bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Clinical Study of Different Caries Removal Techniques in Pediatric Patients
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the acceptance of pediatric patiens using Er: YAG laser
      in comparison with the conventional techniques for caries removal.

      The study was carried out on 100 children between the ages of 9-12, who had class 1 occlusal
      caries in one of their permanent first molars. The patients were divided into two groups;
      conventional technical group and laser group. Rotary handpieces was used in conventional
      technique group, Er:YAG laser was used in the laser group for caries removal. The heart rate
      of each patient was measured during the caries removal procedure at 30 seconds intervals. The
      pain during the procedure was determined by VAS. CFSS-DS scale was used to determine the
      anxiety level of the patients before and after the procedure. FIS was used to determine how
      patients are disturbed from the smell, taste, sound, vibration and sight of the devices after
      the procedure. The video segments were collected from the patients during the caries removal
      and the procedural pain were evaluated by the FLACC scale.
    

Detailed description: 
      Based our results, ın the laser group, the patients were found to experience less pain and
      discomfort compared to conventional technique according to the VAS and FLACC scores. The rate
      of patients with dental anxiety decreased significantly in the laser group compared with the
      conventional group according to CFSS-DS performed after the procedure. According to the
      sensory survey, the laser group had good acceptability compared to the conventional technique
      group in terms of vibration and sight. The laser group showed a lower percentage increase in
      heart rate comparsion between beginning and end of procedure. It was observed that the cavity
      preparation time was longer in the laser group.
    

Intervention name(s): Rotary handpieces; Er:YAG laser
Intervention type(s): Device; Device
Intervention description(s): Dental Caries removal; Dental Caries removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Er:YAG laser; Caries removal; Dental anxiety; Acceptability
Effect of the XP1100RF Therapy on Thighs Circumference Reduction
Condition: Thighs Circumferential Reduction; Subcutaneous Fat Cell Disruption
Study type: Interventional

Summary: 
      This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive
      temporary reduction of thighs circumference by disruption of adipocyte cells.
    

Detailed description: 
      This study is a prospective, single-arm, open label study of thighs circumference reduction
      following 4 treatment sessions delivered once a week over a 4-week period. The objective of
      the study is to demonstrate the effectiveness of the treatment after 30-day in achieving
      thighs circumference reduction of ≥1 cm relative to the base line assessment.
    

Intervention name(s): XP1100RF
Intervention type(s): Device
Intervention description(s): Treatment of adipose tissue within the fat layer with XP1100RF device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fat Reduction; Lipolysis
Comparison of Instillation and Packing in Mydriasis for Premature Infants
Condition: Preterm Infants
MeSH terms: Mydriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1%
      tropicamide by conventional instillation and lower conjunctival fornix packing in premature
      infants.
    

Detailed description: 
      Adequate pupil dilatation was needed for screening and treatment of retinopathy of
      prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were
      instilled many times until the pupil reached the maximum size. However, poor mydriasis were
      found in many eyes despite maximum instillation was used. From the clinical observation, we
      found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to
      dilate the pupil than instillation in some patients. The purpose of this study was to compare
      the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation
      and lower conjunctival fornix packing in premature infants.
    

Intervention name(s): 1% tropicamide and 2.5% phenylephrine
Intervention type(s): Drug
Intervention description(s): For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tropicamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: preterm infants; mydriasis; pupil dilation
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Condition: Hypothalamic Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label, single-arm study designed to evaluate the body weight response to setmelanotide
      administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
    


Intervention name(s): Setmelanotide
Intervention type(s): Drug
Intervention description(s): Setmelanotide for SC injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb
      Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with
      Psoriasis Vulgaris
    


Intervention name(s): TC cream; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): A well-characterized botanical drug for topical treatment of psoriasis vulgaris; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The prevalence of type 2 diabetes (T2D) is increasing worldwide, with ~380 M currently
      suffering from this chronic, debilitating disease. T2D is characterized by high blood glucose
      levels in the mornings and after meals. The largest hyperglycemic spike often occurs after
      breakfast. Targeting this meal may be a simple, feasible strategy to improve glycemic control
      and reduce risk for diabetes complications. It is hypothesized that consuming a low
      carbohydrate high fat (LCHF) breakfast for 3 months, when compared to a standard low-fat
      breakfast will improve blood glucose control, increase satiety and improve body composition
      in people with T2D. This information will test whether the simple dietary strategy of
      limiting carbohydrates at breakfast could help in managing T2D.
    

Detailed description: 
      A 3-month parallel-group randomized controlled trial will be conducted. Eligible participants
      will be randomized to either the Low-carb High-fat breakfast (LCHF, n=41) or a low-fat
      "standard care" control breakfast (CTL, n=41), to be consumed daily for a period of 3 months.

      Due to COVID-19 pandemic, this study was adapted to be conducted remotely through
      video/telephone conference meetings between participants and study staff, along with mailing
      of study materials before and after the intervention for remote data collection.

      Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which
      to choose each morning. Breakfast options (designed by a registered dietitian) will be
      controlled in macronutrient content and calories (~400-500 kcal), but allow for personal
      preference and autonomy to promote adherence.
    

Intervention name(s): Low-Carb High-Fat breakfast; Low fat "standard care" control breakfast
Intervention type(s): Other; Other
Intervention description(s): Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.; Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Condition: Tuberculosis, MDR
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and
      development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with
      the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded
      initiative on the development of new Anti-TB drug to treat drug-resistant forms of this
      infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original
      drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).
    

Detailed description: 
      Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter,
      placebo-controlled (add-on), double-blind and two arms trial.

      The study consists of two following phases: treatment phase - 6 months and follow-up phase 12
      months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.

      All data will be compiled in an Electronic Data Capture System with further statistical
      analysis according to approved Statistical Analytical Plan.
    

Intervention name(s): FS-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.; Placebo without any active pharmaceutical ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tuberculosis; Multi-drug resistant TB; TB treatment
Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      It is known that individuals with spinal cord injury are at increased risk for respiratory
      tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal
      muscles that are vital to deep breathing and the ability to cough. The purpose of this study
      is to look at the effectiveness of two different treatments in preventing pneumonia and other
      respiratory problems in persons with SCI.

      This is a randomized controlled trial investigating the effectiveness of two different
      treatments. Participants will be randomly assigned to one of the two treatment groups. They
      will not be told the details of the other intervention since this could influence or change
      their activities during the study.
    


Intervention name(s): Manual and mechanical assisted cough; Incentive spirometry
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will be given a pulse oximeter and taught both manually assisted and mechanically assisted coughing techniques to maximize their cough. Manually assisted coughing consists of air stacking to deep insufflations. An abdominal thrust is then applied upon glottic opening to augment the cough. These subjects will also have rapid access to a mechanical in-exsufflator (CoughAssistTM) and will be trained on how to access and use this device. Mechanically assisted coughing (MAC) involves the use of the CoughAssistTM to expand the lungs and then quickly reverse the pressure to rapidly empty the lungs with expiratory (cough) flows of 600 L/m. An abdominal (manual) thrust is applied in conjunction with the negative pressure (exsufflation) to further increase cough.; These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Other intervention name(s): CoughAssistTM; In-exsufflator; spirometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Spinal cord injuries; Cough; Peak cough flow; Respiratory therapy; Rehabilitation
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
Condition: Subcutaneous Fat
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending
      dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD
      part will involve 9 proposed dosing cohorts.
    

Detailed description: 
      The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind,
      randomized (except Cohorts 6 to 9 [open-label]) study in healthy subjects to evaluate the
      safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the
      Phase 2a part of the study.
    

Intervention name(s): CBL-514, placebo; CBL-514, placebo; CBL-514
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
Which side of the abdominal region to receive CBL-514 or placebo would be randomized.
No PK samples will be collected in this cohort.; One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
Which side of the abdominal region to receive CBL-514 or placebo would be randomized.; Both sides of the abdominal region will receive CBL-514.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
Condition: NAFLD( Non-alcoholic Fatty Liver Disease )
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a
      Chinese herb formula.
    

Detailed description: 
      1) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2)
      Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a
      euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3)
      Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating
      levels of adipokines.
    

Intervention name(s): Chinese herb (YiQiSanJu)
Intervention type(s): Drug
Intervention description(s): Chinese herb formula:Huangqi,huanglian,yinchen,ect
Other intervention name(s): YiQiSanJu Formula
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and
      effective for capturing fecal residues of moxifloxacin in healthy volunteers.
    

Detailed description: 
      The aim of the study is to evaluate the performances of different DAV132 dose regimens in
      healthy volunteers:

        -  To capture antibiotic residues in the colon without interfering with its systemic
           pharmacokinetics.

        -  To prevent antibiotic-induced changes of the intestinal microbiota. In addition, the
           security of DAV132 given at different dose regimens during 7 days will be evaluated.

      This is a prospective, randomized, controlled, repeated doses, 12 parallel groups, open-label
      study, blinded to analytical and microbiological evaluations.
    

Intervention name(s): Moxifloxacin; DAV132; Negative control
Intervention type(s): Drug; Device; Other
Intervention description(s): Oral route; Oral route; Oral route
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
BRAF V600E and Redifferentiation Therapy in Radioiodine-refractory Papillary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Observational

Summary: 
      Papillary thyroid cancer (PTC) is the most common neoplasia in the thyroid gland. The
      combination of surgery, followed by radioiodine therapy (RIT) and thyroid-stimulating hormone
      (TSH) suppressive therapy is usually a curative option for differentiated thyroid cancer
      (DTC). Although DTC has a good prognosis generally, it is problematic when dedifferentiation
      is suspected and radioiodine refractoriness presumed. One possible therapy option for
      redifferentiation is the pretreatment with retinoids. From 2008 to 2014 there were 13
      patients with PTC who were treated with retinoids after thyroidectomy before a further course
      of radioiodine. A recent study has shown that the efficacy of Selumetinib, another option for
      redifferentiation depends on the mutational status of the treated patient. In this
      retrospective study the investigators looked for a similar association between BRAF V600E and
      redifferentiation therapy with retinoids. As retinoids have fewer side effects compared to
      TKI, it is worth performing studies to assess the importance of genetic marker for the
      response and to estimate the chances of this specific patient collective. BRAF V600E seems to
      be associated with better long-term response after redifferentiation therapy with 13-cis RA
      in RAI-R PTC. Therefore, evaluation of BRAF mutational status prior to redifferentiation
      therapy could be beneficial for predicting response.
    


Intervention name(s): Redifferentiation with retinoid acid
Intervention type(s): Drug
Intervention description(s): In this retrospective study, patients with radioiodine refractory papillary thyroid cancer routinely received (clinical indication, no study medication was given) retinoid acid for redifferentiation prior to further course of radioiodine therapy.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Twelve patients with radioiodine-refractory papillary thyroid cancer were treated with
        retinoic acid before a further course of radioiodine therapy. One patient had to be
        excluded from the analysis due to missing data in this retrospective analysis. Furthermore,
        they were compared with twelve patients with radioiodine-sensitive thyroid cancer who were
        considered as cured after a maximum of two radioiodine therapies.
To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
Condition: Dental Implants; Alveolar Mucosa
Study type: Interventional

Summary: 
      This study will compare two commonly used soft tissue grafting techniques (free gingival
      graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental
      implants with a lack of keratinized mucosa.

      To investigators knowledge, these 2 types of grafts have not been compared for differences in
      clinical (amount of KM increase, tissue thickness increase and esthetics) and
      patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
    

Detailed description: 
      Research data and daily clinical observations reveal that implants with lack of surrounding
      keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more
      prone to persistent gingival inflammation, faster disease progression and compromised plaque
      control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant
      soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding
      implants in question. While FGG is typically associated with higher postoperative discomfort
      than CTG, it has also been considered the gold standard in the treatment of these clinical
      conditions.

      Specific aims for this project include the evaluation of:

        -  KM width at 6 and 12 months following grafting with FGG and CTG

        -  Change in tissue thickness of the grafted sites at 6 and 12 months

        -  Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month

        -  Patient centered outcomes including pain, bleeding, swelling and change in daily
           activities at 1 week for both groups and at 1 month for the CTG group
    

Intervention name(s): Free Gingival Graft (FGG); Connective Tissue Graft followed by Laser Gingivoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Free Gingival Graft (FGG) was performed on all study sites in this arm.; Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
Other intervention name(s): palatal autogenous soft tissue graft; palatal autogenous subepithelial soft tissue graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keratinized tissue; Keratinized mucosa; Attached mucosa; Dental implants; Free gingival graft; Connective tissue graft; Patient-centered outcomes