bioihbjkbjnl/mcl2 huggingface dataset:
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
Condition: Peyronie's Disease
MeSH terms: Penile Induration
Study type: Interventional
Phase: Phase 1

Summary: 
      Two recent studies have identified low levels of serum testosterone in association with
      Peyronie's Disease (PD), with a significant correlation noted between severity of
      testosterone deficiency and severity of curvature. The study hypothesis is to determine
      whether treatment with testosterone may help men with PD and penile curvature.
    


Intervention name(s): Vitamin D2; Vitamin E; Testosterone Pellets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral softgel 2000 IU once daily 9 months; oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily
1 softgel of 200 IU daily 9 months; subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Other intervention name(s): 21st Century Dietary Supplement; GERI-CARE; Testopel 75 mg testosterone pellets
Intervention MeSH terms: Vitamin D; Ergocalciferols; Vitamins; Vitamin E; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low testosterone; penile curvature
Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control
Condition: Dentures
Study type: Interventional

Summary: 
      This clinical investigation will evaluate the effectiveness, tolerability and safety of two
      denture fixative creams versus no fixative control
    

Detailed description: 
      A single-centre, randomised, 3-way cross-over, clinical investigation comparing the
      performance of two denture fixative versus no denture fixative control in full denture
      wearers and an exploratory sub study in partial denture wearers. The study will assess the
      performance and tolerance of two denture fixative cream formulations (Paraffin based and
      Polydecene based) when applied to full dentures.
    

Intervention name(s): Paraffin based Denture Fixative
Intervention type(s): Device
Intervention description(s): Denture fixative applied in strips to secure dentures in place
Other intervention name(s): Denture Fixative
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The denture fixative cream formulations will be tested in a 3-arm cross-over-design, where subjects will be randomised to a sequence including the two intervention (denture fixative) arms and a control (no fixative) arm.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Denture Fixative
Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
Condition: Cholera; Diarrhea; Vibrio Infections
MeSH terms: Cholera; Vibrio Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and immunogenicity of one and two doses of
      the killed oral cholera vaccine.
    

Detailed description: 
      Cholera is an important public health problem worldwide, particularly in endemic areas of the
      developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO.
      Provision of safe water and food, adequate sanitation and improved personal and community
      hygiene are the main public health interventions against cholera. These measures cannot be
      implemented in the near future in the most cholera-endemic areas.

      Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa,
      Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among
      vaccine recipients.

      Distribution of 2 doses of the cholera vaccine is often difficult in field settings and
      limits its utility in emergency situations, since an interval of 2 weeks is usually required
      between doses. Recent data from Vietnam suggests that greater vibriocidal responses following
      2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh
      comparing immune responses to the vaccine among children supplemented with vitamin A and
      zinc, seroconversion after the first dose was robust in all groups suggesting that one dose
      may be used in the control of cholera.

      Data regarding the immune response following one dose of this reformulated vaccine is
      currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to
      recipients, then this vaccine may be used more extensively for public health purposes,
      especially during times of outbreaks.

      The objective of this study is to confirm the safety of the killed oral cholera vaccine among
      adult and children volunteers.
    

Intervention name(s): Killed bivalent whole cell oral cholera vaccine; Heat Killed E. coli Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Each 1.5 mL dose, given orally, contains:
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS; Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cholera; Vaccine; Kolkata; West Bengal; India; Immunogenicity; Safety
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Condition: Child Nutrition Sciences
Study type: Interventional

Summary: 
      This study aims to determine if a cow's milk-based formula with added nutrients has an effect
      on memory, reaction time, strategy or other cognitive development indicators in children 4-5
      years of age.
    

Detailed description: 
      This study aims to determine if a cow's milk-based formula with added nutrients has an effect
      on memory, reaction time, strategy or other cognitive development indicators in children 4-5
      years of age.
    

Intervention name(s): Cow's milk-based formula with added nutrients; Cow's milk-based formula
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Healthy Children
Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
Condition: Female Breast Neoplasms; Carcinoma, Ductal, Breast
MeSH terms: Breast Neoplasms; Carcinoma, Ductal; Carcinoma, Ductal, Breast
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale

      Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant
      treatment planning.

      Purpose

      Randomized phase III trial to compare the effectiveness of surgical therapy with or without
      axillary dissection following conservative treatment in women with stage I breast cancer.

      To determine the possibility to avoid axillary surgery in patients with early breast cancer,
      finding an alternative method to define the need of adjuvant treatment without compromising
      long-term disease control.
    

Detailed description: 
      OBJECTIVES:

      To compare the efficacy of conservative surgery, with or without axillary lymphnode removal
      (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by
      adjuvant treatment.

      To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological
      panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one
      unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more
      than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and
      GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).

      To determine the relationship between the biological variables (hormone receptor status,
      grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these
      patients.

      OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment
      arms.

      Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients
      undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant
      strategy was previously described.

      Patients are followed every 4 months for the first two years, every 6 months for the
      following two years, and then annually thereafter.

      PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years

      ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female
    

Intervention name(s): axillary dissection
Intervention type(s): Procedure
Intervention description(s): Conservative breast surgery with or without axillary dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; axillary dissection
Pivotal Response Treatment (PRT) Telemedicine
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the application of a modified version of PRT
      designed specifically as a parent-training model via telemedicine, with the goal of
      increasing access to empirically validated care. The project will feature an 18-week trial of
      parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with
      ASD. Intervention will focus on enhancing the following developmental skills: expressive and
      receptive language, play, and social interaction. Outcome measures will address changes in
      the aforementioned domains during structured observation and standardized assessment.
    

Detailed description: 
      The purpose of this study is to evaluate the application of a modified version of PRT
      designed specifically as a parent-training model via telemedicine, with the goal of
      increasing access to empirically validated care. The project will feature an 18-week trial of
      parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with
      ASD. Intervention will focus on enhancing the following developmental skills: expressive and
      receptive language, play, and social interaction. Outcome measures will address changes in
      the aforementioned domains during structured observation and standardized assessment.
    

Intervention name(s): Pivotal Response Treatment
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention for autism
Other intervention name(s): PRT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Irbesartan 300 mg Tablets under fasted conditions
    


Intervention name(s): Irbesartan; Avapro
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester
      formulations can be used effectively to treat men with low testosterone.
    

Detailed description: 
      Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations
      of T-esters [testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)]
      administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in
      total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU +
      TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily
      for 7 days. All subjects were enrolled into a single group and proceeded through the four
      Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the
      study-state pharmacokinetics profile of the TU formulation was evaluated.
    

Intervention name(s): Oral testosterone undecanoate (TU) (300 mg T equivalents/dose); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose); Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Intervention model description: All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone; male hypogonadism; low testosterone
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
Condition: Healthy; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into
      the bloodstream and how long it takes the body to eliminate it in participants with impaired
      liver function and healthy participants. The side effects and tolerability of pirtobrutinib
      will also be evaluated. Participation could last about 46 days.
    


Intervention name(s): Pirtobrutinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LOXO-305, LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Repeatability in Measurements of Two ssOCT and One OLCR Biometer
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Achieving high accuracy and precision in ocular biometry has become primordial for cataract
      surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive
      one.

      Aim of this study is to determine the repeatability of ocular biometric parameters obtained
      using three biometry devices, two ss-OCT biometers and an OLCR device.
    

Detailed description: 
      Accurate and repeatable biometric measurements are essential in providing an optimal
      refractive outcome.

      ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology
      showing its superiority through better signal-to-noise ratio, the wavelength light source
      being projected into the eye, one at a time; thus improving tissue penetration.

      This a prospective observational study that would include patients which attended
      pre-surgical examination. A written informed consent will be obtained from each patient.

      Only one eye from each patient will be included in the study. All patients included in the
      study will undergo biometric measurements in a random fashion with the three devices
      (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three
      times with each device and between the measurements they will be asked to blink or keep their
      eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality
      requirement of each device will be taken for analysis.
    

Intervention name(s): biometric measurement IOLMaster 700; biometric measurement Lenstar LS 700; biometric measurement Anterion Heildelberg
Intervention type(s): Device; Device; Device
Intervention description(s): Three biometric measurements will be performed with 3 devices for all the patients included; Three biometric measurements will be performed with 3 devices for all the patients included; Three biometric measurements will be performed with 3 devices for all the patients included
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ss-OCT; OLCR; biometry
Evaluating the Association Between Pericardial Fat and Coronary Heart Disease - Ancillary to MESA
Condition: Coronary Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Coronary heart disease (CHD) is the leading cause of death in the United States. One common
      risk factor for CHD is obesity. The presence of certain types of fat over others is more
      commonly associated with the development of CHD. This study will use data from a previous
      study to examine the association between pericardial fat, a type of fat that surrounds the
      heart, and CHD.
    

Detailed description: 
      CHD is caused by a narrowing of the small blood vessels that supply blood and oxygen to the
      heart. It usually results from atherosclerosis, a condition in which deposits of fat,
      cholesterol, and other substances build up along the inner walls of arteries. Risk factors
      for CHD include tobacco use, high blood pressure, diabetes, and obesity. Visceral fat, the
      type of fat found in the abdomen and surrounding vital organs, is considered a greater risk
      factor for CHD than subcutaneous fat, the type of fat found directly below the skin.
      Pericardial fat, the fat surrounding the heart, is similar to visceral fat, and may be
      particularly damaging because of its lipotoxicity effects and its ability to trigger
      inflammation in the coronary arteries. Increased amounts of pericardial fat may therefore
      accelerate the development of atherosclerosis and CHD. The purpose of this study is to
      evaluate the relationship between pericardial fat and the development of CHD.

      This study will use previously collected data from participants in the Multi-Ethnic Study of
      Atherosclerosis (MESA) study, a study that examined characteristics of the subclinical, or
      the early stages of, cardiovascular disease in individuals. There will be no study visits
      specifically for this study. Participants' study data and computed tomography (CT) scans will
      be analyzed to determine the following: 1) the presence of pericardial fat and subclinical
      CHD at study entry; 2) changes in pericardial fat levels and plaque formation; and 3) the
      presence of pericardial fat and CHD at a 6-year follow-up visit.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participant in the MESA study
      
Keywords: Coronary Heart Disease
Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology
Condition: Peritoneal Dialysis
Study type: Interventional

Summary: 
      Subjects with peritoneal dialysis are randomized to different groups. The different groups
      receive different intra-abdominal volumes and different glucose-concentrations.

      The effects on blood pressure and other cardiovascular parameters (e.g. central blood
      pressure, augmentation index, ...) will be evaluated.
    


Intervention name(s): Different abdominal volumes and different glucose-concentrations during peritoneal dialysis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Children with Down syndrome (DS) have language development particularities that have negative
      effects in the communication capacity. By this way, Augmentative and Alternative
      Communication (AAC) is indicated to this population. The aim of this study was to verify the
      AAC impact in the lexical gain of children with DS.
    

Detailed description: 
      Five children with DS, with the same cognitive level, participated in this study.
      Longitudinal follow-up of twelve months of speech-language therapy with AAC use was
      undertaken. A lexical evaluation was done at the beginning and the end of this follow-up.
      Correct responses in the lexical evaluation were increased, but not necessarily in the spoken
      modality. The comparisons showed significant results in use of substitutions processes, and
      to no-answers.
    

Intervention name(s): speech-language therapy with AAC intervention
Intervention type(s): Behavioral
Intervention description(s): speech-language intervention in weekly 40-minutes sessions, without the presence of parents or caregivers, and 5 to 10-minutes to parents training and orientation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Down syndrome; communication AIDS for disabled; language development disorders; vocabulary; gestures; language tests; child