bioihbjkbjnl/mcl2 huggingface dataset:
Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men
Condition: Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to understand how testosterone, the major male sex hormone, controls
      the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone,
      which controls sugar; fat and protein use in the body and maintains muscle strength and bone
      calcium content. Both testosterone and GH decline in older men. The age-related fall in these
      hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle
      wasting and impaired sexual function.
    

Detailed description: 
      Repletion of testosterone in older men drives pulsatile GH secretion via conjoint
      facilitation of feedforward by the primary secretagogues GHRH and GHRP and repression of
      feedback by the dominant inhibitor, somatostatin; and, in corollary, testosterone acts via
      aromatization to estradiol and/or reduction to 5 alpha-dihydrotestosterone
    

Intervention name(s): Placebo; Testosterone; Anastrazole; Dutasteride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): im and orally; injections; orally x 21 days; orally x 21 days
Intervention MeSH terms: Anastrozole; Testosterone; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients
Condition: Dental Anxiety
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through
      buccal versus intranasal mucosa in managing uncooperative children undergoing dental
      treatment.
    

Detailed description: 
      Thirty six children fulfilling the requirements of having a dental condition that needed
      treatment in two dental settings, not exceeding thirty minutes each. They were randomly
      assigned to one of two groups, according to the treatment offered at the first visit. At the
      first visit, either buccal or intranasal aerosolized midazolam was administered. At the
      second visit the alternate route was implemented in a cross-over design with a one week
      washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout
      the treatment session.
    

Intervention name(s): Buccal midazolam; Intranasal midazolam
Intervention type(s): Drug; Drug
Intervention description(s): The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.; Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigation of the Uterine Cervix Using CervicalMD
Condition: Colposcopy
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the CervicalMD device's ability to collect
      digital imagery suitable for a colposcopy examination.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women identified with an abnormal Pap smear
      
Biospecimen description: 
      LEEP specimens
    
Keywords: colposcopy; Cervical intraepithelial neoplasia; cervical cancer; cervical precancer
Bauhinia Forficata in Diabetic Patients
Condition: Diabetes
Study type: Interventional

Summary: 
      Among the plants most used in folk medicine for the treatment of diabetes are the species of
      the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these,
      Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due
      to this fact it is included in the Medicinal Plants List of the Brazilian Public Health
      System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its
      chemical composition and its pharmacological potential. From the chemical point of view the
      main components identified in hydro alcoholic extract of the leaves are O-glycosylated
      derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical
      studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract
      of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity
      of B. forficata in clinical level was performed in only two studies, both with few patients,
      and questionable methodological quality that used tea as a pharmaceutical form, a fact that
      allows us to question the validity of data considering the risks of no dose reproducibility
      ingested by patients during the study. Thus the investigators here intend to determine the
      effects of a standardized extract of B. forficata in the control of patients with diabetes
      mellitus
    


Intervention name(s): B. forficata; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study is designed to determine the minimal effective oxytocin maintenance dose required
      during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely
      used to help contract the uterus and keep it contracted after the delivery of the baby and
      placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order
      to determine the minimal effective dose, the investigators will conduct a dose-finding study.
      The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is
      considered satisfactory and the next patient will receive the same dose. If the uterus does
      not contract well, this is considered unsatisfactory and the next patient will receive a
      higher dose. The dose for the next patient will be determined based on the results of the
      uterine contraction of the previous patient.

      The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a
      satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower
      than that found in previous studies without an initial bolus (less than 16 IU/h).
    

Detailed description: 
      This study will be conducted as a prospective, double blinded clinical trial (patient,
      anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential
      allocation fashion. The objective of the study is to determine the minimum effective dose of
      oxytocin infusion required to produce appropriate uterine contraction during and after
      cesarean delivery under neuraxial anesthesia in non-laboring women. For the purpose of this
      study, the minimum effective dose is defined to be that at which adequate response occurs in
      90% of patients, i.e. ED90.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Biased coin up-and-down design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean delivery; oxytocin; uterotonic; pregnancy
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of the Dry Powder Formulation of GSK2269557 in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta
      (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of
      inflammatory airway diseases. GSK2269557 has already been administered as a nebulized
      solution in single and repeat doses to humans and has been well tolerated across the range of
      doses used. The purpose of this study is to evaluate the safety, tolerability and
      pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study
      is the first administration of dry powder GSK2269557 in humans.

      Part A will consist of four treatment periods separated by at least 14 days wash out periods.
      In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects
      receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500
      mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed
      before each dose escalation. Part B will be a parallel group design conducted in a separate
      group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3
      subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the
      same as the dose that was well tolerated in Part A. The study duration, including screening
      and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for
      subjects in part B of the study.
    


Intervention name(s): GSK2269557; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry powder for oral inhalation (100 and 500 mcg /blister) once daily using DIKUS device. The doses of GSK2269557 planned for Part A are: 100 mcg, 500 mcg and 3000 mcg; Dry powder for oral inhalation once daily using DIKUS device
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics; pharmacokinetics; healthy volunteers; Pi3K-delta; GSK2269557; safety; dry powder inhaler
Acupuncture and Pain Processing
Condition: Fibromyalgia
MeSH terms: Fibromyalgia
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia
      pain, via alterations in the processing of pain in the central nervous system.
    

Detailed description: 
      Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This
      includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks),
      and a follow-up visit and treatment 1 week after completion of the study treatment sessions.
      To determine the effects of acupuncture on pain, patients and healthy controls will undergo
      psychophysical pain testing at four points throughout the study: Baseline (appointment 1),
      post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up
      session (1 week from last treatment - appointment 10).Participants will also fill out a brief
      report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2
      minutes per day and will occur throughout the 6 week study period.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Treatment given twice per week for 4 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
Condition: Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is going to evaluate the safety and effectiveness of intranasal
      DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the
      optimal dose of intranasal DEX in breast lumpectomy.
    

Detailed description: 
      Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and
      effective anaesthesia techniques. Presently, this procedure is usually performed under
      general or local anaesthesia. General anaesthesia provides an effective sedation; however,
      for minor procedures, general anaesthesia is resource-intensive and postoperative
      complications, such as nausea, vomiting or extended time to ambulation, are more likely.
      Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an
      efficient drug regimen is required that reduces analgesic consumption, minimises
      opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following
      surgery.

      Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation
      without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects
      have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious
      sedation under monitored anaesthesia care (MAC) that is a logical middle ground between
      general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide
      satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric
      patients. The intranasal route is not only effective, but also well-tolerated and convenient
      This trial is going to evaluate the safety and effectiveness of intranasal
      DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the
      optimal dose of intranasal DEX in breast lumpectomy.
    

Intervention name(s): 0.9% saline; dexmedetomidine 1µg.kg-1; dexmedetomidine 1.5µg.kg-1; Dexmedetomidine 2µg.kg-1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.; dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.; Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.; dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
Other intervention name(s): placebo; Ai Bei Ning1 µg.kg-1; Ai Bei Ning1 µg.kg-1; Ai Bei Ning 2µg.kg-1
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Intranasal; Dexmedetomidine; Anaesthesia; Breast Lumpectomy
Clinical Trial of Recombinant Hepatitis E Vaccine
Condition: Hepatitis E
MeSH terms: Hepatitis A; Hepatitis E; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine whether the preventive hepatitis E are
      effective in the prevention of hepatitis E occurring at least 30 days after the
      administration of the third dose of vaccine.

      The secondary purpose of this study is to to evaluate the safety and immunogenicity and
      immunopersistence of the study vaccine.

      The initial study is planed to be ended on month 19 and the results were analysed and used
      for registration purpose. The extended study will be continued to assess the long-term
      efficacy, immunogenicity and safety.
    

Detailed description: 
      Participants were randomly allocated into two groups, one received Hepatitis E vaccine and
      the other received hepatitis B vaccine. The study was carried out with two stages. In the
      first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited
      adverse events for 1 month after each injection. Serum samples from all the subjects were
      collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and
      immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and
      monitored for solicited adverse events for 1 month after each injection. Serum samples from
      9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely
      after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events
      during the trial were followed up.

      Suspected hepatitis cases were identified through an established active hepatitis
      surveillance system. The sentinels of the system comprised all the healthcare facilities in
      the field. Suspected hepatitis was defined as when patients presented with systemic symptoms
      such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase
      (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from
      these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV
      antibodies and HEV-RNA.
    

Intervention name(s): hepatitis E vaccine; Hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscularly given at 0, 1, 6m for three doses.; Intramuscularly given at 0, 1, 6m for three doses.
Other intervention name(s): Hecolin
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hepatitis E; vaccine; efficacy
Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668
      Administered Subcutaneously to Healthy Volunteers.
    


Intervention name(s): REGN668: Injection Rate 1; REGN668: Injection Rate 2
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive REGN668 via SC injection; Subjects will receive study drug via alternate delivery (if necessary)
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteers
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of
      JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared
      with healthy participants with normal hepatic function and no liver cirrhosis.
    


Intervention name(s): JNJ-56136379
Intervention type(s): Drug
Intervention description(s): JNJ-56136379 will be administered orally in fed condition.
Intervention MeSH terms: JNJ-56136379
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
Condition: Hospital-Acquired Pneumonia
MeSH terms: Healthcare-Associated Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, single arm, open-label, multi-center clinical study evaluating the
      effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have
      initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic
      treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI
      in the hospital for at least 7 full days. There are no formal hypothesis tests planned for
      this study. The number and percent of participants having clinical cure, failure, and
      indeterminate at TOC visit in the cMITT analysis population will be summarized.
    


Intervention name(s): Zavicefta, Ceftazidime-Avibactam
Intervention type(s): Drug
Intervention description(s): Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus
Condition: Cesarean Section Complications; Pain; Postpartum Anxiety
Study type: Interventional

Summary: 
      The postpartum period is a process in which both physical (bleeding, infection, anemia) and
      emotional (delay in breastfeeding and mother-baby relationship) problems occur in women.
      Among the conditions that physically affect the woman who has had a cesarean section, a
      decrease in bowel movements is often seen and this decrease can last for 24 hours or longer.
      Initiation of bowel movements after surgery, time of first flatulence and defecation are
      important factors that determine postoperative patient comfort.
    

Detailed description: 
      Pain after cesarean section is usually associated with incision site and uterine
      contractions. There are various medical treatment and midwifery applications for the
      resolution of pain and gas output after cesarean section. Recently, it has been stated that
      in addition to the treatments applied after surgery, non-drug methods should be used to
      increase the effectiveness of recovery. These methods include applications such as hot
      application, abdominal massage, music therapy, chewing gum. The effect of hot application in
      patients with post-operative gas problems is the acupuncture points of the foot, warm and
      moist heat stimulation and the small intestine, colon, anus and other reflective areas.
      activates blood circulation. It is predicted that postpartum comfort will increase in the
      postpartum postpartum, whose pain decreases with postpartum heat application and intestinal
      mobility returns to normal. The aim of this study is to determine the effect of applying heat
      to the feet after cesarean section on postpartum comfort, pain and gas output.
    

Intervention name(s): Warm Application to Feet
Intervention type(s): Other
Intervention description(s): Warm Application to Feet after Cesarean Section
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In order to ensure randomization in the study, a random numbers table was created by dividing into two groups out of 238 samples by taking 10% more than the number of samples determined on the site https://www.randomizer.org/. In order to avoid bias, the assignment of women to the intervention and control groups according to the randomization list will be determined by a midwife working in the clinic, who is not one of the study authors. In the study, the CONSORT scheme will be followed during the application.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Cesarean Section; Pain; Postpartum Comfort