bioihbjkbjnl/mcl2 huggingface dataset:
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
Condition: Non-anemic Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose
      iron dietary supplement. The investigators seek to determine if the low-dose iron dietary
      supplement will restore iron levels to normal range with fewer side effects than typically
      experienced at higher doses of iron supplementation.
    

Detailed description: 
      The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron
      dietary supplement on markers of iron status among a sample of premenopausal women that are
      iron-deficient without anemia. This study will also assess the incidence of mild adverse
      events (constipation, nausea, etc.) that are relatively common with other over the counter
      iron dietary supplements and that the investigators hypothesize will be reduced with this
      lower-dose formulation.
    

Intervention name(s): Blood Builder®/Iron Response®
Intervention type(s): Dietary Supplement
Intervention description(s): The low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it.
One tablet will be taken once a day offering a total daily serving of:
15 mg of Vitamin C
400 mcg of Folate
30 mcg Vitamin of B-12
26 mg of Iron
125 mg of Beet Root
Other intervention name(s): Low-dose iron dietary supplement
Intervention MeSH terms: Iron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-anemic Iron Deficiency, Iron Supplementation
Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)
Condition: Statin Induced Myalgia
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease
      the rate of Muscle Pain in patients with previous statin related Muscle Pain.
    


Intervention name(s): Coenzyme Q 10; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): PO Coenzyme Q 10 120 mg QD; po Placebo QD
Other intervention name(s): ubiquinone
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coenzyme Q 10; Statin; Myalgia
Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the
      efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients
      with chronic hepatitis B and varying degrees of renal impairment.
    

Detailed description: 
      Approximately 48 patients with chronic hepatitis B will be enrolled into four groups
      representing varying degrees of renal function. Grouping will be achieved through estimation
      of creatinine clearance (CLcr) using the Cockcroft-Gault method of calculation at the time of
      screening:

      Group 1: Mild (Clcr = greater than or equal to 50 to less than 80 mL/min)

      Group 2: Moderate (Clcr = greater than or equal to 20 to less than 50 mL/min)

      Group 3: Severe (Clcr = greater than or equal to 10 to less than 20 mL/min)

      Group 4A-B: End stage renal disease (ESRD) including hemodialysis:

        -  Group 4A (Clcr = less than 10 mL/min)

        -  Group 4B (Patients undergoing hemodialysis)

      At the baseline visit (day 0), blood and urine samples will be collected pre-dose (prior to 0
      hour) after which patients will receive an oral dose of liquid adefovir dipivoxil according
      to the treatment guideline outlined in the protocol.

      Pharmacokinetic parameters in plasma will be determined for the day 0 and week 12 visits for
      all patients and at the week 48 visit for group 1, 2, 3, and 4A patients. Pharmacokinetic
      parameters in urine will be determined for the day 0, week 12 and week 48 visits for group 1,
      2, 3, and 4A patients.

      At week 4, 8, 16, 20, 24, 28, 32, 36, 40, and 44 visits, pharmacokinetic assessments in
      plasma will be determined pre-dose (Ctrough levels) in groups 1, 2, 3, and 4A. For group 4B
      patients, pharmacokinetic assessments will be determined at weeks 4 and 8 prior to and upon
      completion of hemodialysis.

      Evaluations of safety and efficacy will be conducted at 4 weekly intervals up to week 48 for
      groups 1, 2, 3, and 4A, and up to week 12 for group 4B. At these visits, patients will
      receive the next study medication allocation. Study medication administration will continue
      for up to a total of 48 weeks.
    

Intervention name(s): Adefovir Dipivoxil for oral suspension, 2 mg/mL
Intervention type(s): Drug
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain and Cognitive Function of Patients With RPD
Condition: Missing Posterior Occlusal Contact
Study type: Interventional

Summary: 
      To evaluate the influence of restoring lost posterior occlusal contacts with removable
      partial denture (RPD) on the brain activity and cognitive function in controlled type 2
      diabetic patients
    


Intervention name(s): Flexible partial denture
Intervention type(s): Device
Intervention description(s): removable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Removable partial dentures; Electro-encephalogram; Mini mental state examination; Controlled type 2 diabetes.
Comparison of Two Different Doses of Azithromycin for Treatment of Yaws
Condition: Yaws
MeSH terms: Yaws
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be a single blinded, randomized, controlled open label non-inferiority phase
      III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The
      ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg
      dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws
      patients will be included in the study. Patients will be randomized to receive treatment with
      the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg
      azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The
      follow-up period of patients will be 6 months. Assessments before, during and after the
      antibiotic treatment will include full medical history, clinical assessment of the lesion
      and, laboratory investigations. The primary efficacy parameters are healing of the lesion at
      4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.
    


Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Comparison of two different dosing strategies for the treatment of yaws
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
Condition: Human Papilloma Virus Infection
MeSH terms: Infections; Virus Diseases; Papillomavirus Infections; Papilloma
Study type: Observational

Summary: 
      This is a post-licensure safety observation cohort study to describe the general safety of
      GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Males who are members of a large geographically diverse US health plan.
      
Keywords: Warts; Papillomavirus infections; DNA virus infections; Virus diseases; Skin diseases, viral; Tumor virus infections; Skin diseases, infectious; Skin diseases
Impact of COVID-19 on Personal Protection Among Dentist in Egypt
Condition: COVID 19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Dentist exposed to coronavirus (COVID-19) may not have adequate access to personal protective
      equipment (PPE), safety procedures, and diagnostic protocols. Our objective will be to
      evaluate the reality and perceptions about personal safety among dentist in Egypt
    

Detailed description: 
      This is a cross-sectional, online survey-based study administered to Dentist in Egypt. A
      20-item questionnaire will be developed and distributed using Google Forms.

      Participants were recruited through social networking websites and applications (Twitter,
      Instagram, Facebook, LinkedIn, and WhatsApp). The questionnaire will be conducted from 24 May
      2020 and until 30 june 2020.

      The survey will be delivered in Enlish. Participants will be able to complete the survey only
      once and will be allowed to terminate the survey at any time they desired. The survey will be
      anonymous and confidential. An introductory paragraph outlining the purpose of the study will
      be posted along with the survey.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire developed and distributed using Google Forms.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        dentist
      
Keywords: COVID-19; Personal Protection; Dentist; Egypt
Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with
      advanced non-small lung cancer, with placebo control.
    

Detailed description: 
      Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with
      multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
    

Intervention name(s): Anlotinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.; Basic dosage, take once when limosis in the morning.
Other intervention name(s): AL3818
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anlotinib; Cancer; NSCLC; Non-small Cell Lung Cancer
Characterization of the Role of Histamine in Children With Asthma
Condition: Asthma; Allergic Asthma; Non-allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Asthma, a chronic disease which produces significant morbidity and mortality in children, is
      a significant health problem to a large segment of society. Despite considerable advances in
      the diagnosis and treatment of asthma over the past several years, a sizeable portion of
      patients do not respond to the "core" treatments. The investigators are now learning that the
      underlying pathophysiology of disease is different among patients with asthma therefore;
      treatments which are beneficial in some patient groups may be not achieve affect in other
      groups.

      Antihistamines have been studied in the past for the treatment of asthma. These studies have
      shown that there may be a beneficial effect of antihistamines in patients with allergic
      asthma where histamine likely plays a large role in disease and treatment response. However,
      there is not enough evidence to include these drugs in the standard treatment of asthma.

      The investigators hypothesize that histamine plays a definable, significant role in disease
      pathogenesis and treatment response in children with allergic asthma. The investigators plan
      to test this overall hypothesis through two specific aims. The first aim will characterize
      the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be
      accomplished by comparison of the microvasculature response to histamine in children with
      allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis
      with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences
      in the pharmacodynamic response to histamine.
    


Intervention name(s): Levocetirizine 0.5 Mg/mL Oral Solution
Intervention type(s): Drug
Intervention description(s): Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine
      fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .
    


Intervention name(s): quetiapine fumarate extended-release; quetiapine fumarate extended-release
Intervention type(s): Drug; Drug
Intervention description(s): 200mg,oral,single dose; 300mg,oral,single dose
Other intervention name(s): SEROQUEL XR; SEROQUEL XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study; pharmacokinetics parameters
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of
      different baclofen formulations.
    


Intervention name(s): Baclofen IR; Baclofen ER
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg; single dose; 30 mg; single dose
Intervention MeSH terms: Baclofen
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALK29; Alcohol Dependence; Pharmacokinetics
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in
      reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate
      response to current antidepressant therapy.
    


Intervention name(s): MSI-195; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Depressive Disorder
The Glycaemic Index of Manuka Honey
Condition: Healthy
Study type: Interventional

Summary: 
      Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different
      geographical locales around the North Island of New Zealand and tested for glycaemic index
      (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed
      honey containing 25g of available carbohydrate in 200 ml water and the blood glucose
      responses measured (area under the curve; AUC) and compared to that of 25 g of available
      carbohydrate from glucose.
    


Intervention name(s): Manuka Honey
Intervention type(s): Dietary Supplement
Intervention description(s): honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water
Other intervention name(s): Manuka Health New Zealand Manuka honey
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: manuka honey; glycaemic index; blood glucose control; individuals; current disease; medication use
Effect of Dilatation and Curettage on the Endometrial Receptivity
Condition: Embryo Implantation
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in
      patients with recurrent implantation failure
    


Intervention name(s): D&C; ICSI
Intervention type(s): Procedure; Procedure
Intervention description(s): Dilatation and curettage; Intra Cytoplasmic Sperm Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Digital Therapy in Shoulder Rehabilitation.
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Digital therapy may provides real time visual feedbacks. Instrumented devices objectively
      quantify the patient's performance during rehabilitation and thus could be helpful for the
      personalization of the exercises.

      The interactive ball of this trial allows measuring both movement and pressure applied on it.
      Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel
      digital therapy gaming system was therapeutically relevant during shoulder rehabilitation;
      (ii) to understand whether the device was effective in improving patients' engagement in
      comparison to a control non-gaming rehabilitation program.
    


Intervention name(s): PG; CTRL
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Shoulder Digital therapy; Shoulder non-digital therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Atopic Dermatitis by a Full-Body Blue Light Device
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      Multicentric, placebo-controlled, double-blinded, three-armed, prospective, randomized
      controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1
      (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm
      wavelength), and arm 3 (irradiation for 30min at low-dose (placebo)). Irradiation will be
      scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the
      last irradiation.
    


Intervention name(s): Full Body Blue Light Device
Intervention type(s): Device
Intervention description(s): Full body blue light irradiation (phototherapy) of atopic dermatitis patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee Injury
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      In terms of the surgical treatment of the cartilage injury, various techniques and ways are
      created to repair or regenerate articular surface of synovial joint following traumatic
      damage or degeneration of the cartilage. The option for surgical treatments based on the size
      and depth of the cartilage knee injury may include knee debridement, radiofrequency,
      drilling, microfracture, mosaicplasty, allogenic osteochondral transplantation and autologous
      chondrocyte transplantation. The first two techniques mentioned have been used in treating
      the cartilage knee injury involving the partial defects meanwhile the latter techniques have
      been used for Grade III and IV cartilage defects based on ICRS. However, most of the surgical
      options up only provide more of Type I collagen rather than Type II collagen. The available
      treatments are more symptomatic rather than preventive or regenerative. Stem cell has big
      potential in this area where it has ability to differentiate to cartilage. As allogeneic
      umbilical cord blood MSCs are readily available and can be administered immediately, this
      study therefore aims to prove the efficacy of allogeneic umbilical cord-derived mesenchymal
      stem cells (UC-MSCs) for treating large defects knee injury.

      The study is a prospective, randomized controlled, open label, phase IIb clinical trial,
      involving 50 patients with large defects of cartilage injury for follow-up duration of 24
      months. Patients will be assigned into 2 arms; Arm A - 25 subjects will receive
      Chondrocell-EX (UC-MSCs) and Arm B - 25 subject will receive marrow cellution. All patients
      will undergo debridement prior to receiving their assigned treatment. The patients will be
      assessed on KOOS, IKDC, VAS and MRI.
    


Intervention name(s): Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs); Marrow cellution
Intervention type(s): Biological; Procedure
Intervention description(s): Human umbilical cord-derived mesenchymal stem cells; Patients will undergo marrow cellution surgical procedure.
Other intervention name(s): Chondrocell-EX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Roniciclib Mass Balance Study
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the
      body in a so called mass-balance study. This means to investigate how the study drug is
      absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from
      the body.
    


Intervention name(s): roniciclib (BAY 1000394); roniciclib (BAY 1000394)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution; 5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment