bioihbjkbjnl/mcl2 huggingface dataset:
Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the effects on disease activity, in the
      absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly
      by SC injection for 12 weeks.
    


Intervention name(s): MEDI-522; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0); 4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether there are differences in postprandial
      cardiometabolic metabolic indices following interesterified fats used commercially versus
      application appropriate non- interesterifed alternative fat.
    

Detailed description: 
      Aim: The current study aims to investigate the acute effects of commercially available
      interesterified fat versus versus application appropriate non- interesterifed alternative fat
      on 8 h postprandial cardiometabolic outcomes.

      Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a
      non interesterifed, application appropriate fat.

      Subjects: Participants will include 40 healthy male and female volunteers aged between the
      ages of 35 and 75 years (since during this age metabolic changes start to take place).

      Power calculation: Based on previous studies carried out by our group at King's College
      London, a sample size of 20 participants (males and females separately) will allow a 2.16%
      (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50
      participants will be recruited allowing for a 20% dropout rate.

      Expected value:The study will provide novel information on the acute effects of commercially
      relevant processed fats on postprandial lipaemia.
    

Intervention name(s): Interesterified fat; Non- interesterified fat; Rapeseed oil; Butter
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50 g fat provided as commercially available interesterified fat.; 50 g fat provided as commercially available non-interesterified fat.; 50 g fat provided as commercially available rapeseed oil.; 50g fat provided as commercially available spreadable butter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Interesterified; Postprandial; Lipid
Thalidomide in Treating Patients With Thyroid Cancer
Condition: Head and Neck Cancer
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the
      tumor.

      PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have
      thyroid cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the antitumor activity of thalidomide, in terms of tumor response and duration
           of response, in patients with metastatic follicular, papillary, or medullary thyroid
           carcinoma that is unresponsive to systemic radioiodine.

        -  Compare the differences in antitumor activity of this drug in patients with medullary
           carcinomas vs those with papillary or follicular carcinomas.

        -  Determine the toxic effects and duration of toxic effects of this drug in these
           patients.

      OUTLINE: Patients receive oral thalidomide once daily for 2 weeks and then twice daily.
      Treatment continues for 1 year in the absence of disease progression or unacceptable
      toxicity.

      PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
    

Intervention name(s): thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Primary purpose: Treatment
Keywords: stage IV papillary thyroid cancer; stage IV follicular thyroid cancer; thyroid gland medullary carcinoma; recurrent thyroid cancer; insular thyroid cancer
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
Condition: Hip Injuries
MeSH terms: Hip Injuries
Study type: Observational

Summary: 
      In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total
      Hip Arthroplasties (THA), it was determined that the investigators could simultaneously
      capture in vivo sound and motion of the femoral head within the acetabular cup during
      weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP),
      metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound
      analysis as an impulse excitation technique for testing hip conditions and for measuring
      femoral head sliding in the acetabular component of human hip joints by acoustic means.
      Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for
      subjects implanted using various surgical approaches. It could be hypothesized that subjects
      having various surgical approaches could lead to an increase or reduction of in vivo hip
      separation. Therefore, the objective of this study is to analyze a total of 30 subjects
      implanted with either an anterior (10 patients), anterior-lateral (10 patients), or
      posterior-lateral (10 patients) surgical approach to determine if any of these surgical
      approaches leads to less or more in vivo hip separation. All subjects will be analyzed under
      in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.
    


Intervention name(s): Fluoroscopy surveillance of patients while walking
Intervention type(s): Radiation
Intervention description(s): While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
Other intervention name(s): DePuy Orthopaedics hip implant
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients implanted with a direct-anterior surgical approach will be provided by Dr. William
        Barrett of Valley Orthopedic Associates in Renton, WA.

        Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of
        Steven J. MacDonald of the London Health Sciences Center, London, Ontario.

        Patients implanted with a posterior-lateral approach will be provided by Dr. David F.
        Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
      
Keywords: Surgical approach; Direct-anterior; Anterior-lateral; Posterior-lateral; Hip implant; Total Hip Arthroplasty; Total Hip replacement; Hip replacement; Hip prosthesis
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to obtain continuous glucose monitoring (CGM) data from
      individuals taking Welchol compared to placebo. The CGM data will determine the effect on
      glucose control of adding Welchol to an anti-diabetic medication regimen.
    

Detailed description: 
      To understand the effect of the addition of colesevelam HCl to oral agent therapy in
      individuals with type 2 diabetes on glycemic control by utilizing a novel technology,
      continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no
      studies of this compound that have employed continuous glucose monitoring (CGM) with
      ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose
      patterns associated with this therapy. We plan to employ CGM at critical points throughout
      the study. AGP analysis will enable rapid assessment of the clinical status of the subject.
      Using statistically stable estimates of hourly values represented by five percentile curves
      AGP depicts glucose exposure, variability and stability. Previously, we have used AGP
      analysis to characterize glucose perturbations in individuals ranging from normal glucose
      tolerance to overt type 2 diabetes.
    

Intervention name(s): colesevelam HCl; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3.75 grams of colesevelam HCl (6 tablets)
Other intervention name(s): Welchol
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modified Intermittent Fasting in Psoriasis
Condition: Psoriasis Vulgaris; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      The complexity of psoriasis is partially affected by dietary effects, and some diets have
      shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of
      these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with
      psoriasis have been reported to have impaired intestinal integrity and it has been suggested
      that gut health affects skin health, pointing towards a gut-skin axis. Understanding how
      dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly
      improve our understanding on the development of psoriasis. Modified intermittent fasting
      (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect
      on gut and skin remains underexplored.
    

Detailed description: 
      To study the role of gut health, more specifically the intestinal barrier, in individuals
      with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over
      study. The investigators will test whether MIF can improve (i) skin lesions (clinical and
      molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and
      (iii) the timing of these improvements. As such, it can be determined whether fasting
      benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal
      for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be
      tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating
      between MIF and usual diet).
    

Intervention name(s): Modified Intermittent Fasting followed by Regular Diet; Regular Diet followed by Modified Intermittent Fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows.; Regular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Fasting; Modified intermittent fasting; Leaky gut; Intestinal barrier
R(+)PPX High Dose Treatment of ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and
      spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative
      stress.
    


Intervention name(s): R(+) pramipexole dihydrochloride monohydrate
Intervention type(s): Drug
Intervention description(s): 100 mg tid orally daily
Intervention MeSH terms: Pramipexole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: neuroprotection; oxidative stress
The Effects of Telerehabilitation in Chronic Hemiplegic Patients
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The present study was conducted to investigate the effects of telerehabilitation on upper
      extremity functions and activities of daily living in chronic hemiplegic patients.
    

Detailed description: 
      A total of 40 chronic hemiplegic subjects were included in the study. The patients were
      divided into 2 groups by simple randomization method. As the Telerehabilitation Group (TR),
      Group 1 completed the treatment program, which included upper extremity and lower extremity
      strengthening exercises, for eight weeks, three days a week for 45-60 minutes, 10
      repetitions, with online supervision. Group 2 was planned as a face-to-face training group
      and the same exercises were performed in the clinical setting, accompanied by a
      physiotherapist. The evaluations were made before and after the treatment. The Modified
      Ashworth Scale was used for upper extremity spasticity evaluation. The Wolf Motor Function
      Test was used to evaluate upper extremity functionality. The Barthel ADL Index was used to
      evaluate Activities of Daily Living (ADL). The Brunnstrom Staging Survey was used to evaluate
      the level of motor recovery. The Treatment Satisfaction Inquiry Survey was used to evaluate
      the satisfaction of the patients with the treatment method. Heart Rate (HR) values and oxygen
      saturation (SaO2) were measured with Pulse Oximetry to monitor vital signs.
    

Intervention name(s): Tele rehabilitation Group
Intervention type(s): Behavioral
Intervention description(s): It has been determined that the telerehabilitation method applied in chronic hemiplegic patients increases daily living activities, upper extremity functionality, and spasticity levels decrease.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fuctionallity; chronic hemiplegia; Spastisity; Tele-rehabilitation; upper extremity
PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Observational

Summary: 
      ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC),
      although no improvement in overall survival (OS) has been done in the last 25 years , with
      Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median
      survival of about 7-8 months in patients with extended disease (ED).

      In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant
      advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and
      Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen
      in SCLC.

      Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16
      females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2,
      Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.

      Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per
      patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%),
      1 in 13 patients (28%) and 2 in 4 patients (9%).
    


Intervention name(s): ifosfamide
Intervention type(s): Drug
Intervention description(s): PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile.
Other intervention name(s): cisplatin, etoposide
Intervention MeSH terms: Cisplatin; Etoposide; Ifosfamide
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All eligible patients had histologically or cytologically proven SCLC, with measurable
        disease defined by RECIST criteria, and received at least one cycle of chemotherapy.
        Patients with central nervous system (CNS) metastases were included in the study.
      
Keywords: small cell lung cancer; extended disease; limited disease; chemotherapy; cisplatin; etoposide; ifosfamide
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults
Condition: Healthy Male Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate
      lactation in breastfeeding women. The intranasal administration of OT has recently attracted
      attention as a potential novel treatment in several psychiatric disorders including autism.
      However, given the anatomy of the nasal cavity, the current design of nasal sprays would be
      expected to provide an inadequate delivery of medication to the areas of the nasal cavity
      where direct transport into the brain via the olfactory nerve could potentially occur.
      OptiNose has developed an intranasal delivery device that provides improved reproducibility
      of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity
      where the olfactory nerve innervates the nasal cavity.

      The primary objective of this study is to identify any differences between single dose 8 or
      24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose
      device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers.
      This will be measured in terms of brain activity as measured with functional magnetic
      resonance imaging (fMRI), performance on cognitive tests, and physiological markers.
    


Intervention name(s): 8IU intranasal oxytocin; 24 IU intranasal oxytocin; 1 IU intravenous oxytocin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: oxytocin; fMRI; social cognition; heart rate variability; pupillometry; eye tracking
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and
      November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.

      The objective of this study is to determine whether the association SMC and LNS reduces the
      number of confirmed malaria cases among children 6-59 months during the monthly SMC
      distribution sessions.
    

Detailed description: 
      Main objective:

      To compare confirmed cases of malaria among children aged 6-59 months between the group
      receiving SMC combined with LNS (intervention group) and the group receiving only SMC
      (control group) during the monthly SMC distribution sessions (4 rounds)

      Secondary objectives:

      To compare among children aged 6-59 months between two groups

        -  Fever cases

        -  Acute malnutrition cases (global, moderate and severe)

        -  Medical referral cases and their reasons

      Study site:

      The study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each
      group (intervention and control groups) is composed of 9 health areas.

      Number of participants:

      Between 17500 and 22000 in each group (estimation)
    

Intervention name(s): Lipid-based Nutrient Supplement (LNS); Seasonal malaria chemoprevention
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): For each round of SMC distribution (total of 4 rounds):
For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks
For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks; For each round of SMC distribution (total of 4 rounds):
For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg
For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg
D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine
Other intervention name(s): Sulfadoxine-pyrimethamine plus amodiaquine
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Seasonal malaria chemoprevention; Lipid-based nutrient supplement; Children; Mali
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of Part A of this study is to compare, in a single dose and multiple
      doses the safety, tolerability, and pharmacokinetics (PK) profile administered in Japanese
      and Caucasian participants and of Part B of the study is to assess the food effect of a
      single dose of INS1007 administered in Japanese and Caucasian participants.
    


Intervention name(s): INS1007; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets.; Oral tablets.
Other intervention name(s): AZD7986; Brensocatib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study
Condition: Suture, Complication; Istmocel
Study type: Interventional

Summary: 
      This study aims to investigate the effect of suture materials with different absorption times
      on istmocel.
    


Intervention name(s): Suture materials effect on istmocel
Intervention type(s): Procedure
Intervention description(s): Effect of suture materials with different absorption times on istmocel
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rapid; suture material; istmocel