bioihbjkbjnl/mcl2 huggingface dataset:
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Condition: Non-allergic Rhinitis
MeSH terms: Rhinitis; Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is
      estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic
      inflammation of the inner lining of the nose and is characterized by the following symptoms:
      rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining
      rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than
      twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the
      knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and
      non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic
      rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal
      spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM
      (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal
      spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in
      VAS for major nasal symptom on week 4.

      (Estimated placebo effect is 25%.)
    


Intervention name(s): Capsaicin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): via nasal spray; via nasal spray
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal
      Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese
      adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then
      infants aged approximately 2 months.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose; suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose; suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: 13vPnC; Healthy subjects; China
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Infertility, Female
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female; Syndrome
Study type: Interventional

Summary: 
      The objective of the study is to provide preliminary evidence for the safety and
      effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under
      ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS)
      who have not responded to first-line ovulation induction treatment or are contraindicated for
      or decline such treatment.
    


Intervention name(s): AblaCare System
Intervention type(s): Device
Intervention description(s): The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.
Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: PCOS; Infertility related to PCOS; Ovulation restoration
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      The results of previous studies suggest further development of [18F]EF5 as a PET tracer for
      imaging hypoxia. This is a non-randomized prospective study to obtain information on
      reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
    

Detailed description: 
      All patients will undergo normal diagnostic and staging procedures, including a conventional
      18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an
      18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous
      injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for
      measurement of plasma radioactivity. A low-dose CT (helical) will be performed for
      attenuation correction and anatomical reference. After that, a PET scan will be performed
      (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way
      4-7 days after the first scan. A representative histologic sample of primary tumor is
      pre-condition for study and an effort is made to store part of fresh histologic material in
      liquid nitrogen for later use in immunohistochemical analysis.

      Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current
      clinical standards after completion of the current protocol. Follow-up information
      (event-free survival and overall survival) will be gathered.
    

Intervention name(s): 18F-EF5; Pretreatment PET/CT-scan (performed two times)
Intervention type(s): Drug; Procedure
Other intervention name(s): PET/CT static imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-EF5; PET/CT; Reproducibility
Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery
Condition: Bradycardia
MeSH terms: Bradycardia
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim
      of this study was to evaluate the efficacy of atropine sulfate for prevention of brad
      arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.
    

Detailed description: 
      120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic
      gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either
      atropine sulfate or normal saline solution (as placebo).
    

Intervention name(s): IM atropine; IV atropine; Atropine mixed with second dose succinylcholine; IM normal saline; IV normal saline; Normal saline mixed with second dose succinylcholine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia; Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia; Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline; 1 ml normal saline IM 30 minutes before induction of anesthesia; IV 10 ml normal saline 3 minutes before induction of anesthesia; Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Other intervention name(s): IM atropine sulphate; IV atropine sulphate; atropine sulphate with succinylcholine; Normal saline; Normal saline; Normal saline with succinylcholine
Intervention MeSH terms: Atropine; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atropine; Succinycholine; Laparoscopy; Gynecology
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in
      pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve
      weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at
      each visit. Patients will have a dilated fundus exam and corneal measurements taken at first
      and last visit.
    


Intervention name(s): BETAXON (levobetaxolol HCl); AZOPT (brinzolamide)
Intervention type(s): Drug; Drug
Intervention description(s): levobetaxolol suspension, 0.5%; brinzolamide suspension, 1%
Intervention MeSH terms: Brinzolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Glaucoma; Ocular Hypertension
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The study seeks to provide evidence of the effectiveness and obtain patient reported outcome
      (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN
      (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C
      virus (HCV) infected participants in Austria.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)
      
Keywords: Paritaprevir; Dasabuvir; Ombitasvir; Chronic Hepatitis C; HCV
Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Medically Unexplained Symptoms
Study type: Observational

Summary: 
      This prospective observational study aims to evaluate the influence of somatic symptom load
      and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and
      vomiting (PONV). Physiological and psychological variables are assessed in female patients
      with an increased risk for PONV prior to a planned surgical intervention with a 33-item
      questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the
      occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized
      that patients with high sum scores for somatic symptom load (measured with the Patient Health
      Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the
      Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and
      vomiting (PONV) than patients with low scores in both self-rating instruments.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients in a universitary hospital who are scheduled for elective surgery in
        general anesthesia (planned interventions in general surgery, orthopedia, traumatology,
        gynecology, neurosurgery (except intracranial interventions)and who present with an
        increased risk to experience postoperative nausea and vomiting.
      
Keywords: Anxiety; Somatoform Disorders
Liver Cancer HepaSphere Combined With Cryosurgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.
    

Detailed description: 
      By enrolling patients with liver cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of HepaSphere
      interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery
      for liver cancer.
    

Intervention name(s): HepaSphere combined with cryosurgery
Intervention type(s): Procedure
Intervention description(s): liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Cancer; HepaSphere; cryosurgery
Community Resilience to Acute Malnutrition
Condition: Malnutrition, Child
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The study evaluates the impact of a multi-sectoral intervention (water, sanitation, and
      hygiene; training on climate smart activities; care groups for mothers; market gardens) on
      the prevalence of acute malnutrition as the primary outcome using a randomized intervention
      trial between 2012-2017 with four points of data collection (2012, 2014, 2015, and 2017).
    

Detailed description: 
      Concern Worldwide has developed a model of intervention called Community Resilience to Acute
      Malnutrition (CRAM). This model is based on the need for (a) the introduction of longer-term
      programming to build community resilience to shocks, while recognising that there may be a
      need for humanitarian intervention, and (b) a multi-sectoral package of activities given
      experience in programming from other settings. The goal of the study is to rigorously test
      the impact of the model and associated activities on community resilience to shocks in the
      Goz Beida area of Chad. Where community resilience is proxied by the primary outcome
      variable: acute malnutrition.

      In order to answer this question, 69 villages had been randomized to either receive the full
      multi-sectoral program or not. In each village, approximately 20 households were surveyed
      (randomly selected from a household list from a previous emergency distribution) for a total
      of 1420 households. Those households were then surveyed in November/December 2012 (prior to
      the intervention), and again a the same time period in 2014, 2015, and 2017.

      Data was collected on household demographics, livelihoods, child health, and nutrition,
      including child (6-59 months) anthropometry.
    

Intervention name(s): multisectoral package of activities
Intervention type(s): Behavioral
Intervention description(s): A multi-sectoral package of village level activities, including having a well dug, a shared latrine installed, training on handwashing and hygiene across the water chain, training on conservation agriculture techniques, care groups for pregnant and breastfeeding mothers, and training on market gardens.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Panel cluster randomized intervention trial
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative,
      treatments are available. Traditional Chinese medicine is one of the most frequently chosen
      alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with
      topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to
      exhibit potential anti-psoriatic efficacy. The study objective is to investigate
      pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM)
      Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild
      to moderate plaque-type Psoriasis.

      This was a single site, randomized, double-blinded, placebo controlled study of topical
      indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis
      during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and
      clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH),
      Taichung, Taiwan. All patients provided written informed consent before inclusion in the
      study. The study protocol was approved by the institutional review board (IRB) of CMUH.
    

Detailed description: 
      Estimated enrollment:

      Total of 24 subjects:

      mild to moderate psoriasis patients will be randomized into treatment group (n=16) placebo
      group (n=8)

      Study evaluation:

      A baseline and end of the study evaluation on the patients will be performed, including
      physical examination, hemogram and blood biochemical analysis (including glutamic-oxaloacetic
      transaminase, glutamic-pyruvic transaminase, and creatinine measurement). The baseline and
      end of the study of total body surface area involvement and Psoriasis Area Severity Index
      (PASI), PGA, OTPSS scores will be also calculated.
    

Intervention name(s): Indigo naturalis ointment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The Indigo naturalis ointment was composed of a 1:10 mixture of Indigo naturalis powder and a vehicle consisting of Vaseline: microcrystalline wax: olive oil (5:6:9 ratio); The placebo was a mixture of blue dye powder (54.8% Indigo carmine aluminum lake [Blue #32] and 45.2% Allura Red AC aluminum lake [Red #40] powders), Vaseline, microcrystalline wax, and olive oil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Indigo Naturalis; chinese medicine
Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose
Condition: AIDS
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of
      a HIV candidate vaccine after administration of one oral dose of chloroquine.
    

Detailed description: 
      The Protocol Posting has been updated following Protocol amendment 1, October 2009.
    

Intervention name(s): GSK Biologicals' HIV vaccine (732461); Chloroquine
Intervention type(s): Biological; Drug
Intervention description(s): 1 dose intramuscular injection; One dose of 300 mg
Other intervention name(s): Nivaquine®
Intervention MeSH terms: Chloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chloroquine; Human Immunodeficiency Virus
A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an
      age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric
      coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the
      lowest and higher levels of enteric coating will also be assessed.
    


Intervention name(s): tofacitinib modified release (MR)
Intervention type(s): Drug
Intervention description(s): Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state.
Treatment F: a 10 mg oral dose of tofacitinib IR solution
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Work hypothesis

      A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
    


Intervention name(s): Sardine diet
Intervention type(s): Other
Intervention description(s): Diet rich in sardine: 100g/day of sardine 5 times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Sardine; Type 2 diabetes
Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients
Condition: Adverse Reaction to Other Drugs and Medicines
Study type: Interventional
Phase: Phase 4

Summary: 
      the investigators examined the hypothesis that hyperprolactinemia may alter uterin,
      endometrial and intraovarian blood flow and may contribute to increased infertility by
      another way.
    


Intervention name(s): cabergoline treatment
Intervention type(s): Drug
Intervention description(s): cabergoline treatment for hyperprolactinemia group
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment