bioihbjkbjnl/mcl2 huggingface dataset:
Acute Caffeine Ingestion on Futsal Performance
Condition: Caffeine; Placebo
Study type: Interventional

Summary: 
      Caffeine supplementation has been recognized such as an useful strategy for improving
      performance in intermittent sports, however caffeine ingestion in futsal has been barely
      studied. In this randomized placebo-controlled study, we investigated the effects of acute
      caffeine supplementation in improving neuromuscular performance and physical match activity
      in futsal players.
    

Detailed description: 
      To date, no previous investigation has studied the effect of acute caffeine ingestion on
      futsal performance during futsal-specific testing and during a simulated match. Therefore,
      the aim of this investigation was to establish the effects of acute caffeine intake on
      futsal-specific tests (e.g. futsal kicking velocity) and match-play running performance in
      male futsal players.
    

Intervention name(s): Caffeine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Gelatine capsule with caffeine (3 mg/kg body mass of caffeine) (Bulk Powders, London, United Kingdom). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.; Gelatine capsule with placebo (Cellulose; Guinama, Valencia, Spain). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Healthfulness of Food From Grocery Stores Versus Eating Out Among People Receiving Food Benefits (SNAP)
Condition: Diet Habit
Study type: Observational

Summary: 
      The objective of this cross-sectional study was to characterize the dietary intake of SNAP
      participants and nonparticipants by food source, including grocery stores, sit-down
      restaurants, and fast food.
    

Detailed description: 
      The study used 4,237 low-income adults from the National Health and Nutrition Examination
      Survey (NHANES) (2003-2006 and 2011-2014). De-identified data was collected from demographic
      questionnaires and 24 hour dietary recalls. We assessed intake of calories, solid fats, added
      sugars, and servings of non-starchy vegetables, whole fruits, and whole grains, by food
      source in SNAP participants and income-eligible nonparticipants. Associations between SNAP
      participation and dietary intake were analyzed using multivariate linear regression
      controlling for relevant sociodemographic characteristics.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        4,237 low-income adults in the National Health and Nutrition Examination Survey (NHANES)
        (2003-2006 and 2011-2014)
Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, double-blind, randomized, and controlled study. The investigational
      product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week
      course of therapy.

      DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic
      activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes
      mellitus patients.

      Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen
      level of diabetes mellitus patients better than that of the Control Group.
    

Detailed description: 
      There will be 2 groups of treatment, each consisting of 68 subjects, with the treatment
      regimens as the following:

      Treatment I : DLBS1033 bioactive fraction tablet @ 490 mg, three times daily. Treatment II :
      Placebo tablet of DLBS1033, three times daily.

      Clinical examination to evaluate the efficacy of the investigational drug will be performed
      at baseline and every follow-up visit (at interval of 4 weeks) over the 8 weeks of study
      period. All subjects will be advised to follow such a lifestyle modification throughout the
      study period.

      All subjects will be under direct supervision of a medical doctor during the study period.

      During the study period, anti-diabetes treatment taken by study subjects should still be
      continued. Other treatment related to subjects' concomitant illnesses, such as hypertension,
      and/or dyslipidemia, is allowed during subjects' participation in the study.

      Other medication such as anti-platelets, fibrinolytic agents and anti-coagulants, or other
      treatment including herbals/alternatives which may affect haemostatic system, are not allowed
      to be used during the study period.
    

Intervention name(s): DLBS1033; placebo tablet of DLBS1033
Intervention type(s): Drug; Drug
Intervention description(s): 1 DLBS1033 tablet 490 mg thrice daily for 2 months; 1 placebo tablet of DLBS1033 thrice daily for 2 months
Other intervention name(s): Disolf; placebo tablet of Disolf
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBS1033, Type 2 DM, fibrinolytic, hypercoagulation
Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy
Condition: Cerebral Palsy; Hyperbaric Oxygen Therapy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Abnormal gait is a common issue in children with CP. As a result of motor weakness and a lack
      of voluntary motor control. Furthermore, gait in children with cerebral palsy is
      characterized by a slower walking speed, a shorter stride length, and more time spent in
      double support. Deficits in postural control constitute a major limitation to the motor
      development in children with CP. The performance of static and dynamic tasks, such as
      sitting, standing, and walking, is limited in these children due to postural instability.
      Postural control deficits in CP are caused by altered sensory processing, motor impairment,
      and biomechanical alignment, which result in altered neuromuscular responses.

      HBO2 therapeutic benefits in CP are attributed to an increase in dissolved oxygen in plasma
      and tissue, which aids tissue regeneration, So, the purpose of this study was to investigate
      the long-term effects of hyperbaric oxygen therapy on spatiotemporal gait parameters and
      functional balance skills in children with CP.
    

Detailed description: 
      This was a randomized clinical trial. Thirty-nine children with spastic cerebral palsy with
      ages ranging from 5 to 10 years referred from local pediatric rehabilitation centers
      participated in this study. All children were classified randomly using sealed envelopes into
      two groups (Control and Study groups). The children in the control group received traditional
      physical therapy and the study group received the same traditional physical therapy in
      addition to hyperbaric oxygen therapy. Written informed consent from the child's legal
      guardian was obtained. The study was authorized by the Ethics Committee for Research at Cairo
      University in accordance with the ethical standards of the Declaration of Helsinki. PBS was
      used to assess functional balance and GAITRite was used to assess spatiotemporal gait
      parameters. Measurements of functional balance and spatiotemporal gait parameters were taken
      three times: at the start of the intervention, eight weeks later, and six months after
      cessation of HPO2 therapy to assess the long-term effect.
    

Intervention name(s): Traditional Physical Therapy; Hyperbaric oxygen therapy
Intervention type(s): Other; Device
Intervention description(s): Stretching for tight muscles, strengthening for weak muscles, postural reactions training, proprioceptive training, and walking training were all part of the neurodevelopmental treatment plan.; HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spastic cerebral palsy; Hyperbaric oxygen therapy; Functional Balance; Gait parameters
National Cooperative Growth Study in CKD
Condition: Growth Hormone Deficiency
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      The purpose of this study is to learn whether growth hormone being administered to children
      with Chronic Kidney Disease is effective and if it has any side effects.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric clinic
      
Keywords: Growth Failure AND; Chronic Renal Insufficiency OR; End Stage Renal Disease
Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad
      spectrum vaccine for Influenza.

      This clinical trial will evaluate the safety and the immune response of increasing doses of
      OVX836 after intramuscular or intranasal administrations in healthy volunteers.
    

Detailed description: 
      This study is a single center, randomized, sequential dose escalation, placebo-controlled,
      observer-blind study conducted in healthy subjects aged 18-49 years.

      The OVX836 recombinant vaccine is based on the well conserved nucleoprotein of the Influenza
      virus.

      Three different dose levels of OVX836 (30µg, 90µg, 180µg) will be assessed sequentially and
      administered either by the intramuscular route (Study Part A) or by the intranasal route
      (Study Part B).

      There will be 6 cohorts in total with one cohort testing one dose level and one route of
      administration. Each study cohort will be composed of 12 subjects, with 9 subjects receiving
      the OVX836 vaccine and 3 subjects receiving the placebo. Each subject will receive one
      administration of OVX836 or placebo on Day 1 and one administration on Day 29.

      The study duration for each subject is approximately 5 months.
    

Intervention name(s): OVX836 (Intramuscular); Placebo (Intramuscular); OVX836 (Intranasal); Placebo (Intranasal)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.; 2 consecutive administrations of placebo at Day 1 and Day 29.; 2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.; 2 consecutive administrations of placebo at Day 1 and Day 29.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase I, single center, randomized, observer-blind, placebo-controlled study.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza; vaccine; nucleoprotein
Muscle Strength and Functional Autonomy of Elderly Women
Condition: Muscle, Ligament and Fascia Disorders
MeSH terms: Muscular Diseases
Study type: Observational

Summary: 
      This study shows an evaluation of the correlation between the muscle strength levels and
      functional autonomy of elderly women.
    

Detailed description: 
      The aim of this study was to evaluate the correlation between the muscle strength levels and
      functional autonomy of elderly women with impaired muscle-skeletal system depending on the
      normal IGF-1 level. The target-population was composed by elderly women aged between 60 and
      75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1
      levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength
      (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of
      daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence
      method) were performed.
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        The population consists of 123 elderly women residents of São Lucas shelter, located in
        Cacimba Velha, Teresina-PI, Brazil. The sample consists of 35 elderly women. The elderly
        participants in the study signed a written informed consent.
      
Biospecimen description: 
      Whole blood
QLB After Nephrectomy
Condition: Pain, Postoperative; Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy
      procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).
    

Detailed description: 
      Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the
      end of an operation, still under general anesthesia, 50% patients will obtain QLB with
      ropivacaine.

      Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine
      solution (0.2 mL per kg).

      Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative
      period.

      Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours
      after the end of the operation. 24 -hours period.

      At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain.
      Neuropathic Pain Symptom Inventory (NPSI) will be used.
    

Intervention name(s): QLB; PCA; GA; Oxycodone; Sevoflurane; Fentanyl; Rocuronium
Intervention type(s): Procedure; Device; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg); Patient-controlled analgesia; General anesthesia; administered by PCA; Inhalational anesthetic during GA; painkiller during GA; muscle relaxant during GA
Intervention MeSH terms: Fentanyl; Oxycodone; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly allocated to one of the study arms: QLB or control group.
Masking: Single (Participant)
Primary purpose: Treatment
Study Comparing Risperidone vs Placebo as add-on Therapy in Patients With Generalized Anxiety Disorder Who Are Sub-optimally Responding to Standard Therapy.
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine the effectiveness of risperidone as an adjunctive
      treatment in patients with GAD who demonstrate a less-than-optimal response to their current
      anxiolytic treatment.
    

Detailed description: 
      Many patients with Generalized Anxiety Disorder (GAD) do not benefit or show only partial
      benefit from current psychotropic therapies. This trial was conducted for the purpose of
      determining the effectiveness of risperidone as an adjunctive treatment in patients with GAD
      who demonstrate a less-than-optimal response to their current anxiolytic treatment (either
      allowed antidepressants, benzodiazepines, or buspirone, or combination). Patients were
      randomized (patients are assigned different treatments based on chance) to either risperidone
      or placebo for 4 - 6 weeks of double-blind (neither the patient nor the physician knows
      whether drug or placebo is being taken, or at what dosage) treatment. Patients randomized to
      risperidone continued on their current anxiolytic treatment (treatment for anxiety) and
      received risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through
      14, and 1 mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29,
      the dose could be increased to 2 mg per day for the rest of the trial (4 to 6 additional
      weeks). At each dose level, risperidone was taken by mouth in a single daily dose. Patients
      were asked questions every one or two weeks, depending on the phase of the trial, to
      determine efficacy (effectiveness) and safety. The study hypothesis is that risperidone will
      be more effective as an adjunct to standard psychotropic treatments for symptoms of
      Generalized Anxiety Disorder than placebo, as measured by a composite of the four most
      troubling symptoms identified at baseline.

      Risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through 14, and 1
      mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29, the dose
      could be increased to 2 mg per day for the rest of the trial (4 to 6 additional weeks). At
      each dose level, risperidone was taken by mouth in a single daily dose.
    

Intervention name(s): risperidone oral tablets
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anxiety; antipsychotic
A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir
      (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy
      matched control participants. The primary hypothesis is that the area under the curve (AUC)
      (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic
      insufficiency is similar to that observed in healthy matched controlled participants.
    


Intervention name(s): Vaniprevir 300 mg; Vaniprevir 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): single dose administration of 300 mg oral tablet; single dose administration of 200 mg oral tablet
Other intervention name(s): MK-7009; MK-7009
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Perianal Abscess Cavity Packing vs no Packing.
Condition: Perianal Abscess; Ischiorectal Abscess
MeSH terms: Abscess
Study type: Interventional

Summary: 
      This prospective randomized trial will be conducted in all patients undergoing packing or no
      packing for perianal abscess cavity after incision and drainage, for 6 months after approval
      from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random
      sampling technique based on inclusion criteria. Patient will be assessed for post-operative
      pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue
      will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be
      started.

      Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of
      life, wound healing, post operative fistula in ano and chronic post surgical pain either due
      to packing or no packing.
    

Detailed description: 
      This is an experimental randomized control trial will start 6 months after approval from
      Institution Review Board. All patients with perianal abscess after incision and drainage
      cavity will be either packed or not after informed consent. Pack will be changed daily as
      regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of
      dressing solution in which gauze is soaked. Other group with dressing will be changed daily
      and will be assessed for healing week. There is no pain in simple dressing applied over
      cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture.
      During this period, laboratory investigation CBC, CRP will be sent to check the response.
      Sits bath will be advised to both groups. Post-operative pain, cavity healing will be
      assessed by faculty.
    

Intervention name(s): No packing of perianal abscess cavity
Intervention type(s): Procedure
Intervention description(s): introducing new method to no packing of abscess cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental Randomized Control Trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional

Summary: 
      This study evaluates plaque burden and characteristics in early-treated FH patients compared
      to late-treated FH patients and healthy individuals.
    


Intervention name(s): Coronary computed tomography angiography (CCTA)
Intervention type(s): Diagnostic Test
Intervention description(s): Participants undergo coronary computed tomography angiography (CCTA)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study
      that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had
      elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1
      second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other
      controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor
      antagonist [LTRA], or immunotherapy).
    


Intervention name(s): omalizumab (Xolair); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.; The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Omalizumab (Xolair); Atopic Asthma