hackint0sh/New-Dataset huggingface dataset:
This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place. conditions: Neurofibromas, Cutaneous conditions: Neurofibromatosis 1 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Kybella name: Asclera name: 755nm Alexandrite Laser name: 1064nm Nd:YAG Laser measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Numeric Rating Scale (NRS-11)/Patient Satisfaction measure: Skindex 16 measure: Patient Reported Outcomes measure: Clinician Reported Outcomes measure: Rate of healing measure: cNF appearance (volume) measure: cNF appearance (height) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wellman Center for Photomedicine city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
nctId: NCT06300489 id: CARTOnG-2401 briefTitle: Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer overallStatus: RECRUITING date: 2024-03-03 date: 2025-01-31 date: 2025-10-31 date: 2024-03-08 date: 2024-03-08 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: irinotecan liposomes+capecitabine measure: DLT（dose-limiting toxicity） measure: MTD（maximum tolerable dose） sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Ji Zhu role: CONTACT phone: 0571-88128152 email: leo.zhu@126.com lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06300476 id: 2023-1511 briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1) overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-20 date: 2026-12-30 date: 2029-12-30 date: 2024-03-08 date: 2024-03-08 name: West China Hospital class: OTHER briefSummary: The purpose of the study is to assess the safety and efficacy of JWK006 in Stargardt Disease(STGD1).
JWK006 is packed by adeno-associated virus vector that expressing ABCA4 gene. conditions: Stargardt Disease 1 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 9 type: ESTIMATED name: JWK006 measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) measure: Visual acuity measure: Ophthalmoscope Measurement measure: Qualitative and quantitative assessments of autofluorescence pattern (FAF) measure: multifocal electroretinogram (mfERG) sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital city: Chengdu state: Sichuan zip: 610044 country: China lat: 30.66667 lon: 104.06667 hasResults: False
nctId: NCT06300463 id: 23-06026214 briefTitle: Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases overallStatus: RECRUITING date: 2024-03-26 date: 2025-09 date: 2027-03 date: 2024-03-08 date: 2024-04-12 name: Weill Medical College of Cornell University class: OTHER name: Agenus Inc. briefSummary: The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:
Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years. conditions: Colorectal Cancer Metastatic conditions: Liver Metastases conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Botensilimab name: Balstilimab name: AGEN1423 name: Radiation measure: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm measure: Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm measure: Pathological Response Rate Per Arm measure: Radiographic Response Rate Per Arm measure: Number of Participants Per Arm with ctDNA Clearance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Casey Owens role: CONTACT phone: 646-962-8189 email: cdo4001@med.cornell.edu name: Myriam Elizaire-Williams role: CONTACT email: mye4001@med.cornell.edu lat: 40.71427 lon: -74.00597 hasResults: False
nctId: NCT06300450 id: 2022P002171 briefTitle: Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy acronym: PAD-ALERT overallStatus: RECRUITING date: 2023-03-01 date: 2025-02-28 date: 2025-07-30 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Esperion Therapeutics, Inc. briefSummary: This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy. conditions: Peripheral Artery Disease conditions: Peripheral Vascular Diseases conditions: Dyslipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this patient- and provider-facing alert-based CDS (EPIC BPA) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, investigators and outcomes assessors will be blinded to the assignment of the clinician to the computer alert or control (non-alert) group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Computer Alert measure: Frequency of prescription of oral LDL-C-lowering therapy measure: Change in LDL-C level measure: Frequency of all-cause mortality measure: Frequency of major adverse cardiovascular events measure: Frequency of major adverse limb events measure: Frequency of all-cause hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Gregory Piazza, MD, MS role: CONTACT phone: 617-732-6984 email: gpiazza@bwh.harvard.edu role: CONTACT phoneExt: Piazza email: gpiazza@bwh.harvard.edu name: Gregory Piazza, MD, MS role: PRINCIPAL_INVESTIGATOR name: Samuel Goldhaber, MD role: SUB_INVESTIGATOR name: Ron Blankstein, MD role: SUB_INVESTIGATOR name: Jorge Plutzky, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
nctId: NCT06300437 id: MS-372-2023 briefTitle: The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program overallStatus: RECRUITING date: 2024-03-03 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-03-12 name: Kasr El Aini Hospital class: OTHER briefSummary: In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program. conditions: Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this study, children undergoing elective surgery under general anesthesia will be randomized into 2 groups.
* Group (C): will include the children who will not receive jaw thrusting (just sub laxed open mouth) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: jaw thrust name: control (sub laxed jaw) measure: time to successful endotracheal tube insertion measure: Number of attempts to successful intubation measure: Complication sex: ALL minimumAge: 1 Year maximumAge: 15 Years stdAges: CHILD facility: Cairo university hospitals status: RECRUITING city: Cairo country: Egypt name: Khaled Sarhan role: CONTACT phone: +201020067816 email: khaled.sarhan@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
nctId: NCT06300424 id: KY2024-162 briefTitle: Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC acronym: NEOVADE overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2027-09 date: 2024-03-08 date: 2024-04-17 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions. conditions: Non Small Cell Lung Cancer conditions: EGFR Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: almonertinib name: Carboplatin name: Nab paclitaxel measure: Major Pathological Response (MPR) measure: Pathological Complete Response (pCR) measure: Objective Response Rate (ORR) measure: Overall Survival (OS) measure: Event Free Survival (EFS) measure: Incidence of Adverse Events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences status: RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Wen-zhao Zhong, PhD role: CONTACT phone: +86 20 83827812 phoneExt: 51221 email: syzhongwenzhao@scut.edu.cn name: Jun-Tao Lin, PhD role: CONTACT email: 237801160@qq.com name: Wen-zhao Zhong, PhD role: PRINCIPAL_INVESTIGATOR name: Jun-Tao Lin, PhD role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
nctId: NCT06300411 id: SRG-514-01 briefTitle: SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-09 date: 2024-03-08 date: 2024-03-08 name: SURGE Therapeutics class: INDUSTRY briefSummary: This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 18 type: ESTIMATED name: SRG-514 measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Pharmacokinetics of SRG-514 measure: Pharmacokinetics of SRG-514 measure: Pharmacodynamics of SRG-514 measure: Wound healing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06300398 id: ECS_IAMA23_0101 briefTitle: IAMA-6 Oral Dose Study in Healthy Adults overallStatus: RECRUITING date: 2024-01-08 date: 2024-09 date: 2024-09 date: 2024-03-08 date: 2024-03-12 name: Iama Therapeutics S.r.l. class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults. conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: IAMA-6 name: Placebo measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with physical examination abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participants with clinical laboratory abnormalities measure: Number of participants with hearing abnormalities measure: Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses measure: AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses measure: Urine volume measure: Na+ excretion measure: K+ excretion measure: Sleep assessment sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Centro Ricerche Cliniche Di Verona S.r.l. status: RECRUITING city: Verona country: Italy name: Stefano Milleri, MD role: CONTACT phone: +39 0458126618 email: stefano.milleri@crc.vr.it lat: 45.4299 lon: 10.98444 hasResults: False
nctId: NCT06300385 id: IstanbulBUFC5 briefTitle: Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-08 date: 2024-04-04 name: Istanbul Bilgi University class: OTHER briefSummary: Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes. conditions: Sports Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups randomized controlled study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Electromyostimulation name: Strengthening exercises measure: Visual analog scale measure: Strength measurement measure: Fatigue assessment measure: Grip strength assessment sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Istanbul Bilgi University status: RECRUITING city: Istanbul zip: 34440 country: Turkey name: Hulya Sisli, PhD role: CONTACT phone: 2123115303 phoneExt: +90 email: hulya.sisli@bilgi.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06300372 id: Medipol Hospital 2 briefTitle: Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-04-02 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery. conditions: Liver Failure conditions: Acute Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes assessor and participants will be blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: M-TAPA plane block name: Postoperative pain management measure: Opioid consumption (Fentanyl PCA) measure: Pain scores (Numerical rating scale-NRS measure: Need for rescue analgesia (meperidine) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Mega Hospital Complex status: RECRUITING city: Istanbul state: Bagcilar country: Turkey name: Ayse Ince, Assist Prof, MD role: CONTACT phone: +905366774988 email: drayseince@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06300359 id: Prognostic indicators of GBS briefTitle: Prognostic Indicators of Gullian-Barre Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-03-08 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments. conditions: Guillain-Barre Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Prognostic indicators of Gullian-Barre syndrome sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06300346 id: Soh-Med-23-12-02MS briefTitle: Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-18 date: 2024-08-18 date: 2024-03-08 date: 2024-03-08 name: Sohag University class: OTHER briefSummary: Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.
Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Propofol measure: Incidence of nausea and vomiting with spinal anesthesia measure: Measurement of hemodynamics postoperative sex: FEMALE minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
nctId: NCT06300333 id: Ectopic tubal pregnancy briefTitle: Treatment of Ectopic Pregnancy by Low Dose of Methotrexate overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy conditions: Ectopic Pregnancy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Methotrexate measure: descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
nctId: NCT06300307 id: CT-ATX-01-DM1-1.1 briefTitle: Study of ATX-01 in Participants With DM1 acronym: ArthemiR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: ARTHEx Biotech S.L. class: INDUSTRY briefSummary: The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo.
ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b. conditions: Myotonic Dystrophy 1 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: ATX-01 name: Placebo measure: Incidence of adverse events measure: Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior measure: Maximum observed plasma concentration (Cmax) of ATX-01 measure: Area under the plasma concentration-time curve (AUC) of ATX-01 measure: Video hand opening time measure: Change from baseline in ankle dorsiflexion strength by quantitative myometry measure: Change from baseline in Impact on Activities of Daily Living questionnaire item scores sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False