bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles
Condition: Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison
      study in subjects with moderate to severe forehead wrinkles.

      One botulinum toxin type A will be injected in one side of the forehead and the other one
      will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to
      each side of the forehead will be randomized.
    

Detailed description: 
      There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and
      Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways
      electrophysiologically and clinically and results obtained with one formulation cannot be
      extrapolated to the other. There are only few clinical research directly comparing the two
      formulations in the treatment of forehead lines.
    

Intervention name(s): Botulinum Toxin Type A - Azzalure; Botulinum Toxin Type A - Vistabel
Intervention type(s): Drug; Drug
Intervention description(s): One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.; One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Forehead Wrinkles Toxin
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Condition: Upper Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections; Tonsillitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or
      Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the
      SR formulation.
    


Intervention name(s): Azithromycin SR
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Overweight, Quality of Life and Psychological Difficulties in Teenagers
Condition: Obesity
Study type: Observational

Summary: 
      Obesity is a major public heath issue. It may have various impacts on a patient's life by
      causing psychological problems, altering a patient's quality of life,etc. These led to the
      investigators' hypothesis which is examining the psychological dimensions of a teenager
      suffering for obesity.
    

Detailed description: 
      There are two groups in this study : healthy volunteers and teenagers suffering from obesity.

      Patients and healthy volunteers will come to the nutrition clinic center Naturalpha where the
      patient will complete a questionnaire. The included patients will also complete a
      questionnaire privately (without the presence of the parents), they will also be weighted and
      measured.

      No further tests or questionnaires will be given after the enrollment day.
    

Intervention name(s): questionnaires about quality of life
Intervention type(s): Other
Intervention description(s): all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two categories of teenagers will be included : obese teenagers and average weighted
        volonteers
      
Keywords: Obesity; quality of life; teenagers; psychological impact
Use of Nutraceuticals in Clinical Practice
Condition: Dyslipidemias; Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Observational

Summary: 
      The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic
      actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended
      in the clinic. In particular the study will analyze how much the nutraceutical is prescribed
      and what are the purposes for which it is used and at what dosages.
    

Detailed description: 
      The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic
      actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended
      in the clinic. In particular the study will analyze how much the nutraceutical is prescribed
      and what are the purposes for which it is used and at what dosages. In particular, attention
      will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10
      mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day),
      alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10
      (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200
      mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).
    

Intervention name(s): Nutraceutical
Intervention type(s): Dietary Supplement
Intervention description(s): Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention
A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy
Condition: Unexplained Recurrent Miscarriage and Recurrent Implantation Failure
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Recurrent miscarriage(RM) and recurrent implantation failure (RIF) are clinical challenge for
      clinicians and patients who are desperate for a healthy child.The specific etiology contains
      chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders,
      reproductive system infections, autoimmune and environmental factors. However there are still
      50% to 60% RM and RIF which don't have a clear cause,mainly associated with alloimmune
      factors.Among various treatments,lymphocytes active immunotherapy is the most common
      treatment method, and its clinical efficacy is widely recognized although its action
      mechanism is not clear so far.
    

Detailed description: 
      The main mechanism of active immunotherapy includes upregulating Th2-type cytokines,
      downregulating Th1-type cytokines, making Th1 / Th2 shift to Th2, inducing maternal serum
      IL-6 and sIL6R, PIBF, EGF; inducing the expression of Fas / Fasl on lymphocyte surface;
      increasing the proportion of CD8 + cells, Th2-type cells and CD + CD25 + Treg cells,
      decreasing the activity of CD56 + CD16 + NK cell and so on.The purpose of this study is to
      observe the treatment effects of active immunotherapy on uRM and RIF patients. What's more,we
      will used flow cytometry, and quantitative real-time PCR (qPCR) methods to characterize
      Th1、Th2 and Treg cell populations after immunotherapy,ecpecting to find out the exact
      molecule mechanism of immunotherapy with paternal or third party lymphocytes.
    

Intervention name(s): low-dose lymphocyte immunotherapy
Intervention type(s): Procedure
Intervention description(s): Peripheral venous blood (PBMCs) was drawn from the husbands of uRM and RIF patients and then the PBMCs were resuspended and administered intradermally to uRM and RIF patients 3 times at 3-week intervals. Once conceived, the uRM and RIF patients undergo 2 rounds of treatment at 8-week intervals.
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uRM; RIF; Th1; Th2; Treg; lymphocyte immunotherapy
Effects of Therapeutic Mobile Game on Anxiety
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days,
      and will complete assessments measuring a broad range of anxiety and mood-related symptoms,
      with a focus on SAD symptoms, and metrics of functional impairment during this time. After
      the treatment period, participants will be followed at 6 month and 12 month after the
      completion of the study.
    

Detailed description: 
      This study aims to assess the feasibility and efficacy of the digital therapeutic ABM-01 in
      adults ages 22-65 with SAD. Participants access ABM-01 on their mobile smart phone and
      complete treatment over a period of 30 days. Enrolled participants will be randomly assigned
      to one of two groups (Experimental Group and Placebo Control) and be assessed over five
      periods of time (Baseline Session, 30-Day Treatment Phase, Post-Treatment Session, 6-Month
      Follow Up Session, 12-Month Follow Up Session).

      Participants will complete the 30-Day Treatment Phase as well as the five assessments
      remotely. During the treatment period, participants complete assessments social anxiety and
      generalized anxiety symptoms, as well as safety and medication use questionnaires.
    

Intervention name(s): ABM-01; Digital Control
Intervention type(s): Device; Device
Intervention description(s): Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT); Placebo control for ABM-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Four Different Electronic Cigarettes
Condition: Smoking
Study type: Interventional

Summary: 
      To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four
      different marketed electronic cigarettes. Furthermore, to measure overall product liking by
      subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in
      the future.
    

Detailed description: 
      This will be a single-center, randomized, open-label, parallel study during which up to 140
      healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of four (4) marketed EC products in tobacco consumers who are
      exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
    

Intervention name(s): FT21039; FT21041; FT21044; FT21042
Intervention type(s): Other; Other; Other; Other
Intervention description(s): An electronic cigarette; An electronic cigarette; An electronic cigarette; An electronic cigarette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Fallopian Tube Neoplasms
Study type: Observational

Summary: 
      This is a non-interventional, cross-sectional, multicentre, observational study planned to be
      conducted at 15 sites across all geographical regions of India. The study targets to enrol
      240 patients with approximately 16 patients from each site. Written approval of Independent
      Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from
      willing patients will be obtained prior to the start of the study.
    

Detailed description: 
      This is a non-interventional, cross-sectional, multicentre, observational study to be
      conducted at 15 sites from different geographical regions across India. The study targets to
      enrol 240 patients with nearly 16 patients per site over 6 months. The study will enrol
      females with diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study
      medication will be prescribed or administered as a part of study procedure.

      The study will start only after obtaining written approval of Independent Ethics Committee
      (IEC) / Institutional Review Board (IRB) and written informed consent of the patient.

      The study will start only after obtaining written approval of Independent Ethics Committee
      (IEC) / Institutional Review Board (IRB) and written informed consent of the patient.
      Eligible patients will undergo physical examination and data of demographics, vital signs,
      present/ past history of illness, family history of breast/ovarian cancer, current and
      previous chemotherapy regimen and current medication will be collected.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer
        patients.
      
Keywords: BRCA, ovarian cancer, fallopian tube cancer
Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial
Condition: Symptoms and Signs; Pain; Ureteral Calculi
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional

Summary: 
      Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted
      after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many
      research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a
      self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture
      reaching the bladder, showing decreased SRS and good tolerance. To date, these promising
      results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a
      marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by
      marketed PSS and conventional DJ after uncomplicated URS for stone treatment.
    


Intervention name(s): Administration of USSQ Symptoms questionnaire after stent positioning
Intervention type(s): Other
Intervention description(s): Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Symptoms and Signs; Pain; Ureteral Calculi; Ureteroscopy; Ureteral Stents
Electronic Tools to Assist With Identification of and Counseling for Overweight Patients
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to design and assess the impact of an electronic alert and tool
      set to assist with physician identification and counseling of overweight patients.
    

Detailed description: 
      Overweight adults (Body Mass Index [BMI] 25-29.9) are at high risk for developing obesity,
      but rates of physician identification and counseling of overweight adults are low. Alerts and
      tools embedded in the electronic medical record have shown promise in enhancing quality
      improvement efforts.

      Our aim is to design and assess the impact of an electronic alert and tool set to assist with
      identification and counseling of overweight patients with a BMI 27-29.9. Although the
      category of overweight patients spans BMI 25-29.9, we are including only patients with BMI
      27-29.9 in order to focus resources on the most at-risk pre-obese population.

      We will develop a tool set including the following components: automatic calculation of BMI,
      alert for overweight status, counseling template for weight loss goal-setting, linkage to
      referral options, and access to relevant patient handouts. Physicians in the Northwestern
      Memorial Faculty Foundation General Internal Medicine (NMFF GIM) practice who consent to
      participate in the study will be randomized into two groups, with one group of physicians
      receiving access to these tools. The other group of physicians will continue to provide their
      usual care for overweight patients. Outcome measures will include the following: tool usage;
      documentation of overweight in the problem list, encounter diagnosis, or note text;
      counseling for overweight and documentation of specific behavioral goals. Measures will be
      obtained via retrospective chart review.
    

Intervention name(s): Electronic tool set for counseling overweight patients
Intervention type(s): Behavioral
Intervention description(s): Physicians randomized to the "electronic tools" arm will receive access to a tool set to aid with counseling of overweight patients. This tool set includes the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians randomized to the "usual care" arm will not receive access to these tools, and will continue to provide their usual care for overweight patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Overweight; Diagnosis; Counseling; Medical Records Systems, Computerized
Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
Condition: Neoplasms
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This research involves assessment of cognitive outcome in childhood cancer as well as
      evaluation of a cognitive rehabilitation program for improving learning and problem solving
      difficulties in children with cancer.
    

Detailed description: 
      The purpose of this study is to help determine specific cognitive-behavioral and
      neurobiologic impairments associated with chemotherapy treatments in children with cancer and
      to assess the efficacy of a cognitive intervention program for improving cognitive
      impairments in these children.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.
      
Keywords: Carcinomas; Squamous Cel; Adenocarcinoma; Acute Lymphocytic Leukemia
Tumor Gene Expression in Women With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to compare changes in expression of glucocorticoid-induced genes that
      may be involved in cell survival signaling in the tumors of ovarian cancer patients before
      and after an intraoperative dose of 20mg dexamethasone.
    

Detailed description: 
      This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of
      ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken
      at the first opportune time during surgery. Dexamethasone 20 mg IV will then be administered,
      and a second biopsy taken 30 minutes later. Samples at two and four hours later will also be
      obtained if surgery is still in progress and biopsiable tumor remains. Tissue will be
      snap-frozen. Subsequently tumor will be microdissected out from stroma, and tumor RNA will be
      extracted for gene expression profiling. Sixteen patients with epithelial ovarian cancer
      receiving dexamethasone will be studied, and an additional eight patients with epithelial
      ovarian cancer will receive a small saline (placebo) injection and serve as controls.
      Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL to minimize
      any theoretical adverse effect of a single dose of dexamethasone on wound healing.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 MG OF DEXAMETHASONE OR PLACEBO; Placebo saline
Other intervention name(s): Saline Placebo
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Subject has intraabdominal disease either proven or strongly; suspected to be ovarian or primary peritoneal cancer
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin®
      cartridges (liquid somatropin) in children with growth hormone deficiency.
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists; Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the clinical research study is to assess the safety of treating
      children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will
      assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid
      Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence
      of disease flare.
    


Intervention name(s): Abatacept; Placebo; Abatacept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).; IV infusions, IV, N/A, every 4 weeks, 6 months.; Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly
Other intervention name(s): Orencia; Orencia
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Juvenile Idiopathic Arthritis