bioihbjkbjnl/mcl2 huggingface dataset:
Urdu Version of Lower Extremity Functional Scale: Reliability and Validity Study
Condition: Musculoskeletal Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      The objective of the research is to translate and to culturally familiarize the Lower
      extremity functional scale into the Urdu language along the investigation if the Lower
      Extremity Functional Scale is reliable and validate in the Pakistani population with Lower
      extremity musculoskeletal disorders and to check the correlation with Short Form - 36.
    

Detailed description: 
      The questionnaire will be translated into Urdu and cross-culturally modified. Internal
      consistency, test-retest reliability, conceptual validity, discriminative validity,
      responsiveness, and concurrent validity will be examined in 150 participants seeking
      treatment for lower extremity dysfunction using the Urdu version of the Lower Extremity
      Functional Scale.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani population with Lower extremity musculoskeletal disorders was included in the
        study.
      
Keywords: Lower Extremity Functional Scale; Musculoskeletal Disorder; Cultural adaptation; Validity; Urdu Version; Reliability; Lower Extremity
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of
      zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.

      The duration of clinical benefit from zidovudine (AZT) may be limited because of development
      of viral resistance to the drug. Use of combination antiretroviral therapy can potentially
      reduce viral load and prevent emergence of multidrug resistance.
    

Detailed description: 
      The duration of clinical benefit from zidovudine (AZT) may be limited because of development
      of viral resistance to the drug. Use of combination antiretroviral therapy can potentially
      reduce viral load and prevent emergence of multidrug resistance.

      In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment
      arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After
      12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients
      in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater
      than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in
      Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are
      randomized to each original treatment regimen until a maximum of 130 patients per arm have
      been entered. Stage 2 patients receive treatment for at least 48 weeks.

      AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered
      blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on
      or about 5/23/97.
    

Intervention name(s): Nevirapine; Zidovudine; Didanosine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zidovudine; Nevirapine; Didanosine
Primary purpose: Treatment
Keywords: Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Nevirapine
Diurnal Changes of the Cornea - a Pilot Study
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Observational

Summary: 
      Aim of this study is to gain a better understanding of the diurnal changes of the cornea to
      improve toric IOL power calculations.
    

Detailed description: 
      Higher patient expectations concerning unaided visual acuity after cataract surgery has led
      to an increase in use of toric intraocular lenses (toric IOLs) for the correction of corneal
      astigmatism. Although it was shown that toric IOLs significantly reduce astigmatism, there is
      still some difficulty in predicting the remaining astigmatism correctly. The main source of
      error appears to be the pre-operative measurement of the cornea. However, it is questionable,
      if this error derives from a measurement error due to the imprecise measurement technique, or
      natural diurnal changes of the cornea. Additionally, measurements of the cornea pose several
      challenges: different corneal biometry devices cannot be used interchangeably and it is
      difficult to decide, which device is measuring the cornea correctly as there is no gold
      standard.

      Especially, in eyes with small corneal astigmatism the error increases. Recently it was shown
      that the astigmatism meridian was on median 9° off for corneas with 1.0D of astigmatism and
      only 4° for corneas with 2.0D of astigmatism. Similar findings were observed by Shammas et
      al. Norrby furthermore showed that 5% of all corneas show more than 0.5D of fluctuations
      between measurements at different (post-operative) time-points. The reasons are not explored,
      but diurnal changes, temperature and humidity potentially influencing the tear film, as well
      as pupil size and asphericity of the cornea could play a role. Read and Collins observed
      diurnal changes of corneal radii within 24 hours, but in their study only young healthy
      volunteers were included and only one measurement device (Scheimpflug imaging, Pentacam HR)
      was used. Lau and Pye and Shen et al. measured the diurnal changes of the cornea, but no data
      concerning corneal radii were reported. Harper et al. observed diurnal changes of the central
      corneal thickness. However, none of these studies investigated on diurnal changes of the
      corneal radii in the elderly population. Aim of this study is to gain a better understanding
      of the diurnal changes of the cornea to improve toric IOL power calculations.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 volunteers/patients (10 patients >50 years old; 5 patients with a corneal astigmatism of
        >1 D)
Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers
Condition: Venezuelan Equine Encephalitis Virus Infection
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Venezuelan Equine; Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase I study will assess the basic safety, tolerability, and immunogenicity of a
      DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by
      electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will
      comprise evaluation of intradermal or intramuscular administration by electroporation.
      Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0
      mg/ml) for each route of administration. Electroporation will be administered using the
      TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional
      group of subjects will serve as a placebo control, receiving injections of saline with
      electroporation. The overall goal of this study will be to determine if further human
      clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection
      of dose and route of administration for future studies.
    


Intervention name(s): Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate; 0.9% saline placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Venezuelan equine encephalitis virus; DNA vaccine; electroporation; intradermal; intramuscular
E-cigarette Nicotine Pharmacokinetic Study
Condition: Healthy Volunteers; Smoking
Study type: Interventional

Summary: 
      This study will compare nicotine delivery and product satisfaction in healthy subjects either
      using several different types of electronic cigarettes or smoking a conventional cigarette.
    


Intervention name(s): Use electronic cigarette or smoke conventional cigarette
Intervention type(s): Other
Intervention description(s): Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An Interaction Study With Digoxin and AZD1305
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to learn more about how digoxin is handled by the body,
      i.e. absorption, distribution, metabolism and excretion, when administered alone and in
      combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled
      by the body when administered alone and in combination with digoxin and to learn more about
      how AZD1305 and digoxin administered alone and in combination affect the body.
    


Intervention name(s): AZD1305; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Extended Release tablet, repeated administration; Tablet, repeated administration
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; interaction; pharmacokinetic
Telemedicine for Sleep Apnea Patients
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Objective: Set up an interoperable telemedicine system for the follow-up of patients with
      sleep apnea syndrome.
    

Detailed description: 
      The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine)
      criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of
      CPAP data from patients' home and classical follow-up) during the 3 first months of the
      follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of
      at least 1hr in the use of CPAP.
    

Intervention name(s): With teletransmission
Intervention type(s): Device
Intervention description(s): Teletransmission of alerts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: CPAP; adherence; SAOS; telemedicine
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
Condition: Chronic Critical Limb Ischemia; Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and performance of the Xpert(TM)
      self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in
      patients undergoing percutaneous intervention for the treatment of documented chronic
      critical limb ischemia (CLI).
    

Detailed description: 
      Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million
      Americans annually. The diabetic population is particularly prone to the most severe clinical
      problems associated with PAD and the amputation rate amongst such patients is elevated
      five-fold. It has been shown that patients who undergo amputation for PAD/CLI have a much
      higher mortality rate in the months that follow.

      Despite medical advances in the fields of pharmacology and wound care, the vast majority of
      patients who present with CLI will ultimately require amputation in the absence of improved
      blood flow. Recently, much attention has been directed towards less invasive endovascular
      solutions for treating patients with CLI. This study will evaluate approximately 140 subjects
      with Rutherford Class IV-VI PAD in a multi-center study in order to accurately estimate limb
      salvage rates for this treatment.
    

Intervention name(s): Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLI; Critical Limb Ischemia
Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
Condition: Neuropathy, Diabetic
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fluid retention; Autonomic Neuropathy
Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar
      bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and
      compliance of the two reduced volume PEG-based bowel preparation will be also compared.
    


Intervention name(s): 2L PEG-CS plus bisacodyl; 2L PEG-ASC
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit); Patients will asked to take PEG-ASC according to labeling instructions
Other intervention name(s): Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets); Moviprep
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Condition: Endometriosis; Sexual Dysfunction
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      This study aimed to assess the effects of dydrogesterone on sexual function in women with
      endometriosis using Female Function Sexual Index (FSFI).
    

Detailed description: 
      Sexual dysfunction is an important outcome for patients with endometriosis. In this study, we
      compare the fsfi (female sexual function index) questions and the scores before and after
      dydrogesterone treatment in patients with endometriosis. We aim to measure the effect of
      dydrogesterone in patients with endometriosis.
    

Intervention name(s): Dydrogesterone
Intervention type(s): Drug
Intervention description(s): 79 women, aged between 18 and 45 years, who were examined at our tertiary gynecology outpatient clinic between April 2019 and March 2020, with surgically diagnosed endometriosis, were included in this study. They received a treatment with 5 mg dydrogesterone administered orally twice daily for 21 days; from the 5th to 25th day of each menstrual cycle, for a total of 6 months. They were evaluated pre- and posttreatment in terms of their age, parity, and body mass index (BMI). Female Function Sexual Index (FSFI) and visual analogue scale (VAS) scores were recorded pre- and posttreatment
Intervention MeSH terms: Dydrogesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of SNPs in the BCMO1 Enzyme
Condition: Beta-carotene Bioavailability; Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      Summary:

      Chronic intake of foods low in vitamin A (retinol) and provitamin A forming an unbalanced
      diet with little variety is common in young individuals in the United Kingdom (UK) population
      and can lead to subclinical micronutrient deficiency. Provitamin A sources such as β-carotene
      are cleaved centrally by the β-carotene 15,15'-monooxygenase (BCMO1) into retinal, the
      precursor of retinol. However, the amount of β-carotene and retinol produced after ingestion
      of β-carotene is highly variable between healthy individuals, with approximately 40% of the
      subjects being classified as low responders. Several stable isotope studies have shown a
      large disparity between the most efficient converters and the most inefficient converters of
      β-carotene with variations of up to 8-fold. It is possible that differences in β-carotene
      response may be due to single nucleotide polymorphisms (SNPs) in genes involved in aspects of
      β-carotene conversion. Previous work has shown that carriers of both, the 379V and 267S+379V
      BCMO1 variant alleles had a reduced ability to convert β-carotene. More importantly, 44% of
      the western population have the 379V haplotype. A high percentage of the Western population
      may therefore not be able to achieve adequate vitamin A intake if dietary β-carotene is a
      major source of their vitamin A intake. This is of particular relevance to vegetarians, to
      young individuals aged 19-24 years who have lower intakes of preformed retinol than any other
      age group, and to pregnant women. The aim of this study is to establish whether the maximum
      recommended dose for β-carotene of 7mg/day by the British Expert Committee on Vitamins and
      Minerals (EVM) can overcome the SNP effect in the BCMO1 enzyme.

      Hypothesis:

      The investigators hypothesize that the current maximum recommended intake of 7 mg of
      β-carotene per day cannot overcome the low convertor phenotype in BCMO1 to fulfill vitamin A
      requirements in these people.
    


Intervention name(s): Beta-carotene
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Beta carotene; Retinol
Free Fatty Acids: Short Exposure Study
Condition: Hypogeusia
MeSH terms: Ageusia
Study type: Interventional

Summary: 
      This study will examine whether or not short, daily exposures change a person's ability to
      detect free fatty acids in a solution by its taste. Repeated exposure should improve a
      person's ability to detect free fatty acids.
    

Detailed description: 
      The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste
      - is a relatively new area of research. Previous work suggests that subjects require an
      average of between two and three testing sessions of approximately an hour each before they
      can reliably detect NEFA, and the average number of visits to get the lowest threshold is
      six. Streamlining this process is of great interest to researchers who wish to test many
      people as quickly as possible. Other taste qualities, including umami and sweet, have shown
      improvement in detection sensitivity in subjects that have undergone ten second exposures to
      these taste qualities for 10 days upon subsequent re-testing. We seek to determine if the
      same improvements can be seen with fat taste.
    

Intervention name(s): NEFA; Sucrose
Intervention type(s): Other; Other
Other intervention name(s): Oleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Taste; Fat Taste; Threshold Testing
A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of clinical and high clinical exposures
      of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK),
      and pharmacodynamics (PD) of VX-548 and its metabolite.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-548; Moxifloxacin; Moxifloxacin Placebo; VX-548 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Capsules for oral administration.; Tablets for oral administration.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment