bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),
      safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,
      odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected
      subjects without cirrhosis.
    

Detailed description: 
      This is a Phase 2b multicenter study. The study will include a screening period of maximum 6
      weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The
      total study duration for each subject will be 36 to 38 weeks. This study investigates a 3
      direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir
      (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease
      inhibitor). The results of this study will enable the selection of treatment and duration to
      be further developed.
    

Intervention name(s): AL-335; Odalasvir; Simeprevir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AL-335 800 mg (2*400) tablet will be administered once daily.; Odalasvir 25 mg tablet will be administered once daily.; Simeprevir 75 mg capsule will be administered once daily.
Intervention MeSH terms: Simeprevir; Odalasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; AL-335; Odalasvir; Simeprevir; ODV; SMV; ACH-3102; ACH-0143102; TMC435
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
Condition: Liver Transplantation; Liver Diseases; Biliary Atresia; Morbidity;Infant; Mortality
MeSH terms: Liver Diseases; Biliary Atresia
Study type: Interventional

Summary: 
      The Department of Organ Transplantation in Memorial Hospitals has started Pediatric Liver
      Transplantation Program in 2016. As of the end of 2020, we have performed 169 pediatric liver
      transplantation. The aim of this study is to investigate the overall mortality, morbidity and
      risk factors for adverse outcomes in pediatric liver transplantation. The patients' records
      will be retrospectively scanned and the data will be gathered.
    


Intervention name(s): Liver Transplantation
Intervention type(s): Procedure
Intervention description(s): Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      This study will determine the immune response to malaria infection in healthy volunteers
      compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can
      cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very
      serious in children. Developing an effective vaccine against the parasite that causes malaria
      is a crucial step toward controlling the disease; however, vaccines tested so far have
      provided very short-lived protection. A better understanding of the natural immunity to
      malaria may provide insight that can be applied to developing a more effective vaccine.

      People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali,
      and are in good health may be eligible for this study.

      Participants undergo a complete physical examination at the start of the study and then once
      a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year
      to collect blood samples for research. The visits last about one hour, including a 30-minute
      observation time after the blood draw.
    

Detailed description: 
      Malaria results in at least 2.7 million deaths per year, the majority among African children.
      The development of a vaccine

      against Plasmodium falciparum is regarded as a crucial step toward control of this disease.
      Unfortunately, vaccine

      candidates have resulted in short-lived protection at best. The ineffectiveness of current
      vaccines may reflect the kinetics

      of naturally acquired immunity to malaria in that multiple infections are required over years
      before partial protection is

      achieved and then immunity is lost, or becomes less effective, in the absence of recurrent
      infection. The mechanisms

      underlying the delayed acquisition and presumably rapid loss of humoral immunity are poorly
      understood. A more

      detailed understanding of these processes at the cellular level may be important for vaccine
      development. We are

      currently studying the cellular basis of humoral immunity to P. falciparum through research
      collaboration between the

      Malaria Research and Training Center (MRTC) in Bamako, Mali and the National Institutes of
      Health (NIH) in the United

      States. This protocol supports that research by ensuring a supply of blood samples from
      healthy Malian adults in order to

      establish normal immunologic parameters for this population and to optimize research assays
      performed at the MRTC.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults in a malaria endemic area in Mali
      
Keywords: Immunology; Mali; Donor; Natural History
Effectiveness of Deep Transcranial Magnetic Stimulation in Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain
      stimulation technique, is effective for treating major depression. We hypothesize that 4
      weeks of DTMS will be associated with significant improvements in depressive and anxious
      symptoms without significant side effects.
    

Detailed description: 
      The aim of this pilot study is to assess, naturalistically, the effectiveness of deep
      transcranial magnetic stimulation (DTMS) in a sample of subjects with treatment-resistant
      depression. To do this, enrolled depressed outpatients will be assigned to receive 4 weeks of
      daily DTMS and will be evaluated at baseline and during week 5. We hypothesize that treatment
      with DTMS will be associated with significant clinical improvements in depressive and anxious
      symptoms, and will be well tolerated.
    

Intervention name(s): Deep Transcranial Magnetic Stimulation (DTMS)
Intervention type(s): Device
Intervention description(s): DTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depression; Deep Transcranial Magnetic Stimulation; Naturalistic Trial; DTMS
Evaluation of a Food Supplement on Sleep Quality
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
    


Intervention name(s): cyclamax
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sleep quality; food supplement; randomized controlled trial; actigraphy; Leeds; Volunteers presenting moderate primary insomnia
Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
Condition: Obesity; Body Weight; Weight Loss; Overweight
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is an ongoing major public health problem in most countries of the world for which
      the agrifood industry still remains criticized because of the abundant offer of high
      sugar-lipid-energy dense foods, particularly in the fast-food sector. The resulting societal
      pressure on the food industry probably explains in part the efforts that have been deployed
      to seek natural active ingredients and to develop functional foods favorably influencing
      energy balance. Capsaicin is a food non-nutrient constituent that was shown to decrease
      appetite sensations and subsequent energy intake. The measurement of heart rate variability
      revealed an association between the increase in sympathetic nervous system (SNS) activity and
      the satiating effects induced by capsaicin. This is concordant with the observation that
      pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased
      satiety and reduced energy intake.

      The objective of this study is to evaluate the long effects of Capsimax on appetite
      sensations and energy expenditure under conditions of moderate energy restriction and to
      evaluate the long-term effects of Capsimax on energy intake and expenditure under conditions
      of moderate energy restriction.
    


Intervention name(s): Capsimax; Energy restriction
Intervention type(s): Drug; Other
Intervention description(s): Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg; Personalised diet plan targeting a 500 kcal/day energy restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the relative bronchoprotection (at trough)
      conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to
      moderate asthmatics. Patients will be preselected into two groups on the basis of their
      beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a
      differential effect on the bronchoprotection conferred by both formulations of salbutamol, as
      evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any
      effect can be explained by the S enantiomer in the racemic formulation.
    


Intervention name(s): levosalbutamol; racemic salbutamol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be asked to take two puffs four times a day for 2 weeks; Patients will be asked to take two puffs four times a day for 2 weeks; Patients will be asked to take two puffs four times a day for 2 weeks
Other intervention name(s): Ventolin
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Genotype; Beta2adrenoreceptor; Levosalbutamol
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
Condition: Rhinitis, Allergic; Asthma, Allergic
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Observational

Summary: 
      The purpose of this study is to verify and validate the intrinsic diagnostic value in terms
      of sensitivity and specificity of proteomic profiles determined during a pre-study for
      discriminating between allergy related asthma and allergy related rhinitis.
    


Intervention name(s): Classification as "asthmatic" or "rhinitis only" via proteomic analysis; Classification as "asthmatic" or "rhinitis only" according to a metacholine test
Intervention type(s): Biological; Biological
Intervention description(s): Proteomic profiles are established for each patient using plasma and serum samples; A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The asthma and allergic rhinitis patients included in this study are recruted from the
        Pneumology Departments of the University Hospitals of Nîmes, Marseilles, and Montpellier.
      
Biospecimen description: 
      Serum and plasma samples are taken on patient inclusion. For the purposes of this study, only
      proteomic profiles via SELDI-TOF will be characterized. Excess serum and plasma will be
      stored in the CHU de Nîmes Biothèque.
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for
      injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection
      of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition
    

Detailed description: 
      Multi-Center, Open-Label, Randomized, Two treatment, Parallel, Single period, Multiple-Dose,
      Steady state, Global Bioequivalence study of Amphotericin B Liposome for Injection 50mg /vial
      of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) Liposome for Injection 50mg/vial
      of Astellas Pharma US, inc. in patients with Visceral Leishmaniasis under fed
      condition.Sufficient number of patients will be enrolled to have 140 evaluable patients. (90
      to 100 patients from India and 40 to 50 patients from Bangladesh).
    

Intervention name(s): Amphotericin B Liposome; AmBisome (Amphotericin B) Liposome
Intervention type(s): Drug; Drug
Intervention description(s): Manufactured for: Auromedics Pharma LLC, USA; Marketed by: Astellas Pharma US, Inc. USA
Other intervention name(s): AmBisome
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the
      therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a
      chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT
      is effective in treating HS.
    

Detailed description: 
      This study will investigate the efficacy of PDT using aminolevulinic acid (ALA) and either
      blue light or intense pulsed light on active lesions of HS. We will attempt to validate the
      success noted in a previously published case series using PDT with ALA and blue light (Gold,
      Bridges et al). We will evaluate effect of treatment by number of lesions, global disease
      severity, and patient self-assessment with the Dermatology Life Quality Index (DLQI).

      Detailed informed consent will be obtained prior to treatment at study enrollment. The first
      four treatment visits will involve clinical evaluation, photography and application of the
      ALA to the affected area. After a 45 minute incubation period, the area will be washed and
      then treated with either blue light or intense pulsed light (IPL), depending on body
      area/investigator choice. One and three-month follow-up visits will involve evaluation of
      efficacy, but no active treatment.

      Gold M, Bridges TM, et al. ALA-PDT and blue light therapy for hidradenitis suppurative. J
      Drugs Dermatol. 2004; 3 (1 Suppl):S32-5.
    

Intervention name(s): Photodynamic Therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Success Rates of Femoral Artery Catheterization
Condition: Pulmonary Disease; Electrolyte Disorder; Metabolic Disease; Sepsis
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The use of USI has eased practical application of interventional procedures, and reduced
      complications and procedure durations. For vascular interventions with ultrasound imaging,
      short- or long-section imaging of vascular structures is performed. Both techniques have
      their own advantages and disadvantages.

      This study aims to compare the success rates of femoral artery catheterization using both
      imaging techniques.
    

Detailed description: 
      The research will include newborns undergoing open heart surgery and patients requiring
      arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral
      artery cannulation will be randomized with the closed envelope method and separated into two
      groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique
      (Group B). The intervention will be performed by a single experienced individual. The
      preparation duration, puncture duration, number of punctures, number of unsuccessful arterial
      punctures, development of hematoma and other complications will be recorded and the groups
      will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1.
      Patients undergoing KVC surgery and patients requiring arterial catheterization in the
      neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic
      disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS

        1. Local infection

        2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)

      1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament,
      femoral artery diameter, femoral artery and vein location properties 2. Preparation duration,
      number of punctures, complications developing during the procedure
    

Intervention name(s): Femoral artery catheterization
Intervention type(s): Procedure
Intervention description(s): The intervention will be performed by a single experienced individual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: newborns,femoral artery, catheterization
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
Condition: Submental Fat
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be
      randomized into one of 5 treatment groups comprised of RZL-012 with or without additional
      study treatments:
    

Detailed description: 
      In the first stage of the study, 5 subjects will be randomized into each of the treatment
      groups. Study outcomes will be assessed up to one week thereafter to determine the need to
      modify additional study treatments. Subsequently up to 10 additional subjects will be
      randomized into each of the treatment groups for the second stage of the study.

      For each subject, the study will consist of a screening period, baseline period in which
      subjects will receive a single treatment session of RZL-012 and a follow-up period. RZL-012
      will be administered during a single treatment session via multiple injections into the
      submental area under the chin. Subjects will thereafter be monitored for safety and efficacy
      for at least 84 days.

      Each subject will be treated with the same dose of RZL-012 :

      • RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection
      point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012, Each subject
      will receive additional study treatments in accordance with the treatment group to which the
      subject is randomized.
    

Intervention name(s): RZL-012; RZL-012+Lidacaine injection prior treatment; RZL-012+Medrol; RZL-012+Celecoxib+Zyrtec; RZL-012+facial and neck wrap
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50mg/ml drug formulation; 5ml lidocaine will be injected 10 minutes before RZL-012 treatment; oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use; 200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6; Universal Facial Band
Intervention MeSH terms: Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      In recent years, an increased approach has appeared in the use of autologous blood products
      to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as
      a potential solution for infertile women with poor ovarian reserve in reproductive specialty.
    

Detailed description: 
      Quantitative and qualitative functional improvement of ovarian function has been reported in
      several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation,
      stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed
      fertility to women with poor reserve volume, advanced maternal age, or either naturally
      occurring or premature menopause. But, these encouraging results should be supported by
      several new studies.

      This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in
      rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some
      women variables (age, menstrual status, parity, BMI) as predicting factors in success of
      ovarian injection with PRP.
    

Intervention name(s): Autologous PRP preparation
Intervention type(s): Other
Intervention description(s): For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide
Other intervention name(s): Plasma Rich Platelets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Rejuvenation , Infertility