with pneumococcal vaccine
* Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
* Has history of autoimmune disease
* Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
* Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
* Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)
* Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
* Hospitalized for acute illness within 3 months before study vaccination
* Is a pregnant woman or nursing mother
* History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
* History of fever illness within 3 days before study vaccination
* Received antibiotic therapy for any acute illness within 7 days before study vaccination
* Hypersensitivity to any components of the vaccine, including phenol
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India

The purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or younger
* patient at DAGA Memorial Hospital, Nagpur, India
* had chest x-ray within last 24 hours
* consent obtained from one parent
* assent obtained if child is 8 years or older

Exclusion Criteria:

* thermal image cannot be done within 24 hours of chest x-ray
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.

OBJECTIVES:

* Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.
* Determine adverse events related to this regimen in this patient population.
* Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.

OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.

Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.

Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.

Eligibility Criteria:
* Documented leptomeningeal metastases
* Carcinomatous meningitis that is previously untreated or failed prior therapy OR
* Lymphomatous meningitis
* Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious
* Age 18 and over
* Karnofsky Performance Status 60-100%
* Life expectancy of at least 6 weeks
* Absolute neutrophil count greater than 1,500/μL
* Platelet count greater than 100,000/μL
* Creatinine no greater than 2.0 mg/dL
* No congestive heart failure
* No unstable angina
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir
* No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting)
* No uncontrolled infection
* Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed
* No other concurrent chemotherapy for other sites of disease
* No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas
* No prior radiotherapy to greater than 30% of bone marrow
* Prior radiotherapy to the neuroaxis allowed
* No concurrent radiotherapy for other sites of disease or for progressive disease
* Recovered from any prior recent therapy
Treatment of Functional Dyspepsia With Acupuncture

Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.


Eligibility Criteria:
Inclusion criteria:

- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.

Exclusion criteria:

* Subjects unable to give informed consent
* Pregnant or breast-feeding females or women who get pregnant midway
* Subjects who have received acupuncture treatment before
* Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
* Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
* Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
* Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
* H. pylori eradication treatment within the past 12 months before study start
* H. pylori positive patients
* Patients with bleeding diathesis
* Known or suspected hypersensitivity to acupuncture.
Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.


Eligibility Criteria:
Inclusion Criteria At Screening:

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
* Non smokers
* Mild to moderate asthmatics according to GINA guidelines for at least 12 months.
* History of asthma symptoms increasing in response to external allergens.
* Testing positive on skin prick test to an allergen associated with the subject's asthma

Exclusion Criteria:

* Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
* Receipt of prescribed or over the counter medication within 14 days of the first study day.
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

The aim of the current study to assess the efficacy of voclosporin in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS). As well as to assess the safety and tolerability of voclosporin over 24 weeks in subjects with FSGS.

Eligibility Criteria:
Inclusion Criteria:

1. Primary FSGS diagnosed by renal biopsy.
2. Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be immunosuppressant treatment-naïve, or receiving treatment with steroids.
3. Stable proteinuria, renal function, and BP.

Exclusion Criteria:

1. Clinical or histologic evidence of secondary FSGS.
2. Histologic evidence of collapsing variant FSGS.
3. eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment.
4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
5. Current or medical history of:

   * Congenital or acquired immunodeficiency.
   * In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
   * Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
   * Current or past lymphoproliferative disease or previous total lymphoid irradiation.
   * Severe viral infection within 3 months of screening, or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
   * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease

The purpose of this dual phase cross-sectional, controlled and prospective, open label, exploratory study is to determine the general characteristics of visuospatial exploration and its neural substrate in subjects with Parkinson's Disease (PD) and to explore the impact of professional art therapy intervention in a cohort of subjects with Parkinson's Disease on visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere, quality of daily living and motor symptoms.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria (Patients with PD)

* Diagnosis of PD according to United Kingdom Parkinson's Disease Society Brain Bank;
* Hoehn and Yahr stage 2 to 3;

Exclusion Criteria:

Exclusion Clinical Criteria (For both PD and Controls):

* History of dementia, or MoCA \< 22;
* Untreated depression, or score of \>20 on Beck Depression Inventory II;
* History of florid visual, tactile, olfactory or acoustic hallucinations requiring the administration of neuroleptics.
* Presence of psychosis requiring the administration of neuroleptics or sedatives.
* Presence of severe motor fluctuations with most of the 50% of day spent in off-time.
* Presence of bothersome dyskinesias.
* Presence of severe dystonia involving the head-neck axis including anterocollis, laterocollis and torticollis.
* Presence of severe fluctuations in attention, alertness or cognition.
* Presence of any clinically significant abnormality on vital signs.

Exclusion Ophthalmologic and Ophtalmometric Criteria (For both PD and Controls):

* Visual abnormalities requiring exclusive correction with eye glasses (of note, contact lenses are NOT an exclusion criterion).
* History of clinically active ophthalmologic abnormalities including but not limited to macular degeneration, symptomatic cataract, symptomatic retinopathy, recent orbital trauma with periorbital ecchymosis, symptomatic thyroid eye disease, refractory problems of moderate or severe degree (of note, mild refractory problems are NOT an exclusion criterion, chromatic discrimination problems including daltonism are NOT an exclusion criterion).
* History of any clinically significant CNS abnormality resulting in an active visual field deficit including but not limited to brain tumors, brain abscess, inflammatory encephalic lesions, traumatic brain injury or stroke.
* Clinically significant abnormal findings on routine bedside examination of the vision system during a standard clinical neurological exam.

Exclusion MRI Criteria (For both PD and Controls):

* Major or unstable medical illness;
* Left hand dominance;
* Pacemakers, neurostimulators, intracranial clips, metal implants, external clips or metal foreign bodies within 10 cm of the head;
* Current pregnancy or nursing;
* Pregnancy planned;
* Claustrophobia;
* Large body habitus (280 lb or more)

Exclusion Criteria for Art Therapy (For PD subjects only):

* Severe inability to perform line drawing;
* Severe inability to manipulate soft/light materials like clay.
Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.

This study aims to evaluate the use of transcutaneous tibial nerve stimulation (TTNS) and parasacral nerve stimulation (PSS) methods in the treatment of overactive bladder (OAB) symptoms in patients with Multiple Sclerosis (MS), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. To investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.

Participants will be divided into 3 groups: TTNS, PNS, and placebo groups, and all participants will be given behavioral treatment. Tibial nerve stimulation will be given to the TTNS group, sacral nerve stimulation will be given to the PNS group, and sham current will be given to the placebo group. Stimulation treatments will be applied 2 days a week for 30 minutes each for 6 weeks. Participants will be evaluated before and after treatment. The parameters of urination frequency, urgency, and urinary incontinence will be evaluated with a 3-day voiding diary (BD), maximum flow rate (Qmax), time to reach maximum flow (TQmax), average flow rate, flow time (Tw), voiding time and voiding volume (VV) values will be evaluated by uroflowmetry, post-voiding residual (PVR) volume will be evaluated by ultrasound, and quality of life will be evaluated by King's Quality of Life Questionnaire (KHQ); Expanded Disability Status Scale (EDSS), Overactive bladder form (OAB-v8), Incontinence Severity Index (ISI), Neurogenic Bladder Symptom Score (NBSS) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Having symptoms related to overactive bladder (OAB-v8 score ⩾8),
* Over 18 years of age
* No relapse for at least 1 month
* All types of MS, including those with relapses
* Female MS patients with an Expanded Disability Status Scale (EDSS) score below 7.0
* Agreeing to participate in the research

Exclusion Criteria:

* Patients with urinary tract infections
* Patients diagnosed with diabetes mellitus
* Patients using diuretic drugs or patients with a clean intermittent catheter
* Patients with a history of different urological diseases
* Patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations
* Patients who are pregnant or in the postpartum period
* Lack of activity performance for 2 weeks (regardless of which group)
Psychodynamic Therapy For Co-occurring Borderline Personality Disorder and Alcohol Use Disorder

The purpose of the study is to determine the feasibility and effectiveness of a modified form of psychodynamic psychotherapy for persons suffering from co-occurring borderline personality disorder and an alcohol use disorder.

Borderline Personality Disorder (BPD) is a condition that can cause significant distress and increased risk of death. Many persons with BPD also have an alcohol use disorder (AUD) and there is evidence that this can worsen the outcome and course of both disorders.

A manual-based form of psychodynamic therapy (PT), labeled dynamic deconstructive psychotherapy, has been developed for particularly challenging patients with BPD, especially those with co-occurring substance use disorders. It aims to remediate specific neurocognitive capacities that are responsible for processing of emotional experiences, and so diminishes symptoms of BPD and promotes the development of a coherent and differentiated self-structure. PT has been shown to be helpful for BPD, but has not been tested for people who have BPD with co-occurring substance use disorders.

The proposed study is a randomized controlled trial of PT for persons with BPD and co-occurring AUD that will generate some initial data that can be used to determine the need and feasibility for further outcome studies. Participants are randomized to either a study group receiving weekly PT or to a control group receiving usual care. Enrollment is 15 participants in each group. The study group will receive 12-18 months of PT, with naturalistic follow-up. Outcome measures are administered by a research assistant at enrollment, 3 months, 6 months, 9 months, 12 months, and 30 months.

The investigators anticipate that the PT group will show trends towards better retention in treatment and greater reduction in parasuicides, alcohol misuse, and institutional care. If so, this would have important and positive implications for the large group of patients who suffer from BPD and co-occurring AUD.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years
* Meets diagnostic criteria for borderline personality disorder and for active alcohol abuse or dependence
* At least average intelligence

Exclusion Criteria:

* Meets diagnostic criteria for schizophrenia, or schizoaffective disorder
HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in Advanced Solid Tumors

This is a phase Ib/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of HMPL-453 combined with chemotherapy or anti-PD-1 antibody in patients with advanced solid tumors.

The study includes a dose escalation phase and a dose-expansion phase.

Patients with advanced solid tumor will be enrolled in the dose escalation phase to assess the tolerability, safety, and PK profile of HMPL-453 monotherapy or combination therapy.

Patients with specific types of advanced or metastatic tumors harboring certain FGFR gene alterations will be enrolled in the dose expansion phase to assess the preliminary efficacy of HMPL-453 combination therapy.

Eligibility Criteria:
Inclusion Criteria

* Dose escalation phase: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor who progressed on or are intolerant of standard therapy;
* Dose expansion phase: patients with UC, GC/GEJ, or IHCC harboring specific FGFR gene alterations;
* Age 18 to 75 years;
* Those who are able to give written informed consent, and able to comply with protocol-specified visits and related procedures;
* Ability to swallow study drug;
* ECOG PS of 0 or 1;
* Measurable lesion according to RECIST v1.1, refer to the protocol;
* Adequate organ and bone marrow function;
* Life expectancy ≥ 12 weeks;
* Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.

Exclusion Criteria

* Patients who previously received selective FGFR targeting therapy;
* Concurrent participation in another interventional clinical study, excluding those in the follow-up period and have not recently received investigational intervention;
* Current or previous history of central nervous system (CNS) metastases；
* Current or previous history of retinal detachment；
* Known history of primary immunodeficiency;
* Female patients who are pregnant or lactating；
* Patients who in the opinion of the investigator may be unsuitable for participating in the study;
* Patients with acute or chronic active hepatitis B or C infection;
* Known human immunodeficiency virus (HIV) infection and syphilis infection；
* Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia；
* Uncontrolled hypertension despite optimal medical management；
* Received live vaccine within 30 days before the first dose of study drug(s);
* Those who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first study treatment or who are expected to be in need of major surgery; those with unhealed wounds, ulcers or fractures.
BRAVE: Building Resilience and Values Through E-health

The purpose of this study is to determine the feasibility and acceptability of tracking survivors' and their caregivers, stressors, affect, and symptoms using an electronic diary method, in the time period surrounding their routine check- up with their oncologist.


Eligibility Criteria:
Inclusion Criteria:

1. 11-25 years old
2. previously received a pediatric cancer diagnosis and treatment for such
3. completed cancer treatment \<5 years ago, in remission
4. Own a smart phone or tablet
5. are English proficient

Exclusion Criteria:

* no cognitive, motor, or sensory deficits that could preclude completion of study measures.