bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa:
      carbon dioxide (CO2) laser excision versus surgical deroofing.
    

Detailed description: 
      -  We will be treating patients with Stage 2 (interconnected sinus tracts and nodules)
           hidradenitis suppurativa who have somewhat active involvement (including drainage) in
           the axillae. We will only be treating ONE axilla per patient.

        -  After patients are screened and deemed appropriate candidates, they will be randomized
           to a treatment group: CO2 laser excision or surgical deroofing.

        -  For each patient, there will be a single intervention (either CO2 laser excision or
           surgical deroofing), after which there will be 5 planned follow-up appointment at
           following intervals: 1 week, 2 weeks, 4 weeks, 3 months, 6 months. This will take place
           over course of 6 months for each patient.

        -  During the study, subjects will be asked to provide information on quality of life
           measures, and filling out questionnaires (DLQI and Skindex29) at each visit.

        -  Inclusion criteria:

             1. Be at least 13 years old and have a diagnosis of hidradenitis affecting the
                underarms.

             2. Agree to follow and undergo all study-related procedures, and follow-up over six
                month period.

        -  Exclusion criteria:

             1. Patients who have already undergone surgical excision to affected area.

             2. Patients who are pregnant or breast feeding will not be able to take part in the
                study due to the unknown effects of CO2 laser in pregnant females, as well as risk
                of lidocaine use during pregnancy and breastfeeding

             3. Patients with a history of allergy to lidocaine or topical anesthetics will not be
                able to take part in this study.

             4. Patients with a history of vitiligo as the CO2 laser may cause new spots of
                depigmentation.

             5. Patients with a pacemaker/defibrillator in place.
    

Intervention name(s): CO2 (carbon dioxide) laser; Surgical Deroofing
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hidradenitis suppurativa
Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety and tolerability of the first IV dosing of SLV338 in
      healthy volunteers.
    


Intervention name(s): SLV338; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 - 1000 mg IV; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SLV338; phase I; healthy volunteers
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
    


Intervention name(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dietary Protein Requirements on Unbalanced Diets
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to determine ad libitum daily energy and protein intake,
      energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12
      consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.
    

Detailed description: 
      Following the protein leverage hypothesis, energy intake may be a derivative of protein
      intake. Therefore, in response to an unbalanced menu relative to the usual daily intake
      target, protein intake should be prioritized. Individuals may over-consume carbohydrate and
      fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily
      intake target amount of protein is ingested, and not the target of total energy intake
      because of a deficit of protein intake. In contrast, individuals may under-consume energy
      when the menu has an increased protein to carbohydrate and fat ratio. The protein leverage
      hypothesis requires evidence for why protein intake is more important than carbohydrate or
      fat in relation to food intake regulation.
    

Intervention name(s): Differences in protein content of meals
Intervention type(s): Dietary Supplement
Intervention description(s): Differences in protein content (energy percent) of meals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Energy intake; Protein requirement; Satiety; Protein leverage hypothesis
Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade UTUC
Condition: High-Grade Upper Tract Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin
      (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the
      overall survival for high-grade upper tract urothelial carcinoma.
    

Detailed description: 
      The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin
      (Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles) for 2-4 cycles
      can help shrink the tumor before undergoing surgery and improves the overall survival for
      high-grade upper tract urothelial carcinoma.
    

Intervention name(s): Radical nephroureterectomy; Distal ureterectomy; Neoadjuvant Chemotherapy
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff; Distal ureterectomy.; Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.
Other intervention name(s): GC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant chemotherapy; upper tract urothelial carcinoma
Oral and Gut Microbiota Changes During Long-term Fasting in Humans
Condition: Healthy; Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of this longitudinal trial is to investigate the effects of a 10±3-day fasting period
      in 30 subjects. Changes in the oral and gut microbiota, halitosis, as well as inflammatory
      and antioxidative parameters and biomarkers of sulfur metabolism will be analysed.
    

Detailed description: 
      Fasting has been linked with changes in gut microbiota as part of the physiological
      adaptation. Furthermore, associations have been described between oral disease and nutrition
      (diet rich in carbohydrates). The aim of the present longitudinal clinical study is to
      explore the effect of a 10±3-day fasting period on the oral and gut microbiota. 30
      systemically healthy subjects attending the Buchinger Wilhelmi Clinics for fasting, will
      participate. Changes in oral microbiota will be assessed in plaque and saliva samples and a
      number of inflammatory markers will be analyzed in Gingival Crevicular fluid (GCF) and blood
      obtained before, during and after the fasting period. The changes in the oral microbiota will
      be associated to the composition of the gut microbiota. Changes in periodontal parameters and
      halitosis related to the fasting period will be further evaluated. Given the known
      association between sulfur metabolism and the redox status, parameters from the antioxidant
      status and oxidative damages will also be assessed.
    

Intervention name(s): Long-term fasting
Intervention type(s): Procedure
Intervention description(s): The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.
Intervention model: Single Group Assignment
Intervention model description: single-arm, prospective, monocentric, interventional study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oral microbiota; intestinal microbiota; inflammatory status; redox status; sulfur metabolism; halitosis
Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove that the group treated with CKD-501 in combination
      added that the reduction of glycated hemoglobin superior to placebo treated group added in
      combination.
    

Detailed description: 
      The aim of this phase III study was to evaluate the efficacy and safety of additional
      combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not
      adequately controlled for blood glucose by the combination of D150 and D745 10mg .

      Furthermore, the extension study for additional 28 weeks is designed to confirm long term
      safety of CKD-501 as an oral hypoglycemic agent.
    

Intervention name(s): CKD-501 0.5mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745; orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
Other intervention name(s): Lobeglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial
Condition: Elective Cesarean Section
Study type: Interventional

Summary: 
      In this prospective, randomized, placebo controlled trial the investigators were able to
      demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus
      placebo, irrespective of the timing of administration, ie before skin incision or after
      umbilical cord clamping
    

Detailed description: 
      Background. Perioperative antibiotic prophylaxis during elective cesarean section at term to
      reduce postoperative maternal infectious morbidity is generally used but may not be efficient
      based on the available data. Also, the optimal timing of prophylactic antibiotic
      administration is unclear.

      Methods. The investigators compared the effectiveness of cefazolin, administered before skin
      incision versus after umbilical cord clamping versus placebo in a three-arm randomized trial.
      The primary endpoint of the study was postoperative infectious morbidity, defined as wound
      infection, endometritis, or urinary tract infection. Results: The primary outcome was
      observed in 18/370 women in group 1 (4.9%) and in 14/371 women in group 2 (3.8%), whereas it
      was noted in 45/371 women in group 3 (12.1%; p<0.001 for group 1 vs. group 3; p<0.001 for
      group 2 vs. group 3; p<0.001 for group 1 vs. group 2 vs. group 3). The number needed to treat
      to avoid one primary outcome was 13. Comparing groups 1 and 2, there was no statistically
      significant difference regarding the primary outcome (p=0.6).

      Conclusions. In this prospective, randomized, placebo controlled trial the investigators were
      able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section
      versus placebo, irrespective of the timing of administration, ie before skin incision or
      after umbilical cord clamping.
    

Intervention name(s): Keflex; Keflex; saline solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2g of i.v. cefazolin singleshot administered before skin incision; 2g of i.v. cefazolin singleshot administered after umbilical cord clamping; 100cc administered before skin incision
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: elective cesarean section; antibiotic prophylaxis; cefazoline; wound infection
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
Condition: Alcohol Use; Smoking; Contraception
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Choices Plus, a randomized controlled study, will determine the efficacy of the Project
      CHOICES intervention plus a referral to an evidence-based smoking cessation program in
      reducing the risk of alcohol- and tobacco-exposed pregnancies.
    

Detailed description: 
      This randomized controlled study will examine the effect of the ChoicesPlus intervention
      compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels;
      increasing consistent use of effective contraception; increasing engagement in smoking
      cessation treatment and increasing smoking cessation. In addition, our examination of the
      incremental costs of the ChoicesPlus intervention (e.g., staff time, materials,
      administrative services, total medical charges pre- and post-intervention) will provide a
      basis for future cost/benefit analyses that will inform policymakers and healthcare
      organizations of the potential benefits of implementing ChoicesPlus. Results from this study
      will inform and advance future efforts in the service of promoting healthy prenatal behavior
      and reducing the prevalence of alcohol and tobacco-exposed pregnancies.
    

Intervention name(s): Choices Plus; Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.; Participants are provided with informational materials about healthy lifestyle and local resources.
Other intervention name(s): Treatment As Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: alcohol-exposed pregnancy; tobacco-exposed pregnancy; alcohol; contraception; smoking; pregnancy
Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects
Condition: Healthy; Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study was to assess the acute effects of increasing doses of pinitol on
      glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after
      consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.
    


Intervention name(s): Pinitol
Intervention type(s): Dietary Supplement
Intervention description(s): Three doses of Fruit Up® (diluted with mineral water to a final volume of 330 ml) were evaluated, and were equivalent to an intake of 2.5, 4.0 and 6.0 g of pinitol. The placebo beverage contained equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Other intervention name(s): 3-O-methyl-D-chiro-inositol
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Glucose; Insulin; 3-O-methyl-D-chiro-inositol
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Condition: Adenoid Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic
      regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and
      to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home
      following surgery.
    


Intervention name(s): Dextromethorphan; Acetaminophen; Dexmedetomidine; Ketamine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Preoperative oral dextromethorphan 1 mg/kg; Preoperative oral acetaminophen 15 mg/kg; Intraoperative intravenous dexmedetomidine 0.5 μg/kg; Intraoperative intravenous ketamine 0.5 mg/kg
Other intervention name(s): Robitussin; Tylenol; Precedex; Ketalar
Intervention MeSH terms: Acetaminophen; Dexmedetomidine; Ketamine; Dextromethorphan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
Condition: Metrorrhagia; Menorrhagia; Leiomyoma; Adenomyosis; Pelvic Pain; Endometriosis; Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Leiomyoma; Endometriosis; Adenomyosis; Menorrhagia; Metrorrhagia; Pelvic Pain
Study type: Interventional

Summary: 
      The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety,
      and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to
      abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through
      a randomized surgical trial.
    

Detailed description: 
      The overall hypothesis is that neither mode of hysterectomy will be consistently superior to
      the other with respect to each of the three domains of complications, cost, and
      patient-centered outcomes. The overall goal of the study is to determine which clinically
      relevant factors may impact the choice of LH compared to AH. The results of the study may be
      useful for clinicians, patients, hospital administrators and health policy makers.
    

Intervention name(s): Laparoscopic hysterectomy; Abdominal hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): LAVH, TLH; TAH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Comparative effectiveness; Surgical success
Fatty Liver and Obstructive Sleep Apnea
Condition: Non-Alcoholic Fatty Liver Disease; Obstructive Sleep Apnea
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities
      in liver enzymes can improve following continuous positive airway pressure in patients with
      obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes.
      We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver
      changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this
      reduction can be evident using computerized tomography
    


Intervention name(s): Continuous positive airway pressure
Intervention type(s): Device
Primary purpose: Treatment
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to verify non-inferiority of survival time between
      Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable
      advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of
      responses, time to progression (TTP) safety and quality of life (QOL).
    


Intervention name(s): Isovorin; TS-1
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer; Advanced/Recurrent Gastric Cancer
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Condition: Needlestick Injuries
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      This study will investigate the influence of lidocaine temperature on pain during injection
      of lidocaine. Each participant will receive three injections subcutaneously on the abdomen
      with different temperatures. After each injection, participants will be asked to evaluate the
      pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with
      increasing temperature. The aim of the study is to find a simple method for pain reduction
      that can be used in clinical practice.
    


Intervention name(s): Low temperature lidocaine injection; Room temperature lidocaine injection; Body temperature lidocaine injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 4 °C; 20 °C; 37 °C
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Injections; Temperature; Pain; Healthy volunteers; Lidocaine