bioihbjkbjnl/mcl2 huggingface dataset:
First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a new live
      attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating,
      placebo-controlled study on a genetically modified B. pertussis strain given as a single
      intranasal dose to healthy adult male volunteers.

      Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most
      vulnerable age group), preferably after a single administration very early in life. The
      successful outcome of this project would constitute an important milestone towards nasal
      vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our
      ultimate aim is to protect infants in the most vulnerable age group, before the regular
      vaccination schedule using already available vaccines is applied. The ultimate aim is thus
      not to replace current vaccination schedules with available vaccines, but to add a first
      nasal vaccination to protect very early in life.
    


Intervention name(s): BPZE1; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).; Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Live nasal vaccine for prevention of pertussis
Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
Condition: Alpha1-proteinase Inhibitor Deficiency; Emphysema
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to
      compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to
      alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of
      emphysema will be assessed by the decline of lung density, measured by computed tomography
      (CT).
    


Intervention name(s): Alpha1-proteinase inhibitor; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 60 mg/kg body weight/week intravenous; Lyophilized preparation: 60 mg/kg body weight/week intravenous
Other intervention name(s): Zemaira®
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alpha1-proteinase inhibitor deficiency; Emphysema; Chronic augmentation and maintenance therapy
The Movement Control Training Associated With Conventional Physical Therapy is More Effective Than Conventional Physical Therapy Alone in Pain and Functional Performance?
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      Assess pain, performance function, hip and knee strength and kinematics of trunk and lower
      limbs during single leg hop test after movement control training associated to hip and knee
      muscle strengthening.
    


Intervention name(s): Conventional Physical Therapy
Intervention type(s): Other
Other intervention name(s): hip abductors, lateral hip rotators and knee extensors strengthing exercises with and without weightbearing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial to Evaluate the Effect of a Probiotic in Acne
Condition: Acne; Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      A 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the
      effect of a probiotic in the clinical and subjective evolution of acne in adolescent and
      adult patients.
    

Detailed description: 
      Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in
      westernized populations. Acne pathophysiology is multifactorial and may include alterations
      of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota.
      Acne pathology shares features with inflammatory chronic conditions such as metabolic
      syndrome, obesity or diabetes.

      Probiotics are live microorganisms that when administered in adequate amounts confer a health
      benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic
      conditions, including dermatological diseases as atopic dermatitis and psoriasis. However,
      the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris
      treatment must be ascertained in humans.

      This randomized study aims to evaluate the effect of a probiotic on the treatment and
      clinical and subjective evolution of acne vulgaris.
    

Intervention name(s): Probiotic Bths-08; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks; A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Probiotic; Acne; Microbiome; Microbiota; Symbiotic
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
Condition: Healthy Volunteers (Diabetes Mellitus, Type 2)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial, two approved solutions of the medicine semaglutide will be compared in healthy
      volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions
      are comparable with regards to moving into, through and out of the body when given in two
      separate injections. Participants will receive semaglutide B and semaglutide D in different
      periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous
      injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg).
      The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the
      screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will
      have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each
      period. Participants will have to fast for at least 6 hours overnight with only water allowed
      before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1
      and Period 2.
    


Intervention name(s): Semaglutide B, 1.34 mg/mL; Semaglutide D, 1.0 mg/mL; Semaglutide D, 1.0 mg/mL; Semaglutide B, 1.34 mg/mL
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.; Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.; Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.; Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
Condition: Endocrine System Diseases; Gonadal Disorders
MeSH terms: Polycystic Ovary Syndrome; Endocrine System Diseases; Gonadal Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the effectiveness of low dose human chorionic
      gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its
      endocrine response in patients who had previously failed to ovulate on clomiphen citrate
      alone. The investigators will also compare the effectiveness and endocrine response of this
      approach with the regimen of adding HMG to clomiphen citrate.
    

Detailed description: 
      Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days)
      in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine
      Research Centre) will enroll in this prospective randomized clinical trial study and will
      randomly be divided into three groups.

      The study protocol will be assessed by an independent institutional review board and Royan
      ethics committee. All subjects will be given the written informed consent.

      Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will
      receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of
      experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human
      chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when
      the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C)
      will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG;
      Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to
      follicle size). In both experimental groups HCG administration will be continued until the
      largest follicle is 18-20 mm.

      Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum
      hormonal levels will be recorded and compared between two groups.
    

Intervention name(s): low dose human chorionic gonadotropin; Clomiphen citrate plus HMG
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate; patients will receive Clomiphen Citrate plus HMG
Other intervention name(s): human chorionic gonadotropin
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Human chorionic gonadotropin; Clomiphene citrate; chronic anovulation; Polycystic Ovary Syndrome; Follicolugenesis
Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers
Condition: Alert Fatigue, Health Personnel
MeSH terms: Fatigue; Alert Fatigue, Health Personnel
Study type: Interventional

Summary: 
      In the present study, Sponsor aim to evaluate the effects of EnXtra® as to improve Accuracy &
      Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers. A Randomized,
      Placebo-controlled, Double-blind Crossover Study of 60 randomized cross over for total study
      duration of approximately 25 days with 5 days of treatment period for each arm and 5-7 days
      wash out period between both arms.
    


Intervention name(s): Experimental: EnXtra 300 mg/ capsule; Microcrystalline cellulose (MCC) 300mg
Intervention type(s): Other; Other
Intervention description(s): One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days; One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Crossover Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.
Condition: Ventricular Tachycardia; Ischemic Heart Disease
MeSH terms: Heart Diseases; Tachycardia; Myocardial Ischemia; Coronary Artery Disease; Tachycardia, Ventricular; Ischemia
Study type: Interventional

Summary: 
      The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter
      ablation of ventricular tachycardia in patients with ischaemic heart disease can be
      effectively performed using Ripple Mapping.
    

Detailed description: 
      Patients who have ischaemic heart disease and are at sufficient risk of, or have suffered,
      ventricular tachycardia may receive implantable cardioverter defibrillator (ICD) devices. ICD
      devices provide life-saving shocks to terminate ventricular tachycardia. There is however
      substantial evidence that correlates each life-saving shock with worsening prognosis.

      Catheter ablation is a procedure that can treat the cause of ischaemic ventricular
      tachycardia (VT). Most catheter ablation procedures for ischaemic VT are performed in normal
      rhythm, with an end-point of arrhythmic substrate modification. Arrhythmic substrate
      modification refers to the process by which abnormal electrical activity in cardiac scar
      tissue (from ischaemic heart disease) is identified and treated by ablation.

      Substrate modification catheter ablation procedures for ischaemic VT have been demonstrated
      to reduce ICD shocks and VT episodes in randomised trials compared to medications. However,
      ablation procedure outcomes are still imperfect with a recurrence rate of 50-60%.

      Ripple Mapping is a method of mapping the hearts electrical signals, that may allow better
      identification of the abnormal activity within scar and so improve recurrence rates following
      ablation.

      Patients referred for ablation of ischaemic VT, who have an ICD, will undergo their procedure
      with Ripple Mapping and subsequently followed up over a year, at 3 monthly intervals. The
      main assessed outcome will be ICD or VT events over a year. This will be compared to the
      number of ICD or VT events the year prior to ablation.
    

Intervention name(s): Ripple Mapping guided ischaemic VT ablation
Intervention type(s): Procedure
Intervention description(s): Endocardial mapping of the ventricle performed with Ripple Mapping (CARTO3v6, Biosense Webster Inc). Ablation (SmarTouch Thermocool Catheter, Biosense Webster Inc) delivered to areas of abnormal "late" electrical activity within ventricular scar tissue.
Intervention model: Single Group Assignment
Intervention model description: Prospective clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventricular; Tachycardia; Ischaemic; Mapping; Ablation
Satiety and Glucose Indices in Adults
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an herb with known alpha-glucosidase
      inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and
      glucose indices in overweight/obese individuals.
    

Detailed description: 
      Subjects are randomly assigned (double blinded) to 300 mg SC, 500 mg SC or placebo using a
      cross-over design on three different days (1 month wash out). Subjects consuming a capsule
      containing placebo or treatment(s) are examined before and after a fixed breakfast meal (50%
      carbohydrate; 30% fat; 20% protein).

      Subjective appetite sensations are rated using visual analog scales (VAS) for hunger,
      satiety, fullness, and prospective food intake. In addition, the desire for specific tastes
      is analyzed and measurements are taken twice before breakfast (fasting baseline). After
      baseline screening and blood draw, postprandial appetite and taste perception ratings and
      blood will be obtained at multiple time points during the 3 hour postprandial period (30, 60,
      90, 120,180 min). Blood will be analyzed for glucose/insulin, gut peptides, and other markers
      in response to the meal.
    

Intervention name(s): 300 mg SC; 500 mg SC; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Salacia (T1) capsule given with breakfast (mixed meal tolerance test); Salacia (T2) capsule given with breakfast (mixed meal tolerance test); Placebo capsule given with breakfast (mixed meal tolerance test)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children
Condition: Gingivitis; Plaque
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction
      in gingival inflammation of a new flossing system (GumChucks®) compared to string floss, and
      to assess preference between the two flossing products in children, parents, and dentists.
    


Intervention name(s): GumChucks; String floss
Intervention type(s): Device; Device
Intervention description(s): GumChucks® is an innovative flossing system resembling mini nunchucks. The two-handle design eliminates the need to wrap the floss around fingers, and a proper flossing technique is facilitated by the nature of its curved shaped.; Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Interdental plaque; Flossing aid; Children; Gingival inflammation
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with
      primary hypercholesterolemia (high cholesterol) after eating a meal that is high in
      cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the
      cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a
      cholesterol-enriched test meal.
    


Intervention name(s): ezetimibe; Comparator: placebo
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0653
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Hypercholesterolemia
A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Classic Plus Versus YVOIRE Classic in Nasolabial Fold Injection
Condition: Wrinkles
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with
      lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).
    

Detailed description: 
      The objective of this study was to confirm the superiority of HA IDF II plus (with lidocaine)
      injected in the nasolabial fold compared to HA IDF II (without lidocaine) in the improvement
      of local pain and evaluate the wrinkle-correcting effect, GAI and safety.
    

Intervention name(s): HA IDF plus; HA IDF
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: split-face design study. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: facial nasolabial fold wrinkles
Cortisol Control of Human Inflammatory Responses to Endotoxin
Condition: Sepsis
MeSH terms: Sepsis
Study type: Interventional

Summary: 
      The purpose of the research is to study a common and dangerous medical condition called
      'septic shock' that often occurs in critically ill patients. In order to learn about septic
      shock in humans, we will administer a substance called 'endotoxin' to participants in this
      study. Endotoxin causes a temporary period of inflammation in the human body, a brief
      'virtual' infection. This is an established method for the investigation of inflammation
      properties. We are interested in how the natural hormone, cortisol, can affect the human
      response to endotoxin. We know that when cortisol is given at the same time as endotoxin it
      can decrease the inflammation that occurs due to endotoxin. In this study we will test
      whether or not cortisol, when given the day before the endotoxin, will work to change the
      inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study
      participants will receive cortisol on the day before they receive the endotoxin and one-third
      of the study participants will receive a placebo (no medication) before the endotoxin.
    


Intervention name(s): Çontrol; Hydrocortisone; Hydrocortisone
Intervention type(s): Other; Drug; Drug
Intervention description(s): Intravenous saline; Intravenous stress dose of hydrocortisone; Intravenous pharmacologic hydrocortisone
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Systemic sepsis
Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
Condition: Advanced Breast Cancer; Antibiotic; Stable Disease With a Trend of Progression
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II,single center,prospective, single arm clinical trial. The objective is to
      evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast
      Cancer whose evaluation is stable disease with a trend of progression.
    

Detailed description: 
      This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro
      and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The
      objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in
      Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
    

Intervention name(s): Moxifloxacin Hydrochloride 400mg Tablet
Intervention type(s): Drug
Intervention description(s): Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment