bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Dill in Thyroiditis and Nodular Goiter Patients
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Goiter; Thyroiditis; Goiter, Nodular
Study type: Interventional

Summary: 
      The aim of the study was to investigate the functional and morphological effects of Anethum
      graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels,
      anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for
      90 days.

      The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with
      benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens
      L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose
      capsules were filled with 300 mg powder. Placebo was prepared in the same manner using
      maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at
      the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine
      (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg)
      and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and
      at the end of the trial with ultrasonography to identify the changes and effectiveness of
      dill dosage forms.

      After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were
      examined in the group with and without Anethum graveolens L..

      Again, after the study, the size of thyroid nodules was evaluated in the group who received
      and did not receive Anethum graveolens L. by ultrasonography.
    


Intervention name(s): Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
Intervention type(s): Dietary Supplement
Intervention description(s): Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
Other intervention name(s): Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups were created. Patients with thyroid nodules were divided into two groups given dill and placebo. The study was planned for 90 days. 900 mg of powder dill was given daily to the dill group. Placebo was given to the control group. Serum thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) levels of both groups were examined at the beginning and at the end of the study. Thyroid nodule dimensions were measured at the beginning and at the end of the study by ultrasonography. The results were evaluated statistically.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anethum graveolens L.; Thyroiditis; Nodular Goiter
Study to Determine Pharmacodynamic Effects and Pharmacokinetics of KUC 7483 CL in Patients With Spinal Cord Injury and Neurogenic Detrusor Overactivity
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
    


Intervention name(s): KUC 7483 CL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ridge Preservation With New Class of Osteoplastic Materials
Condition: Tooth Extraction; Atrophy of Edentulous Alveolar Ridge
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Return to normal life and shortening rehabilitation period of patients after surgical removal
      of teeth is important and urgent social problem. In this regard, higher demands for quality
      of care and treatment of patients, which requires the development of new approaches to the
      treatment of patients, the introduction of new technologies and the associated development of
      new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry
      is augmentation of bone defects generated during the surgical treatment of diseases and
      injuries of the bones. The results of surgical repair of bone defects are more dependent on
      the course of the process of reparative osteogenesis. Long-term periods of clinical studies
      indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and
      years, and in some cases no bone defects filled with bone tissue.

      This project aims at addressing the preservation of bone volume in humans after tooth
      extraction using biomaterials with optimum performance. The practical significance of the
      project is to establish an effective tissue response and, thus, possible subsequent quality
      installation of dental implants. The proposed solution is based on the scientific development
      of the operative techniques, and a comparative analysis of several classes of biomaterials
      (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite
      mineralization having osteoinductive (stimulating) properties.
    


Intervention name(s): Octacalcium phosphate; Bio-Oss; Tricalcium phosphate
Intervention type(s): Device; Device; Device
Intervention description(s): Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide; Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Other intervention name(s): OctoFor; TriCafor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tooth; extraction; alveolar socket; socket preservation; ridge preservation; bone graft; tricalcium phosphate; octacalcium phosphate; xenograft; bio oss
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare disease activity, as measured by PASI score, of three MEDI-507 dosing
      (injection)regimens vs. placebo.
    

Detailed description: 
      The primary objective of this study is to compare disease activity, as measured by PASI
      score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4
      weeks) versus placebo administered weekly by SC injection.
    

Intervention name(s): MEDI-507; Placebo; MEDI-507; MEDI-507
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody); Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks); Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Gastroesophageal Reflux Disease in Azerbaijan
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended
      to evaluate the prevalence of the disease in the regions as well as the capital by cluster
      sampling ,ethitology and to compare the outcomes depending on the geographical location.
    

Detailed description: 
      It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo
      clinic, was received and validated. The questionnaire was translated by 3 individuals from
      english to azeri and back trasnlated by 3 native english speakers.

      Power analysis was performed. The research was presented for the approval to Ethical
      Committee of Azerbaijan Medical University.

      Prior to the actual study, a pilot study with smaller number of participants was performed
      and the results were evaluated.

      Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical
      University.

      110 employees were hired for using a survey in different regions of Azerbaijan. Written
      consent was obtained from every person evaluated. Statistical ananlysis was performed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on
        reflux disease in the given age range and calculated by proportion of males and females.
      
Keywords: gastoesophageal reflux disease; prevalence; Azerbaijan
Study to Investigate the Induction of an Protective Immune Response to Malaria
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional

Summary: 
      The objective of the study is to induce a protective immune response against malaria in
      healthy human volunteers. The different parts of the immune response will then be studied.
    

Detailed description: 
      Efforts to develop vaccines against malaria still represent a substantial focus of current
      research activities. Factors that have hampered the development of a subunit vaccine include
      the complexity of the malaria life cycle, the wide variety of immune response induced by the
      malaria parasite, and an incomplete knowledge of protective immunity. This study is therefore
      aimed at inducing protective immunity against malaria in 15 healthy volunteers. Volunteers
      will be exposed to the bites of infectious mosquitoes 3 times with live P. falciparum
      sporozoites under chloroquine prophylaxis. Challenge with infected mosquitoes will be given
      after stopping chloroquine prophylaxis.

      Five volunteers will form a control group; they will be exposed to non-infectious mosquitoes
      under chloroquine prophylaxis.

      Endpoints include the time and height of parasitemia after challenge, the development of
      fever and immunological parameters.
    

Intervention name(s): exposure to malaria sporozoites
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Falciparum; Plasmodium; Malaria
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections; Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective will be to test the safety of two intravenous infusions of Altastaph, a
      human immunoglobulin product. The study will also test the ability of Altastaph to protect
      against S. aureus infection.
    

Detailed description: 
      Survival of Very-Low-Birth-Weight (VLBW) infants (<1500g at birth) has improved dramatically,
      but these patients remain subject to significant morbidity and mortality due to
      Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW
      neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting
      for 15-20% of all infections in this patient population. This controlled study will assess
      the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The
      study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of
      age.
    

Intervention name(s): Staphylococcus aureus Immune Globulin (Human) 5%
Intervention type(s): Drug
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Staphylococcal infection; Gram positive bacteria; Staphylococcus; Staphylococcus aureus
Brown Fat Activity and Bariatric Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie
      intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been
      added as another potential player. Activation of BAT results in enhanced energy expenditure
      and promotes weight loss. Here, the investigators will study the effects of bariatric surgery
      on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The
      investigators will explore different pathways that may affect BAT activation in this patient
      population.
    


Intervention name(s): Bariatric Surgery
Intervention type(s): Procedure
Intervention description(s): Patients will undergo bariatric surgery as routinely scheduled. The type of bariatric procedure will be suggested by the surgeon based on clinical considerations.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BAT; Bariatric Surgery; Energy Metabolism
Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to bone
      tissue death.

      PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young
      patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.
    

Detailed description: 
      OBJECTIVES:

        -  Identify possible pharmacogenetic risk factors for avascular necrosis (AVN) in pediatric
           patients who received intensive therapy for acute lymphoblastic leukemia on clinical
           trial CCG-1882.

        -  Compare whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor
           C/C start site genotype are more common among patients who developed AVN than among
           patients who did not.

      OUTLINE: This is a retrospective, cohort, multicenter study. Patients are stratified
      according to gender and treatment regimen on clinical trial CCG-1882 (augmented vs regular
      Berlin-Frankfurt-Munster).

      DNA is extracted from slides of blast samples that were previously obtained from patients
      treated on clinical trial CCG-1882. DNA genotyping is performed, and genotypes (proportion of
      population with variant alleles or frequency of variant alleles) are compared between
      patients who did and did not develop avascular necrosis.

      PROJECTED ACCRUAL: A total of 671 tissue samples from patients (294 females and 377 males)
      will be accrued for this study.
    

Intervention name(s): polymorphism analysis
Intervention type(s): Genetic
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients who received intensive therapy for acute lymphoblastic leukemia on
        clinical trial CCG-1882.
      
Keywords: childhood acute lymphoblastic leukemia
Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The main objective was to compare the differences of PSG parameters and plasma melatonin
      levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was
      detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male
      healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8
      weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include
      sleep architecture and power analysis) and scales.
    

Detailed description: 
      1. Design and participants: The patients with MDD were screened from the hospital, age- and
           gender-matched healthy controls were recruited by advertising from the community who
           signed written informed consent before participation.

        2. Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg
           Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S),
           and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks'
           treatment with escitalopram for patients with MDD. As for healthy volunteer, these
           measures were evaluated only once. In addition, all participants were assessed
           Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).

        3. Treatment: Each patient was provided with escitalopram.

        4. Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h
           intervals for 24 h from all participants.

        5. Sleep and EEG recordings: The PSG of participants was evaluated for one night at
           baseline (all participants) and 8 weeks treatment (MDD).

        6. Analysis the PSG architecture and power ratio.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram 10-20mg/d
Other intervention name(s): no other intervention
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Intervention model description: Major depressive disorder compared to health control
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of The Taste Of Different Oral Liquid Preparations Of CP-690,550 In Trained Adult Product Testers
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the palatability of several different CP-690,550 oral preparations in
      trained product tester healthy volunteers.
    

Detailed description: 
      To develop a palatable pediatric oral solution dosage form of CP-690,550.
    

Intervention name(s): CP 690,550 oral solutions
Intervention type(s): Drug
Intervention description(s): flavored and unflavored prototype CP-690,550 formulations
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: taste study open label investigational drug oral therapy
Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
Condition: Zika Virus; Zika Virus Infection
MeSH terms: Virus Diseases; Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika
      virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6
      antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered
      intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated
      2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.
    


Intervention name(s): VLA1601; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): purified inactivated ZIKV vaccine candidate adsorbed on alum; Phosphate buffered saline (PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; prevention
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340
Condition: PAIN
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy people is to evaluate safety, toleration and time course
      of plasma concentration of single oral doses of PF-06273340. The effect of food on the
      Pharmacokinetic of PF-06273340 may also be investigated.
    


Intervention name(s): PF-06273340 or Placebo; PF-06273340 or Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.; PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Single Dose; Pharmacokinetics; Safety; Toleration
Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to
      investigate the clinical safety and toleration (including systemic pharmacokinetics), wound
      healing and antiscarring potential of two applications of intradermal RN1001 in healthy male
      subjects
    

Detailed description: 
      Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each
      subject served as their own control, i.e. Arm 1 incisions/biopsies randomly received one of
      two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in
      reverse. The randomisation of the treatment allowed for control of possible positional
      effects on healing and subsequent scarring. Subjects were initially dosed and wounded
      (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and
      punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2
      punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were
      excised for histological analysis after 12 months and not re-dosed. All subjects, regardless
      of treatment were treated according to best practices for moist wound healing.
    

Intervention name(s): Avotermin (RN1001)
Intervention type(s): Drug
Intervention description(s): 100ul/linear cm of wound. Dosed before surgery and 24h later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science