bioihbjkbjnl/mcl2 huggingface dataset:
FC Patch Low: Metabolism Study
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study is to investigate the effects of the transdermal patch on the
      parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism
      in healthy women who require contraception.
    


Intervention name(s): Gestodene/EE Patch (BAY86-5016); EE/Levonorgestrel (Microgynon, BAY86-4977)
Intervention type(s): Drug; Drug
Intervention description(s): 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles; 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
Intervention MeSH terms: Levonorgestrel; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; Gestodene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of pregnancy
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
Condition: Insomnia Chronic; Pain, Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Observational [Patient Registry]

Summary: 
      A prospective observational crossover study of 160 consenting adult patients who underwent
      pain management. For insomnia treatment, each patient ingested different prescribed doses of
      Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary
      to collect data including pain score, sleep scores, sleep duration, sleep medication dose,
      and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was
      measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep
      scale. A change in the pain or sleep scores by 2-points was considered significant.
    

Detailed description: 
      Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is
      to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine;
      for the management of insomnia in patients with chronic pain.

      Methods: A prospective observational crossover study of 160 consenting adult patients who
      underwent pain management. For insomnia treatment, each patient ingested different prescribed
      doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated
      sleep diary to collect data including pain score, sleep scores, sleep duration, sleep
      medication dose, and adverse effects. Each patient completed the diary for 3 continuous
      weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using
      the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered
      significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using
      Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 was
      considered significant.
    

Intervention name(s): Clonidine 0.1mg pill; Clonidine 0.2mg pill; Zopiclone 3.75mg pill; Zopiclone 7.5mg pill
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Routine prescription for insomnia; Routine prescription for insomnia; Routine prescription for insomnia; Routine prescription for insomnia
Other intervention name(s): Clonidine 0.1mg tablet; Clonidine 0.2mg tablet; Zopiclone 3.75mg tablet; Zopiclone 7.5mg tablet
Intervention MeSH terms: Clonidine; Zopiclone
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A cohort of consecutive adult patients who underwent pain management at a Canadian pain
        clinic
      
Keywords: sedative; hypnotic
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
Condition: Asphyxia Neonatorum
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Asphyxia Neonatorum; Asphyxia
Study type: Observational

Summary: 
      The histology of the placenta of newborn infants with perinatal asphyxia and
      hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could
      be a biomarker for neurodevelopmental outcome at 18-24 months of age.
    


Intervention name(s): hypothermia therapy
Intervention type(s): Other
Intervention description(s): newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All newborn infants with a gestational Age >35 weeks, fulfilling the inclusion criteria of
        perinatal asphyxia and hypoxic-ischaemic encephalopathy, born in Switzerland and treated in
        the University Hospital of Zurich with hypothermia therapy after birth
Intracranial Pressure in Monopolar and Bipolar Hysteroscopy
Condition: Intracranial Pressure Increase
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      Two distinction fluids are used in operative hysteroscopy. One is monopolar and the second is
      bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum
      physiologic. This study aims to compare intracranial pressure in patients undergoing
      monopolar and bipolar hysteroscopy.
    

Detailed description: 
      Operative hysteroscopy is currently used in the treatment of several diseases including
      submucosal myomas, polyps, uterine septum, and abnormal intrauterine bleeding. Two different
      methods for distension of the uterus for hysteroscopy are available currently. One is
      monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar
      fluid contains serum physiologic. Passage of the distention fluid into the uterine veins
      during hysteroscopy might lead to volume overload, water intoxication, hyponatremia,
      pulmonary edema or brain edema. However, the effect of monopolar hysteroscopy or bipolar
      hysteroscopy on intracranial pressure in patients undergoing hysteroscopy is unknown. Optic
      nerve sheath diameter (ONSD) measurement is a surrogate marker of invasive intracranial
      pressure. This study aims to compare the impact of monopolar and bipolar hysteroscopy on
      intracranial pressure by using ONSD measurement in patients undergoing hysteroscopy.
    

Intervention name(s): Monopolar hysteroscopy; Bipolar hysteroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Unipolar resectoscopes are used in this group and the distention fluid is mannitol; Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
Condition: Cancer of Colon
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The aim of our study is to determine the effect of implementation of the ERAS (enhanced
      recovery after surgery) protocol in our institute and its impact on hospital length of stay
      and outcome of surgery.
    


Intervention name(s): enhanced recovery after surgery program in colorectal cancer surgery
Intervention type(s): Procedure
Intervention description(s): to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are
      usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of
      pain during this procedure and also continue to have discomfort during voiding for few days.
      The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac
      suppository during flexible cystoscopy has been proven to be effective. This study was done
      to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent
      removal by rigid cystoscopy when compared to placebo and to assess its safety in these
      patients
    

Detailed description: 
      Consecutive consenting male patients undergoing DJ stent removal under local anesthesia
      during 2014-15 were enrolled. Patients were randomized to receive 75 mg oral diclofenac or
      placebo 1 hour prior to procedure by double blind randomization. Intraurethral 2% lignocaine
      jelly (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at first void and
      at 24 hours after cystoscopy was assessed using visual analogue scale [VAS] (0 to 100).
      Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were
      assessed.
    

Intervention name(s): Diclofenac sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac for pain relief; Placebo for comparison
Other intervention name(s): Voveran
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Digital Data in Mental Health Therapy
Condition: Depressive Symptoms; Anxiety Generalized
MeSH terms: Depression
Study type: Interventional

Summary: 
      The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment intends
      to better understand how digital data, social media, and electronic communication can be used
      in mental health therapy.
    


Intervention name(s): Digital data
Intervention type(s): Behavioral
Intervention description(s): Receiving digital data prior to a scheduled mental health session
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Innovations in HIV Testing (TI)
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The investigators propose to improve HIV prevention and care through expanding HIV testing
      options to include self-testing for young women, their peers and their sex partners, and by
      facilitating linkage to care.
    

Detailed description: 
      Study Description Brief Summary: The investigators propose to improve HIV prevention and care
      through expanding HIV testing options to include self-testing for young women, their peers
      and their sex partners, and by facilitating linkage to care.

      Detailed Description: The investigators propose to improve HIV prevention and care through
      expanding HIV testing options to include self-testing for young women, their peers and their
      sex partners, and by facilitating linkage to care. In this study the investigators proposed
      two phases. The first phase, explained in this submission, is formative and involved two
      parts: 1) conducting formative qualitative research to understand perceptions of HIV testing
      and HIV self-testing in the study population and 2) conducting observed HIV self-testing to
      better understand any challenges with self-testing and the materials needed to make the
      process clear. The second phase of the study is a randomized controlled trial where the
      investigators will randomize approximately 400 young women to receive either 1) CHOICE of
      self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once
      young women have been randomized, they will be asked to recruit up to 4 peers or male sex
      partners to test with the method of their randomization group.
    

Intervention name(s): Oraquick HIV Self Test - Choice; Atomo HIV Self Test - Choice; Oraquick HIV Self Test and Atomo HIV Self Test - Both
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): This is an oral swab in home HIV test.; This is a blood finger prick in home HIV test.; This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24
In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis-associated pain in pre-menopausal women.
    

Detailed description: 
      This is a Phase 3 multicenter, double blind randomized study to assess the continued safety
      and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in
      premenopausal women with moderate to severe endometriosis-associated pain who completed the 6
      month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2
      periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

      Participants who received elagolix in the pivotal study who met all entry criteria continued
      to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an
      additional 6 months in this extension study; participants who received placebo in the pivotal
      study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg
      BID for up to 6 months.

      An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding,
      and analgesic medication use for endometriosis associated pain on a daily basis.

      All participants who prematurely discontinued treatment (unless pregnant or elected surgery
      for endometriosis) or completed the 6-month Treatment Period in this extension study were to
      enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.
    

Intervention name(s): Elagolix
Intervention type(s): Drug
Intervention description(s): Elagolix tablets administered orally
Other intervention name(s): Orilissa™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis associated pain; Elagolix; Gonadotropin-Releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP)
Lidocaine Infusion for Major Abdominal Pediatric Surgery
Condition: Elective Major Abdominal Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine
      in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and
      hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten
      return of bowel function.
    

Detailed description: 
      The inflammatory response after major abdominal surgery is of great importance for patients,
      physicians and perioperative medicine1. Perioperative excessive stimulation of the
      inflammatory and hemostatic systems may result in development of postoperative ileus,
      ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and
      pain excessive inflammatory response such as impaired gastrointestinal motility, so
      modulation of inflammatory responses may decrease severity of such complications 2,3.

      Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia,
      reduce postoperative opioid requirements, accelerate postoperative recovery of bowel
      function, attenuate postoperative fatigue, reduced the duration of hospitalization, and
      facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4.
      Administration of local anesthetics to epidural space has analgesic effect, blunt stress
      response; provide rapid mobilization, early extubation with rapid recovery of bowel function
      5. However, insertion of an epidural catheter carries risks especially in pediatric
      populations. So, systemic lidocaine may become another strategy for improving perioperative
      outcome which is safe and effective2.
    

Intervention name(s): Lidocaine Infusion; saline Infusion
Intervention type(s): Drug; Drug
Intervention description(s): children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively; children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
Condition: Healthy
Study type: Interventional

Summary: 
      We hypothesize that continuous positive pressure applied to the airway will decrease the
      ability of the nose to warm and humidify inspired air compared to zero or negative pressure.

      We will use continuous positive airway pressure (CPAP), a device commonly used to treat
      patients with sleep apnea, to vary the pressure in the airway and determine if increased
      pressure decreases the ability to warm and humidify inspired air. If our hypothesis is
      correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea;
      i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.
    


Intervention name(s): Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: CPAP pressure of -5cm/water during cold, dry air exposure; CPAP pressure of 0cm/water during cold, dry air exposure; CPAP pressure of 5cm/water during cold, dry air exposure; CPAP pressure of 10cm/water during cold, dry air exposure
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Smallpox; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the immunogenicity and safety of an investigational
      smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
    


Intervention name(s): IMVAMUNE
Intervention type(s): Biological
Intervention description(s): Subjects receiving two subcutaneous vaccinations
Other intervention name(s): MVA-BN
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Atopic dermatitis; Smallpox; Vaccination
Comparison of Treatments in Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      Randomized controlled trial, a method used to implement the random allocation sequence is
      numbered containers.

      The aim of the study is to compare operative treatment, ultrasound guided laser ablation and
      ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great
      saphenous trunks. On the grounds of the available data, the study hypothesis is that using
      laser or operative treatment more than 20 percent better outcome can be achieved compared to
      foam sclerotherapy.
    

Detailed description: 
      In operative treatment the great saphenous vein will be removed after flush ligation by
      femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is
      inserted through a tiny distal entry point. The probe is guided into place using ultrasound
      and the procedure is performed under local tumescence anesthesia. Laser energy is delivered
      to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam
      (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the
      venous trunk under ultrasound control. In each group patients will use supportive treatment
      stockings 2 weeks after treatment. The patients in all groups are followed up one year by
      ultrasound scanning.
    

Intervention name(s): Operative treatment; Laser ablation; Foam sclerotherapy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.; In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.; Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Other intervention name(s): Vein stripping; Ultrasound guided laser ablation; Ultrasound guided foam sclerotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: varicose veins, oedema