bioihbjkbjnl/mcl2 huggingface dataset:
Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to collect basic function, radiographic and patient satisfaction
      data for observation and analysis.
    

Detailed description: 
      Evaluation of the effect of the component design on functional performance by comparing
      postoperative Knee Society Scores (KSS) with preoperative.

      Evaluate post-operative radiographic findings. Evaluate the effect of component design on
      patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with
      preoperative.

      Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of
      life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension
      patient questionaire (EQ-5D).
    

Intervention name(s): Primary total knee replacement (Scorpio NRG CR Total Knee System)
Intervention type(s): Device
Intervention description(s): Scorpio NRG CR Total Knee System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition
Condition: Skin Condition; Body Composition
MeSH terms: Skin Diseases; Disease
Study type: Observational

Summary: 
      Goal is to investigate the differences in skin condition and body composition among women
      with different dietary habits aged 30-45 years. Study will be focused onto sub-groups of
      female subjects following omnivorous, vegetarian or vegan diet.
    

Detailed description: 
      Investigators will investigate differences among female subjects aged 30-45 years following
      one of the following diet for at least 3 years:

        -  vegan

        -  vegetarian

        -  omnivorous

      Study will focus into the differences in dermal protein density and dermal thickness, skin
      hydration and trans-epidermal water loss. Study will focus also into body composition,
      specifically into % of body fat and % of lean body weight.
    

Intervention name(s): dietary habit
Intervention type(s): Other
Intervention description(s): As it is observational study, women that follow three different dietary patterns will be inlcuded .
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy women aged 30-45 years following vegan or vegetarian or omnivorous diet for at
        least 3 years.
Misoprostol for Cervical Priming Prior to Vacuum Aspiration
Condition: First Trimester Pregnancy; Surgical Termination of Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite of the widespread use, and extensive studies, the optimal route of administration of
      misoprostol before surgical abortion remains to be defined. Following administration of 400
      mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours,
      but the longer the interval the greater the risk or bleeding and expulsion of the uterine
      contents before the surgical evacuation. Sublingual administration seems to give adequate
      plasma concentration and cervical priming faster than oral or vaginal administration. This
      may allow a shorter waiting time with maintained efficacy, less side effects and logistic
      advantages.
    


Intervention name(s): Misoprostol sublingual, 1h; Placebo sublingual,1h; Misoprostol sublingual, 3h; Misoprostol vaginal, 1h; Misoprostol vaginal, 3h; Placebo sublingual, 3h; Placebo vaginal, 1h; Placebo vaginal, 3h
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy; Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy; Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy; Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy; Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy; Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy; Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy; Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
Other intervention name(s): Misoprostol (Cytotec)
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Misoprostol; First trimester pregnancy; Surgical abortion; Cervical priming
Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound
Condition: Ultrasound
Study type: Observational

Summary: 
      This will be a single center, methodological study in healthy male subjects to evaluate the
      intra-period, inter-period and inter-observer reproducibility of flow measurements in the
      superior mesenteric artery, using Doppler Ultrasound.
    

Detailed description: 
      This will be a single center, methodological study in healthy male subjects, aged 18-50, to
      evaluate the intra-period, inter-period and inter-observer reproducibility of flow
      measurements in the superior mesenteric artery, using Doppler Ultrasound.
    

Intervention name(s): Doppler Ultrasound
Intervention type(s): Other
Intervention description(s): Flow measurements using Doppler ultrasound
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male volunteers
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
Condition: Liver Failure
MeSH terms: Liver Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      A three sequence, open-label, multi-center, prospective, study in stable liver transplant
      patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of
      LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
    

Detailed description: 
      A three sequence, open-label, multi-center, prospective, study in stable liver transplant
      patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of
      LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

      Stable liver transplant patients who fulfill all I/E criteria will be enrolled and kept on
      Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for
      Prograf, all patients will be converted to once daily LCP-Tacro for 14 days with one fixed
      dose change allowed at Day 15.

      On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will
      be converted back to their original twice daily dose of Prograf for a safety follow-up period
      of 30 days ending with a safety assessment on day 53.
    

Intervention name(s): LCP Tacro; Prograf
Intervention type(s): Drug; Drug
Intervention description(s): In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.
LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.
Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL.; Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.
Other intervention name(s): tacrolimus; Tacrolimus
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Pharmacokinetics; Liver Transplantation
Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (FP-01.1) in Healthy Volunteers Following Virus Challenge
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity
      of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers
      following a dose of influenza A virus.
    

Detailed description: 
      This study is designed to further investigate the safety and tolerability of FP-01.1 in
      healthy subjects and to explore the effect of prior vaccination with Vaccine FP-01.1 (250
      μg/peptide) or placebo on the incidence, severity and duration of the signs and symptoms of
      influenza and the magnitude of viral load in nasal secretions and duration of viral shedding,
      after challenge with an A/California/H1N1 2009 influenza virus, in healthy male and female
      subjects. The study will also be used to provide additional information on the immunological
      responses (both humoral and cell-mediated immune [CMI] responses) following Vaccine FP-01.1
      treatment and to investigate potential markers for protection against influenza A infection.
    

Intervention name(s): Vaccine FP-01.1; Placebo; Virus Challenge
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Live, wild-type A/California/H1N1 2009
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: FP-01.1; Influenza A; Flu; Vaccine; Virus; H1N1; Challenge
Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium
Condition: Patient Satisfaction; Prosthetic Complication; Clinical Outcomes
Study type: Interventional

Summary: 
      This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical
      outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses
      supported by six maxillary implants and opposed by distal extension removable partial
      denture.
    

Detailed description: 
      thirty patients were selected for this study from a previous study who have already received
      previous implants in the maxillary arch. The patients were divided into two groups: Group1
      received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal
      extension partial denture, Group 2 received maxillary PEEK composite full arch fixed
      prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated
      using visual analogue scale (VAS) after one year months , Prosthetic complications were
      measured on the patient and implant levels after one year
    

Intervention name(s): Osstell® device (Integration Diagnostics Ltd.).
Intervention type(s): Device
Intervention description(s): After trans-mucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate the Interaction Between GSK3915393 and Grapefruit Juice and Itraconazole
Condition: Celiac Disease; Coeliac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part first time into human study (FTIH) study for GSK3915393. Parts A and B of
      the study will evaluate the safety, tolerability and pharmacokinetics (PK) of single
      ascending and repeat oral doses of GSK3915393 in healthy adult participants. Part C will
      evaluate the impact of co-administration of GSK3915393 with grapefruit juice and itraconazole
      on the PK of GSK3915393.
    


Intervention name(s): GSK3915393 Capsules; GSK3915393 Solution for Infusion; Placebo capsules; Itraconazole; Water; Grape fruit juice
Intervention type(s): Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): GSK3915393 capsules will be given orally.; GSK3915393 solution for infusion will be administered intravenously.; Placebo matching GSK3915393 capsules will be given orally.; Participants will be administered with GSK3915393 along with ITZ orally; Participants will be administered with GSK3915393 along with water orally; Participants will be administered with GSK3915393 along with GFJ orally
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 3-part study. Parts A and C will have a 5 period crossover design Part B will be conducted as a parallel group dose escalation study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Celiac disease; Itraconazole; Grape fruit juice; GSK3915393; Healthy Participants; Pharmacokinetics; First time into human
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin
      lesions and improves neurologic outcome in neonates with localized herpes simplex virus type
      2 infection when administered for 6 months in a placebo-controlled study.

      II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic
      morbidity.

      III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the
      natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory
      abnormalities associated with long-term oral ACV therapy in infants and young children.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution.

      All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly
      assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease
      involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography,
      and magnetic resonance imaging; and entry criteria continue to be met.

      Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group
      is treated with oral acyclovir, while the control group receives an oral placebo.

      Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease,
      and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly for
      at least 4 years.

      The study duration is estimated to be 4 years.
    

Intervention name(s): acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: herpes simplex virus infection; herpesvirus infection; immunologic disorders and infectious disorders; rare disease; viral infection
Evaluation of Periodontal Distractor in Acceleration of Canine Retraction
Condition: Canine Retraction
Study type: Interventional

Summary: 
      evaluate the effect of periodontal distractor with and without interseptal bone cuts on the
      displacement of the maxillary canines, to assess the effect of two approaches on the pain
      intensity and on the pulp vitality of the retracted canines.
    

Detailed description: 
      The sample of the study consisted of 32 canines in 16 female patients (16- 21 years old)
      requiring extraction of bilateral maxillary first premolars and canine retraction. They were
      divided into two groups: canine retraction was done by buccal periodontal distractor with
      distal interseptal bone cuts (Group I), canine retraction was done by buccal periodontal
      distractor without distal interseptal bone cuts (Group II). After bilateral maxillary
      premolar extraction in both groups inter septal bone cuts was done in group I only. Then the
      periodontal distractor was cemented and activated twice per day in both groups. Rate of
      canine retraction was evaluated before and after complete canine retraction direct in
      patient's mouth with digital caliper. Pain intensity was evaluated at 1st ,2nd ,4th and 7th
      days after activation through visual analog scale (VAS). An electrical vitality test was
      evaluated before and after the distraction procedure.
    

Intervention name(s): periodontal distractor
Intervention type(s): Device
Intervention description(s): custom made device from hyrex screw
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
Condition: Coronary Disease
MeSH terms: Heart Diseases; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This purpose of this study is to determine if the administration of ezetimibe and simvastatin
      together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100
      mg/dL in patients at risk for Heart Disease.
    


Intervention name(s): MK0653, ezetimibe / Duration of Treatment: 27 Weeks; MK0733, simvastatin / Duration of Treatment: 27 Weeks; Comparator: simvastatin / Duration of Treatment: 27 Weeks
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea
Condition: Adherence to CPAP in Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops
      breathing or experiences shallow breathing for short periods of time during sleep. The most
      common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,
      but many people have trouble adhering to the treatment schedule. This study will evaluate the
      effectiveness of two behavioral therapy programs used in combination with CPAP for improving
      treatment adherence in people with OSA.
    


Intervention name(s): Motivational Enhancement Therapy; Educational Counseling
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Obstructive Sleep Apnea; OSA; Adherence; CPAP; Cognition
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
Condition: Acute Respiratory Infection; Diarrheal Disease
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose is to determine if the consumption of study product has an effect on acute
      respiratory infections and/or diarrheal disease.
    


Intervention name(s): Cow's milk; Follow-On Formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Powdered whole cow's milk; Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?
Condition: Deaths
MeSH terms: Poisoning; Organophosphate Poisoning
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide
      poisoning (Organophosphorous poisonings)
    

Detailed description: 
      The present study was designed to critically analyze the role of pralidoxime in patients with
      moderate to severe poisoning by dividing them into two comparable groups in all aspects and
      using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by
      8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to
      maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would
      avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.
    

Intervention name(s): Pralidoxime
Intervention type(s): Drug
Intervention description(s): Pralidoxime was compared to placebo to study the effects of the drug on mortatlity
Other intervention name(s): Oximes
Intervention MeSH terms: Pralidoxime
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pralidoxime, atropine, organophosphorous poisoning.