bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation
Condition: Skin Aging; Skin Rejuvenation
Study type: Interventional

Summary: 
      Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of carbon dioxide
      gas [CO2] for therapeutic purposes. Radiofrequency (RF) is a method that uses electric
      current to generate heat into the layers of the skin and the subcutaneous tissue. Both
      techniques are indicated to the treatment of skin laxity. The aim of this study was to
      compare the effects of CA an RF on human skin. Methods: Eight patients who underwent
      abdominoplasty surgery received a single procedure of both treatments. Untreated skin was
      used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was
      performed on the right and RF on the left side. Sample collection period ranged from zero to
      120 days. CA was administered at a velocity of 40 ml/min, and the total quantity of CO2
      infused was approximately 20ml. RF was carried out in a temperature higher than 40ºC on the
      epidermis for 5 minutes after reaching this temperature.
    

Detailed description: 
      Untreated skin was used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical
      region CA was performed on the right side and RF on the left side. CA was administered using
      the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC
      and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately
      20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited are. For
      the RF treatment, the epidermal temperature was controlled using an infrared thermometer
      monitored to reach 40ºC and treatment time was of five minutes starting after having reached
      this temperature. Sample collection varied from zero to 120 days after application. The
      samples were then fixed, cut in paraffin (5 µm) and stained with Picro sirus and Weigert.
      Morphological analyses were acquired using a Zeiss Axiophot® microscope, and they were
      processed using Adobe Photoshop®.
    

Intervention name(s): Carboxytherapy; Radiofrequency
Intervention type(s): Other; Other
Intervention description(s): Carboxytherapy was performed on the right side and RF on the left side. CA was administered using the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately 20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited area.; The epidermal temperature was controlled using an infrared thermometer monitored to reach 40ºC and treatment time was of five minutes starting after having reached this temperature.
Other intervention name(s): Physical Therapy treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Carbon dioxide; Carboxytherapy; Radiofrequency
Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to assess the effectiveness of the Compound Sodium Alginate
      Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus
      in patients diagnosed with Gastroesophageal Reflux Disease (GERD).
    


Intervention name(s): Sodium Alginate Double Action Tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four tablets as a single dose; 4 tablets as a single dose
Other intervention name(s): Gaviscon Double Action Tablets
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; GERD; Acid reflux; Compound Sodium Alginate Double Action Chewable Tablet; Gaviscon Double Action Tablets
Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this phase IV study is to identify innovative early imaging parameters as
      predictors of the long-term clinical response to brolucizumab in terms of fluid resolution in
      patients with wet Age-related Macular Degeneration (wAMD) with the purpose to evaluate their
      potential in supporting the treatment regimen choice (q12w or q8w).
    

Detailed description: 
      This is a one-year, open-label, single arm, multicenter, phase IV study in patients with
      untreated active subfoveal Choroidal Neovascularization (CNV) secondary to wAMD The study
      consists of a screening period of up to 2 weeks and a treatment period with brolucizumab from
      Baseline (Day 1) up to Week 48.
    

Intervention name(s): Brolucizumab
Intervention type(s): Drug
Intervention description(s): 120 mg/ml solution for intravitreal injection
Other intervention name(s): RTH258, Beovu
Intervention model: Single Group Assignment
Intervention model description: The study is a one-year, open-label, single arm, multicenter, phase IV study in patients with wAMD.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neovascular age-related macular degeneration; anti-VEGF; brolucizumab; choroidal neovascularization; multimodal imaging biomarkers; fluid resolution; Macular degeneration; age-related macular degeneration (ARMD); vision loss; macula damage; retina damage; dry macular degeneration; wet macular degeneration; AMD
Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
Condition: Mechanical Complication of Intrauterine Device
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of current study is to compare the rates of IUCD expulsion and complications in
      immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean
      delivery)
    

Detailed description: 
      Intrauterine devices (IUDs) are among the most effective forms of contraception, offering
      greater than 99% efficacy per year of use and are completely reversible .

      Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective
      option for postpartum contraception. "Post-placental" refers to insertion within 10-15
      minutes of placental delivery, after vaginal or cesarean delivery.
    

Intervention name(s): IUCD
Intervention type(s): Drug
Intervention description(s): IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction
Condition: Anterior Cruciate Ligament Injury; Knee Injury
MeSH terms: Wounds and Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive
      stability, studies are showing consistently poor long-term outcomes. Unusually high risks of
      early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all
      seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which
      itself may be due to fear of re-injury. Decreased knee bending for force absorption
      simultaneously decreases performance level and increases risk for injury and arthritic
      changes.

      The purpose of the proposed study is to compare a current best-practice plyometric training
      program to one utilizing body weight support to increase repetition and improve performance
      in the initial phases. The investigators hypothesize that we will see larger improvements in
      absorptive capacity of the knee and better confidence in activity immediately following body
      weight support training, as well as improved retention of training effects after a two-month
      period.
    


Intervention name(s): Standard Plyometric Training; Plyometric Training with BWS
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises.; Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises while their body weight is supported via adjustable harness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; plyometrics; motor learning; psychological factors
Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the safety and tolerability and to determine the
      Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in
      healthy male subjects.
    

Detailed description: 
      BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male
      subjects.

      Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times
      from each subjects.

      PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone,
      Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
    

Intervention name(s): BR-A-657
Intervention type(s): Drug
Intervention description(s): 120, 360mg or placebo 7days
Other intervention name(s): Fimasartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: BR-A-657; Fimasartan; multiple-dose; pharmacokinetic; pharmacodynamic; safety
Inhalation Intervention for Nausea in the Emergency Department
Condition: Nausea; Vomiting
MeSH terms: Emergencies; Nausea; Vomiting
Study type: Interventional

Summary: 
      Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal
      saline) pads to treat nausea in emergency department patients.
    

Detailed description: 
      This study is to investigate if inhaling the scent of a typical medical alcohol prep pad will
      alleviate nausea as compared to a identically packaged normal saline prep pad for the
      Emergency Department patient with nausea. The study length will be 10 minutes long. The
      subjects will take several deep nasal inhalations at the 0, 2, 5 minute marks. Level of
      nausea will be recorded during these times and at 10 minutes. The investigators will also
      assess satisfaction of the intervention. As in previous post operative unit studies,the
      hypothesis is that there will a significant difference in levels of nausea between the
      alcohol pad group versus the normal saline pad group.
    

Intervention name(s): Alcohol prep pad group; Normal Saline prep pad
Intervention type(s): Other; Other
Intervention description(s): Subjects inhale scent of alcohol pad; Subjects inhale scent of placebo (normal saline) pads
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nausea; Vomiting; Antiemetic
Study of SRX246 Capsules in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study of SRX246 in humans, and is being conducted to begin to establish a
      safety profile of orally administered SRX246.
    

Detailed description: 
      This protocol represents the first in human study of SRX246, and is being conducted to begin
      to establish a safety profile, and collect human tolerability and pharmacokinetic data of
      orally administered SRX246.
    

Intervention name(s): SRX246; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of SRX246 capsule; Single oral dose of placebo capsule
Intervention MeSH terms: SRX246
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase 1; Safety; Tolerability; Pharmacokinetics
A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective open label, randomised, parallel group, comparative pilot.
    

Detailed description: 
      Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first
      positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of
      pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear
      stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos,
      endometrial thickness and morphology on day of HCG administration, estradiol levels at day of
      HCG administration, implantation rate, number of days stimulated with gonadotrophins and
      number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive
      pregnancy test, pregnancy outcome.
    

Intervention name(s): Menotrophin; Follitropin alfa
Intervention type(s): Drug; Drug
Intervention description(s): 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.; 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
Other intervention name(s): Menopur; hMG; highly purified menotrophin; rFSH; recombinant FSH
Intervention MeSH terms: Menotropins; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug
      in the blood), and immunogenicity (how the study drug affects the immune system) of single
      dose and dose levels of an investigational drug called YQ23.
    

Detailed description: 
      This is a first-in-man, phase 1, single-blind, randomized, placebo-controlled study in
      healthy volunteers. It will be conducted at a single centre and will enroll approximately 64
      subjects. Subjects will either receive a single dose of study drug or placebo in a 3:1 ratio.
      Eight dose levels of YQ23 will be evaluated.

      Each dose level group will be divided into 2 cohorts, with each cohort being dosed at last 24
      hours apart. The leading cohort will comprise of 2 subjects, with 1 subject receiving YQ23
      and 1 subject receiving placebo. The remaining cohort will comprise of 6 subjects, with 5
      receiving YQ23 and 1 receiving placebo.

      Safety assessments will be performed throughout the dosing and follow-up periods, and
      multiple PK samples will be collected.
    

Intervention name(s): YQ23; Matching Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated; Single dose of the matching placebo delivered via intravenous route.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation study to determine the safe dose level.
Masking: Single (Participant)
Primary purpose: Other
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
Condition: Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is
      being accepted in the West as a treatment option for managing POI and various functional
      gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to
      evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who
      underwent gastric surgery for a later large-scale study.
    

Detailed description: 
      Before surgery, patients were randomized (using simple randomization) to either acupuncture
      (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in
      duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by
      Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days
      starting on postoperative day 1. The acupuncture points which were used were based on
      traditional Korean medicine. No acupuncture treatment was performed in the NA group.
    

Intervention name(s): acupuncture
Intervention type(s): Device
Intervention description(s): Acupuncture treatment after gastric cancer surgery during 5 postoperative days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acupuncture; Gastric cancer
The Role of Bacteria and Genetic Variations in Cystic Fibrosis
Condition: Psuedomas Infection; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study will examine 1) the role of hereditary factors in cystic fibrosis; i.e., the
      relationship of the disease to specific gene variations, and 2) the role of bacterial
      products involved in lung infections substances produced by bacteria may worsen the disease.

      Patients with cystic fibrosis who are being followed by the Medical College of Wisconsin or
      the University of Wisconsin-Madison are eligible for this study. Participants will have blood
      tests, pulmonary function tests, a sputum culture, and buccal swabbing (cotton swabbing of
      the inside of the cheek to collect cells for DNA study). In addition, their medical records
      will be reviewed for a history of lung infections and the results of various tests, including
      pulmonary function studies, chest X-rays and bacterial cultures. Blood samples collected
      previously at the Medical College of Wisconsin or the University of Wisconsin-Madison will
      also be analyzed for antibodies to bacteria.

      Although this is a one-time study, participants may be asked to return for repeated tests.

      ...
    

Detailed description: 
      Individuals with cystic fibrosis (CF) are susceptible to chronic bacterial colonization by
      Pseudomonas aeruginosa, which results in deterioration of lung function and, eventually,
      death. In this study, we hope to improve our understanding of the innate immune response to
      infection by strains of P. aeruginosa that express type III cytotoxins and to delineate
      better the role of modifier genes in disease progression.

      We will examine relationships between the patient's clinical course, the presence of
      antibodies to P. aeruginosa, and single nucleotide polymorphisms in suspected CF modifier
      genes.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Individuals with cystic fibrosis (CF) are susceptible to chronic bacterial colonization by
        @@@Pseudomonas aeruginosa, which results in deterioration of lung function and, eventually,
        death. In this study, we hope to improve our understanding of the innate immune response to
        infection by strains of P. aeruginosa that express type III cytotoxins and to delineate
        better the role of modifier genes in disease progression.@@@
      
Keywords: Type III Secretion Pathways; Exotoxin A Polymorphisms; Cystic Fibrosis and Pseudomonas Aeruginosa; Adenosine Deaminase Deficiency; Severe Combined Immune Deficiency; SCID; ADA-SCID; Immune Deficiency
Salivary Cortisol Measurements by Mass Spectrometry
Condition: Endocrine Disorders
MeSH terms: Endocrine System Diseases
Study type: Observational

Summary: 
      Cortisol is a hormone critical for survival in times of stress. Currently most measurements
      are done with blood samples. The hypothesis of this study is cortisol measured from saliva
      using mass spectrometry can be used to replace measurements by blood.
    

Detailed description: 
      Cortisol levels change depending on the time of day. Salivary samples were collected from
      health controls at bedtime, midnight and first morning waking on two consecutive nights and
      salivary cortisol levels were measured using mass spectrometry. In a patients with possible
      endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal
      insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes
      after cosyntropin.
    

Intervention name(s): Non intervention study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with possible endocrine disorders seen during outpatient pediatric endocrinology
        visit or inpatient consultations. Healthy controls were open to the general public in
        California.
      
Biospecimen description: 
      Saliva was collected using Salivabio children's swab (SCS).