bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine
      add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee
      which will be done in contrast to combined glucosamine sulfate and chondroitin.
    

Detailed description: 
      Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with
      some controversy about efficacy. it seems that addition of other agents may improve efficacy
      and decrease the required dose and cost. common oral corticosteroids such as low dose
      prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on
      therapy may expose the patients to new side effects which should followed and addressed.

      In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of
      knee will be enrolled to the study. the patients will randomly be assigned to one of four
      groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate
      plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC
      (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will
      consist 60 patients. the investigator(s) will be blind to the groups and interventions.
    

Intervention name(s): Glucosamine and chondroitin sulfate; glucosamine and chondroitin sulfate plus Prednisolone; Glucosamine and Chondroitin sulfate plus Chloroquine; Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.; In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day; In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.; In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis of the Knee; Glucosamine Chondroitin sulfate; Prednisolone; Chloroquine
Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy
Condition: Breast Cancer; Fertility
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of
      loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.
    

Detailed description: 
      To characterize the attitude of pre menopausal patients with breast cancer regarding the
      risks of infertility based on the following variables:

        -  Age at diagnosis

        -  Number of children

        -  Will of having children

        -  Marital status

        -  Scholarity

        -  Period of time from the diagnosis

        -  Time of the last menstruation period

        -  Chemotherapy administration

        -  Clinical staging at the diagnosis

        -  Pathological evaluation

        -  Documentation of the cancer therapy
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pre menopausal women diagnosed with breast cancer prior treatment
      
Keywords: Breast cancer; Fertility
Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.
Condition: Facial Wrinkles
MeSH terms: Facies
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a study to find out how an investigational product, Belotero, compares to a second
      product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are
      wrinkles on the face that go from the outside of the nostrils to the edges of the mouth.
      Additionally, this study determined Belotero is safe and tolerable and corrects facial
      wrinkles, such as nasolabial folds.
    


Intervention name(s): Belotero; Zyplast
Intervention type(s): Device; Device
Intervention description(s): Belotero, injectable hyaluronic acid gel device, implanted into the nasolabial fold in the Treatment Phase of the study (multiple injections of 0.1 to 0.2 mL, up to a maximum of 3 mL over 2 treatment sessions). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered.; Zyplast Collagen Implant, an injectable dermal collagen device, implanted into the nasolabial fold in the Treatment Phase of the study (average injection of 1.0 mL). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered. Zyplast was obtained by each site from commercially available supplies.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial wrinkles; Nasolabial fold
Inverse Ratio Ventilation on Bariatric Operation
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      for evaluating inverse ratio ventilation of laparoscopic bariatric surgery
    

Detailed description: 
      inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during
      care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio
      could improve the oxygenation and respiratory mechanics on the obese patient also.
    

Intervention name(s): inverse ratio ventilation
Intervention type(s): Other
Intervention description(s): change the I: E ratio 1:2-1:1-2:1
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing
      healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI
      Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12
      mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a
      single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and
      urine pharmacokinetics in spontaneously breathing healthy volunteers.
    

Detailed description: 
      This is a Phase 1 open-label study of three doses of amikacin/fosfomycin. Approximately 30
      healthy volunteers will be dosed in five cohorts of six subjects each. The first (sentinel)
      subject in each of the first three cohorts will be dosed alone. If no significant safety or
      tolerability events occur, the remaining five subjects in each of the first three cohorts
      will be dosed. The first cohort (n=6) will be administered the 30/12 mg dose of
      amikacin/fosfomycin. The second cohort (n=6) will be administered the 60/24 mg dose of
      amikacin/fosfomycin. The third cohort (n=6) will be administered the 90/36 mg dose of
      amikacin/fosfomycin. All doses in cohorts 1, 2, and 3 will be delivered with the PARI
      Investigational eFlow Nebulizer System. The fourth cohort (n=6) will be administered the
      90/36 mg dose of amikacin/fosfomycin using the PARI LC Sprint Nebulizer. The fifth cohort
      (n=6) will test the lowest dose level at which all subjects achieved > 0.3 µg/mL amikacin
      peak serum concentration. The nebulizer used to deliver doses in cohort 5 will be determined
      after amikacin concentrations from cohorts 1 through 4 are reviewed.
    

Intervention name(s): amikacin/fosfomycin
Intervention type(s): Drug
Intervention description(s): single aerosolized dose
Intervention MeSH terms: Amikacin; Fosfomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of SpO2 Measurement Using a Smartwatch
Condition: Hypoxia; Hypercapnia
MeSH terms: Hypoxia; Hypercapnia
Study type: Interventional

Summary: 
      The aim of the study is to compare the measurement of peripheral blood oxygen saturation
      using a smartwatch with a medical-grade pulse oximeter.
    

Detailed description: 
      Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring
      biological signals and they are used for home monitoring of health conditions. The newest
      models of smartwatches even measure peripheral blood oxygen saturation (SpO2). The study aims
      to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch
      with a medical-grade pulse oximeter under the condition of normobaric hypoxia. Healthy
      participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% O2 and 88%
      N2 and the hypercapnic and hypoxic gas mixture of 12% O2, 5% CO2, and 83% N2), which will
      temporarily reduce their blood oxygen saturation. SpO2 measurements will be taken by hand
      from the watch and the pulse oximeter simultaneously. The agreement of the measurements of
      both devices will be evaluated.
    

Intervention name(s): Hypoxic gas mixture; Hypercapnic and hypoxic gas mixture; SpO2 measurement
Intervention type(s): Other; Other; Other
Intervention description(s): Gas mixture of 12% O2 and 88% N2 for five minutes.; Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.; Two SpO2 measuring devices are active simultaneously during measurement.
Intervention MeSH terms: Nitrox
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants go through all study arms, in random order. Two measuring devices are active simultaneously during measurement on each participant and their functioning is compared.
Masking: Single (Participant)
Primary purpose: Other
Keywords: SpO2; pulse oximetry; smartwatch
A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple
      ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses
      (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a
      high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
    


Intervention name(s): CAT 2003; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Low Level Laser Therapy and Interferential Current in Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of the low level laser therapy and
      interferential current in 168 patients with knee osteoarthritis
    

Detailed description: 
      Interventional
    

Intervention name(s): Active Interferential Current; Active Laser; Placebo Interferential Current; Placebo Laser
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Involves the application of medium frequency alternating currents; Involves the application of low level laser over the knee; It is a sham interferential therapy; It is a sham laser therapy
Other intervention name(s): interferential therapy; IFC; low level laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Open Label Pharmacokinetic-Pharmacogenetic Study on Polymorphisms in the Organic Cation Transporter OCT1
Condition: Drug Metabolism; Membrane Transport
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of the organic cation transporter OCT1
      polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and
      adverse effects.
    


Intervention name(s): Drug application Amitriptyline; Drug application Desvenlafaxine; Drug application Sumatriptan; Drug application Proguanil; Drug application Fenoterol; Drug application Thiamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Amitriptyline: 25 mg, single oral application; Desvenlafaxine: 50 mg, single oral application; Sumatriptan: 50 mg, single oral application; Proguanil: 200mg, single oral application; Fenoterol: 180 mcg, single intravenous application; Thiamine: 200mg, single oral application
Intervention MeSH terms: Thiamine; Proguanil; Sumatriptan; Amitriptyline; Desvenlafaxine Succinate; Fenoterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Many youth with chronic disease have difficulty taking medication every day and therefore do
      not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood
      disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is
      the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of
      life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the
      investigators' recent feasibility study of the same title. Overall goals are reducing
      barriers to HU use and improving adherence for youth 10-18 years through creation of a daily
      medication habit. The goal of the proposed multi-site study is to test the efficacy of the
      HABIT intervention at 6 months and sustainability of the effect at 12 months.
    

Detailed description: 
      Barriers to medication adherence are common in youth with chronic illness and are a source of
      racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell
      Disease (SCD) is characterized by chronic and acute illness and reduced quality of life
      (QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is
      the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor
      adherence is common among youth and young adults with SCD.

      The importance of poor medication adherence, use of community-based health workers (CHWs) to
      bridge the gap between health services and underserved parent-youth dyads affected by SCD,
      the strength of the science, the success of the investigators' multi-ethnic feasibility
      study, and the potential application of study findings to youth with other serious chronic
      illnesses speak to the importance of this trial.
    

Intervention name(s): HABIT Intervention
Intervention type(s): Behavioral
Intervention description(s): In addition to standard care and education handouts, dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Hydroxyurea; Community health worker (CHW); Text messages; Medication adherence
Validation of a Portable Sleep Device in Patients With Co-existing Medical Illnesses
Condition: OSA
Study type: Interventional

Summary: 
      The standard sleep study for diagnosing obstructive sleep apnea (OSA) in patients with
      co-existing illness is by conducting an attended polysomnography (PSG) with more than 7
      channels for recording physiological parameters in the sleep center, as recommended by
      international guidelines. However the guidelines are more than 10 year old without update.
      With the growing and aging of the population, there is a need to explore if portable
      monitoring devices could be used in this group of population, so this group of patients can
      be managed in a timely manner. Portable monitoring devices have been used widely in patients
      without significant co-existing illness. These devices record at least 4 physiological
      parameters for diagnosing OSA and can be performed in an unattended setting e.g. at home
      because of the simplicity. This can shorten the waiting time for making a diagnosis using
      PSG.

      Eighty patients suspected of OSA, with stable co-existing illnesses, will be recruited for
      the study. Informed consent will be signed before participation. They will be offered a
      standard attended PSG in the sleep center. A portable monitoring device "Nox T3" will be
      hooked up to the patients concurrently during the PSG.
    


Intervention name(s): NOX T3
Intervention type(s): Device
Intervention description(s): portable sleep study device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Periodontal Disease and Post-menopausal Osteoporosis
Condition: Osteoporosis; Osteopenia; Periodontal Disease
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Periodontal Diseases
Study type: Observational

Summary: 
      The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their
      relationship in gingival crevicular fluid of post-menopausal women with
      osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that
      the use of bisphosphonates in periodontal disease.

      Study hypothesis:

      "The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease
      affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis
      processes "
    

Detailed description: 
      81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic
      periodontitis were studied. Samples of gingival crevicular fluid were collected by paper
      strips and ELISA test was conducted to determine the total concentration of RANKL, OPG, and
      then obtain the values of the RANKL / OPG ratio. We analyzed 66 samples of gingival
      crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia /
      osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites
      obtained of 14 controls patients with normal osseous condition.

      Statistical analyzes were computed and analyzed using Graphpad Software. To determine if the
      data correspond to a normal distribution the D'Agostino-Pearson test was used. The values of
      cytokines (RANKL and OPG) and its ratio (RANKL / OPG) were compared using Mann-Whitney Test t
      U. Analysis Spearman correlation and linear regression for statistic was also performed to
      determine whether there was any relationship between the variables analyzed. It was
      considered as statistically significant p value ≤ 0.05.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with osteopenia / osteoporosis and controls with normal osseous condition. Both
        groups with chronic periodontitis
Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of
      the brain called the substantia nigra. In the early stages of the disease, the disease
      responds to agents that replace dopamine such as levodopa. Patients with more advanced
      disease have wide fluctuations in their response to levodopa, exhibiting on and off periods.
      This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell
      line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that promotes
      survival of dopaminergic neurons. This is a protein produced by recombinant technology that
      is almost identical to the naturally produced factor. Results of animal studies indicate that
      GDNF has the potential to benefit patients with advanced Parkinson's disease.

      The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of
      advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter
      implanted into the putamen, the area of the brain associated with Parkinson's disease, and an
      infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be placed
      into the pump and delivered through the catheter to the brain. The purposes of this study are
      to determine the potential benefits and side effects of GDNF. The performance and safety of
      the catheter/infusion pump system will also be assessed. The study will last for 6 months.
      Subjects will undergo neurological testing, computerized gait assessment and neurological
      imaging.
    


Intervention name(s): recombinant-methionyl human glial cell line-derived neurotrophic factor
Intervention type(s): Drug
Primary purpose: Treatment
Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV
      combination vaccine compared with those of separate DTaP and IPV vaccines administered to
      healthy infants at 2, 4, and 6 months of age.
    

Detailed description: 
      A multinational, multicenter, randomized, comparative, open-label, phase 3 study

      Primary Objective: To assess the vaccine response rates after the three-dose primary
      vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary
      vaccination and to assess the safety of the investigational products
    

Intervention name(s): DTaP-IPV combination vaccine; DTaP vaccine and IPV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5-mL IM; 0.5-mL IM
Other intervention name(s): Boryung DTaP Vaccine Inj. (Prefilled syringe); IPVAX INJ. PREFILLED SYRINGE INJ
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention