bioihbjkbjnl/mcl2 huggingface dataset:
Peri-implant Conditions Mimic Periodontal Conditions
Condition: Peri-Implantitis; Peri-implant Mucositis; Peri-implant Health; Periodontitis; Gingivitis
MeSH terms: Gingivitis; Mucositis; Periodontitis; Peri-Implantitis
Study type: Observational

Summary: 
      Except for patients with referred clinical bruxism and uncontrolled medical conditions, the
      study included 123 implants with implanted fixed prostheses that had lasted at least six
      months after functional prosthetic loading. In all implant patients, the health scale ranged
      from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth
      depth, loss of clinical attachment, and dental implants. The health and illness of the
      implants have been determined. Patients were divided into three groups: peri-implantitis,
      peri-implant mucositis, and peri-implant health.

      Inclusion Criteria:

        -  Patients between the ages of 18- 70

        -  Drugs that have a systemically healthy and controlled treatment situation

        -  Drivers who have implant-supported fixed prostheses that have been at least six months
           after functional prosthetic loading Among these groups, it was checked whether
           periodontitis was seen in patients with peri-implantitis, gingivitis in patients with
           peri-implant mucositis, and whether healthy gums were seen in individuals with
           peri-implant health.

      To determine the health and disease status of individuals' implants, plaque index (Silness
      Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket
      depth measurements, and clinical attachment level were collected.
    


Intervention name(s): disease
Intervention type(s): Other
Intervention description(s): compare to diseases
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The health and illness of the implants have been determined. Patients were divided into
        three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.
Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
Condition: Atrophy; Vaginal Atrophy; Genital Diseases, Female
MeSH terms: Genital Diseases; Genital Diseases, Female; Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the
      treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary
      endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale
      (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by
      patient filled Vulvovaginal Atrophy.
    


Intervention name(s): Pixel CO2 Laser System
Intervention type(s): Procedure
Other intervention name(s): FemiLift
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)
Condition: Amyotrophic Lateral Sclerosis (Healthy Volunteers)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1:

      This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and
      period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part
      to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule
      formulation under fasted conditions.

      Two treatments are as follows:

        -  Treatment A: SAR443820 - tablet formulation in fasted condition

        -  Treatment B: SAR443820 - capsule formulation in fasted condition Each administration
           will be a single dose of SAR443820 separated by a wash out of at least 5 days.

      Part 2:

      This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and
      period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part
      to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic
      parameters of single dose of SAR443820 in tablet formulation.

      Two treatments are as follows:

        -  Treatment C: SAR443820 - tablet formulation in fasted condition

        -  Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be
           a single dose of SAR443820 separated by a wash out of at least 5 days.

      Participants are not allowed to participate in more than one part of the study. In both Parts
      1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each
      treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult
      male and female participants.
    

Detailed description: 
      Screening period: up to 4 weeks (Day -28 to Day -2). In both Part 1 and Part 2: Period 1: Day
      -1 to Day 3 and 5 days wash out period. Period 2: Day -1 to Day 3 and until end-of-study
      visit at Day 6.
    

Intervention name(s): SAR443820; SAR443820
Intervention type(s): Drug; Drug
Intervention description(s): Tablet by oral administration; Capsule by oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vacuum Device for Hemostasis in Obstetrics and Gynecology
Condition: Primary Postpartum Hemorrhage; Administration of Sulprostone; Vaginal Childbirth
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible
      for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of
      500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours
      after delivery.

      In clinical practice, if after giving birth, the placenta is not expelled naturally, an
      active management should be triggered. After obstetric maneuvers therapeutic, options begin
      with uterotonic treatments before considering invasive treatments such as embolization,
      vessel ligation and hysterectomy. However, the morbidity associated with these techniques and
      the desire to preserve fertility mean that new therapeutic solutions have been conceived,
      which has recently led to the development of an innovative intrauterine hemostasis medical
      device : a hemostatic intrauterine suction cup.

      Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this
      biomedical research, the study of a new medical device. Our hypothesis is that the uterine
      walls will append to the walls of the suction cup after the latter is put under vacuum. The
      actuation of the suction cup will lead to the aspiration of all sides of the uterus.

      Considering that postpartum haemorrhage is an emergency situation where vital prognosis of
      the patient is engaged, we selected to collect the consent of the patient using an emergengy
      procedure.
    

Detailed description: 
      In this study, as a first pass in human of this innovative non CE marked medical device, we
      aim to demonstrate the feasibility of using the hemostatic intrauterine suction cup for
      patients who present primary PPH (blood loss ≥ 500ml) after a vaginal delivery requiring
      administration of Nalador®. We will evaluate the placement of hemostatic suction cup in the
      uterus, the application of vacuum and its removal from the uterus.
    

Intervention name(s): Hemostatic Intra-Uterine suction cup
Intervention type(s): Device
Intervention description(s): The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.
Intervention MeSH terms: Hemostatics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve
      Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed
      as a Day-Case surgery.
    

Detailed description: 
      The purpose of this study is to investigate whether the patients with morbid obesity
      requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according
      to a "day-case surgery" modality.

      The sequence of this study is the following:

        1. patients consultation for bariatric management: during this consultation, the
           investigator is looking for exclusion criteria and prescribes laboratory tests.

        2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic
           Sleeve Gastrectomy is proposed.

        3. during a second consultation, the surgeon informed the patient about the proposition of
           the staff and his potential inclusion in this study

        4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve
           Gastrectomy is done in the Day-Case Surgery Unit.

        5. the following day the surgery, a nurse calls the patient to identify a potential
           postoperative outcome (nausea, vomiting, uncontrolled pain...)

        6. the 8th postoperative day, a consultation is done with laboratory tests and dietary
           follow-up.

        7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency
           of the surgery procedure.
    

Intervention name(s): Laparoscopic Sleeve Gastrectomy
Intervention type(s): Procedure
Intervention description(s): the operative technique consists in few steps:
position of 4 trocars and insertion of a nasogastric tube
dissection and mobilization of the greater curvature of the stomach
preparation of the stomach for division
gastric partition
extraction of the gastric remnant
postoperative surveillance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Sleeve Gastrectomy; obesity management
Alcohol Metabolism and Disease Risk in Asians
Condition: Healthy
Study type: Interventional

Summary: 
      The primary pathway of alcohol metabolism involves two main enzymes, alcohol and aldehyde
      dehydrogenase. Several genes that encode these enzymes have variants that alter the rate of
      alcohol metabolism and increase levels of acetaldehyde. The variant ALDH2*2 allele is
      associated with the flushing response (i.e., Asian glow) and is found almost exclusively in
      individuals of east Asian descent. Although having variant ALDH2 alleles is protective
      against heavy drinking and alcohol use disorders, for those who do drink, these variants also
      are associated with elevations in risk for several health problems. The premise of this study
      is that we can affect early drinking behavior through personalized communication about these
      health-related risks.
    


Intervention name(s): Phenotype Feedback Intervention; Genotype Feedback Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.; Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
Other intervention name(s): PHEN; GENE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety Evaluation of a Q-fever Vaccine, NDBR 105
Condition: Q Fever
MeSH terms: Q Fever; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect
      data on incidence of occupational Q Fever infection in at risk personnel.
    

Detailed description: 
      Study Objectives:

      1. Continue to collect and assess safety data on Q Fever Vaccine, Phase I, Inactivated,
      Freeze-Dried, NDBR 105, and 2) Provide vaccine that potentially protects personnel at risk
      for occupational exposure to Q Fever and collect data on incidence of occupational Q Fever
      infection (subclinical and clinical) in immunized personnel.
    

Intervention name(s): Q Fever Vaccine (NDBR 105
Intervention type(s): Biological
Intervention description(s): Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis
Does Helipyl Eradicate
Condition: Eradication
Study type: Interventional
Phase: Phase 4

Summary: 
      Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus
      reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates
      helicobacter, which it claims to do.
    

Detailed description: 
      This is a pilot project. There is quite limited literature on this product and Helicobacter
      pylori eradication. My personal opinion is that the literature and guidelines are
      contradictory. The European guideline is that Helicobacter pylori should not be corrected
      unless there are "serious" symptoms . On the other hand, Helicobacter is a carcinogen. Quite
      often, parents ask us, children's gastroenterologists, to screen their children for
      Helicobacter because they are symptomatic and are being eradicated, and know that
      Helicobacter is contagious. This creates a difficult situation: not answering the question is
      not an option according to the parents' opinion. Going into the question and eradicating
      "classic" is against all guidelines.

      Hence this pilot project: 10 complaints-free carriers of Helicobacter pylori (> 5 years) will
      be treated with Helipyl for one month (product supplied by the company). Beforehand, at the
      end of the treatment and a month after stopping of the treatment, we do a C13 breath test.
    

Intervention name(s): lactobacillus reuteri DSMZ 17648
Intervention type(s): Other
Intervention description(s): to evaluate if this product can eradicate helicobacter pylori
Intervention model: Single Group Assignment
Intervention model description: helipyl is given to patients with non symptomatic helicobacter pylori infection
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the eradication efficacy of 10-day triple therapy
      with 10-day sequential therapy with tetracycline or metronidazole.
    

Detailed description: 
      Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori
      infection worldwide.

      Objective: To determine whether sequential treatment eradicates H. pylori infection better
      than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese
      people.

      Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary
      referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers
      and infected by H. pylori.

      Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease
      test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

      Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of
      the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus
      amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin
      (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole
      (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus
      clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as
      control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.)
      for 10 days.
    

Intervention name(s): 5RA-5RCM; 5RA-5RCT; 10RCA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.; rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.; rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.
Other intervention name(s): Pariet x 10 days; Hiconcil x 1st 5 days then; Klaricid x last 5 days +; Flagyl x last 5 days; Pariet x 10 days; Hiconcil x 1st 5 days then; Klaricid x last 5 days +; Acromycin x last 5 days.; Pariet x 10 days; Klaricid x 10 days; Hiconcil x 10 days.
Intervention MeSH terms: Clarithromycin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; antibiotic resistance; sequential therapy; Taiwan
Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects
Condition: Articular Cartilage Lesion of the Femoral Condyle
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, phase III, multicenter, open label, randomised clinical trial of
      co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product
      (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage
      defects of knee joints.

      After screening visit patients were booked for arthroscopy and at that time they were
      randomised to either ACT3D-CS with co.don chondrosphere® (Group A) or to MF(Group B), a
      marrow-stimulating method based on the penetration of the subchondral bone plate at the
      bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their
      procedure of MF (treatment surgery) and patients of group A had their cells harvested from
      healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional
      spheroids , that are transplanted in an open knee procedure (treatment surgery)into the
      defect. Patients subsequently followed the same rehabilitation program and had post-surgery
      visits. After the 12-month-visit a interim analyses will be performed and the 24-month-visit
      is defined as final assessment. Then patients have follow-up assessments up to 60 months
      post-treatment-surgery.
    

Detailed description: 
      see above
    

Intervention name(s): co.don chondrosphere®; Microfracture
Intervention type(s): Drug; Procedure
Intervention description(s): co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes. The dose depends on the size of the defect, recommended dose is 10-70 spheroids/cm2 defect.; A procedure in which the subchondral bone is perforated to allow a bloodcloth to form new tissue.
Other intervention name(s): ACT3D-CS; Subchondral drilling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage defects; Knee joint; Femoral Condyle
Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to access the safety and efficacy of multiple injections of KH902 in
      patients with Diabetic Macular Edema (DME).
    

Detailed description: 
      With improvement of our living standard, patients who suffered from Diabetes become more and
      more. As the investigators know, Diabetes can induce many ocular diseases leading to vision
      loss. And according to observations, DME is diagnosed as one main cause of vision loss in the
      patients with Diabetes.

      As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments
      show its effect and safety not only in treating AMD, but also in patients with DME. The new
      drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The
      previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the
      growth, migration, pullulation of vascular endothelial cells and neovascularization induced
      by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial
      to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.
    

Intervention name(s): KH902
Intervention type(s): Biological
Intervention description(s): Intravitreal injection of 0.5mg/eye/time KH902
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KH902; Diabetic macular Edema; Intravitreal injection; Multiple injections; 20 patients; 0.5mg/eye/time