AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Abdominal ultrasound
Description: Abdominal ultrasound will be performed as part of screening and safety follow- up studies. The ultrasound will be performed in a radiology department and will take approximately 20-30 minutes.
Study NCT02362711 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NPC-16 Standard Dosing Regimen Group
Study NCT02362711 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NPC-16 Continuous Dosing Regimen Group
Study NCT02362711 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Group
Study NCT03408847 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: Beclomethasone dipropionate in addition to MC-EVOO
Description: Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.
Study NCT03408847 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Beclomethasone dipropionate in addition to refined oil
Description: Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.
Study NCT00475280 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Geriatric assessment adapted therapy
Description: Geriatric assessment is performed before the induction phase starts.
Study NCT01445860 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Simvastatin/PF-03882845
Description: Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.
Study NCT03772756 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Endoscopic ultrasound guided radiofrequency ablation
Description: Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.
Study NCT03772756 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: chemoradiotherapy
Description: Receive chemoradiotherapy
Study NCT03772756 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: chemoradiotherapy
Description: Receive chemoradiotherapy
Study NCT02611323 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Obinutuzumab
Description: Participants will receive a fixed dose of obinutuzumab, 1000 milligrams (mg) via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 1000 mg via IV infusion on Day 1 of every other month (starting from Month 2) for up to 24 months, until disease progression or unacceptable toxicity.
Study NCT02611323 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Participants will receive a fixed dose of rituximab, 375 milligrams per square meter (mg/m\^2) via IV infusion to be given on Day 1 of Cycles 1 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 375 mg/m\^2 via IV infusion on Day 1 of every other month (starting from Month 2) for up to 8 months, until disease progression or unacceptable toxicity.
Study NCT02611323 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polatuzumab Vedotin
Description: Participants will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) (for FL), and 1.8 mg/kg (for DLBCL) on Day 1 of each 21-day cycle for up to 18 weeks during induction treatment. Polatuzumab vedotin will not be given during the post-induction period.
Study NCT02611323 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Participants will receive venetoclax film-coated tablets at doses of 200, 400, 600, or 800 mg (for FL), and 400, 600, or 800 mg (for DLBCL) on Days 1 to 21 of each 21-day cycle. Post-induction venetoclax may continue for up to 8 months, until disease progression or unacceptable toxicity.
Study NCT01186016 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Genetic Education Session
Description: The intervention includes receiving education about genetics and smoking. The content is basic genetics and education about the multifactorial nature of smoking; research findings about genetic contributions to smoking, potential applications of this research for cessation treatment, and legal, ethical and social implications of future use of genotyping for cessation. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.
Study NCT01186016 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Nutrition Education Session
Description: To control for an attention placebo effect, the control group will receive information about nutritional guidelines as established by the USDA and the FDA. The attention control group will be referred to as the Nutritional Education Session (NES) group. The content of NES sessions one and two are use of the USDA (MyPyramid) dietary and food safety guidelines. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.
Study NCT00422045 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Low Level Laser Therapy
Description: Low Level Laser Therapy done after surgery.
Study NCT04282694 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Low-dose computed tomography (LDCT)
Description: Early detection of lung cancer by LDCT and smoking cessation counselling
Study NCT00153257 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Ugytex
Description: Anterior repair reinforced by a specially designed mesh: UgytexTM
Study NCT04405739 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EIDD-2801
Description: Oral capsule of EIDD-2801
Study NCT04405739 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral placebo capsule
Study NCT03347058 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Supportive programming
Description: Access to a suite of resources, including digital tools, person-to-person support, and educational resources
Study NCT01959802 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Vitrectomy
Study NCT04070079 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Tenofovir Alafenamide
Description: TAF 25mg once daily orally, for 48 weeks
Study NCT03952637 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: We are proposing the use of immune modulation to transiently deplete B-cells using rituximab. It will be infused at -21 days and -14 days before gene transfer.
Study NCT03952637 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sirolimus
Description: Sirolimus is a macrocytic lactone that inhibits T lymphocyte activation and proliferation by inhibiting activation of mammalian Target of Rapamycin (mTOR) kinase that suppresses cytokinedriven T-cell proliferation. We plan to give sirolimus from day -21 to Day 90 with option to extend to day 365 if clinically indicated.
Study NCT03952637 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: Subjects will receive IV methylprednisolone 1 mg/kg or a maximum dose of 50 mg, 60-120 minutes prior to vector administration on day 0 to mitigate potential acute innate immune response against the vector.
Study NCT03952637 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone (oral solution, dose 0.5 mg/kg) will be taken daily on Days 1-3.
Study NCT03952637 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Audiology assessment with ABR
Description: The audiology assessment will be performed in the Audiology Clinic using a standard audiogram to measure thresholds for pure tones and speech, word recognition, tympanometry, and otoacoustic emissions if the subject is capable and tolerant of these measures. The assessment will take approximately 30 minutes. The ABR is a noninvasive neurophysiologic test to evaluate electrical signal transmission from the 8th cranial nerve to the brainstem and the cortex in response to specific tones. Electrodes are placed on the scalp and on each earlobe. An earphone gives off a brief click or tone and the electrodes pick up the brain's responses to these sounds and record them. This will be performed by a trained neurophysiology technician to monitor possible change in hearing during treatment. The procedure will be performed in the Interventional Radiology suite while the subject is sedated following the MRI, fMRI, and MRS of the brain.
Study NCT03952637 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Bone density scan (DEXA)
Description: Type II subjects - This is a noninvasive enhanced form of X-ray that is used to measure bone loss. Loss of bone density is a known complication with GM1 gangliosidosis due to decrease in weight-bearing activities with disease progression. The procedure will be performed in the Nuclear Medicine Department. The subject s femur, spine, and whole body will be scanned at baseline and then yearly for 3 years. The procedure will take approximately 10 minutes and may be limited due to the subject s cooperation.
Study NCT03952637 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Electrocardiogram (EKG)
Description: Performed as part of screening and for safety before sedated procedures. The ECG will take approximately 10 minutes and may be limited due to the subject s cooperation.
Study NCT03952637 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Echocardiogram
Description: Performed as part of screening. The Echo will be done in the Echo Lab and may take approximately 20-30 minutes. The exam may be limited due to the subject s cooperation level.
Study NCT03952637 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Electroencephalogram (EEG) awake and extended overnight
Description: Completed at baseline. The subject will also have an EEG if clinically indicated (for example encephalopathy, seizures, or other change in neurological status or if changes on the previous study are deemed to warrant a follow up study) during post treatment follow up. The procedures will be conducted in the Neurology Testing Department. The total time for an awake EEG, including lead placement, is approximately 40 minutes. An extended overnight EEG will take approximately 12 hours. The exam may be limited due to the subject s cooperation level.
Study NCT03952637 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Laboratory tests
Description: Performed on blood and urine include safety labs, clinically indicated labs and research collections. Additional specimens may be collected for the PI s biorepository or as clinically indicated. Blood volumes for clinical diagnostic testing and research will be consistent with Clinical Center laboratory guidelines.
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Lumbar puncture
Description: Performed to obtain cerebrospinal fluid (CSF) to measure GM1 ganglioside, beta-gal enzyme, AAV antibodies, Pentasaccharide biomarkers and other research tests. CSF will also be sent for cell count and differential, glucose, protein, and culture as well as CSF neurotransmitters. The amount of CSF obtained will be less than or equal to 0.75 mL/kg body weight. The procedure will be performed while under sedation following MRI imaging. If a sedated MRI is not being performed, then the LP will be performed in consultation with the pediatric consult service using conscious sedation and local anesthesia. The procedure will take approximately 15 minutes.
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Brain MRI/MRS/fMRI
Description: Magnetic resonance imaging (MRI), functional MRI (fMRI) and spectroscopy (MRS) Procedure/Surgery - The subject will undergo noncontrast MRI, including DTI sequences, fMRI, and MRS in the 3T scanner using the same image acquisition sequences and the same MRS voxels to capture the same metabolites as prior sequencing under natural history protocol 02-HG0107. The MRI, fMRI, and MRS will be interpreted for signs of disease progression or stabilization and any signs of treatment toxicity by two board-certified radiologists with specialty training in neuroradiology. The scan will require anesthesia. Sedation will be administered by the anesthesia service after a preanesthesia consultation to assess risk. The type of sedation and whether the subject will be intubated for the procedure will be at the discretion of the anesthesia service.
Study NCT03952637 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Neurocognitive testing
Description: Type II Subjects - The Vineland-3 will be administered under the supervision of a psychologist. The Vineland-3 provides several types of scores, measure of personal and social independence designed to examine the domains of communication, daily living skills, social skills and motor development. Other standard neurocognitive instruments may be used depending on the subject s ability, and some visits will (may) include a measure of intelligence /cognitive development if the child is able to achieve a basal score. Neurocognitive testing will take approximately 2-3 hours depending on subject cooperation. The assessments will not address sensitive topics. Type I Subjects - Bayley Scales of Infant and Toddler Development (BSID-III), a well-normed and validated, examiner-administered evaluation of cognition, language, and motor skills for children from birth to 42 months of age.
Study NCT03952637 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Neurology exam
Description: Neurology exam will be performed by a neurologist in the screening and followup appointments to monitor for any adverse reactions and to assess for clinical response to the treatment. The exam will be scripted for consistency within subject visits and between subjects and will take approximately 30 minutes to one hour. The exam will be videotaped. The exam may be limited due to the subject s cooperation level.
Study NCT02058914 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: High Glucose sweetened beverage
Description: HG-sweetened beverage
Study NCT02214459 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: DASH Mobile mhealth enhanced coaching
Description: Phone calls with a health coach that utilize the tracking data collected by the app and devices.
Study NCT02676297 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tiotropium
Description: four inhalations
Study NCT03952637 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: PICC or other Central line placement
Description: PICC line or other central line placement will be done under sedation in Interventional Radiology. The procedure will be done under sedation and may take 20 minutes. A chest Xray will be done after placement to confirm correct positioning of the catheter.
Study NCT02676297 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tiotropium
Description: four inhalations
Study NCT04129424 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Insulin pump (Microtech, Equil®)
Description: Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose .
Study NCT02095704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paracetamol oral solution
Description: dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
Study NCT02095704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paracetamol tablet
Description: dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
Study NCT03861455 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dupilumab
Description: patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Skeletal survey
Description: A skeletal survey will be performed to assess the degree of skeletal involvement of the disease. This will include X-rays of the a/p lateral spine, chest, and pelvis. The exam will take approximately 30 minutes. The exam may be limited due to the subject s cooperation level.
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Skin biopsy
Description: Skin biopsy will be performed on subjects who have not already had a skin biopsy under the 02-HG-0107 protocol. The procedure will be done under sedation using local anesthetic. After washing the skin with chlorhexidine and numbing the skin with injectable lidocaine, a 3mm circle of skin is removed under sterile conditions and the wound is dressed. The entire procedure takes approximately 5 minutes.
Study NCT03861455 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: patient receive placebo
Study NCT01642264 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: WeBREATHe Training Program
Description: The WeBREATHe Training Program is a web-based, interactive training program to teach pediatric respiratory therapists, nurses and nurse practitioners how to help their patients' parents to quit smoking.
Study NCT03759171 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Guitars for Vets Intervention
Description: This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.
Study NCT05640128 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Aldosterone in HPLC-MS/MS
Description: Aldosterone in HPLC-MS/MS
Study NCT03921528 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SRK-015
Description: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 will be administered every 4 weeks by intravenous infusion.
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Speech and modified barium swallow study
Description: Performed as a marker of response to treatment and safety. The swallow assessments will include a parental swallowing questionnaire and cranial nerve assessment. The NIH Swallowing Questionnaire from the Speech Language Pathology Section is designed to identify the presence and or absence of functional swallowing dysfunction as perceived by the subject and or caregiver. This 4point scale assists with further identification of clinical/research assessments of oral pharyngeal swallowing function if indicated in the form of a modified barium swallow. In addition to swallow assessments, tape recording of speech will also be included with diadochokinetic tasks and sustained phonations as well as speech if able. Recordings will be stored on a shared drive accessible only by the study team. The assessment may take approximately 30 minutes to 1 hour.
Study NCT03952637 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ophthalmology exam
Description: The ophthalmology exam will be performed by an ophthalmologist in the screening and follow-up appointments to support subtype diagnosis and assess efficacy. Pictures of bilateral macula will be taken and saved to a secure database. OCT will also be performed. These exams will only be administered to Type I subjects.
Study NCT02216760 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Ripple Mapping guided VT ablation
Description: RM will be used to guide identification of conduction channels and hence substrate guided ablation
Study NCT02216760 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional VT ablation
Description: Substrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation)
Study NCT00876525 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
Description: The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
Study NCT00475280 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Stem cells autotransplantation
Description: Stem cells autotransplantation is performed after consolidation treatment
Study NCT01193842 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV
Study NCT03274336 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: questionnaire
Description: questionnaire post preanesthetic interview
Study NCT03274336 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: questionnaire
Description: questionnaire post preanesthetic interview
Study NCT03274336 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: face-to-face interview
Description: Group A = face-to-face interview
Study NCT03274336 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: brochure
Description: after reading a brochure a face to face interview will take place
Study NCT03274336 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: brochure
Description: after reading a brochure a face to face interview will take place