TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03952637

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AAV9-GLB1
Description: The risks of administering this treatment in a subject with GM1 gangliosidosis are not completely known. The major risk associated with intravenous infusion is from the subject s immunological response to the viral capsid and/or the beta-gal protein. To reduce this possibility, immune modulation therapy is being started prior to vector delivery and maintained for six months afterward. There is a theoretical risk that the integration of a small percentage of the rAAV vector DNA into the host cell genome could cause cellular transformation to cancer cells and lead to a malignancy. This has never been seen in subjects receiving intravenous AAV9 gene therapy so the risk of this complication, is likely very low.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AAV9-GLB1
Description: The risks of administering this treatment in a subject with GM1 gangliosidosis are not completely known. The major risk associated with intravenous infusion is from the subject s immunological response to the viral capsid and/or the beta-gal protein. To reduce this possibility, immune modulation therapy is being started prior to vector delivery and maintained for six months afterward. There is a theoretical risk that the integration of a small percentage of the rAAV vector DNA into the host cell genome could cause cellular transformation to cancer cells and lead to a malignancy. This has never been seen in subjects receiving intravenous AAV9 gene therapy so the risk of this complication, is likely very low.

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 type: DRUG
Group type: EXPERIMENTAL
Intervention: NPC-16 Standard Dosing Regimen Group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NPC-16 Continuous Dosing Regimen Group

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Group
Study: NCT03408847

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.

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 type: PROCEDURE
Group type: OTHER
Intervention: Geriatric assessment adapted therapy
Description: Geriatric assessment is performed before the induction phase starts.
Study: NCT02228889

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Assess overall complications at 1 year postoperatively

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Assess overall complications at 1 year postoperatively

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Abdominal wall reconstruction with XenMatrix
Description: Abdominal wall reconstruction with XenMatrix

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Strattice
Description: Strattice mesh

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: XenMatrix
Description: Xenmatrix mesh
Study: NCT01445860

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 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.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: chemoradiotherapy
Description: Receive chemoradiotherapy

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: chemoradiotherapy
Description: Receive chemoradiotherapy
Study: NCT01186016

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.

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 type: DEVICE
Group type: EXPERIMENTAL
Intervention: Low Level Laser Therapy
Description: Low Level Laser Therapy done after surgery.
Study: NCT04282694

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 type: DEVICE
Group type: OTHER
Intervention: Ugytex
Description: Anterior repair reinforced by a specially designed mesh: UgytexTM
Study: NCT04405739

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EIDD-2801
Description: Oral capsule of EIDD-2801
Study: NCT03952637

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: NCT04405739

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral placebo capsule
Study: NCT03347058

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 type: PROCEDURE
Group type: OTHER
Intervention: Vitrectomy
Study: NCT04070079

Intervention type: DRUG
Group type: OTHER
Intervention: Tenofovir Alafenamide
Description: TAF 25mg once daily orally, for 48 weeks
Study: NCT02058914

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: High Glucose sweetened beverage
Description: HG-sweetened beverage
Study: NCT02214459

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 type: DRUG
Group type: EXPERIMENTAL
Intervention: tiotropium
Description: four inhalations
Study: NCT03952637

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.

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 type: DRUG
Group type: EXPERIMENTAL
Intervention: tiotropium
Description: four inhalations

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tiotropium
Description: four inhalations
Study: NCT02095704

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paracetamol tablet
Description: dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
Study: NCT03861455

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 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.

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.

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.

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.

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 type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: patient receive placebo
Study: NCT01642264

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 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.

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 type: OTHER
Group type: OTHER
Intervention: Aldosterone in HPLC-MS/MS
Description: Aldosterone in HPLC-MS/MS
Study: NCT03921528

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.

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.

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 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.

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.

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.

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 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

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 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 type: PROCEDURE
Group type: OTHER
Intervention: Stem cells autotransplantation
Description: Stem cells autotransplantation is performed after consolidation treatment
Study: NCT01193842

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV
Study: NCT03274336

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: questionnaire
Description: questionnaire post preanesthetic interview

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: questionnaire
Description: questionnaire post preanesthetic interview

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: questionnaire
Description: questionnaire post preanesthetic interview

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: face-to-face interview
Description: Group A = face-to-face interview

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: brochure
Description: after reading a brochure a face to face interview will take place

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: brochure
Description: after reading a brochure a face to face interview will take place
Study: NCT01193842

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacological Study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacological Study
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Given PO

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine Sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine Sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vorinostat
Description: Given PO
Study: NCT03423134

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: New adhesive strip
Description: This is a strip made of a newly developed adhesive
Study: NCT03764085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rheosorbilact®
Description: Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ringer lactate
Description: Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.
Study: NCT02517216

Intervention type: OTHER
Group type: OTHER
Intervention: parabolic flight

Intervention type: DEVICE
Group type: OTHER
Intervention: MRI