hackint0sh/New-Dataset huggingface dataset:
To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies. conditions: Myotonic Dystrophy 1 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 30 type: ESTIMATED name: neurocognitive evaluations measure: Motor function evaluation by Muscular Impairment Rating Scale measure: cognitive evaluation by Wechsler Intelligence scale measure: cognitive evaluation by Raven Matrices measure: cognitive evaluation by Continous Performance Test 3 measure: cognitive evaluation by Trail Making Test A-B measure: cognitive evaluation by Digit Span and CORSI Test measure: cognitive evaluation by Rey Figure test measure: clinical evaluation by Epworth Sleepiness Scale measure: cognitive evaluation by Wisconsin Card Sorting Test measure: cognitive evaluation by Tower of London test measure: cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory measure: cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales sex: ALL minimumAge: 1 Year maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Maria Grazia D'Angelo status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria Grazia D'Angelo role: CONTACT phone: +39031 877870 email: grazia.dangelo@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False
nctId: NCT06378203 id: MEDEA 1013 briefTitle: Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI] acronym: RIMUDI overallStatus: RECRUITING date: 2023-12-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-22 date: 2024-04-22 name: IRCCS Eugenio Medea class: OTHER briefSummary: Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.
It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance. conditions: Muscular Dystrophies conditions: Limb Girdle Muscular Dystrophy conditions: Facio-Scapulo-Humeral Dystrophy conditions: Becker Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan which will subsequently be carried out "independently" at domicile.
The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) which allows to perform personalized games at home primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) measure: 6 minute walk test (6MWT) measure: Motor Function Measure scale (MFM) measure: Performance of Upper Limb (PUL) measure: Time up and go (TUG) measure: Modification of fatigue and quality of life scales from T0 to T6 measure: Short Form 36 (SF36) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria G D'Angelo, MD role: CONTACT phone: 031877111 phoneExt: +39 email: grazia.dangelo@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False
nctId: NCT06378190 id: TranspoCART19 briefTitle: Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology acronym: TranspoCART19 overallStatus: RECRUITING date: 2024-03-11 date: 2027-04 date: 2028-10 date: 2024-04-22 date: 2024-04-22 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Spanish Clinical Research Network - SCReN name: Fundación Canaria de Investigación Sanitaria name: Fundación para la Investigación Biomédica del Hospital 12 de Octubre briefSummary: The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:
nctId: NCT06378164 id: P0041406 briefTitle: The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers overallStatus: RECRUITING date: 2023-12-01 date: 2025-04 date: 2026-04 date: 2024-04-22 date: 2024-04-22 name: The Hong Kong Polytechnic University class: OTHER name: Chinese University of Hong Kong name: Neuroscience Research Australia name: The University of New South Wales briefSummary: To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers. conditions: Older Adults With a History of Falls studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 98 type: ESTIMATED name: Exercise name: Active Control measure: Choice Stepping Reaction Times measure: Spring Scale Test measure: Mini Balance Evaluation System Test measure: Motor Control Test measure: Falls Efficacy Scale - International measure: Trail-Making Test measure: Programme Adherence measure: Prospective Falls measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Freddy Man Hin LAM, PhD role: CONTACT phone: 27666720 email: freddy-mh.lam@polyu.edu.hk name: Freddy Man Hin LAM role: CONTACT name: Freddy Man Hin LAM, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
nctId: NCT06378151 id: 2023P002243 briefTitle: Time-limited Trials in the Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-28 date: 2025-09-30 date: 2024-04-22 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER briefSummary: A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department. conditions: Emergencies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinician-level randomization primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: TLT training measure: Time to complete TLT conversations measure: Patient-reported acceptability of TLT conversations measure: Intervention fidelity measure: Clinician-reported feasibility measure: Clinician-reported satisfaction measure: EHR documentation by inpatient clinicians measure: Heard and understood measure: Patient-reported end-of-life quality of communication measure: Decisional regret scale measure: The number of days to the first family meeting in ICU measure: ICU length of stay (LOS) measure: Hospital LOS measure: The number of family meetings measure: ICU procedures (e.g., CPR, pressors, etc.) measure: ICU mortality measure: Patterns of hospital disposition measure: Rate of hospice utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
nctId: NCT06378125 id: CIR-NA I briefTitle: Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes overallStatus: RECRUITING date: 2022-12-19 date: 2024-12-31 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: University Hospital Schleswig-Holstein class: OTHER briefSummary: A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes. conditions: Safety Issues conditions: Pharmacokinetic studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Double (Participant, Investigator) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD) name: immediate-release nicotinic acid (SAD) name: Placebo controlled-ileal-release nicotinic acid (SAD/MAD) name: Placebo immediate-release nicotinic acid (SAD) measure: Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Treatment-Emergent Serious Adverse Events [Safety and Tolerability] measure: Haemoglobin measure: White blood cells measure: Blood creatinine measure: Blood urea measure: Blood uric acid measure: Glomerular filtration rate measure: Blood ALT measure: Blood AST measure: Blood GGT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Schleswig-Holstein, Campus Kiel status: RECRUITING city: Kiel state: Schleswig-Holstein zip: 24105 country: Germany name: Corinna Geisler, PhD role: CONTACT phone: +4943150022243 email: studien.nutrisys.kiel@uksh.de lat: 54.32133 lon: 10.13489 hasResults: False
nctId: NCT06378112 id: 2734/CEIH/2022 briefTitle: Extraction Socket Augmentation. A Clinical Study acronym: GTO overallStatus: RECRUITING date: 2022-05-20 date: 2025-01-15 date: 2025-12-30 date: 2024-04-22 date: 2024-04-22 name: Universidad de Granada class: OTHER briefSummary: Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested.
The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation). conditions: Edentulous Alveolar Ridge With Labial Resorption studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.
* Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: GTO® measure: Dimensional bone changes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental School status: RECRUITING city: Granada zip: E18071 country: Spain name: Manuel Toledano, Professor role: CONTACT email: toledano@ugr.es name: Raquel Osorio role: CONTACT email: rosorio@ugr.es name: Manuel Toledano, Professor role: PRINCIPAL_INVESTIGATOR name: Raquel Osorio, Professor role: SUB_INVESTIGATOR name: Cristina Vallecillo, PhD role: SUB_INVESTIGATOR name: Marta Vallecillo-Rivas, PhD role: SUB_INVESTIGATOR name: Manuel Toledano-Osorio, PhD role: SUB_INVESTIGATOR lat: 37.18817 lon: -3.60667 hasResults: False
nctId: NCT06378099 id: InFaPro briefTitle: Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments acronym: InFaPro overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-02 date: 2025-08 date: 2024-04-22 date: 2024-04-25 name: Universidad de Antioquia class: OTHER name: Farmacias Pasteur briefSummary: Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols. conditions: Community Pharmacy Services studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3 to 5, and 7 to 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group. primaryPurpose: OTHER masking: NONE maskingDescription: Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention. count: 800 type: ESTIMATED name: Patient guided and followed by the pharmacist measure: Resolution time of the MA and the frequency of referral to a physician. measure: Characterization of the population visiting drugstore or drugstore/pharmacy measure: Identification of the presence and classification of the MA measure: Need to acquire an OTC medication to treat the MA sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06378086 id: TEO-PAS-2302 briefTitle: RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-05 date: 2024-04-22 date: 2024-04-22 name: Teoxane SA class: INDUSTRY briefSummary: This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.
If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary. conditions: Pain conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Split-face design primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: RHA® Redensity with new anesthetic agent name: RHA® Redensity with lidocaine measure: Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids. measure: Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, New York city: New York state: New York zip: 10028 country: United States role: CONTACT phone: 212-472-2900 lat: 40.71427 lon: -74.00597 hasResults: False
nctId: NCT06378073 id: DPT/Batch-Fall19/557 briefTitle: Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-05 date: 2024-06-01 date: 2024-09-01 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: "A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.
In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS" conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 189 type: ACTUAL name: Incentive Spirometer name: Numeric Pain Rating Scale measure: Incentive Spirometer measure: Incentive Spirometer sex: ALL minimumAge: 48 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Bahria Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: The University of Lahore Teaching Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Punjab Institute of Cardiology Hospital city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
nctId: NCT06378060 id: KM04 briefTitle: Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia overallStatus: RECRUITING date: 2024-03-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-22 date: 2024-04-22 name: Hematology department of the 920th hospital class: OTHER briefSummary: The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia. conditions: Severe Aplastic Anemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Modified transplantation system measure: overall survival (OS) measure: Acute graft-versus-host disease incidence measure: Transplantation-related motality measure: Chronic graft-versus-host disease incidence measure: incidence of Intensive fungal disease measure: EB virus reactivation rate measure: CMV reactivation rate sex: ALL minimumAge: 3 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China status: RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Wang PI sanbin, Doctor role: CONTACT phone: 0871-64774206 email: Wangsanbin2022@126.com lat: 25.03889 lon: 102.71833 hasResults: False
nctId: NCT06378047 id: MCC-22325 briefTitle: Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-10 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Angiodynamics, Inc. briefSummary: This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART). conditions: Pancreatic Cancer conditions: Locally Advanced Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Pembrolizumab name: Irreversible Electroporation measure: Safety and Tolerability measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Alicia Chin role: CONTACT phone: 813-745-4673 email: Alicia.Chin@moffitt.org name: Victoria Kryliouk role: CONTACT email: Victoria.Kryliouk@moffitt.org name: Mokenge Malafa, MD role: PRINCIPAL_INVESTIGATOR name: Mohammed Al-Jumayli, MD role: SUB_INVESTIGATOR name: Junsung Choi, MD role: SUB_INVESTIGATOR name: James Costello, MD, PhD role: SUB_INVESTIGATOR name: Aamir Dam, MD role: SUB_INVESTIGATOR name: Jason Denbo, MD role: SUB_INVESTIGATOR name: Sophie Dessureault, MD, PhD role: SUB_INVESTIGATOR name: Martine Extermann, MD, PhD role: SUB_INVESTIGATOR name: Jessica Frakes, MD role: SUB_INVESTIGATOR name: Pamela Hodul, MD role: SUB_INVESTIGATOR name: Sarah Hoffe, MD role: SUB_INVESTIGATOR name: Dae Won Kim, MD role: SUB_INVESTIGATOR name: Richard Kim, MD role: SUB_INVESTIGATOR name: Bela Kis, MD, PhD role: SUB_INVESTIGATOR name: Allan Lima Pereira, MD, PhD role: SUB_INVESTIGATOR name: Shaffer Mok, MD role: SUB_INVESTIGATOR name: Russell Palm, MD role: SUB_INVESTIGATOR name: Jose Pimiento, MD role: SUB_INVESTIGATOR name: Paulo Rodriguez, PhD role: SUB_INVESTIGATOR name: Christine Sam, MD role: SUB_INVESTIGATOR name: Andrew Sinnamon, MD role: SUB_INVESTIGATOR name: Amalia Stefanou, MD role: SUB_INVESTIGATOR name: Jonathan Strosberg, MD role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
nctId: NCT06378034 id: 2023-A01926-39 briefTitle: Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2024-07-15 date: 2026-09-30 date: 2024-04-22 date: 2024-04-22 name: Ingredia S.A. class: INDUSTRY briefSummary: The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia. conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Lactium name: Placebo measure: Sleep efficiency measure: Sleep diary measure: Insomnia Severity Index measure: PSQI measure: Sleep quality by cctigraphy sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT hasResults: False