bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      That is a double-blind randomized trial with parallel control to demonstrate the safety and
      immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is
      to determine the safety and immunogenicity of acellular Tdap vaccine.

      The experimental group will receive acellular Tdap vaccine and the control group will receive
      a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will
      be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the
      vaccine.
    

Detailed description: 
      Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects:
      Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric
      complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound
      performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in
      Nuevo Leon State.

      The experimental group will receive acellular Tdap vaccine and the control group will receive
      a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will
      be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the
      vaccine by trained personnel.

      For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the
      vaccine or placebo were administered, at hospital admission for delivery. Infant: collected
      at delivery (cord), 2, 4 and 6 months of age.

      Immunogenicity will be compared in both groups by measuring the increase of three of the
      following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2
      FIM 2).

      Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one
      month after the application of the vaccine for side effects.
    

Intervention name(s): Biological/Vaccine: Tdap Vaccine
Intervention type(s): Biological
Intervention description(s): Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.
Other intervention name(s): ADACEL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Tdap Vaccine; Pregnant woman; Pertussis
Titration of Intravenous Hydromorphone
Condition: Acute Severe Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory, hypothesis-generating safety and efficacy study for patients who come
      to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain
      will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone
      over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient
      responds to the question, "Do you want more pain medicine?". This question will be asked
      repeatedly 30 minutes after the patient answers "no" or 30 minutes after the most recent dose
      of IV hydromorphone (which occurs if the patient answers "yes"). Up to 10% (approximately 30
      patients) will serve as a pilot at the start of the study.
    


Intervention name(s): Hydromorphone
Intervention type(s): Drug
Other intervention name(s): Dilaudid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute; pain; emergency department; hydromorphone; in ER
AT-301 Nasal Spray in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study.
      The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed
      by a multiple ascending dose (MAD) part (Part 2).
    


Intervention name(s): AT-301B; AT-301A
Intervention type(s): Drug; Drug
Intervention description(s): Nasal Spray; Nasal Spray
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 8 participants per cohort (randomised AT-301A/Placebo : AT-301B, 2:6). Part 1: (SAD) Participants will receive: Cohort 1 - AT- 301A/Placebo or AT-301B 0.1mL per nostril (0.2mL total); or, Cohort 2 - AT-301A/Placebo or AT-301B 0.2mL per nostril (0.4mL total).
Part 2: (MAD) Cohort 3 - AT-301A/Placebo or AT-301B 0.1mL per nostril (0.2mL total), three times/day for 14 days; or, Cohort 4 - AT- 301A/Placebo or AT-301B) 0.2mL per nostril (0.4mL total), three times/day for 14 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary object of this clinical study is to investigate the efficacy of HLCM051 in
      patients with ARDS caused by pneumonitis.
    

Detailed description: 
      The objectives of this clinical study are as follows(ARDS caused by pneumonia cohort):

        1. Primary objective To investigate the efficacy of HLCM051 in patients with ARDS caused by
           pneumonia

        2. Secondary objective To confirm the safety of HLCM05 in patients with ARDS caused by
           pneumonia

        3. Exploratory objective To investigate changes of biomarkers in patients with ARDS caused
           by pneumonia

      The number of patients enrolled is 30 (20 patient in the HLCM051 group and 10 patients in the
      standard therapy group)

      The objectives of this clinical study is as follows(ARDS caused by COVID-19 cohort):

      1. Exploratory objective To investigate the safety and the efficacy of HLCM051 in patients
      with ARDS caused by SARS-Cov-2 infection

      The number of patients enrolled is Approximately 5 (the HLCM051 group only)
    

Intervention name(s): HLCM051
Intervention type(s): Biological
Intervention description(s): HLCM051 is the stem cell product that can be mass-produced, being derived from adult adhesive stem cells that were taken from bone marrow of healthy unrelated donors from whom the informed consent was obtained, and proliferated ex vivo.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 【ARDS caused by pneumonia cohort】Parallel Assignment 【ARDS caused by COVID-19 cohort】Single group
Masking: None (Open Label)
Primary purpose: Treatment
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to understand the effectiveness of a ten-week internet-based
      cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and
      resilience skills, and cognitive processing.
    

Detailed description: 
      The need for mental health services is high among military personnel but perceived stigma and
      other barriers prevent many Soldiers from obtaining the help they need. Alternative mental
      health treatment approaches that mitigate stigma and increase access and compliance are
      greatly needed. One promising treatment approach that has shown efficacy in preliminary
      research and which may address issues related to stigma and barriers to care, is
      internet-based cognitive behavioral therapy (iCBT). Internet-based treatments offer brief,
      interactive, and structured treatment approaches that can be completed by individuals
      relatively anonymously, in the convenience and privacy of their own homes, and according to
      their own schedules. Such interventions could offer Soldiers an alternative treatment method
      that minimizes stigma by allowing private and quasi-anonymous access to treatment and which
      minimizes barriers to care by enhancing access and maximizing schedule flexibility.

      Emerging evidence suggests that iCBT is a particularly promising and well-accepted approach
      for treating large numbers of individuals while minimizing cost and clinicians' time demand.
      The study of internet-based and other computer-assisted therapies is currently in its infancy
      and most studies still lack sufficient methodological rigor to firmly establish the efficacy
      and applicability of these approaches. The proposed project will provide the most
      comprehensive evaluation of iCBT to date by employing functional neuroimaging techniques,
      neurocognitive testing of implicit negative biases and responses to negative feedback, and
      assessment of resilience and coping capacities in addition to standard symptom-based outcome
      measures.
    

Intervention name(s): Internet Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of online treatment program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For the clinical trial there were only 2 arms: MDD and MAC. There were no Healthy Controls in the CBT vs attention monitoring trial; both groups were depressed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Internet Cognitive Behavioral Therapy; fMRI; Neuroimaging
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with
      paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
    

Detailed description: 
      The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at
      6 months, objective response rate, duration of response rate, overall survival and time to
      progression, and safety which include adverse events, vital signs, laboratory tests, of the
      treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small
      cell lung cancer.
    

Intervention name(s): Chidamide; Paclitaxel; Carboplatin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Given orally; Given IV; Given IV; Given orally
Other intervention name(s): CS055; Taxol; TAX; CBDCA; Paraplatin; PLB
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chidamide,lung cancer
Topical Intra-Oral Ketoprofen for Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been
      shown to prevent migraines when used once daily for 3 months in open label studies. This is a
      randomized, double-blind, placebo controlled phase III prevention trial to determine safety
      and efficacy.
    

Detailed description: 
      This is a 4 month trial. During the first month, a prospective headache diary is maintained.
      Migraine frequency, severity (1-10), duration, and all headache medications are recorded.

      Patients are then randomized to receive active gel or placebo gel in double blind fashion.

      Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as
      outlined above, is maintained throughout the trial. Patients may continue to take other
      migraine medications, as needed. No other new migraine therapies may be started during the
      trial.
    

Intervention name(s): topical intraoral ketoprofen gel; Placebo Gel
Intervention type(s): Drug; Other
Intervention description(s): 20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.; An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine; Prevention; Treatment; Ketoprofen; Trigeminal nerve
Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Dexmedetomidine (Dex) activates the α2 adrenergic receptor that is present within the locus
      coeruleus, leading to anxiolysis, hypnosis, analgesia, and sedation.

      We conducted our research to compare the effects of fentanyl and DEX on the postoperative
      analgesic profile and complications in morbidly obese patients after sleeve gastrectomy.
    

Detailed description: 
      The participants were assigned to two groups of equal size (32 patients in each group) by the
      use of computer-generated numbers and sealed opaque envelopes. The participants allocated to
      the DEX group, also known as Group D, received an intravenous loading dose of DEX (1 μg/kg)
      over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a
      maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was
      discontinued upon trocars removal. The patients assigned to the fentanyl group (referred to
      as Group F) were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60
      seconds before induction of anesthesia as a loading dose. Following intubation, a continuous
      infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued
      upon the removal of the trocars.
    

Intervention name(s): Dexmedetomidine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal.; fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine, fentanyl, analgesia,Sleeve Gastrectomy
A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      In China, herbal therapy as a complementary therapy is very popular. Should conventional
      therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit?
      Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be
      collected from the medical records of patients with Alzheimer's disease (AD) in memory
      clinics.
    

Detailed description: 
      Conventional therapy (CT), such as donepezil and memantine are well- known short-term
      treatments for the symptoms of Alzheimer's disease (AD). The efficacy of them, however, drops
      below baseline level after 9 months. Should Chinese herbal medicine make add-on benefit? The
      GRAPE formula was designed by Prof. J Tian, a prepared granules of Chinese herbs, according
      to Qifuyin in Jing Yue Quan Shu (published in A.D. 1624). Patients treated with CT+herbal
      therapy or CT alone for up to and over 12 months are collected. Cognition, activities of
      daily living and behavioral symptoms are selected as outcomes for assessing the
      effectiveness.
    

Intervention name(s): GRAPE granules
Intervention type(s): Dietary Supplement
Intervention description(s): GRAPE granules was mainly consisted of herbal medicines: Ren Shen (Ginseng, 10g/d), Di Huang (Rehmannia glutinosa, 30g/d), Shi Cangpu (Acorus tatarinowii, 10g/d), Yuan Zhi (Polygala tenuifolia, 10g/d), Yin Yanghuo (Epimedium brevicornu, 10g/d), Shan Zhuyu (Cornus officinalis, 10g/d), Rou Congrong (Cistanche deserticola, 10g/d), Yu Jin (Curcuma aromatica, 10g/d), Dan Shen (Salvia miltiorrhiza, 10g/d), Tian Ma (Angelica sinensis, 10g/d), Tian ma (Gastrodia elata, 10g/d), and Huang Lian (Berberine, 10g/d), which were supplied by Beijing Tcmages Pharmaceutical Co., LTD, Each bag of granules with 150ml warm water melt was taken orally twice a day.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        AD patients involved in this retrospective, observational study will be selected from the
        clinic registration system of memory clinics in Beijing. All the participants underwent
        routine clinical assessments, including detailed medical history, cognitive and
        neuropsychological tests, neurological examinations, laboratory tests (i.e. thyroid
        function, folic acid levels, vitamin B12 levels, and routine blood tests), and
        neuroimaging. Participants with detailed medical history will be sampled and grouped into
        two cohorts according the therapies received.
      
Keywords: Complementary therapies
10+10+30 Infant Vaccines Communication Via Radio in Ethiopia
Condition: Infant ALL
Study type: Interventional

Summary: 
      A cohort study to investigate the effectiveness of radio intervention comprising 10-minute of
      drama, 10-minute of discussion led by community extension workers, and 30-minute phone-in
      from listeners on childhood vaccination coverage and timeliness
    

Detailed description: 
      The evaluation is conducted in 2 districts located in the Oromia region of Ethiopia. One of
      the districts will be allocated to receive the 3-month radio intervention while the other
      district that will not have access to the radio intervention will serve as the control.

      Data collection includes survey of mothers at two "key" times: at baseline (when infants are
      at most 5 weeks old; but before beginning the intervention) and at endline (including
      examination of infant vaccination records) at most 21 days after the end of the radio
      intervention. The same mothers and infants to be followed at endline.
    

Intervention name(s): 3-month radio intervention on infant vaccination
Intervention type(s): Behavioral
Intervention description(s): Radio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effect of Fermented Maillard Reacted Whey Protein on Immune Function
Condition: Immune Deficiency
MeSH terms: Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on
      natural killer (NK) cell activity, circulating cytokines and serum protein levels.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on 80 participant without
      diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder
      containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with
      dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E;
      peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562
      cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.
    

Intervention name(s): Fermented Maillard reacted whey protein (F-MRP); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6g of powder containing 4.2g fermented maillard reacted whey protein; 6g of maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Fermented Maillard reacted whey protein; Natural killer cell activity; Immune function; Pre-albumin; Interleukin-12
Ketone Plasma Kinetics After Oral Intake Of Different MCT
Condition: Healthy
Study type: Interventional

Summary: 
      This research project is aimed at identifying the MCT formulation matrixes that provide the
      highest ketoindex values and extended half-life, as well as to provide an initial evaluation
      of the GI tolerability of the various formula. For comparison, ketones salts and esters (food
      grade) will be also evaluated.
    

Detailed description: 
      Monocentric, open, randomized, controlled research project. The global research project will
      include several testing cycles as described in the figure 1. In each cycle, several research
      products (up to 4) will be tested on up to 20 participants in a partial or full cross-over
      design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be
      calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of
      ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of
      AUC-infinite of total ketones) values, new products will be developed for cycle 2.
    

Intervention name(s): 2.5% protein; protein 5%; protein 10%; protein 15%; A2: Peptamen 1.5 Vanilla without Breakfast; B2: only breakfast (no product); C2: 5% protein with breakfast; D2: 5% protein 30 min before breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5%; 5%; 10%; 15%; Peptamen withoug breakfast; only breakfast; C2: 5% protein consumed with breakfast; D2: 5% protein consumed 30 min before breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science