bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars
Condition: Tooth Extraction; Molar, Third; Pain, Postoperative; Trismus; Edema; Anxiety
MeSH terms: Trismus; Pain, Postoperative; Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study was to compare the effect of acupuncture and placebo acupuncture for
      the control of pain, edema, and trismus following the extraction of third molars and control
      of preoperative anxiety. Patients who met the study criteria were randomized to the type of
      acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery
      (right or left).
    

Detailed description: 
      Studies using acupuncture have shown promising results in the control of pain, edema, trismus
      and anxiety control. The use of this technique is interesting considering the negative
      effects of excessive use of medicines and the side effects of medications which are the most
      common treatment used for the control of these complications. However, there are no reports
      in the literature that evaluated the effects of acupuncture on the control of these variables
      following mandibular third molar extraction, using the placebo-needle design and blinding the
      patients, operators, and evaluators. Therefore, the aim of this split-mouth randomized
      triple-blind clinical trial was to compare the efficacy of acupuncture and placebo
      acupuncture for the control of pain, edema, trismus and preoperative anxiety in the
      extraction of third molars.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): The application of acupuncture was performed in four sessions, 30 minutes prior to surgery, 24, 48 and 72 hours following the surgery, before variables measurements. The points were manually stimulated and the needles were inserted up to 4mm. There were 11 points, applied bilaterally, two of them, point VG20 and Yintang, for anxiety control, only at the preoperative time and not bilateral. The points to reduce pain, edema, and trismus were IG4 (Hegu), F3 (Taichong) and E44 (Neiting), TA21 (Ermen), ID19 (Ting-Kong), E6 (Jiagle) and E7 (Towei) , point B60 (Kunlum) and VB34 (Yanglingquan). All patients received the same treatment in all sessions.
After the needle devices were inserted, the needles were re-stimulated manually once after 10 minutes and removed after more 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: third molar; acupuncture; pain; edema; trismus; anxiety
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
Condition: Breast Cancer; Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the
      low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in
      subjects with triple-negative breast cancer in neoadjuvant settings.
    


Intervention name(s): Carboplatin; Paclitaxel; Doxorubicin; Cyclophosphamide; Pegfilgrastim; Filgrastim
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links.; Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.; Inhibition of DNA and RNA synthesis by intercalation between DNA base pairs by inhibition of topoisomerase II and by steric obstruction. Doxorubicin intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA. Doxorubicin is also a powerful iron chelator; the iron-doxorubicin complex can bind DNA and cell membranes and produce free radicals that immediately cleave the DNA and cell membranes.; Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. Cyclophosphamide is a prodrug that must be metabolized to active metabolites in the liver.; Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.; Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
Other intervention name(s): Adriamycin; Doxil; Caelyx; Myocet; cytophosphane
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Pharyngeal Inhibition by rTMS on Swallowing Function
Condition: Oropharyngeal Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis that rTMS on the dominant swallowing
      hemisphere is able to modify swallowing coordination.
    

Detailed description: 
      The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the
      nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on
      healthy subjects. Swallowing function will be studied before and after rTMS with
      videomanometry.
    

Intervention name(s): magnetic stimulation
Intervention type(s): Procedure
Intervention description(s): rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: neuromodulation; swallowing; magnetic stimulation; healthy subjects
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      User questionnaire of Eeva System usability and reports of device malfunctions.
    

Detailed description: 
      This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine
      procedures. The fertilized eggs will be placed in an Eeva dish and the development of the
      embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo
      culture, Eeva blastocyst prediction data will be printed from the system to be used to assist
      the embryologist in selecting the best embryo(s). The performance of the system will be
      summarized and the user feedback from the embryologists will be collected.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in the United States who undergo IVF treatment and imaging of their embryos with
        Eeva.
      
Keywords: in vitro fertilization; assisted reproduction; noninvasive imaging of embryos; time lapse imaging of embryos; traditional morphological grading of embryos; prediction of blastocysts; infertility; Genital Diseases, Male; Genital Diseases, Female
Study of Kids Itch Severity (SKIS)
Condition: Chronic Pruritus
MeSH terms: Pruritus
Study type: Observational

Summary: 
      This purpose of this study is to validate two measures of chronic itching in kids: itch
      severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).
    

Detailed description: 
      There are many diseases that affect children where the primary symptom is pruritus. This
      study aims to validate an age appropriate pediatric version of the ItchyQoL, a
      pruritus-specific quality of life instrument, and the ItchyQuant, a self-reported itch
      severity scale, to better understand how pruritus affects the pediatric population. These
      instruments will comprehensively capture the severity and impact of pruritus in children. The
      physicians want to explore the opportunity to integrate patient-reported outcome measures
      (PROM) as a patient-reported tool in the ambulatory setting.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between the ages of 4 and 17 who have chronic pruritus (for 6 weeks or longer).
        The information detailed below is reflective of the pediatric population which is the
        primary focus of this study though the parents and clinicians will also complete surveys.
QoL and Adherence to One-pill Once-a-day HAART
Condition: HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective of the study is:

      To verify if simplification of the antiretroviral regimen, measured as the reduction of pill
      burden alone, may affect adherence rate of patients.
    


Intervention name(s): reduced number of pills
Intervention type(s): Other
Intervention description(s): Switch to a fixed dose combination one pill/daily HAART
Other intervention name(s): efavirenz EFV; emtricitabine FTC; tenofovir TDF
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adherence; Qol; virologic efficacy; immunologic efficacy; patients' preference; once-daily; HAART; treatment experienced
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the
      safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication
      efficacy in asymptomatic subjects with Helicobacter Pylori infection after multiple doses of
      TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets, or TNP-2198
      capsules combined with rabeprazole sodium enteric-coated tablets and amoxicillin capsules.
    


Intervention name(s): TNP-2198; Rabeprazole Sodium; Amoxicillin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Days 1 to 14, all subjects in each group received TNP-2198 capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.; On Days 1 to 14, all subjects in each group received rabeprazole within 30 minutes before breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes before breakfast.; On Days 1 to 14, all subjects in each group received Amoxicillin capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
Other intervention name(s): Rifasutenizol
Intervention MeSH terms: Amoxicillin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Condition: Schizophrenia; Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia
Study type: Observational

Summary: 
      The purpose of the study is to find and follow-up the metabolic syndrome parameters on
      patients administering atypical antipsychotics.
    

Detailed description: 
      Sampling Method Details: Group of patients using the same atypical anti-psychotic.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Non-interventional study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Female and male patients diagnosed as schizophrenia by DSM-IV criteria; Age between
             18-45 years

          -  Patients who started atypical antipsychotic drug treatment or patients who switched
             from the previous conventional or atypical antipsychotic treatment to another atypical
             antipsychotic drug treatment by the decision of their physicians in psychiatry clinics
             in state and university hospitals.
      
Biospecimen description: 
      Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol,
      triglyceride levels)
    
Keywords: Atypical antipsychotics; Metabolic syndrome; Safety
Influence of Monopoly Game on Subtle Behaviors
Condition: Psychosocial Influence on Cardiovascular Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate how social standing in a game of
      Monopoly may influence behavior.
    

Detailed description: 
      Participants will be asked to fill out questionnaires/surveys and health measures will be
      collected throughout the study visit. These health measures will include: blood pressure,
      heart rate, height/weight, waist circumference, percent body fat, resting metabolic rate, and
      salivary cortisol. Breakfast will be provided and then a 40-minute game of Monopoly™ will be
      played, and lunch will be provided after the game. Participants will be given an
      accelerometer to measure movements, and a food diary to be used for a 24-hour period. Once
      the 24-hour monitoring period has been completed, the participants will be finished with the
      study activities. The accelerometer and food diary will be returned by either bringing them
      to the investigators or mailing the items back to the investigators.
    

Intervention name(s): High Social Status Condition; Low Social Status Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be provided with a high degree of privilege in a game of Monopoly.; Participants will be provided with a low degree of privilege in a game of Monopoly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Social Status; Hispanics; Energy Balance; Stress
The Influence of Doctor-patient Communication on Patients' Willingness to Take Medication
Condition: Healthy
Study type: Interventional

Summary: 
      The experiment aims at investigating whether the doctor-patient communication has an
      influence on patients' willingness to take medication. Patients' attitude towards the
      medication is manipulated via a critical film sequence. Afterwards patients of the two
      experimental groups have a communication with one of the investigators of the study. Patients
      are told that the investigator is a medical doctor. The "doctors" either communicate in a
      patient-centered or doctor-centered style with the patient. Patients in the control group do
      not have the possibility to talk to a "medical doctor". Afterwards patients are offered the
      aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill). Pill
      intake is voluntary. The investigators hypothesize that patients in the experimental group
      with the patient-centered style of communication are more likely to take the pill than
      patients in the experimental group with the doctor-centered style of communication or
      patients in the control group.
    


Intervention name(s): Patient-centered style of communication; Doctor-centered style of communication
Intervention type(s): Other; Other
Intervention description(s): Different doctor-patient communication; Different doctor-patient communication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic
      Dermatitis patients.
    

Detailed description: 
      PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis
      patients twice daily for 8 weeks.
    

Intervention name(s): PAC-14028 cream 1.0%; PAC-14028 cream Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): topical application; topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female
      subjects with androgenetic alopecia.
    

Detailed description: 
      This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical
      Solution in male and female subjects with androgenetic alopecia.
    

Intervention name(s): ATI-50002
Intervention type(s): Drug
Intervention description(s): ATI-50002 Topical Solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccines in the United Kingdom.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7vPnC; Pediacel; NeisVac-C; Menitorix
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single 0.5 mL dose given at 2, 3, 4, and 12 months of age; Single 0.5 mL dose given at 2, 3, 4 and 12 months of age; concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age; concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age; concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Oral Contraceptives and Body Mass Index
Condition: Body Weight; Contraceptive Usage
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral
      contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
    

Detailed description: 
      This study is being conducted to understand how effective oral hormonal birth control (the
      pill) is for women with high body mass index ("BMI" - the ratio of your height and weight
      BMI"). Previous studies of birth control traditionally do not include women above a certain
      BMI number, so safety and efficacy is not clearly understood in this population, yet the pill
      is still widely used in women with high BMI.

      Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral
      contraceptives for 2 months, then randomized into two intervention arms for an additional 2
      months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH,
      FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by
      ultrasound monitoring, and cervical mucus testing will be monitored.
    

Intervention name(s): All participants (Aviane); Portia; Aviane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mcg EE/0.1 mg LNG cyclically; 30 mcg EE/0.15 mg LNG cyclically; 20 mcg EE/0.1 mg LNG continuously dosed
Other intervention name(s): Levonorgestrel and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obesity; Body weight; Oral contraception; Efficacy
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
Condition: Diarrhea; Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine
      versus placebo in the 9 week period after the third dose of the study vaccine in subjects
      with first episode of CDI receiving antibiotics standard of care.

      Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus
      placebo in subjects with first episode of CDI receiving antibiotics standard of care.
    

Detailed description: 
      This study is designed primarily to obtain information on the preliminary efficacy, safety
      and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are
      experiencing their first event of CDI and are being treated with the antibiotic standard of
      care. This study will be conducted in the United States and United Kingdom. Adult subjects
      with limited chronic disease, who are currently receiving treatment for their first episode
      of CDI will be enrolled in this trial. Subjects will be required to be able to take oral
      antibiotics.
    

Intervention name(s): 0.9% Normal Saline; Clostridium difficile toxoid vaccine; Clostridium difficile toxoid vaccine with adjuvant; Clostridium difficile toxoid vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, intramuscular on Days 0, 7, and 28; 0.5 mL, intramuscular on Days 0, 7, and 28; 0.5 mL, intramuscular on Days 0, 7, and 28; 0.5 mL, intramuscular on Days 0, 7, and 28
Other intervention name(s): Normal Saline; ACAM-CDIFF™; ACAM-CDIFF™; ACAM-CDIFF™ Adjuvant; ACAM-CDIFF™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diarrhea; Clostridium difficile infection; Clostridium difficile toxoid