bioihbjkbjnl/mcl2 huggingface dataset:
the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women
Condition: Endometrial Thickness; Pregnancy Rate
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The present randomized double blind study has been carried out in Gynecology and Obstetrics
      Department, Faculty of Medicine, Zagazig university on 70 women were previously received
      clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving
      improper endometrial thickness < 7mm during the period from March 2019 to September 2019
    

Detailed description: 
      Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in infertile women.
      Infertility affects 40% of women with PCOS. Understanding the main causes of infertility and
      selecting an appropriate treatment plan is a diagnostic and therapeutic priority The aim of
      this work was to compare the effect of Clomiphene citrate plus Estradiol Valerate versus
      Letrozole on endometrial thickness and pregnancy rate in infertile PCOS women underwent
      ovulation induction

      The study was designed as a randomized double blind study using a computer-generated
      randomization list and sequentially numbered opaque sealed envelopes, each containing the
      allocation information written on a card. Envelopes were opened sequentially by a study nurse
      to allocate patients to the assigned group. These patients were divided into two groups:

        1. Group A (clomiphene citrate & estradiol group): included 35 anovulatory PCO patients who
           received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals,
           Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white
           tablets of cyclopregynova) from cycle day 8 to 14.

        2. Group B (Letrozole group): included 35 anovulatory PCO patients who received letrozole
           (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.
    

Intervention name(s): Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt; letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
Intervention type(s): Drug; Drug
Intervention description(s): CLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1); Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Letrozole; clomiphene Citrate; PCOS; Endometrial thickness
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Condition: Meningitis, Meningococcal; Rotavirus Infections
MeSH terms: Rotavirus Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine
      without impairing the efficacy of MCC vaccine. The hypothesis tested is that the
      seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant
      administration of RotaTeq® is non-inferior to that without non-concomitant (sequential)
      administration of RotaTeq®.
    


Intervention name(s): RotaTeq®; NeisVac-C®
Intervention type(s): Biological; Biological
Intervention description(s): Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.; Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
Other intervention name(s): V260
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.
Safety and Immunogenicity of CVD 1902 Oral Attenuated Vaccine to Prevent S. Paratyphi A Infection
Condition: Salmonella
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine)
      is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.
    

Detailed description: 
      Enteric fever is a life-threatening illness caused by several types of a bacterium known as
      Salmonella, including Salmonella Paratyphi A. In the United States about 400 cases occur each
      year, and 75% of these are acquired while traveling internationally. Typhoid fever is still
      common in the developing world, where it affects about 21.5 million persons each year.Besides
      being a first step towards a possible oral paratyphoid A vaccine for the prevention of
      enteric fever, this Phase 1 trial will shed light on the suitability of the guaBA,clpX
      strategy for attenuating non-typhoidal Salmonella, also an emerging pathogens of public
      health importance. This randomized, double-blinded, Phase I study in healthy is designed to
      investigate the safety, clinical tolerability, and immunogenicity in a dose escalating
      fashion of a live, oral, attenuated S. Paratyphi A at four dose levels (10^6, 10^7, 10^8, and
      10^9 CFU). We hypothesize that S. Paratyphi A strains harboring mutations in guaBA and clpX
      will be well tolerated in the full dose range tested and that a single inoculation at the
      highest dose will elicit vigorous humoral and cell-mediated immune responses in humans.
    

Intervention name(s): CVD 1902, a Salmonella enterica Serovar Paratyphi A live, oral vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): CVD 1902 consists of ΔguaBA, ΔclpX Salmonella enterica serovar Paratyphi A vaccine strain diluted in sterile phosphate buffered saline to achieve the desired inoculum. Form: liquid. Dose: 10^6, 10^7, 10^8, or 10^9 CFU per mL. Route: oral.; 30 ml of buffer solution (2.0 grams of NaHCO3 dissolved in 150 ml of sterile water) without bacteria, to which food grade corn starch, USP is added, as necessary, to match the turbidity of the vaccine inoculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Salmonella; Vaccine
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this study was to compare the relative bioavailability (rate and extent of
      absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva
      Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of
      Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x
      100/25 mg tablet) in healthy adult subjects administered under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Losartan potassium/Hydrochlorothiazide; Hyzaar®
Intervention type(s): Drug; Drug
Intervention description(s): 100/25 mg Tablets; 100/25 mg Tablets
Other intervention name(s): Losartan potassium/Hydrochlorothiazide (generic name)
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability and pharmacokinetics after a
      single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.
    


Intervention name(s): TC-5214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet; Placebo tablet, single dose and 6 days repeated dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: TC-5214; safety; pharmacokinetics; single dose; repeated dose; Japanese; healthy subjects
Treatment With Pirfenidone for COVID-19 Related Severe ARDS
Condition: Covid19; ARDS
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per
      nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC),
      compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be
      randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or
      SoC (control arm).
    

Detailed description: 
      The objective of the trial is to evaluate the safety and efficacy of treatment with
      Pirfenidone vs SoC in COVID-19 induced severe Acute Respiratory Distress Syndrome (ARDS)
      requiring mechanical ventilation.

      Following initial diagnosis of COVID-19, severe ARDS patient will be admitted to a dedicated
      intensive care unit (ICU) at Soroka University Medical Center (Day 0). Upon admission,
      patients will be randomized according to 1:1 ratio to one of the trial arms and receive
      either Pirfenidone 2,403mg administered through nasogastric tube as 801mg TID (intervention
      arm) plus SoC or only SoC treatment (control arm).

      Patients' vital signs (temperature, blood pressure, pulse rate per minute, breath rate per
      minute, oxygen saturation) urine output, ventilation settings, and respiratory parameters
      will be monitored according to SoC. Symptom will be captured daily from patients as well as
      adverse events (AEs) assessment and recording of the need for any supportive care during the
      period of ICU admission.
    

Intervention name(s): Pirfenidone; Standard of care
Intervention type(s): Drug; Other
Intervention description(s): Treatment with Pirfenidone as mentioned in the experimental arm description.; Treatment with SoC as mentioned in the control arm description.
Other intervention name(s): Intervention Arm; Control Arm
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following initial diagnosis of COVID-19, severe ARDS patient will be admitted to a dedicated intensive care unit (ICU) at Soroka University Medical Center (Day 0). Upon admission, patients will be randomized according to 1:1 ratio to one of the trial arms and receive either Pirfenidone 2,403mg administered through nasogastric tube as 801mg TID (intervention arm) plus SoC or SoC alone (control arm).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Covid-19; ARDS; Pirfenidone
Biocriminology and the Adjudication of Criminal Responsibility: Is There a Consensus Among Scientists' Verdicts?
Condition: Criminalism
Study type: Interventional

Summary: 
      Because of the evolving nature of psychology research, non-scientists are more likely to
      struggle or misinterpret evidence regarding a person's psychological state. Misconceptions
      may thus be highly prevalent within the justice system, leading to negative consequences for
      people with psychological or neurobiological disorders. At the same time, no research has
      been conducted to compare the punishment perspectives of non-scientists, that typically make
      sentencing decisions, to scientists who possess a more advanced understanding of human
      biology and behavior.
    

Detailed description: 
      In this study, closely inspired by the paradigms of Berryessa, Coppola, and Salvato,
      perspectives on punishment based on psychobiological explanations of behaviour are assessed,
      aiming to understand how scientists with knowledge of human psychobiology versus lay people
      (of similar educational level) interpret offending behaviour. Human-science is contrasted to
      natural-science/arts graduates because the former have been exposed to and may possess
      scientific knowledge that shapes their understanding of behaviour, their views, and potential
      (essentialist) biases. In contrast, non-scientists have been found to possess scientific
      misconceptions that can impact their sentencing decisions. This leads to the question whether
      scientists may draw different judgements based on their professional knowledge and experience
      with psychological phenomena. If indeed scientists with greater insight on human behaviour
      are found to hold less punitive views on punishment and rehabilitation, that has important
      implications for criminal justice systems that rely on lay peoples' understanding of science.

      One hundred sixty participants who completed all study procedures (2 main groups of 80
      participants) will be surveyed. A sample size calculation was performed using G*Power version
      3.1.9.4, based on Berryessa and colleagues who conducted a similar survey study in 2021 with
      comparable outcome measures and analyses. The required effect size is based upon
      approximately 3-4 outcome measures. The primary research question is between-groups, while
      secondary ones include within groups measures. Based on the power analysis, a sample of 160
      participants will be targeted, which is enough for sufficient power for f = 0.25, power =
      0.80, df = 4, for 2 different groups.
    

Intervention name(s): Biocriminological Evidence
Intervention type(s): Behavioral
Intervention description(s): Participants in each of the two main groups see a case with and a case without a neurobiological explanation for criminal offending.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Punishment; Responsibility; Attitudes
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
Condition: Gallbladder Diseases
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The investigators describe a novel technique for GB fundus retraction.
    

Detailed description: 
      few methods are available for gall bladder (GB) retraction in SILC to replace the usage of
      ancillary ports imitating retraction from conventional technique, e.g. trans-parietal
      stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way
      to retract the gall bladder fundus.
    

Intervention name(s): cholecystectomy
Intervention type(s): Procedure
Intervention description(s): single incision laparoscopic cholecystectomy
Other intervention name(s): SILC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CMR Repeatability in STEMI
Condition: STEMI
MeSH terms: ST Elevation Myocardial Infarction
Study type: Observational

Summary: 
      The investigators propose to conduct a study to measure the reproducibility of CMR parameters
      that have been used to predict outcome following PPCI: infarct size, left ventricular
      volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ST segment elevation myocardial infarction
Referred Pain Patterns Infraspinatus Muscle
Condition: Shoulder Pain
MeSH terms: Shoulder Pain; Pain, Referred
Study type: Interventional

Summary: 
      The first aim of the study will be to identify the most common ReP pattern and compare its
      coincidence with that described by Travell and Simons. Second, the study aim will be to
      verify whether there are any significant differences by sex and types of technique used in
      regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more
      sensitive.Finally, the third aim of the study will be to determine whether deep dry needling
      will evoke the LTR and ReP more easily than manual palpation.
    

Detailed description: 
      Patients will be recruited from a university's employee and student population by advertising
      at the university. Patients with shoulder complaints (described as pain felt in the shoulder
      or upper arm) will be randomly assigned to either an manual palpation or deep dry needling
      group. Participants will be randomly divided into 2 groups, a deep dry needling group and
      manual palpation group. Visual analogue scale (VAS), referred pain (ReP) pattern and features
      of referred pain of the infraspinatus muscle will be all assessed post-technique.
    

Intervention name(s): Manual palpation; Deep dry needling
Intervention type(s): Other; Other
Intervention description(s): The manual palpation level will kept constant by applying enough digital pressure to cause the finger nail bed to blanch. When the nail will be turn pale, the amount of pressure will be measured at approximately 3 4kg/cm2 and will be maintained for 5-10 seconds to evoke referred pain. A manual palpation referred pain will be present if the pain radiated far enough for the patient to feel more than just a local pain.; Intramuscular needling will be carried out via deep dry needling into myofascial trigger point (MTrP) area without the introduction any substances. The aim is to elicit a local twitch response upon inserting the needle into the MTrP area and perform a neurological stimulation (by rotating the needle 360 degrees) to more easily evoke referred pain, holding for 10 seconds and then extracting the needle gently. The procedure will be followed by one minute of haemostatic compression.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Shoulder pain; Trigger points; Referred pain; Visual analogue scale
A 12 Week Study to Evaluate the Efficacy of an Eye Cream
Condition: Periorbital Hyperpigmentation; Periorbital Edema; Fine Lines; Wrinkle
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      This single center, open-label clinical study was conducted to assess the efficacy and
      tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with
      moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines
      and wrinkles. A total of 37 subjects were enrolled into the study.
    

Detailed description: 
      This single center, open-label clinical study was conducted to evaluate the efficacy and
      tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with
      Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness.
      This study aims to evaluate the following objectives:

        1. To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine
           lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as
           evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and
           subjective questionnaire performed at baseline, week 4, week 8, and week 12.

        2. To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler
           performed at baseline, week 8, and week 12.

        3. To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and
           Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading
           at baseline, week 4, week 8, and week 12.

      A total of 37 subjects completed the study.
    

Intervention name(s): Gentle Cleansing Lotion; Facial Moisturizer; Sunscreen SPF 30
Intervention type(s): Other; Other; Other
Intervention description(s): Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).; Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).; Neutrogena Ultra Sheer Dry Touch SPF 30. Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.
Per FDA this intervention is an over the counter
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dark circles; puffiness; brightening
Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The overall aim of this study is to determine modifications to Exposure and Response
      Prevention (ERP) therapy that are needed in order to effectively deliver treatment for
      Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the
      final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP)
      intervention that will optimize therapist time by utilizing paraprofessionals to assist with
      group-ERP treatment plans. The intervention will be tailored to meet the unique needs of
      low-SES individuals with OCD and be implemented in a community mental health center (CMHC).
    


Intervention name(s): Team ERP (T-ERP) Intervention; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars
Condition: Decay, Dental; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted; Dental Caries
Study type: Interventional

Summary: 
      Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and
      external root resorption. The incidence of caries is high, especially in partially impacted
      third molars in mesioangular and horizontal positions. In this study, investigators aimed to
      examine the caries correlation in the distal second molar with the age, gender, side and DMFT
      scores of the participants.
    


Intervention name(s): Radiologic examination on orthopantomogram; Clinical examination after surgery
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Caries examination on the distal side of the adjacent second molar in the orthopantomogram of patients with an appointment for the extraction of mesioangular or horizontal partially impacted third molars; İnspectional caries examination on the distal side of the adjacent second molar after surgery of patients with mesioangular or horizontal partially impacted third molars
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic