hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06311877 id: 6795 briefTitle: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-14 date: 2025-02-14 date: 2024-03-15 date: 2024-03-15 name: University of South Florida class: OTHER briefSummary: Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia. conditions: Dysgeusia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: mBerry name: No intervention measure: 5-Point Hedonic Rating Scale measure: Chemotherapy-induced Taste Alteration Scale (CITAS) measure: M.D. Anderson Dysphagia Inventory (MDADI) measure: Functional Oral Intake Scale (FOIS) measure: Patients weight measurement sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311864 id: PROxy240215 briefTitle: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-09-15 date: 2024-09-15 date: 2024-03-15 date: 2024-03-15 name: PeriPharm class: OTHER name: Idorsia Pharmaceuticals Ltd. briefSummary: The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia. conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Daridorexant 50 mg measure: Change from Baseline in Quality of Life measure: Change from Baseline in Work Productivity Loss measure: Change from Baseline in the Severity of Insomnia Symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PROxy Network, an initiative of PeriPharm inc. city: Montreal state: Quebec zip: H2Y 2H4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
nctId: NCT06311851 id: PNCC140201 briefTitle: Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-15 date: 2024-04-01 name: Pardis Noor Medical Imaging and Cancer Center class: OTHER briefSummary: Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study. conditions: Cancer conditions: Metastatic Cancer conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bevacizumab measure: Overall Survival Rate measure: Objective response rate measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311825 id: IstanbulUCDH briefTitle: The Effect of Horticultural Therapy on Loneliness and Life Satisfaction in Elderly Adults Living in Nursing Home overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Loneliness in elderly individuals increases with age and negatively affects individuals by decreasing life satisfaction. In recent years, horticultural therapy is a type of therapy that has developed and is added routine care of elderly individuals living in nursing homes. Social interaction, life satisfaction, feelings of success and responsibility and increase while loneliness and depression levels decrease through human-nature interaction in horticultural therapy.
In our country, no study has been found on the effects of horticultural therapy on physical or mental health in elderly individuals. This research will be conducted as a randomized control group study to examine the effects of horticultural therapy on loneliness and life satisfaction in elderly individuals living in nursing homes. conditions: Horticultural Therapy conditions: Loneliness conditions: Satisfaction, Personal conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups randomized control study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 54 type: ESTIMATED name: Horticultural Therapy measure: Loneliness Scale for Elderly measure: Life Satisfaction Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa (IUC) city: Istanbul state: Şişli country: Turkey name: Hülya Bilgin, PhD role: CONTACT phone: 2122244986 phoneExt: 90 email: hulya.bilgin@iuc.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06311812 id: CREC 2023.683 briefTitle: Retrospective Review on Uterovaginal Anomalies overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-02-14 date: 2025-02-14 date: 2024-03-15 date: 2024-03-15 name: Chinese University of Hong Kong class: OTHER briefSummary: Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis. conditions: Abnormalities Uterine conditions: Vaginal Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Incidence of re-stenosis measure: Incidence of re-operation measure: Number of patients with normal menstruation after operation measure: Number of patients with sexual intercourse after operation measure: Number of patients with post-operative infection measure: Number of patients with pregnancy after operation measure: Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies measure: Number of participants with Pre-operative factors affecting post-operative outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311799 id: 2024-0102 briefTitle: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy acronym: FIMPreg overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-15 date: 2024-03-15 name: Geisinger Clinic class: OTHER name: Family Health Council of Central Pennsylvania (FHCCP) name: American Heart Association briefSummary: This study is being done to find out if online references to a food management program for Women, Infants, and Children (WIC) made by doctors will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and have one or more heart-related health risks (high blood pressure, diabetes, or obesity) will be asked to join this study. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their doctor. Group 2 will be sent to WIC by their doctor. Group 3 will get details about WIC from their doctor and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their doctor and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study team after they are done. conditions: Cardiovascular Diseases conditions: Obesity, Maternal conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: WIC Referral name: RDN Referral measure: Difference in WIC enrollment measure: WIC retention measure: WIC adherence measure: Prenatal clinic visit adherence. measure: RDN visit adherence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311773 id: Protocol # 24-01 briefTitle: Pivotal Trial of the Boomerang Catheter for pDVA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-01-15 date: 2029-01-15 date: 2024-03-15 date: 2024-03-15 name: Aveera Medical, Inc. class: INDUSTRY briefSummary: The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia. conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Boomerang Catheter measure: Amputation Free Survival (AFS) measure: Technical success measure: Procedural success measure: Limb salvage measure: Primary patency measure: Primary assisted patency measure: Secondary patency measure: Target wound healing measure: Complete wound healing sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311760 id: D7700C00001 briefTitle: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants overallStatus: RECRUITING date: 2024-04-09 date: 2024-09-24 date: 2024-09-24 date: 2024-03-15 date: 2024-04-18 name: AstraZeneca class: INDUSTRY briefSummary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants. conditions: Healthy Participants Study studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: AZD0292 name: Placebo measure: Number of Participants with Adverse Events measure: Number of Participants with Adverse Events of Special Interest (AESI) measure: Maximum Observed Drug Concentration (Cmax) measure: Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity) measure: Number of Participants with Positive Anti-drug Antibodies (ADAs) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
nctId: NCT06311747 id: 24-1T/45 briefTitle: The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players overallStatus: RECRUITING date: 2024-01-15 date: 2024-07 date: 2024-09 date: 2024-03-15 date: 2024-03-20 name: Ege University class: OTHER briefSummary: 30 tennis players aged 12-18, will be included in the study. After their normal warm-up, the participants will make 30 forehand and 30 backhand strokes. Forehand and backhand stroke accuracy rate will be calculated. After a week, additional oculo-motor exercises will be included in the warm-up and the forehand and backhand stroke accuracy rate will be calculated again. The hypothesis that there will be an improvement in forehand and backhand stroke accuracy after oculo-motor exercises will be tested. conditions: Supportive Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Oculo-motor exercises measure: Forehand and backhand stroke accuracy sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ege University Sports Medicine Clinic status: RECRUITING city: İzmir state: Bornova zip: 35100 country: Turkey name: Cim CINAR role: CONTACT phone: 905375213611 email: cimcinar95@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False
nctId: NCT06311734 id: LW231-I-01 briefTitle: A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-15 date: 2024-03-15 name: Shanghai Longwood Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects . conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: LW231 tablets name: Placebo measure: Number of Participants With Adverse Events (AEs) measure: Maximum Plasma Concentration (Cmax) of LW231 measure: Time to Cmax (Tmax) of LW231 measure: Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231 measure: Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231 measure: Half-life (t1/2) of LW231 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
nctId: NCT06311721 id: 20210033 id: 2023-508336-57 type: EUDRACT_NUMBER briefTitle: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2027-10-22 date: 2027-10-22 date: 2024-03-15 date: 2024-04-02 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®). conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 927 type: ESTIMATED name: ABP 234 name: Pembrolizumab (US) name: Pembrolizumab (EU) measure: Objective response (OR) measure: Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 measure: AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 measure: OR measure: OR measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234 measure: Cmax_dose1 of pembrolizumab (US) measure: Cmax_dose1 of pembrolizumab (EU) measure: Time to maximum concentration following the first dose (tmax_dose1) of ABP 234 measure: Tmax_dose1 of pembrolizumab (US) measure: Tmax_dose1 of pembrolizumab (EU) measure: Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234 measure: Cmax_ss of pembrolizumab (US) measure: Cmax_ss of of pembrolizumab (EU) measure: Time to maximum concentration at steady state (tmax_ss) of ABP 234 measure: Tmax_ss of pembrolizumab (US) measure: Tmax_ss of pembrolizumab (EU) measure: Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234 measure: Ctrough_w4 of pembrolizumab (US) measure: Ctrough_w4 of pembrolizumab (EU) measure: Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234 measure: Ctrough_ss at pre-dose of pembrolizumab (US) measure: Ctrough_ss at pre-dose of pembrolizumab (EU) measure: AUC21d of pembrolizumab (US) measure: AUC21d of pembrolizumab (EU) measure: AUCtau_ss of pembrolizumab (US) measure: AUCtau_ss pembrolizumab (EU) measure: Number of participants who experience a Treatment-emergent adverse event measure: Number of participants who experience a Treatment-emergent serious adverse event measure: Number of participants who experience a Treatment-emergent adverse event of interest measure: Number of participants who experience anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06311695 id: IEO 960 briefTitle: Contrast-Enhanced Spectral Mammography (CESM) acronym: CESM overallStatus: ACTIVE_NOT_RECRUITING date: 2012-01-01 date: 2022-02-28 date: 2024-12-31 date: 2024-03-15 date: 2024-03-15 name: European Institute of Oncology class: OTHER briefSummary: The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB). conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 325 type: ACTUAL name: Contrast Enhanced Mammography measure: Evaluation of negative predictive value (NPV) of the CEM measure: Evaluation of sensitivity of CEM measure: Evaluation of specificity of CEM measure: Positive Predictive Value (PPV) of CEM sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS city: Milan zip: 20141 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06311682 id: LP0162-1336 id: U1111-1285-6559 type: OTHER domain: World Health Organization (WHO) id: 2023-503630-44 type: OTHER domain: European Medicines Agency (EMA) briefTitle: A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis acronym: TRAPEDS 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2026-03-26 date: 2028-04-28 date: 2024-03-15 date: 2024-03-15 name: LEO Pharma class: INDUSTRY briefSummary: The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.
The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.
nctId: NCT06311669 id: 29409010104798 briefTitle: Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-03-15 date: 2024-03-15 name: Ain Shams University class: OTHER briefSummary: The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions conditions: Nonthrombotic Iliac Vein Lesions conditions: Pelvic Congestive Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: iliac vein stenting name: pelvic vein embolization measure: Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ainshams University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
nctId: NCT06311656 id: 18840 id: J5C-MC-FOAA type: OTHER domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company briefTitle: A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2024-05-30 date: 2024-05-30 date: 2024-03-15 date: 2024-03-15 name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company class: INDUSTRY name: Eli Lilly and Company briefSummary: The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: LY4100511 (DC-853) name: Placebo measure: Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853) measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altasciences Clinical Los Angeles, Inc city: Cypress state: California zip: 90630 country: United States lat: 33.81696 lon: -118.03729 hasResults: False
nctId: NCT06311643 id: 35 briefTitle: Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight overallStatus: COMPLETED date: 2023-03-02 date: 2023-09-01 date: 2024-03-01 date: 2024-03-15 date: 2024-03-15 name: Kafrelsheikh University class: OTHER briefSummary: Effect of massage on hormone levels in puerperal women conditions: Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE maskingDescription: the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: Postpartum back massage in study group measure: Leptin and prolactin levels increase sex: FEMALE minimumAge: 25 Years maximumAge: 30 Years stdAges: ADULT facility: Kafrelshiekh university city: Kafrelshiekh zip: 6850001 country: Egypt hasResults: False