bioihbjkbjnl/mcl2 huggingface dataset:
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify one or more doses of BMS-650032 that, when used in
      combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient
      activity against hepatitis C virus (Genotypes 1 and 4).
    


Intervention name(s): BMS-650032; BMS-650032; Placebo; Placebo; Placebo; Peginterferon Alfa-2a; Peginterferon Alfa-2a; Ribavirin; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 200 mg, Twice Daily, 48 weeks; Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response; Tablets, Oral, 0 mg, twice daily, 48 weeks; Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12; Tablets, Oral, 0 mg, twice daily 24 weeks; Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks; Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response; Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks; Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other intervention name(s): Pegasys; Pegasys; Pegasys; Copegus; Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha; Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers
Condition: Denture Retention
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the ability of a marketed denture adhesive to
      restrict food ingress underneath dentures during eating.
    

Detailed description: 
      This is a single center, controlled, single-blind, randomized, two-treatment, two-period,
      cross-over design in participants with full upper and lower dentures. The study hypothesis is
      that this methodology will enable comparisons between denture adhesives and no adhesive to
      demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures
      during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 -
      Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a
      marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by
      weight) to the dentures in a pattern of continuous strips which will be applied to upper and
      lower denture and will be then placed in mouth and participants will also use no adhesive as
      a control. Participants will cross-over between treatments so that all participants will
      participate in all 2 treatment arms. An hour after the participant has worn their denture,
      they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with
      water, the dentures will be removed, and any peanuts that have been migrated under each
      denture will be collected and weighed after a drying process. Participants will also answer a
      short questionnaire on the procedure and record the number of times their denture dislodged
      during the chewing procedure. The number of denture dislodgments reported by the participants
      during the chewing of the peanuts will also be collected and analyzed and this, and the
      questionnaire data, will be used to support the findings of the peanuts mass measure.
    

Intervention name(s): Marketed Denture Adhesive (Super Poligrip Max Seal); No Adhesive
Intervention type(s): Combination Product; Other
Intervention description(s): The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.; No adhesive will be applied.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
Condition: Bipolar Affective Disorders; Cyclothymic Disorder; Schizoaffective Disorder; Major Depressive Disorder; Dysthymic Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Premenstrual Dysphoric Disorder; Social Anxiety Disorder
MeSH terms: Premenstrual Dysphoric Disorder; Depressive Disorder; Depressive Disorder, Major; Anxiety Disorders; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Psychotic Disorders; Panic Disorder; Phobia, Social; Mood Disorders; Bipolar Disorder; Dysthymic Disorder; Cyclothymic Disorder
Study type: Observational

Summary: 
      The aim of this study is to determine whether blood levels of lithium or sertraline are
      affected by different phases of the menstrual cycle and whether there is an effect on
      psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and
      one visit during the follicular phase of the menstrual cycle. On each visit, they will fill
      out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will
      be drawn to measure progesterone level and either a lithium or sertraline level, depending on
      which medication the patient takes. The primary hypothesis in this study is that blood levels
      of lithium and sertraline will be significantly lower in women during the luteal phase of the
      menstrual cycle than during the follicular phase. Examination will also be made of whether
      symptoms will increase in severity during the luteal phase as compared to the follicular
      phase. The investigators expect a negative linear association between symptom severity and
      blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline
      decrease.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The specific psychiatric diagnoses anticipated in the subject pool include the conditions
        that lithium and sertraline are indicated to treat, including Bipolar Affective Disorders,
        Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic
        Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder,
        Premenstrual Dysphoric Disorder, and Social Anxiety Disorder.
      
Biospecimen description: 
      Whole blood will be drawn.
    
Keywords: Lithium; Sertraline
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Condition: Newborn Morbidity; Newborn Complication
MeSH terms: Critical Illness
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure
      temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in
      newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at
      two rural health facilities in Western Kenya and assess the preliminary efficacy of the
      technology in improving health outcomes for newborns.

      This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled
      between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled
      between 1 - 31 Dec, 2020.
    


Intervention name(s): neoGuard vital signs monitor
Intervention type(s): Device
Intervention description(s): The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a simple pre/post interventional study model.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Newborn health; Newborn morbidity; Newborn critical care
Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine which dose of voclosporin is effective in the
      treatment of plaque psoriasis compared to placebo.
    

Detailed description: 
      Psoriasis is a chronic skin condition that can have a significant impact on patient's
      physical and mental well being. The most common form of psoriasis is plaque psoriasis.
      Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin
      inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin
      represents the possibility of a calcineurin inhibitor which is not only as efficacious as
      cyclosporine A, but also has an improved toxicity profile.

      Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to
      placebo.
    

Intervention name(s): voclosporin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): voclosporin 0.2, 0.3, or 0.4 mg/kg po BID; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trials; Immunosuppression; Adult; Chronic Disease; Dermatologic Agents; Female; Humans; Male; Middle Aged; Severity of Illness Index; Treatment Outcome; Quality of Life; Double-Blind Method
Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
Condition: Torque; Pain Perception
Study type: Interventional

Summary: 
      This study aims to examine the variation in muscle torque and discomfort produced when
      electrically stimulating quadriceps femoris using pulsed current with three different phase
      durations in order to establish whether there are any advantages or disadvantages in varying
      the phase duration over the range examined.
    


Intervention name(s): 400 microseconds; 700 microseconds; 1000 microseconds
Intervention type(s): Device; Device; Device
Intervention description(s): Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds; Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds; Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: electrical stimulation; torque
Inspiratory Muscle Training in Individuals With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them,
      the lungs tend to be the most affected due to the accumulation of mucus in the airways, which
      in addition to avoiding the passage of air, favors pulmonary infections. With the evolution
      of the condition, secondary complications arise, such as postural changes, decreased
      respiratory muscle strength, decreased functional capacity and, consequently, quality of
      life. Therefore, respiratory muscle training may be an intervention that improves the
      respiratory condition of these individuals, allowing an improvement in the quality of life
      and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a
      home protocol of respiratory muscle training on respiratory muscle strength, lung function,
      quality of life, posture and functional capacity in adolescents and adults with cystic
      fibrosis. The researchers believe that the training can cause an improvement in the studied
      variables, and can be inserted in the usual treatment of these patients.
    


Intervention name(s): Inspiratory muscle training
Intervention type(s): Device
Intervention description(s): This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cystic fibrosis; quality of life; posture
Mother-to-child Hepatitis D Transmission
Condition: Hepatitis D; Transmission
MeSH terms: Hepatitis A; Hepatitis D; Hepatitis
Study type: Observational

Summary: 
      HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV
      DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication.
      Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about
      vertical HDV transmission are old, justifying a new study.
    

Detailed description: 
      Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing
      according to maternal HBV DNA viral load during the last trimester of pregnancy. Nucleosides
      analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV
      mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant
      women with HBV DNA above 1,000 000 I.U/mL. HDV is a defective virus using HBs Ag for its own
      replication. HDV-HBV co-infection is a re-emerging infectious disease in western countries,
      due to immigration of people coming from endemic areas. Nucleosides analogues have only a
      minor impact on quantitative HBs Ag level (Boyd A et al. AIDS Research and Human Retroviruses
      2013). Data about vertical HDV transmission are old (Rizzetto, et al. J Med Virol 1982),
      before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women,
      justifying a new study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All children born in the Maternity Department, Lariboisiere Hospital, from HBV-HDV
        co-infected women
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
Condition: Colitis, Ulcerative; Surgery
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      For patients with ulcerative colitis, eligible for surgical treatment, which restorative
      surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo
      rectal anastomosis is the best in terms of complications, functional outcome and health
      status and quality of life.
    

Detailed description: 
      This research is designed to answer questions from the medical profession and patients´
      community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique
      needs further development on a broader scale or not.

      The research project will be conducted in the two institutes where INRA procedures have been
      carried out and in the UMCN to recruit matched control IPAA patients. There is a large
      experience with the IPAA procedure in this latter institute. The University of Tilburg will
      participate to work on health status and quality of life aspects. They have a large
      experience with quality of life research in general and have participated in QOL research in
      this topic before.

      The aim of this historical cohort study is to establish the value of INRA, compared to IPAA,
      for patients with ulcerative colitis.
    

Intervention name(s): Ileal Neo Rectal Anastomosis; Ileal Pouch Anal Anastomosis
Intervention type(s): Procedure; Procedure
Intervention description(s): Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis; Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colitis, Ulcerative; Ileo Neo Rectal Anastomosis; Ileal Pouch Anal Anastomosis; Quality of Life; functional results; reconstructive surgery; surgery
Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and
      helping weight loss in obese school age children
    

Detailed description: 
      Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese
      children
    

Intervention name(s): Iron Supplement
Intervention type(s): Drug
Intervention description(s): in iron deficiency anemia
Other intervention name(s): lactoferrin
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Performance of Toric Silicone Hydrogel Contact Lenses
Condition: Astigmatism; Myopia
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the clinical performance and subjective lens
      handling (insertion and removal) of two toric silicone hydrogel contact lenses after one
      month of daily wear each.
    

Detailed description: 
      This was a prospective, randomized, double masked, bilateral, crossover study. Participants
      were expected to attend 6 scheduled visits over a period of approximately 2 months.
    

Intervention name(s): Lens A (fanfilcon A); Lens B (asmofilcon A)
Intervention type(s): Device; Device
Intervention description(s): Daily wear for one month; Daily wear for one month
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
Condition: Carotid Plaque Hemorrhage Appearance
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      To compare two competing newly designed 3D sequences for black blood carotid plaque imaging
      techniques with the industry standard 2D sequnce for black blood.
    

Detailed description: 
      To utilize a 3D sequence instead of the usual 2D commonly standard industry sequence that is
      supplied by the various manufacturers.

      Patients with greater than 50% stenosis that are 3T compatible are imaged using the two
      sequences to compare which sequences better visualize the plaque and it's characteristics

      The purpose is to validate the ability of the new 3D sequence to detect and measure any
      plaque hemorrhage as well as to identify region sof Type 1 hemorrhage.
    

Intervention name(s): there is no intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3
        tesla MRI imaging.
N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare and determine the efficacy of combined N-acetyl
      cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with
      Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
    

Detailed description: 
      In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for
      5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g
      orally in three divided doses, 3 sachets per dose). All patients in other group received
      metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for
      5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this
      period, patients in either group received 100 mg CC (Clomid®; Global Napi
      Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced
      menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle.
      Patients continued treatment for three successive cycles using the same protocol. NAC and
      metformin were stopped only when pregnancy was documented.
    

Intervention name(s): combined N-acetyl cysteine -CC; combined metformin-CC
Intervention type(s): Drug; Drug
Intervention description(s): N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles; Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles
Intervention MeSH terms: Metformin; Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; clomiphene resistance; metformin; N-acetyl cysteine