bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
Condition: Trypanosomiasis, African
MeSH terms: Trypanosomiasis; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the therapeutic combination of I.V. eflornithine +
      oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and
      clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African
      trypanosomiasis (HAT) in the meningoencephalitic phase.
    

Detailed description: 
      Melarsoprol is the most commonly used product for the treatment of patients suffering from
      human African trypanosomiasis (HAT) in the meningoencephalitic (second, late) phase. This
      treatment is frequently complicated by fatal reactive encephalopathy, and at the same time
      resistance is beginning to appear in various countries. Eflornithine is effective and better
      tolerated, but it is more difficult to use. Nifurtimox, registered in several South American
      countries for treatment of Chagas' disease but used off label since the 1970's in series of
      cases of meningo-encephalitic HAT, is at present the only other potential alternative for the
      treatment of late-stage HAT.

      The very limited number of compounds available, the lack of prospects for the development of
      new products and the emergence of resistance are arguments for the use of therapeutic
      combinations. Ideally, drug combinations should allow for reductions in the dosages of the
      drugs used in a way that, in particular in the case of toxic drugs such as those used for
      second stage HAT, the toxicity of the combination does not exceed that of either monotherapy.
      Of the three drug combinations nowadays possible: melarsoprol-nifurtimox,
      melarsoprol-eflornithine and eflornithine-nifurtimox, the last one has (in two different
      dosing regimens) shown the least treatment-associated toxicity and mortality in the 69
      patients treated in one previous and this clinical trial to date. Good tolerability was also
      observed in a case series of 31 patients. The efficacy data to date suggest that efficacy is
      comparable to that of eflornithine and that of melarsoprol (in areas without high melarsoprol
      failure rates).
    

Intervention name(s): Eflornithine; Nifurtimox
Intervention type(s): Drug; Drug
Intervention MeSH terms: Eflornithine; Nifurtimox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human African Trypanosomiasis; Combination; Trypanosoma brucei gambiense Human African Trypanosomiasis
Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during
      percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on
      platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet
      inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in
      a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg).
      Understanding the effects of this combination on platelet inhibition will provide guidance to
      physicians on the use of prasugrel in patients who have already been pretreated with
      clopidogrel.
    


Intervention name(s): Prasugrel; Clopidogrel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.; Loading dose administered once orally.; Loading dose administered once orally
Other intervention name(s): LY640315
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Plavix, Effient
Personal Protective Equipment Effects
Condition: Speech Disorders; Voice Disorders
MeSH terms: Voice Disorders; Speech Disorders
Study type: Observational

Summary: 
      Severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral,
      nasal, and conjunctival mucosas are related to contamination, and wearing personal protective
      equipment (PPE) is strongly suggested. Several communication problems between the patient and
      healthcare workers related to PPE use are reported. In this study, investigators aimed to
      investigate changes in the acoustic parameters of speech sounds when different PPE are used.
    

Detailed description: 
      It was planned as a cross-sectional study enrolled 18 healthy male and female participants.
      After the informed consent, participants were asked to pronounce a [ɑː] vowel for at least 3
      seconds for voice quality estimation. Afterward, all Turkish vowels were produced for a
      minimum of 200 ms. Finally, three Turkish fricative consonants ([f], [s], [ʃ]) were produced
      in consonant/vowel/consonant format and in different vowel contexts within a carrier
      sentence. Recordings were repeated for the following conditions: no PPE, surgical-mask,
      N99-mask, face shield, surgical-mask+faceshield, and N99+faceshield. All recordings were
      analyzed with proper statistical methods.
    

Intervention name(s): mask use
Intervention type(s): Device
Intervention description(s): face mask use
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals. Based on health caregiving people (doctors, nurses)
      
Keywords: speech acoustics
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
Condition: Safety Issues
Study type: Interventional

Summary: 
      This is a three-arm, double-blind, placebo-controlled study to investigate the safety of
      Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used
      individually in healthy infants.

      Infants will be given the content of one capsule (mixed in infant formula or breast milk)
      twice daily (morning and evening) for 15 weeks.
    

Detailed description: 
      This is a three-arm, double-blind, placebo-controlled study to investigate the safety of
      Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used
      individually in healthy infants.

      Infants will be given the content of one capsule (mixed in infant formula or breast milk)
      twice daily (morning and evening) for 15 weeks. Follow-up visits will take place at study
      days 14±3, 42±3, 70±4 and 105±4.

      Caregivers will keep a diary of the volume of formula intake/minutes of breastfeeding, stool
      frequency and consistency (hard, formed, soft/paste or loose/watery), symptoms of digestive
      tolerance (regurgitation and flatulence), sleeping time, crying/fussing time and episodes for
      3 days before each visit. At each visit, the research team will review the diary and conduct
      physical examination, including anthropometric measurements (weight, recumbent length, and
      head circumference).

      Fecal samples will be collected prior to the first administration of the assigned study
      product and at the end of study for microbiota analysis.

      Adverse events (AEs) will be assessed based on inquires to the caregivers. AEs will be
      classified as related or unrelated based on a relationship to study product intake according
      to the investigator.
    

Intervention name(s): Lactobacillus salivarius AP-32; Bifidobacterium animalis subsp. lactis CP-9; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.; Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.; Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active:
Lactobacillus salivarius AP-32.
Bifidobacterium animalis subsp. lactis CP-9. supplied as 0.5 g capsules.
Placebo:
The placebo capsules are identical to the Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 capsules except for the probiotics.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Probiotic; Lactobacillus salivarius AP-32; Bifidobacterium animalis subsp. lactis CP-9; Safety; Healthy infant
AZD Single Ascending Dose Study In Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open label, non-randomised study to access the safety, tolerability,
      pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to
      Japanese subjects.
    


Intervention name(s): AZD3043; AZD3043
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous, single dose; Infusion, single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; AZD3043; Japanese healthy volunteer
Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To
      investigate the possible influence of pregnancy and duration of pregnancy To determine the
      antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics
      parameters before and after pregnancy.
    

Detailed description: 
      HAART in pregnant HIV-infected serves two goals, preventing mother to child transmission and
      providing adequate treatment for the mother. Levels of HIV RNA at delivery and the use of
      antiretrovirals (ARV) are independently associated with decreased transmission[1]. With a
      HAART regimen the transmission rate can be reduced till under the 2 %[1, 2]. Possibly
      suitable drugs which can be used during pregnancy is lopinavir/ritonavir based regimens. In
      Thailand, aluvir is not available therefore a generic lopinavir/ritonavir tablet formulation
      will be used in our study.

      In order to prove adequate levels of lopinavir/ritonavir, we will record 12-hour PK at third
      trimester. Second trimester and post-partum 12-hour PK are optional. Furthermore, we will
      collect safety and efficacy throughout the study.
    

Intervention name(s): generic lopinavir/ritonavir
Intervention type(s): Drug
Intervention description(s): Patients will start with lopinavir/ritonavir new formulation 400/100 mg bid with a low fat diet plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The choice of the 2 NRTIs is at the discretion of the investigator, though in general the use of zidovudine+lamivudine (300/150mg Combivir®) is recommended. If patients can be included at or before gestational week 20, a 12h pharmacokinetic curve will be recorded at week 20 (± 2 weeks)(Group 1). There should be a minimum of 2 weeks between start of lopinavir and pharmacokinetic recording. If they are included after week 20, the first 12h pharmacokinetic curve will be recorded at gestational week 33 (± 2 weeks)(Group 2). For the patients in both groups a 12 hr curve will be recorded.
Subjects in Group 1 will be offered to conduct a second 12h pharmacokinetic curve at week 20 (± 2 weeks), but this is only optional. Both groups will be asked to participate in the post partum curve, again this is optional.
Intervention MeSH terms: Ritonavir; Lopinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generic lopinavir/ritonavir; Pharmacokinetics; Pregnancy; Antiviral activity; Safety
The Effectiveness of Vitamin C in Postoperative Pain Management of Single-level Posterior Lumbar Interbody Fusion (PLIF)
Condition: Fusion of Spine (Disease)
Study type: Interventional

Summary: 
      Postoperative pain management remains a major challenge for surgeons. Despite huge
      technological advances in pain management, many researchers have documented that unrelieved
      pain remains common after surgeries, which is estimated that up to 75% of patients do not
      achieve adequate pain relief postoperatively. The major goal in the management of
      postoperative pain is to minimize the dose of medications to lessen the side effects while
      still providing adequate analgesia, because side effects of commonly used pain medications
      are known to be the reasons that could lead to inadequate postoperative pain treatment. This
      goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive
      and pain reducing effects is vitamin C.

      Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially
      highly concentrated in the brain, which has antioxidant and neuroprotective properties.
      Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery
      and the requirement for vitamin C increases in surgical patients, possibly due to greater
      demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain,
      a result from a recent study with the aim to evaluate the potential role of vitamin C in
      reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral
      vitamin C significantly decreased morphine consumption after surgery.

      Although vitamin C has potential for relieving postoperative pain, there has not been studied
      regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to
      evaluate the effectiveness of vitamin C for surgery of lumbar spine.
    


Intervention name(s): Vitamin C; Placebo drug
Intervention type(s): Drug; Drug
Intervention description(s): for 1 month postoperative period, vitamin C was administered orally to the patients.; for 1 month postoperative period, placebo medication administered orally to the patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin C; effectiveness; pain management; posterior lumbar interbody fusion
A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin
      Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by
      Parke-Davis under fasting conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover design
      under fasting conditions

      Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets versus 400 mg
      Gabapentin Capsules Under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Gabapentin 800 mg tablets, single dose (1 tablet); NEURONTIN® 400 mg capsules, single dose (2 capsules)
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fasting conditions; B: Active comparator Subjects received Parke-Davis formulated products under fasting conditions
Other intervention name(s): Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Gabapentin; Healthy subjects
Healthy.io Method Comparison & User Performance Study
Condition: Urinary Tract Infection; Kidney Failure; Diabetes
MeSH terms: Urinary Tract Infections; Renal Insufficiency
Study type: Interventional

Summary: 
      The objectives of the Healthy.io Method Comparison and User Performance Study are:

        1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission®
           U500 Urine Analyzer.

        2. To evaluate the user performance of Dip.io Device under actual use conditions (home
           environment) based on a user questionnaire and rating scale.
    


Intervention name(s): Dip.io Home Based Dipstick Analyzer; ACON U500 Mission® U500 Urine Analyzer
Intervention type(s): Device; Device
Intervention description(s): First intervention (assigned to the "All participants" arm).; Second intervention (assigned to the "All participants" arm).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Carnitine Supplementation and Skeletal Muscle Function
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Research project objectives The primary aim of the current research project is to use
      carnitine supplementation as the anti-inflammatory intervention for exploring the
      relationship between inflammation and associated with aging reduction of skeletal muscle
      mass.

      Hypothesis The carnitine supplementation modulates the blood cytokines concentration.
      Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with
      aging
    

Detailed description: 
      Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24
      weeks. Before the start, in the mid-point, and after finishing the supplementation the
      following primary outputs variables are performed: body composition analysis (InBody720),
      maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and
      carnitine concentration, blood lipid profile.
    

Intervention name(s): carnitine; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1500 mg/d l-carnitine-l-tartrate; isonitrogenous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: carnitine
Validation of the French Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Condition: Human Characteristics; Attitude to Health
Study type: Observational

Summary: 
      Background: Despite current popularity, positive mental health is under researched. This is
      possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental
      Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to
      measure mental well-being. Its validation has been internationally explored. This report
      presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical
      populations.

      Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75 students
      (STUD), and one clinical population of 121 patients with remitted schizophrenia (PRS) were
      included in the validation study. Participants completed the F-WEMWBS as well as
      complementary measures of psychological constructs potentially related to well-being.
    

Detailed description: 
      Three different populations participated in the study: two non-clinical populations composed
      of students (STUD), and working adults (WORK) and one clinical population comprised of
      patients with remitted schizophrenia (PRS). The STUD population was a convenient sample of 75
      first year students (51 females and 24 males); with 45 from a School of Business Management
      and 30 from a medical university. The WORK population was also a convenient sample of 113 (63
      females and 256 males) working adults including 217 soldiers from Paris Fire Brigade, 93
      nurses and 9 individuals from a research laboratory. The PRS population was comprised of 121
      remitted schizophrenia patients (39 females and 82 males) who were all clients of the
      rehabilitation centre for psychotic disorders (Le Vinatier hospital), situated in Lyon,
      France.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three different populations participated in the study: two non-clinical populations
        composed of students (STUD), and working adults (WORK) and one clinical population
        comprised of patients with remitted schizophrenia (PRS).
      
Keywords: well-being, mental health, schizophrenia, quality of life
Lumbosciatic Syndrome: Vojta Therapy vs. TENS
Condition: Lumbosciatic Syndrome; Pain; Functional Limitation; Vojta Therapy; Transcutaneous Electrical Nerve Stimulation
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This pilot "pre-post" quasi-experimental study evaluates for the first time the effectiveness
      of Vojta Therapy in treating lumbosciatic and compares it with the transcutaneous electrical
      nerve stimulation (TENS) procedure. Patients who agree will be distributed alternately in
      order of arrival to a Physiotherapy Unit, in such a way that half of the sample will be
      treated using TENS and the other half with Vojta.
    

Detailed description: 
      Lumbago/lumbosciatic (with or without radicular implication) is the second most frequent
      cause of primary medical care and the highest cause of disability in the entire world. This
      pathology is normally slight to moderate in the majority of cases, meaning that the
      therapeutical treatment tends to be conservative and thus the interest in increasing the
      range of non-invasive therapeutic possibilities is available.

      Reflex Locomotion or Vojta Therapy began being used in 1959 for the rehabilitation of
      children with motor alterations and infants with a risk of cerebral palsy. Years later it was
      successfully applied to adults with neurological and motor alteration problems. Until now,
      there have been no studies on its use in pathologies of the spine and, in particular at a
      lumbar level.

      A pre-/ post-intervention examination will be performed to obtain an objective clinical
      analysis (measurements of pain, disability, functionality and joint movement), by means of
      simple questionnaires completed by the patient (VAS scale, Oswestry and Roland-Morris
      questionnaires) and exploration techniques (Lasègue manoeuvre, Schöber test, fingertips to
      floor test and walking on heels and toes).
    

Intervention name(s): Physiotherapy technique: TENS; Physiotherapy technique: Vojta Therapy
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were recruited as follows: the rehabilitation doctor evaluated and diagnosed the patient and referred them to the Physiotherapy Unit (PTU) with a prescription for "TENS or Vojta" treatment. It was at the PTU of the health centre where the patient was informed of the possibility of taking part in the study. Patients who agree were allocated alternately in order of arrival to the PTU, in such a way that half of the sample was treated using TENS and the other half with Vojta therapy .
Masking: None (Open Label)
Primary purpose: Treatment