bioihbjkbjnl/mcl2 huggingface dataset:
Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study
Condition: Crying
MeSH terms: Colic
Study type: Interventional

Summary: 
      The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a
      prospective randomized controlled study would improve symptoms of infantile colic.
    

Detailed description: 
      Infantile colic ıs one of the most common problems within the first 3 months of life,
      affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome
      characterized by paroxysmal, excessive, inconsolable crying without identifiable cause.
      Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human
      gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement
      in adults, and recent data demonstrated safety after long-term dietary supplementation for
      newborn infants. The positive effects of this probiotic on intestinal disorders such as
      constipation and diarrhea and in protection from infection,as well as its capacity to
      modulate immune responses.

      The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a
      prospective randomized controlled study would improve symptoms of infantile colic.
    

Intervention name(s): Lactobacillus reuteri; Herbal drop; placebo sterile water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks; Herbal drop containing sodium bicarbonate, Pimpinella anisum oil,foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks
Other intervention name(s): Biogaia; Babs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: probiotic; infantile colic
Comparison of COVID-19 and H1N1 Influenza Pneumonia
Condition: COVID-19; H1N1 Influenza
MeSH terms: COVID-19; Influenza, Human; Pneumonia
Study type: Observational [Patient Registry]

Summary: 
      To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza
      pneumonia.
    

Detailed description: 
      COVID-19 pneumonia patients showed less proportions of underlying diseases, fever and
      respiratory symptoms than those of H1N1 pneumonia patients (p<0.01). White blood cell count,
      neutrophilic granulocyte percentage, C-reactive protein, procalcitonin, D-Dimer and lactate
      dehydrogenase in H1N1 pneumonia patients were higher than those of COVID-19 pneumonia
      patients (p<0.05). H1N1 pneumonia were often symmetrically located in the dorsal part of lung
      inferior lobes, while COVID-19 pneumonia were unsually showed a peripheral but non-specific
      lobe distributions. Ground glass opacity was more common in COVID-19 pneumonia and
      consolidation lesions was more common in H1N1 pneumonia (p<0.01). COVID-19 pneumonia lesions
      showed a relative clear margin compared with H1N1 pneumonia. Crazy-paving pattern, thickening
      vessels, reversed halo sign and early fibrotic leisions were more common in COVID-19
      pneumonia than H1N1 pneumonia (p<0.05). Pleural effusion in COVID-19 pneumonia was
      significantly less common than H1N1 pneumonia (p<0.01).

      Compared with H1N1 pneumonia in Zhejiang, China, the clinical manifestations of COVID-19
      pneumonia was more concealed with less underlying diseases and slighter respiratory symptoms.
      The more common CT manifestations of COVID-19 pneumonia included ground glass opacity with a
      relative clear margin, crazy-paving pattern, thickening vessels, reversed halo sign and early
      fibrotic leisions, while the less common CT manifestations of COVID-19 pneumonia included
      consolidation and pleural effusion.
    

Intervention name(s): computed Tomography
Intervention type(s): Device
Intervention description(s): All cases were detected with computed Tomography
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        pneumonia with COVID-19 pneumonia or H1N1 influenza
      
Keywords: COVID-19, H1N1, Tomography, X-ray computed
A Pilot Study of Dietary Chloride Supplementation on Cardiorenal Function in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to determine if administration of supplemental chloride in the
      form of lysine chloride to patients with congestive heart failure will affect their
      neurohormonal profile as well as response to diuretics.
    

Detailed description: 
      This prospective pilot "pre-post" study was designed to determine if supplementation of
      sodium free chloride ion as a lysine chloride to patients with heart failure could improve
      parameters of neurohormonal status and diuretic responsiveness. Volunteers will receive
      Lysine Chloride 7 grams three times daily for three days. At baseline and then again post
      lysine chloride patients will undergo sampling of venous blood for determination of
      neurohormonal parameters in addition to formal diuretic responsiveness testing.
    

Intervention name(s): Lysine Chloride
Intervention type(s): Dietary Supplement
Intervention description(s): Administration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lysine Chloride
Sperm DNA Fragmentation in Recurrent Pregnancy Loss
Condition: RECURRENT PREGNANCY LOSS
MeSH terms: Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while
      etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals'
      studies, several studies have underlined the importance of sperm quality for a normal embryo
      development. In human, epidemiological studies have demonstrated that several male risk
      factors have effects on development (male mediated development toxicology). However, few
      studies have explored sperm DNA fragmentation on embryo development but after in vitro
      fertilization. In natural pregnancy only rare studies have been performed but with different
      populations definitions and different methods of sperm exploration. In this context sperm DNA
      fragmentation exploration appears justified. The present study purpose to conduct a case -
      control study in order to research paternal role in RPL.
    


Intervention name(s): Blood and sperm samples
Intervention type(s): Other
Intervention description(s): 20 ml of blood and sperm samples for sperm DNA fragmentation exploration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Condition: COPD; Chronic Bronchitis; Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Emphysema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to show that one form of mechanical airway clearance techniques,
      High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish
      exacerbations of COPD which will improve respiratory health status.
    

Detailed description: 
      Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal
      symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a
      relatively benign condition, recent evidence shows that CMH in patients with established COPD
      is associated with greater decline in lung function, more frequent respiratory infections,
      more frequent exacerbations and increased mortality.Using mechanical airway clearance
      techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory
      health status.

      Comparison: Patients randomly assigned to the vest will have fewer exacerbations of
      COPD,better quality of life and less health care use compared to patients assigned to a sham
      vest.
    

Intervention name(s): pneumatic vest; placebo pneumatic vest
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COPD
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease; Hiatal Hernia
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Hernia, Hiatal
Study type: Interventional

Summary: 
      The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD
      patients treated in routine clinical practice at multiple centers across the United States.
    

Detailed description: 
      Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to
      each question) or clinically significant improvement (≥ 50% reduction in total scores) at
      6-month follow-up compared to baseline.

      Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant
      improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete
      discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in
      reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported
      by low incidence of serious adverse events.
    

Intervention name(s): TIF Procedure
Intervention type(s): Procedure
Intervention description(s): The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
Other intervention name(s): TIF - Transoral Incisionless fundoplication
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; Esophagitis; Fundoplication; Anti-reflux surgery; PPI dependent
The Effects of L-arabinose in a Meal in Healthy Men
Condition: Glucose Metabolism
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a meal containing different doses
      of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring
      the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and
      GLP-1) to explain the correlations.
    


Intervention name(s): L-arabinose - effect on glucose metabolism
Intervention type(s): Dietary Supplement
Intervention description(s): L-arabinose is mixed into the dough of the buns and cup cakes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Periodontitis is one of the most common chronic inflammatory disease with the etiology of
      bacterial plaque and is associated with a number of putative bacterial species. The
      periodontal destruction is substantially mediated by the host, driven by the bacterial
      challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial
      bacteria" and the susceptibility of the host are the main aetiological factors of periodontal
      diseases.
    


Intervention name(s): Lactobacillus brevis CD2 Lozenges
Intervention type(s): Drug
Intervention description(s): Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2
Other intervention name(s): Probiotics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group
      study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug
      interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in
      healthy subjects
    


Intervention name(s): ACHN-383; ACHN-789; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose; Oral dose; Oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Airways Function After HFNC Evaluated by IOS
Condition: Small Airway Disorders; COPD
Study type: Interventional

Summary: 
      In addition to pharmacological treatment, nonpharmacological treatment with high-flow nasal
      cannula (HFNC) may play a vital role in the treatment of patients with chronic obstructive
      pulmonary disease (COPD). The impulse oscillation system (IOS) is new noninvasive technique
      to measure the impedance of different portions of the airway with higher sensitivity than
      that of the conventional pulmonary function test (PFT). However, whether IOS is an
      appropriate technique to evaluate the efficacy of HFNC in improving the impedance of
      peripheral small airways in patients with COPD is unclear.
    

Detailed description: 
      Participants with stable COPD from the chest medicine outpatient department will be
      randomized into two groups receiving HFNC or nasal cannula (NC) for 10 min followed by a
      4-week washout period and crossover alternatively. We used a novel analytical measurement
      technique, IOS, to detect the difference in airway impedance in the participants after the
      HFNC or NC interventions. All data, namely IOS parameters, transcutaneous partial pressure of
      carbon dioxide, peripheral oxygen saturation, body temperature, respiratory rate, pulse rate,
      blood pressure, and PFT results at the time of pre-HFNC, post-HFNC, pre-NC, and post-NC, were
      analysed using SPSS (version 25.0, IBM, Armonk, NY, USA).
    

Intervention name(s): high flow nasal cannula and nasal cannula
Intervention type(s): Device
Intervention description(s): HFNC was administered using the MyAIRVO 2 device (Fisher & Paykel Healthcare, Auckland, New Zealand), which provides humidification and high-flow medical gas through an Optiflow NC interface (Fisher & Paykel Healthcare, Auckland, New Zealand) is administered for 10 min..
NC is administered for 10 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high-flow nasal cannula; high nasal flow; chronic obstructive pulmonary disease (COPD); airway impedance; distal airway; peripheral airway; airway resistance
DCVax Plus Poly ICLC in Healthy Volunteers
Condition: HIV-1 Infection; HIV Infection; Healthy Volunteers
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human
      immunodeficiency virus (HIV) infection. The vaccine is composed of a fusion protein
      containing a human monoclonal antibody specific for the dendritic cell receptor, DEC-205
      (CD205), and the HIV gag p24 protein. The vaccine is designed to target HIV antigens directly
      to endocytic pathways in dendritic cells (DCs) that allow for efficient processing and
      presentation of multiple HIV peptides on both MHC class I and II products, which will induce
      HIV-specific CD8+ and CD4+ T cells. This vaccine candidate must be combined with appropriate
      immunostimulants (adjuvants) to induce immunity to the antigen. In the proposed clinical
      trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.
    

Detailed description: 
      This trial will investigate whether delivery of HIV antigens via immunization with
      anti-DEC-205 p24 monoclonal antibody plus poly ICLC, as an adjuvant, is safe and induces
      either cellular or humoral immunogenicity in healthy volunteers. We propose to assess the
      quality of immunity elicited by DEC targeted vaccines in humans. Immunogenicity after HIV
      antigen delivery directly to dendritic cells could provide the proof-of-concept that
      dendritic cell targeted protein vaccines may serve as a stand-alone vaccine strategy or in
      combination with other vaccine modalities against HIV or other diseases.

      The main hypothesis of this study is to assess the delivery of HIV antigens via immunization
      with anti-DEC-205 p24 monoclonal antibody (DCVax-001) plus poly ICLC (Hiltonol) is safe and
      induces either cellular or humoral immunogenicity in HIV-uninfected, healthy volunteers.
    

Intervention name(s): DCVax-001; Poly-ICLC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control; Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control; Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control
Intervention MeSH terms: Poly ICLC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: HIV-1; HIV preventative vaccine; Healthy Volunteers
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Condition: High Frequency Episodic Migraine and Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high
      frequency episodic migraine and chronic migraine.
    


Intervention name(s): TI-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TI-001 is intranasal oxytocin
Other intervention name(s): Intranasal oxytocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Refractory Chronic Migraine; Medically Intractable Chronic Migraine; Oxytocin; Intranasal oxytocin
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
Condition: Rotavirus Disease
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due
      to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the
      safety and immunogenicity of either vaccine.
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: placebo; Comparator: Infanrix(tm) Hexa
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2; 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2; 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles
Condition: Ovarian Stimulation
Study type: Interventional
Phase: Phase 3

Summary: 
      To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation
      controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and
      patients aged between 36 and 39 years old.
    

Detailed description: 
      All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0
      mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation,
      patients started ovarian stimulation as follows:

      Patients < 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of
      rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist
      Cetrorelix is added until the day of rCG administration.

      Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and
      75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH
      antagonist Cetrorelix is added until the day of rCG administration.

      A maximum of 3 embryos were transferred on day 3 of embryo development.
    

Intervention name(s): rFSH: Follicle Stimulating Hormone; rFSH: Follicle Stimulating Hormone; rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa); rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian stimulation; In Vitro Fertilization; Luteinizing Hormone; GnRH antagonist; Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the
      pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in
      combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are
      homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein
      (CFTR) mutation.
    


Intervention name(s): TEZ; TEZ/IVA; IVA
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): tezacaftor; VX-661; tezacaftor/ivacaftor; VX-661/VX-770; ivacaftor; VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment