bioihbjkbjnl/mcl2 huggingface dataset:
Multi-cycle Prolon Diet
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evidence from bio-gerontology research from our laboratory and others have showed that
      short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting
      normal cells and tissues and potentially sensitizing malignant cells to chemo drugs.
      Furthermore, STS improves risk factors associated with aging and age-related disease in
      rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible
      or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in
      a pilot human trial. The objective of the study is to ascertain the impact of the
      fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months.
      The investigators hypothesize that the specially designed dietary regimen can reduce the risk
      factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
    

Detailed description: 
      The Phase I part of the study is designed as a randomized cross-over trial, including two
      arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm.
      After 3 cycles, the Control and Diet groups are crossed over such that the Control group will
      under-go dieting and the Diet group will return to normal diet. Participants will be
      monitored for body weight and physiological changes, as well as the adherence to the dietary
      intervention.

      The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the
      dietary intervention on risk factors for metabolic syndrome and biomarkers associated with
      aging and age-related diseases.

      Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare
      between Control and Diet groups as well as pre- and post-diet values.
    

Intervention name(s): Prolon diet
Intervention type(s): Other
Intervention description(s): 3 cycles of a 5-day Prolon diet very month
Other intervention name(s): Fasting-mimicking diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Condition: Osteomyelitis
MeSH terms: Osteomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study designed to look at the efficacy and safety of daptomycin given at a
      dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections
      caused by Staphylococci. These types of bacteria are among the most common types of bacteria
      causing infections of prosthetic joints.
    


Intervention name(s): daptomycin; daptomycin; vancomycin; teicoplanin; nafcillin; oxacillin; flucloxacillin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 mg/kg; 8 mg/kg; 1 gram; 6 mg/kg; used only at UK sites; 1-2 gram; 1-2 gram; 1-2 mg
Other intervention name(s): Cubicin; Cubicin; Vancocin; Targocid; Unipen; Bactocill; Fluclox
Intervention MeSH terms: Vancomycin; Daptomycin; Teicoplanin; Floxacillin; Oxacillin; Nafcillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteomyelitis; Prosthetic Hip; Prosthetic Knee; MRSA; Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint; Staphylococci
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this six-month treatment extension study is

        -  to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200
           mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses in order
           to further enhance drug administration.

        -  To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate
           formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
    

Detailed description: 
      This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019
      (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT;
      NCT04467697), will extend the participation for up to 170 MRS-TU-2019 subjects who chose to
      enroll into the MRS-TU-2019EXT, for a target of 135 evaluable subjects reaching the 4-month
      ABPM assessment
    

Intervention name(s): SOV2012-F1
Intervention type(s): Drug
Intervention description(s): oral preparation of testosterone undecanoate (TU)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates three batches consistency, immunity duration and safety of inactivated
      Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in
      China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly
      assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines
      manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a
      ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L
      capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at
      day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
    


Intervention name(s): The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor; The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor; The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor; 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor; 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor; 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Analgesia in Knee Arthroscopic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.
    

Detailed description: 
      Intra-articular analgesia is useful in reducing patients' postoperative disability. It
      anticipates and prevents the onset of pain, and helps avoid the need for additional drugs.
      Usually it is possible to reach good analgesia in the immediate postoperative period by the
      administration of analgesic drugs. Recently, intra-articular administration of different
      anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical
      practice. The aim of the administration of these substances should not be the reduction of
      postoperative pain, but its prevention.
    

Intervention name(s): Dexamethasone; Dexmedetomidine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.; patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.; patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
McGrath Videolaryngoscopy for Nasotracheal Intubation
Condition: Nasotracheal Intubation
Study type: Interventional

Summary: 
      McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation,
      thereby reducing intubation time and complications, especially in patients with a difficult
      airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior
      to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as
      judged by the time to intubation and ease of intubation.
    


Intervention name(s): McGrath videolaryngoscopy; Macintosh laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced.; After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Digestive Tolerance of Maltitol and FOS
Condition: Digestive Tolerance in Healthy Adults
Study type: Interventional

Summary: 
      Digestive symptoms following consumption of low digestibe carbohydrates are generally
      assessed product by product but several ingredients can be used simultaneously. The study
      aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.
    


Intervention name(s): maltitol 85% / FOS15%; maltitol alone; maltitol 68% / FOS 32%; maltitol 50% / FOS 50%; FOS alone; Placebo
Intervention type(s): Other; Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study Of Diflucan In Children With Ringworm Of The Scalp
Condition: Tinea Capitis
MeSH terms: Tinea; Tinea Capitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of fluconazole for the
      treatment of tinea capitis in pediatric patients aged 3 to 12 years.
    


Intervention name(s): fluconazole
Intervention type(s): Drug
Intervention description(s): Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if an anti-inflammatory drug, called infliximab,
      will reduce inflammation in the synovial lining in patients with an early stage of
      osteoarthritis of the knee. It will also help determine if the study medication decreases the
      accumulation of synovial fluid and prevents cartilage breakdown.
    

Detailed description: 
      This is an unbalanced randomized, double-blind pilot study of Infliximab (100 mg), placebo
      (100 mg) and Methylprednisolone acetate (80 mg). A total of 16 subjects will be randomized; 8
      subjects will be randomized to receive infliximab, 4 subjects will be randomized to receive
      placebo and 4 additional subjects will be randomized to receive Methylprednisolone acetate.
      Subjects will be seen at screening, day 0, day 14, day 28 and day 56. After study drug
      injection at day 0, patients will return for follow-up visits at approximately 2 weeks, 1 and
      2 months in order to obtain clinical endpoint measures for a total of 10 weeks. Outcome
      measures include blood tests, MRI, ultrasound, synovial lining tissue biopsy questionnaires
      and adverse events.
    

Intervention name(s): Infliximab; Placebo; Standard of Care: Methylprednisolone acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): the study drug will be injected into the joint through a needle; the placebo will be injected into the joint through a needle; Methylprednisolone acetate will be injected into the joint through a needle
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Infliximab; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild to moderate osteoarthritis of the knee
Chronic Hand Eczema - Self-management and Prognosis
Condition: Chronic Hand Eczema; Chronic Hand Dermatitis
MeSH terms: Dermatitis; Eczema
Study type: Interventional

Summary: 
      Hand eczema is a common disease which often gives a chronic course thus affecting many
      functions in daily life. The body of evidence related to self-management of chronic hand
      eczema is poor. Better methods to support self-management of patients with chronic hand
      eczema may potentially improve the prognosis of a disease which is both a tremendous burden
      to the individual and to the society. The purpose of this trial is to evaluate the effect of
      a newly designed guidance programme offering individual counselling compared to conventional
      information with written information sheets.
    

Detailed description: 
      Detailed description of the trial and the intervention can be found in the publication:

      Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a
      study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi:
      10.1186/1471-5945-12-6.

      PMID: 22691871 [PubMed - indexed for MEDLINE] Free PMC Article
    

Intervention name(s): Healthy Skin Clinic
Intervention type(s): Behavioral
Intervention description(s): The intervention is founded upon three concurrent elements. Firstly, a SKIN-profile generated by data from a baseline questionnaire (S=Susceptibility, K=Competencies, I=Individual characteristics, N=Necessary precautions).
Secondly, a patient self-management book which includes a patient's log and is offered in both an online and a physical form. Also support to self-management is offered through possible asynchronous communication and networking.
Finally, a counselling consultation with a nurse, trained within dermatology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hand eczema; Hand dermatitis; Chronic hand eczema; Chronic hand dermatitis; Contact dermatitis; Skin disease; Self-management
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Condition: Bipolar Disorder
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the efficacy and safety of combination therapy with divalproex and
      lithium for treating mania in people with rapid cycling bipolar disorder and a substance
      abuse disorder.
    

Detailed description: 
      Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual
      Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who
      currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who
      have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol
      within the past six months. Patients are initially stabilized on dual therapy of lithium and
      depakote and then randomly assigned to double-blind treatment with either lithium monotherapy
      or continued dual therapy. Patients remain in the study for six months or until they
      experience a relapse. Patients in this study are required to bring a friend or family member
      to all study visits as well as attend chemical dependency services. This study is sponsored
      by the NIMH. Subjects receive study-related care at no cost.
    

Intervention name(s): Lithium; Divalproex; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.; Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.; Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
Other intervention name(s): Lithium Carbonate; Valproic Acid; Depakote
Intervention MeSH terms: Valproic Acid; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      Investigator initiated retrospective chart review to study the effects of changing suture
      material on the healing and outcome of cleft palate surgery were.
    

Detailed description: 
      This study aims to show what the effects of changing suture material were on the healing and
      outcome of cleft palate surgery. The study will be considered successful if we find that
      either there is an effect on the healing after surgery, one of the suture materials seems to
      promote better healing and final outcome, or that there is no difference between the suture
      materials.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        UCDMC pediatric clinic
      
Keywords: cleft palate; suture materials
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
Condition: Aorta, Thoracic Pathologies; Aortic Aneurysm, Thoracic; Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and performance of Relay Pro and Relay
      NBS Pro devices in humans having thoracic aortic pathologies.

      Clinical results will be used to apply for the CE certification.
    

Detailed description: 
      This is a prospective, multicenter, non-randomized, single arm clinical study in patients
      presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are
      planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on
      routine clinical assessments performed as part of the patients' standard care will be
      screened after obtaining the informed consent from the patients, and if eligible, enrolled
      and scheduled for the implantation procedure with the study device.

      Following a baseline assessment, the implantation procedure will be performed according to
      the Instructions for Use and local routine practice. A follow-up visit will be performed 30
      days after the implantation procedure. The investigator will perform assessments of the
      implantation procedure and device system and document adverse events and device deficiencies.
    

Intervention name(s): Thoracic Endovascular Aortic Repair (TEVAR)
Intervention type(s): Device
Intervention description(s): thoracic endovascular repair (TEVAR) with a thoracic stent-graft
Other intervention name(s): RELAY PRO STENT GRAFT; RELAY NBS PRO STENT GRAFT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Relay Pro and Relay NBS Pro device
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Gum Disease Treatment on Host Defense Factors
Condition: Periodontitis; Diabetes Mellitus
MeSH terms: Periodontitis; Diabetes Mellitus
Study type: Interventional

Summary: 
      Human immune system produces many different factors, which will influence health-disease
      statuses. This partially explains why under similar conditions only some people become sick.
      Therefore, specific analyses of such factors in healthy and diseased patients are crucial for
      a better knowledge about diseases development and successful treatments. Human beta defensins
      (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high
      levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of
      infections associated with diabetic wounds. This study will evaluate if treatment of the most
      common gum disease in adults influences production of beta defensins by gingiva. Also,
      clinical improvements and treatment effects on blood glycemic levels will be monitored
      throughout a 2-month period. Patients with or without gum diseases and with or without
      diabetes mellitus will be able to participate. After a complete oral examination to determine
      periodontal status, gingival fluid samples will be collected using paper strips. These
      samples will be collected before and also two-months after oral treatment and will be
      analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In
      weekly sections, one trained specialist will performed treatment of gum diseases under local
      anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would
      be lower in the presence of periodontal disease when compared to a healthy periodontal
      condition; b) diabetes would influence production of these immune protective factors; and c)
      treatment would provide a greater beneficial amount of defensins.
    


Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Beta-defensins; Chronic periodontitis; Diabetes mellitus; Non-surgical periodontal therapy