bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Ginger on Menopausal Symptoms
Condition: Menopause
Study type: Interventional

Summary: 
      This study aimed to examine the impact of one gram of Zingiber Officinale powder on
      menopausal symptoms since a large number of menopausal women in this region (Duhok city in
      the North of Iraq) are reluctant to take the conventional treatment for improving their
      menopausal symptoms and they prefer of taking the ginger powder and surprisingly many of
      those patients reported positive effects on their symptoms and general well being.
    

Detailed description: 
      After taking the scientific and ethical approval from the College of the Pharmacy/ University
      of Duhok and the Directorate of Duhok Health (reference number 24102021-10-36) to look at the
      impact of Zingiber officinale on menopausal symptoms in women between 45 and 60 years old. A
      clinical interventional study was launched at the Gynecology Department in Azadi Teaching
      Hospital in Duhok Governorate, Iraq, from December 2021 to May 2022. This study initially
      recruited seventy women who matched the inclusion criteria. All the recruited women were
      informed about the study protocols, and they had the option to withdraw from it anytime.
      After giving written consent, they were randomly divided into one of two research groups
      through a random number generator software. Thirty-five women functioned as controls and were
      given placebo capsules for twelve weeks (A professional pharmacist formulated a 50mg starch
      purchased from the local market to look similar to the ginger capsule). The other thirty-five
      women were given pure Zingiber Officinale powder (500mg) in capsules twice daily for twelve
      weeks (Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712
      Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)). Twenty women completed the study in the
      placebo group, while thirty women completed the survey in the Ginger group. Unfortunately,
      fifteen participants from the control group and five women from the treatment group didn't
      finish the study and were excluded as they were not tighter to the project protocol.

      The frequency and severity of menopausal symptoms were assessed using an internationally
      recognized questionnaire menopausal rating scale (MRS). Percentage differences between
      pre-treatment were compared to post-treatments.

      The serum estrogen, progesterone, FSH, and LH levels were measured before and after treatment
      using a suitable kit for each hormone by Cobas e 411 analyzers (Roche Diagnostics).
    

Intervention name(s): Zingiber Officinale powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ginger powder; Starch powder
Other intervention name(s): Ginger; control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
Condition: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 3

Summary: 
      This multi-center, open-label, randomized study will evaluate the participant preference with
      subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in
      participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's
      lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)
      on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,
      followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive
      MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8
      cycles of standard chemotherapy (according to local country practice) with 8 cycles of
      MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
    


Intervention name(s): Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP); Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP); Bendamustine; Rituximab; Rituximab; Rituximab; Rituximab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Standard chemotherapy; Standard chemotherapy; Standard chemotherapy; 1400 mg subcutaneously (SC), Day 1 Cycles 2-4; 375 mg/m2 IV, Day 1 Cycles 1-4; 375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8; 1400 mg SC, Day 1 Cycles 5-8
Other intervention name(s): Treanda; Rituxan; MabThera; Rituxan; MabThera; Rituxan; MabThera; Rituxan; MabThera
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Vincristine; Doxorubicin; Liposomal doxorubicin; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
    


Intervention name(s): BI 1744 CL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Culture of Circulating Tumor Cells Isolated From Cancer Patients With Metastatic Disease
Condition: Circulating Tumor Cells
MeSH terms: Neoplastic Cells, Circulating; Neoplasm Metastasis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the feasibility of using novel decellularized
      tissue matrices to isolate and culture circulating tumor cells (CTCs) collected from patients
      with metastatic solid tumor malignancies.
    

Detailed description: 
      There are currently very few practical or reproducible model systems which recapitulate the
      metastatic process well. CTCs are important for the development of metastases and there is
      interest in isolating and culturing them ex vivo to better characterize their biology,
      metastatic potential, and response to different therapies. The investigators have previously
      demonstrated efficient capture and enumeration of CTCs in 4 unique patient cohorts
      (metastatic prostate and locally advanced rectal, cervical and head and neck cancers) in the
      investigators prospective clinical study, LCCC 1408 (Investigation of Circulating Tumor Cells
      from Cancer Patients Undergoing Radiation Therapy). However, CTCs are difficult to culture
      with conventional methods. The investigators propose to culture CTCs using novel
      decellularized tissue matrices. Blood will be collected from cancer patients with metastatic
      solid tissue tumors prior to starting definitive or palliative radiotherapy. The
      investigators will then isolate CTCs and attempt to grow them on various decellularized
      matrices. If this study is successful and feasibility is demonstrated, important pilot
      information will also be gathered which will then be used in power and sample size
      considerations for future CTCs studies.
    

Intervention name(s): Blood draw
Intervention type(s): Other
Intervention description(s): A blood sample of 10mL- 25mL will be collected before the start of radiation treatment.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC
        Hosptials for treatments of oligometastatic cancer.
Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women
Condition: HIV-1-infection; Bacterial Vaginoses
MeSH terms: Infections; Communicable Diseases; Vaginosis, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will enrol African, Caribbean and Black (ACB) women who are known to have a more
      diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of
      protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate
      the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local
      immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal
      estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics
      alone.
    

Detailed description: 
      Women are at increased risk of HIV acquisition compared with men. A number of biological
      factors are associated with increased risk, many of which likely enhance risk by increasing
      inflammation in the female genital tract. Susceptibility to infections and immune responses
      in the female genital tract are regulated by hormones: progesterone increases inflammation
      and HIV susceptibility and estrogen decreases inflammation and enhances colonization with
      Lactobacilli.

      A Lactobacillus dominant vaginal microbiome is associated with increased protection against
      HIV, while a polymicrobial vaginal flora, as seen in bacterial vaginosis, is associated with
      increased risk. About 40% of ACB women have a polymicrobial flora.

      The goal of this study is to establish a Lactobacillus dominant vaginal microbiome in ACB
      women, that will be associated with decreased inflammation and decreased susceptibility to
      HIV, by administering a low level of intravaginal estrogen to increase colonization with
      Lactobacilli together with a Lactobacillus-containing probiotic.
    

Intervention name(s): Estring Vaginal Ring; RepHresh Pro-B
Intervention type(s): Drug; Other
Intervention description(s): Estradiol vaginal ring, containing 2mg estradiol designed for slow release over 30 days; Probiotic supplement containing 2.5 billion CFU of Lactobacilli reuteri RC-14 and Lactobacilli rhamnosus GR-1, administered vaginally or orally
Other intervention name(s): 17 beta-estradiol
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Cardiac Output With LiDCO Rapid and TEE Against Thermodilution Technique in Cardiac Surgery
Condition: Low Cardiac Output
MeSH terms: Cardiac Output, Low
Study type: Observational

Summary: 
      Measurement of the cardiac output is one of the important hemodynamic monitoring tools in
      cardiac surgery. It helps determine the type of medications needed to maintain optimal
      hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary
      artery catheter is considered has the gold standard for the measurement of cardiac output.
      Investigators would like to compare the most popular minimally-invasive devices used to
      measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution
      method at various phases of the cardiac surgery.
    

Detailed description: 
      Measurement of the cardiac output is one of the important hemodynamic monitoring tools in
      cardiac surgery. It helps determine the type of medications needed to maintain optimal
      hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary
      artery catheter is considered has the gold standard for the measurement of cardiac output,
      however over the past 10 to 15 years it has been questioned about its safety and efficacy.
      There has been a surge in recent years of less invasive devices capable of measuring cardiac
      output by various means, including bioimpedance, transpulmonary thermodilution, transthoracic
      and transesophageal echocardiography, and arterial waveform analysis.

      There is a variety of devices currently available for cardiac output measurement by
      arterial-waveform analysis. These devices have been compared to each other, and to the
      pulmonary artery catheter as the gold standard. However, the companies manufacturing these
      devices have made software upgrades that they believe improves their performance. No studies
      have been performed comparing the uncalibrated arterial waveform based cardiac output
      measurement device,LiDCORapid since the software upgrades. In addition to baseline cardiac
      output measurements, Investigators intend to study the effect of volume loading (by
      trendelenburg position), sympathetic stimulus (incision), a vasodilated state (15 minutes
      after separation from CPB) and chest closure on cardiac output measured by the three
      different techniques.

      In addition to cardiac output the investigators would like to measure stroke volume ,Systemic
      Vascular Resistance, stroke volume variation with LiDCO . The main purpose is to validate the
      accuracy of measurements by these two minimally-invasive methods in comparison with
      thermodilution method in various hemodynamic states.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All elective adult cardiac surgery patients who are scheduled in UIHC from Sep 2012 to
        August 2015 will be included.
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Condition: Covid19; Severe Acute Respiratory Syndrome; Distress Respiratory Syndrome
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved
      for this indication, single-center, exploratory, open, randomized, controlled, to study the
      efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and
      criteria high risk to develop SARS.
    


Intervention name(s): Antithrombin + best available treatment; Best available treatment
Intervention type(s): Drug; Drug
Intervention description(s): The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.; The subject will be treated with the best available treatment for COVID-19.
Intervention MeSH terms: Antithrombins; Antithrombin III
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antithrombin; COVID-19; Distress Respiratory Syndrome
A New Technique for Determining Limb Occlusion Pressure
Condition: Tourniquet Safety and Effectiveness
Study type: Interventional

Summary: 
      This study evaluates a novel technique for measuring the minimum pressure necessary to
      achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP).
      Patients will have tourniquets applied to their arms and legs and LOP will be measured using
      the new technique and a gold standard Doppler ultrasound technique.
    

Detailed description: 
      Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to
      achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP).
      However, LOP is not yet routinely measured in all patients due to limitations of current
      techniques. This study evaluates a novel technique for measuring the LOP through the
      tourniquet cuff that overcomes many limitations of current LOP measurement techniques.

      The goal of the study is to determine if the LOP measured by the new technique is
      statistically or clinically different from the LOP measured by a gold standard Doppler
      ultrasound technique in adult and pediatric patients
    

Intervention name(s): Personalized Tourniquet Instrument; Handheld Doppler ultrasound
Intervention type(s): Device; Device
Intervention description(s): Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.; Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: tourniquet; safety; personalized; surgery
Cognitive Training for Older Caregivers
Condition: Life Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to test whether certain brain training activities can promote
      cognitive, emotional, and physical health in caregivers of a loved one with dementia.
      Numerous studies show that family dementia caregiving can be stressful, and can increase
      mental and physical health risks. This study aims to understand how to reduce those risks.
    


Intervention name(s): Online video education; Computerized mental exercises
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
Condition: Osteoarthritis Pain of the Knee
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to
      Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the
      Knee
    

Detailed description: 
      This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study
      evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The
      study will consist of up to a 28-day Screening Phase that will include a Washout Period of
      current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment
      Phase, and a 1-week safety Follow-up Phase.
    

Intervention name(s): Diclofenac sodium active topical patch; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.; A placebo patch without diclofenac sodium was used for the placebo arm.
Other intervention name(s): HP-5000; Placebo
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
Condition: Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, parallel-arm study to determine if a prior intra-articular
      (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or
      pharmacokinetics (PK) of a subsequent IA injection of the corticosteroid triamcinolone
      acetonide (TA) into the same knee, and to determine if a prior IA injection of TA affects the
      safety or tolerability of a subsequent IA injection of LOR into the same knee.
    


Intervention name(s): Lorecivivint (LOR); Triamcinolone acetonide (TA)
Intervention type(s): Drug; Drug
Intervention description(s): 0.07 mg; 40 mg
Other intervention name(s): SM04690
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lorecivivint; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lorecivivint; triamcinolone acetonide
B-vitamin Levels and Adverse Pregnancy Outcomes
Condition: Birth Defect; Pregnancy Loss; Pregnancy Complications; Pregnancy Induced Hypertension; Recurrent Pregnancy Loss; Health Problems in Pregnancy; Gestational Diabetes; Gestational Hypertension; Preterm Birth
MeSH terms: Diabetes, Gestational; Premature Birth; Pregnancy Complications; Abortion, Spontaneous; Fetal Death; Hypertension, Pregnancy-Induced; Hypertension; Congenital Abnormalities
Study type: Observational

Summary: 
      This prospective nested case-control study aims to examine the effects of blood vitamin B
      levels in first-trimester pregnant women on the pregnancy outcomes
    

Detailed description: 
      Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects.
      Effective folate functioning requires essential metabolic interactions with other B vitamins
      including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence
      pregnancy outcomes independently. For example, animal and family studies have identified that
      niacin (B3) deficiency can lead to congenital malformations. However, how folate and related
      B-vitamin levels interact with each other while affecting various pregnancy outcomes
      including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate
      levels in previous studies were mostly measured in plasma which are easily influenced by
      dietary factors, instead of red blood cell folate which can reflect the long-term status.
      Moreover, the difference in the risk of neural tube defects across a range of maternal red
      blood cell folate concentrations has been largely ignored. Using data of pregnant women
      recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021,
      this case-control study aims to examine the association of folate and related B-vitamin
      levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes,
      particularly the association between niacin deficiency and birth defects.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is an observational study without any intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all pregnant women recruited in the birth cohort of Beijing Obstetrics and Gynecology
        Hospital between 2020.12 to 2021.12
      
Biospecimen description: 
      first-trimester maternal blood
    
Keywords: vitamin B; pregnancy outcome
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
Condition: Liver Transplant Disorder
MeSH terms: Kinesiophobia
Study type: Observational [Patient Registry]

Summary: 
      Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
    


Intervention name(s): Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
Intervention type(s): Other
Intervention description(s): All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sixteen individuals older than 18 years of age who had undergone liver transplantation at
        Hacettepe University Hospital at least one year ago and 16 age- and sex-matched healthy
        subjects were included in the study
      
Keywords: liver transplantation; functional capacity; kinesiophobia; balance; physical fitness; physical activity; muscle strength