bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick
      Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus
      abbreviated schedule) in healthy adults 18 to 50 years of age in China
    


Intervention name(s): Abbreviated Zagreb 2-1-1 schedule; Standard Essen 1-1-1-1-1 schedule
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.; Subjects received the standard Essen regimen.
Other intervention name(s): PCEC Rabies vaccine for human use; PCEC Rabies vaccine for human use
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; prevention; rabies; Rabies disease
Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
Condition: Contraception
Study type: Observational

Summary: 
      Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being
      the first oral contraceptive delivering estradiol. It has been recently approved in Mexico.
      To evaluate the clinical profile of this drug combination under routine medical condition, a
      post-authorization safety study required by Mexican Health Authorities will be conducted in
      Mexican women.

      The study will be performed as a descriptive study, no hypothesis will be tested. The cohort
      consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical
      conditions. Subjects should provide all necessary information on health-related events or
      changes in health status during Qlaira use.

      Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or
      not related to Qlaira during at least 2 years of observation.

      In order to comply with the criteria of a non-interventional study, women only will be
      informed about the study, asked to participate and included in the study after Qlaira has
      been prescribed.

      Study patients follow-up will be done in accordance with common clinical practice as
      described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM
      005-SSA2-1993).
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027)
Intervention type(s): Drug
Intervention description(s): Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics
        and gynecology (Ob/Gyn) primary care clinics
      
Keywords: Oral contraceptives; Adverse events; Safety profile; Contraceptive Agents
Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered
      orally compared to intravenously on the maximum acid output in subjects with symptoms of
      Gastroesophageal reflux disease (GERD).
    


Intervention name(s): Esomeprazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 40mg Intravenous infusion over 3 minutes; 40mg Oral
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease; Nexium; Esomeprazole; Administration methods.
A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics of duloxetine
      hydrochloride tablets in Chinese Han Healthy Subjects. The single oral dose and multiple oral
      dose of the drug in the body and the effects of different dosages of the drug will also be
      evaluated.
    

Detailed description: 
      This is an open, parallel assignment (low-dose, moderate-dose and high-dose), inpatient,
      sequential-group pharmacokinetics study of single oral administered and multiple oral
      administered to healthy Chinese male and female subjects at a single investigational site.
      All subjects are from the Chinese Han race.

      Approximately 36 healthy male and female Chinese subjects will participate in this study. One
      half of the subjects enrolled in each dose group will be female. Twelve subjects will be
      enrolled in each of 3 dose level groups.

      Safety will be evaluated from self-reported adverse events, scheduled physical examination,
      vital signs, 12-lead ECGs, and clinical laboratory test results.

      Single-dose blood samples (5 mL) will be obtained within 2 hours before test article
      administration and at 1, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours after test
      article administration.

      Multiple-dose (subjects of moderate dose group finished first step single-dose 30mg trial,
      one week later, will be repeatedly administered duloxetine 30 mg 7days) blood samples (5 mL)
      will be obtained at 4th, 5th, 6th and 7th day before test article administration (to test the
      valley concentration)and at 1, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours after last
      test article administration (7th day).

      Cross-over (subjects of high dose group finished first step single-dose 60 mg generic
      duloxetine trial, one week later, will be administered single-dose innovator duloxetine 60
      mg) blood samples will be obtained as same as first step.
    

Intervention name(s): duloxetine; duloxetine; duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days; 15mg, oral administer; 60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine
Other intervention name(s): Generic duloxetine; generic duloxetine; generic duloxetine; innovator duloxetine
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: duloxetine; pharmacokinetics; antidepressant; antidepressive agents; depression; psychotropic drugs; safety; Chinese; HAN; BDNF
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis; Hyperoxia
Study type: Interventional

Summary: 
      The primary aim of this project is to get further knowledge on the effects of + Gz
      accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung
      perfusion and cardiovascular function in these conditions.
    

Detailed description: 
      Experiments were conducted in a human centrifuge. The protocol aimed at mimicking a routine
      peacetime flight in combat aircraft, and included 10-min exposure to +1.4 - +3.5 Gz. Subjects
      were exposed three times to this sequence, breathing air, 44.5% O2 or 100% O2.

      Ten volunteers wearing anti-G trousers participated in the study. The Ethics Committee
      Ile-de-France III and the French National Agency for Drug Safety (ANSM) approved the protocol
      (number 2009-A01092-55).

      Three different imaging techniques, electrical impedance tomography (EIT), pulmonary
      ultrasound and chest SPECT/CT were used and compared. EIT enabled ventilation monitoring in
      the human centrifuge, whereas pulmonary ultrasound and SPECT/CT gave functional and
      topographical information before and after exposure to +Gz accelerations. EIT analysis
      focused on regional ventilation, SPECT on global lung ventilation and perfusion, CT on the
      presence of atelectasis, and pulmonary ultrasound analysis looked for comet tails in 64 chest
      areas. Arterial blood pressure was recorded continuously by finger photoplethysmography.
      Cardiac output and stroke volume were computed from these recordings, using three different
      algorithms. Echocardiography was used as reference non-invasive technique for stroke volume
      determination and performed before and after exposure to +Gz accelerations.
    

Intervention name(s): hypergravity; gas mixture
Intervention type(s): Other; Other
Intervention description(s): 1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs); breathing air, 44.5%O2 or 100%O2
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: human centrifuge, oxygen, imaging, stroke volume, lung
Effects of Clustering Care on the Physiological Stability of Preterm Infants.
Condition: Premature Baby 26 to 32 Weeks
Study type: Interventional

Summary: 
      This crossover design experimental study aims to compare the physiological stability of
      premature newborns during and after a cluster of care compared to a period when they receive
      standard non clustered care at the neonatal unit.
    

Detailed description: 
      The cluster care will take place at the time of feeding of the premature infants. The
      intervention will start with a calm period of 20 minutes before the start of care (no
      manipulations will be allowed), the baby will then received the cluster care for 20 minutes
      and a quiet period of 30 minutes will follow after the cluster care.
    

Intervention name(s): Clustering care
Intervention type(s): Other
Intervention description(s): During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Investigating Reaction Time Among Children Who Snore
Condition: Snoring
MeSH terms: Snoring
Study type: Observational

Summary: 
      The investigators feel that children who have OSA or sleep-disordered breathing may have a
      different reaction time than normal variants. Children who have OSA are known to have
      behavioral and sleep patterns that are different. It makes sense their reaction time may be
      different than normal as well. We plan to measure reaction times via a 10 minute psychomotor
      vigilance test device in children who snore who are coming in for a sleep study or for
      adenotonsillectomy.
    


Intervention name(s): PVT-192
Intervention type(s): Device
Intervention description(s): PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who snore and are coming to Nationwide Children's for a sleep study or
        adenotonsillectomy.
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
Condition: Uterine Cervical Neoplasms; Cervix Intraepithelial Neoplasia
MeSH terms: Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of
      cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the
      standard treatment is the conisation of cervix (surgical act). A local treatment with the
      antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and
      reduce obstetrical morbidity induced by the conisation.

      This clinical study is aimed at :

        1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix
           exhibiting high grade CIN lesions;

        2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.
    


Intervention name(s): Cidofovir gel
Intervention type(s): Drug
Intervention description(s): topical gel applied once a week for 3 weeks
Intervention MeSH terms: Cidofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervix Intraepithelial Neoplasia grades 2 and 3
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the effect of intravenous anesthetics versus
      the administration of volatile anesthetics on stress and pain levels during autologous fat
      transfer for breast reconstruction in a Day Care Center.
    

Detailed description: 
      The sample of the study will be patients who will have Autologous Fat Transfer for Breast
      Reconstruction.

      Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated
      intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile
      anesthetics (desflurane-remifentanil).

      Specifically, the TIVA group will include patients over 50 years of age with high risk of
      nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia.
      Patients with cardiac and respiratory problems will be included in the DES group.

      The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age),
      Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated
      by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and
      perioperative pain levels will be assessed with CPOT scale (values 0-8).

      Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b.
      How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS
      questions will also be given preoperatively and postoperatively to the ward. The sedation
      levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The
      level of patient's awareness will be assessed by GCS Scale (3 (indicating deep
      unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised
      scale)).

      The presence or absence of nausea / vomiting and the appearance of immediate postoperative
      complications will be examined. Finally, post-operative stress will be examined with stress
      biomarkers, salivary ACTH hormone and salivary cortisol hormone.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil)
Other intervention name(s): remifentanyl; desflurane
Intervention MeSH terms: Propofol; Desflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Admnistration Fat Transfer; Autologous Fat Transfer; Breast Reconstruction; TIVA; volatile anesthesia; stress levels; pain levels
Safety, Tolerability and Pharmacokinetics of FTP-198 in Healthy Australian Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, Phase I, single-dose escalation and multiple-dose escalation
      clinical trial for FTP-198 conducted in Australian healthy volunteers. The safety,
      tolerability, and pharmacokinetics of FTP-198 suspension in healthy volunteers will be
      evaluated using a randomized, double-blind, placebo-controlled trial design.
    


Intervention name(s): FTP-198, single dose; Placebo, single dose; FTP-198, multiple doses; Placebo, multiple doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of FTP-198, 6 dose levels, oral suspension; Placebo matched to FTP-198, oral suspension; Multiple doses of FTP-198, 3 dose levels, oral suspension, 7 days; Placebo matched to FTP-198, oral suspension, 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients
Condition: Liver Cancer; Liver Cirrhosis
MeSH terms: Cholangiocarcinoma; Liver Cirrhosis
Study type: Interventional

Summary: 
      Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both
      radiologic imaging and during surgical resection. Therefore, radioactive seed-guided
      resection of these tumors, analogously to breast cancer, could be an interesting approach.
      The investigators present two cases of cirrhotic patients where this method of tumor
      labelling was used.
    

Detailed description: 
      The investigators selected two cases of patients with liver cirrhosis where seed-guided liver
      resection was used. Seed-guided resection is procedure that is usually commonly used in
      breast cancer surgery but so far not in liver surgery.

      This report emphasizes the difficulties, which surgeons and radiologists may face in tumor
      entities that are difficult to identify both macroscopically, by palpation and intraoperative
      imaging techniques.

      The first case was a patient suffering from suspected hepatocellular carcinoma with the
      background of alcoholic liver cirrhosis. This patient already underwent liver surgery to
      remove the suspected tumour but the lesion could not be removed correctly as identification
      was not possible neither with palpation nor with the help of intraoperative ultrasound. For
      this reason, the patient was selected for seed-guided resection.

      The second patient, who presented nine months after the first one, presented with the
      suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization.
      Therefore, the patient was selected for seed-guided resection.
    

Intervention name(s): Radioactive Seed Implantation
Intervention type(s): Device
Intervention description(s): In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
Condition: Postoperative Disease Recurrence; Crohns Disease
MeSH terms: Crohn Disease; Recurrence
Study type: Interventional

Summary: 
      Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric
      resection group and local mesenteric resection group.
    

Detailed description: 
      Randomization was performed intraoperatively once the surgeon had determined that there were
      no other sites of disease and that either type of anastomosis could be performed safely.
      Computer generated randomization was carried out within strata using randomized permuted
      blocks to ensure balance of the groups.

      All surgery was performed by a single group of surgeons experienced in the surgical treatment
      of Crohn's disease. Surgery was performed open or laparoscopically depending on patient
      factors and surgeon preference. The resection was performed grossly normal resection margins,
      with side-to-side anastomosis. The presence of mesenteric marginal thickening with
      confirmation by naked eye assessment of the mucosal aspect of the bowel were used to
      establish the limits of the disease.
    

Intervention name(s): mesenteric excision
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Web-based Programs to Improve and Strengthen Romantic Relationships
Condition: Romantic Relationship
Study type: Interventional

Summary: 
      This study investigates the effectiveness of www.OurRelationship.com, which provides
      self-help, web-based programs to improve romantic relationships and related outcomes. Couples
      will be randomly assigned to complete the OurRelationship program, the PREP Online program,
      or a wait-list control group and followed for six months.
    

Detailed description: 
      Nationwide, lower-income (LI) couples (those with household incomes <200% of the federal
      poverty level) - many of whom are also African American, Hispanic/Latino, or rural couples -
      face numerous challenges to their relationships. Chief amongst those challenges are: 1)
      higher risk of relationship problems and 2) lack of access to effective relationship services
      to prevent or intervene with relationship distress. Compared to higher-income couples, LI
      married and cohabiting couples are significantly more likely to divorce or separate and
      report lower relationship quality. Unfortunately, LI couples are least likely to receive
      interventions to prevent or solve relationship problems. To overcome these barriers, we
      propose to test the effectiveness of two effective web-based curricula - OurRelationship and
      PREP Online.

      A total of 750 LI couples will be recruited nationwide and randomly assigned to the PREP
      Online program, the OurRelationship program, or a wait-list control group and followed for
      six months. Once randomly assigned to group, couples will be assessed at one month, two
      months, four months, and six months following randomization. After couples randomized to the
      wait-list control group finish their waiting period, they will be able to select the program
      they would like to complete (OurRelationship or ePREP) but will not complete research
      assessments during or following their participation in the program. Interested couples can
      find out more information (and sign up for the study) at www.OurRelationship.com
    

Intervention name(s): OurRelationship; PREP Online
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Integrative Behavioral Couple Therapy; Prevention and Relationship Enhancement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Relationship Distress; Relationship Satisfaction; Marriage; Web-based; Internet