hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06300450, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Esperion Therapeutics, Inc., descriptionModule 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., conditionsModule conditions: Peripheral Artery Disease, conditions: Peripheral Vascular Diseases, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Computer Alert, outcomesModule primaryOutcomes measure: Frequency of prescription of oral LDL-C-lowering therapy, secondaryOutcomes measure: Change in LDL-C level, otherOutcomes measure: Frequency of all-cause mortality, otherOutcomes measure: Frequency of major adverse cardiovascular events, otherOutcomes measure: Frequency of major adverse limb events, otherOutcomes measure: Frequency of all-cause hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Gregory Piazza, MD, MS, role: CONTACT, phone: 617-732-6984, email: gpiazza@bwh.harvard.edu, contacts role: CONTACT, phoneExt: Piazza, email: gpiazza@bwh.harvard.edu, contacts name: Gregory Piazza, MD, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Samuel Goldhaber, MD, role: SUB_INVESTIGATOR, contacts name: Ron Blankstein, MD, role: SUB_INVESTIGATOR, contacts name: Jorge Plutzky, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06300437, orgStudyIdInfo id: MS-372-2023, briefTitle: The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this study, children undergoing elective surgery under general anesthesia will be randomized into 2 groups.* Group (J): will include the children who will receive jaw thrusting during fiberoptic intubation.* Group (C): will include the children who will not receive jaw thrusting (just sub laxed open mouth), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: jaw thrust, interventions name: control (sub laxed jaw), outcomesModule primaryOutcomes measure: time to successful endotracheal tube insertion, secondaryOutcomes measure: Number of attempts to successful intubation, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo university hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Khaled Sarhan, role: CONTACT, phone: +201020067816, email: khaled.sarhan@kasralainy.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06300424, orgStudyIdInfo id: KY2024-162, briefTitle: Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC, acronym: NEOVADE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial People's Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Non Small Cell Lung Cancer, conditions: EGFR Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: almonertinib, interventions name: Carboplatin, interventions name: Nab paclitaxel, outcomesModule primaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Pathological Complete Response (pCR), secondaryOutcomes measure: Objective Response Rate (ORR), otherOutcomes measure: Overall Survival (OS), otherOutcomes measure: Event Free Survival (EFS), otherOutcomes measure: Incidence of Adverse Events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations 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, contacts name: Wen-zhao Zhong, PhD, role: CONTACT, phone: +86 20 83827812, phoneExt: 51221, email: syzhongwenzhao@scut.edu.cn, contacts name: Jun-Tao Lin, PhD, role: CONTACT, email: 237801160@qq.com, contacts name: Wen-zhao Zhong, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jun-Tao Lin, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06300411, orgStudyIdInfo id: SRG-514-01, briefTitle: SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: SURGE Therapeutics, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: SRG-514, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability], primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: Pharmacokinetics of SRG-514, secondaryOutcomes measure: Pharmacokinetics of SRG-514, secondaryOutcomes measure: Pharmacodynamics of SRG-514, secondaryOutcomes measure: Wound healing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300398, orgStudyIdInfo id: ECS_IAMA23_0101, briefTitle: IAMA-6 Oral Dose Study in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Iama Therapeutics S.r.l., class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Neurodevelopmental Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: IAMA-6, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs), primaryOutcomes measure: Number of participants with serious adverse events (SAEs), primaryOutcomes measure: Number of participants with physical examination abnormalities, primaryOutcomes measure: Number of participants with vital sign abnormalities, primaryOutcomes measure: Number of participants with electrocardiogram (ECG) abnormalities, primaryOutcomes measure: Number of participants with clinical laboratory abnormalities, primaryOutcomes measure: Number of participants with hearing abnormalities, secondaryOutcomes measure: Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Urine volume, secondaryOutcomes measure: Na+ excretion, secondaryOutcomes measure: K+ excretion, secondaryOutcomes measure: Sleep assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centro Ricerche Cliniche Di Verona S.r.l., status: RECRUITING, city: Verona, country: Italy, contacts name: Stefano Milleri, MD, role: CONTACT, phone: +39 0458126618, email: stefano.milleri@crc.vr.it, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
protocolSection identificationModule nctId: NCT06300385, orgStudyIdInfo id: IstanbulBUFC5, briefTitle: Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule 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., conditionsModule conditions: Sports Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 parallel groups randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Electromyostimulation, interventions name: Strengthening exercises, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Strength measurement, primaryOutcomes measure: Fatigue assessment, primaryOutcomes measure: Grip strength assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Bilgi University, status: RECRUITING, city: Istanbul, zip: 34440, country: Turkey, contacts name: Hulya Sisli, PhD, role: CONTACT, phone: 2123115303, phoneExt: +90, email: hulya.sisli@bilgi.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06300372, orgStudyIdInfo id: Medipol Hospital 2, briefTitle: Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Liver Failure, conditions: Acute Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: DOUBLE, maskingDescription: Outcomes assessor and participants will be blinded to the study, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: M-TAPA plane block, interventions name: Postoperative pain management, outcomesModule primaryOutcomes measure: Opioid consumption (Fentanyl PCA), secondaryOutcomes measure: Pain scores (Numerical rating scale-NRS, secondaryOutcomes measure: Need for rescue analgesia (meperidine), secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University Mega Hospital Complex, status: RECRUITING, city: Istanbul, state: Bagcilar, country: Turkey, contacts name: Ayse Ince, Assist Prof, MD, role: CONTACT, phone: +905366774988, email: drayseince@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06300359, orgStudyIdInfo id: Prognostic indicators of GBS, briefTitle: Prognostic Indicators of Gullian-Barre Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule 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., conditionsModule conditions: Guillain-Barre Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prognostic indicators of Gullian-Barre syndrome, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300346, orgStudyIdInfo id: Soh-Med-23-12-02MS, briefTitle: Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-18, completionDateStruct date: 2024-08-18, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule 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, conditionsModule conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, outcomesModule primaryOutcomes measure: Incidence of nausea and vomiting with spinal anesthesia, secondaryOutcomes measure: Measurement of hemodynamics postoperative, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300333, orgStudyIdInfo id: Ectopic tubal pregnancy, briefTitle: Treatment of Ectopic Pregnancy by Low Dose of Methotrexate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy, conditionsModule conditions: Ectopic Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, outcomesModule primaryOutcomes measure: descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06300307, orgStudyIdInfo id: CT-ATX-01-DM1-1.1, briefTitle: Study of ATX-01 in Participants With DM1, acronym: ArthemiR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: ARTHEx Biotech S.L., class: INDUSTRY, descriptionModule 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.There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo.ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b., conditionsModule conditions: Myotonic Dystrophy 1, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: ATX-01, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) of ATX-01, secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC) of ATX-01, secondaryOutcomes measure: Video hand opening time, secondaryOutcomes measure: Change from baseline in ankle dorsiflexion strength by quantitative myometry, secondaryOutcomes measure: Change from baseline in Impact on Activities of Daily Living questionnaire item scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False