bioihbjkbjnl/mcl2 huggingface dataset:
The Randomized Controlled Cocoa-Appetite Trial
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite
      in humans. In addition the study is designed to test epicatechin, a compound found in cocoa
      and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite
      in humans.
    

Detailed description: 
      The study is a four-way randomized double-blinded crossover trial with randomization balanced
      for beverage and lab visit order.
    

Intervention name(s): Lo-Flav; Hi-Flav; Epicatechin; Procyanidins
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage.; High-flavonoid cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.; Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage; Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers
Condition: Difficult to Healing of Skin Ulcers
MeSH terms: Skin Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study for a six-month trials, Randomized, open, and parallel comparison before and after
      its own, Stage test includes screening stage, treatment period and follow-up period. In
      accordance with chronic wound criteria for the patient, By producing the principle of random
      number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according
      to the situation of wound healing time and decided to use the secondary treatment, To observe
      the clinical efficacy and safety.
    


Intervention name(s): UC-MSCs Gel group; Gel group
Intervention type(s): Biological; Other
Intervention description(s): This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,Observation of UC-MSCs Gel group patients efficacy, safety and tolerability of selective parameter.; This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,observed and compared Gel group patients may be no efficacy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint
Condition: Osteoarthritis of the Hand
MeSH terms: Arthritis; Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with
      pain due to osteoarthritis of the basal thumb joint.
    

Detailed description: 
      A prospective phase I study to evaluate the safety of a single intra-articular injection of
      Ampion™ as a treatment for arthritis of the basal thumb joint.

      Primary Objective is:

      To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL)
      when injected into the basal thumb joint.
    

Intervention name(s): AMPION™; Saline
Intervention type(s): Biological; Biological
Intervention description(s): AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.; Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if DNA vaccination of chronic HBV patients under
      treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after
      treatment discontinuation.
    

Detailed description: 
      Despite the availability of effective vaccines against hepatitis B, over 370 million people
      worldwide remain persistently infected with HBV. Persistent infection is associated with
      chronic liver disease that can lead to the developement of cirrhosis and hepatocellular
      carcinoma in two-third of persons. Treatment of chronic hepatitis B relies on the use of
      analogs such as lamivudine, adefovir, entecavir or immunostimulators such as interferons.
      Although analogs are efficient, genotypic resistance occurs after one year of treatment and
      the rate of virologic relapse is high after treatment discontinuation.

      HBV is a non cytopathic virus and liver damage is caused by immune response against infected
      hepatocytes and to a non specific inflammatory response. Immune response contributes to the
      virus clearance. In acute hepatitis B infection, T cell response is polyclonal, specific and
      vigorous, whereas in patients with chronic infection, responses remain weak, less specific
      and hardly detectable in peripheral blood.

      T cell responses could be induced or restored by antigenic stimulation such as vaccination.
      In a previous phase I clinical trial, we showed that DNA vaccination with plasmid pCMVS2.S is
      safe and can specifically, but transiently activate T-cell responses in chronic HBV-carriers
      not responding to current antiviral therapies.

      Analogs such as lamivudine and adefovir were shown to enhance T cell responses concomitantly
      with viral load decrease. In this phase I/II clinical trial, we would like to determine if
      DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell
      responsiveness and delay virologic reactivation after treatment discontinuation.
    

Intervention name(s): DNA vaccine pCMVS2.S
Intervention type(s): Biological
Intervention description(s): Patients will receive injections of 1 ml of vaccine (1 mg/ml) at weeks 0, 8, 16, 40 and 44
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DNA vaccine
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      NNZ-2591 when administered to healthy volunteers.
    

Detailed description: 
      This study is in two stages:

      Stage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy
      volunteers to establish safety, tolerability and pharmacokinetic parameters.

      Stage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple
      Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and
      pharmacokinetic parameters.
    

Intervention name(s): NNZ-2591; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of NNZ-2591; Comparator for double-blind MAD
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage 1: Open-label, single dose with 2 dose cohorts. Stage 2: Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose (MAD) with 2 dose cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate relative bioavailability during the new and
      traditional formulations of SHR6390 in healthy subjects
    


Intervention name(s): SHR6390
Intervention type(s): Drug
Intervention description(s): SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
Condition: Alzheimer Disease; Cerebral Amyloid Angiopathy
MeSH terms: Alzheimer Disease; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial
Study type: Interventional

Summary: 
      Until now there is no medical treatment and/or intervention that can slow, stop or reverse
      the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to
      demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild
      cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in
      humans".

      Specific Aims:

        1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB
           function by dynamic contrast-enhanced MRI (DCE-MRI).

        2. Evaluate effect of EVOO on cognitive function and on selected biomarkers
    


Intervention name(s): EVOO; OO
Intervention type(s): Other; Other
Intervention description(s): Extra-virgin olive oil that is rich with oleocanthal and other phenols.; Olive oil low in oleocanthal and other phenols.
Other intervention name(s): OC-rich EVOO; Olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and
      t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals
      who maintained their normal dietary and exercise patterns.
    


Intervention name(s): Tonalin®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group); Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Impact of Neuro-linguistic Programming on Schoolchildren's Performance
Condition: Academic Skill Disorder; Child Behavior
MeSH terms: Learning Disabilities
Study type: Interventional

Summary: 
      Neuro-Linguistic Programming (NLP) is a methodology developed in the 1970s by Richard Bandler
      and John Grinder, based on the idea that language and behavior are interconnected and can be
      systematically modeled and changed. NLP is often used as a form of psychotherapy, coaching,
      or personal development, although its effectiveness has been debated in the scientific
      community.

      NLP practitioners believe that our thoughts, emotions, and behavior are influenced by our
      internal representations of the world, which are constructed through language and sensory
      experiences. Changing the use of language and the perception of experiences, thoughts,
      emotions, and behavior can be adjusted accordingly. NLP uses various techniques to achieve
      this, including reframing, anchoring, and rapport-building. Reframing involves changing the
      perception of a situation by putting it in a different context or perspective. Anchoring
      consists in associating a particular state of mind or emotion with a specific physical or
      sensory stimulus, such as a touch or a smell. Rapport-building involves establishing a
      connection and a sense of trust with another person through mirroring and matching their body
      language, tone of voice, and language patterns.
    

Detailed description: 
      Neuro-Linguistic Programming (NLP) techniques have been used in various contexts, including
      education. Some educators and practitioners believe that NLP can help children develop their
      communication skills, self-confidence, and self-awareness and improve their learning
      outcomes. Some NLP techniques adapted for children include: (1) Anchoring involves linking a
      particular emotional or sensory state with a physical stimulus, such as a touch or a visual
      cue. For example, a teacher might use a specific gesture or word to help a child feel more
      confident before a test. (2) Reframing: This technique involves helping a child see a
      situation or problem differently. For example, a teacher might help a child reframe a
      difficult math problem as a fun challenge. And (3) Meta-modeling: This technique involves
      helping children become more aware of their language patterns and the language patterns of
      others, which can improve communication skills and self-awareness.
    

Intervention name(s): Neuro-linguistic program
Intervention type(s): Behavioral
Intervention description(s): Intervention: Neuro-linguistic program developed by three specialists (a clinical psychologist, a social worker, and one education specialist).
4 (45 minutes) sessions for teachers, and 2 for children (total of 6 sessions)
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Skeletal Muscle Response to Amino Acids and Load Carriage Exercise
Condition: Muscle Loss; Muscle Anabolism; Muscle Performance
Study type: Interventional

Summary: 
      Warfighters often experience physical overload, as the uniform and associated gear that they
      carry burdens them with substantial loads. The loads increase energy expenditure to levels
      that exceed a Warfighter's typical energy intake. The typical assault load is approximately
      25 kg, although loads as high as 55 kg are often carried, which when combined with extreme
      energy expenditures can degrade health and performance, and increase the risk of injury.
      Branched-chain amino acid (leucine) supplementation may confer protection against the
      negative effects of operational stress by stimulating muscle protein synthesis and reducing
      degradation. This study will determine if leucine-enriched nutrition supplementation confers
      protection against the negative consequences of sustained load carriage exercise, and explore
      the mechanisms by which leucine might impart protection.
    


Intervention name(s): Leucine-enriched nutritional supplement; Placebo
Intervention type(s): Other; Other
Intervention description(s): A protein and carbohydrate supplement with high levels of leucine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
OTR Tablet 10 mg Fasted-state Bioequivalence Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single Dose, randomised, cross-over study to confirm the
      bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state in
      Chinese subjects with chronic pain
    

Detailed description: 
      The investigation is designed as an open-label, single dose, randomized, and cross-over study
      to determine the PK profile of oxycodone from OTR tablet 10 mg and OXYCONTIN tablet 10 mg in
      Chinese subjects with chronic pain in a fasted state.

      the China regulations for drug registration require that controlled medicine (opioid is
      categorized to be a controlled medicine) should not be applied in healthy volunteers in
      clinical studies. In this BE study, subjects with histories of chronic pain are chosen as the
      target population.

      Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK
      data. The subjects with abnormal liver and kidney functions, which may affect the metabolism
      of oxycodone.

      As a general rule, cross-over design is applied in the study to decrease the inter-individual
      variations between the two cohorts. A washout period lasting for at least 7 half-lives of the
      investigational medicine is needed to eliminate the drug residual from the previous period

      open label design is applied since the plasma concentration of oxycodone is to be objectively
      tested and analysed and randomization will be applied to reduce selection bias.
    

Intervention name(s): Oxycodone Tamper Resistant; OXYCONTIN®
Intervention type(s): Drug; Drug
Intervention description(s): Orally administered Oxycodone Tamper Resistant 10mg; Orally administered OXYCONTIN® Tablet 10 mg
Other intervention name(s): Oxycodone Tamper Resistant (OTR) Tablet 10 mg; OXYCONTIN® Tablet 10 mg
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Condition: Cervical Incompetence
MeSH terms: Uterine Cervical Incompetence
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor
      block and duration until meeting discharge criteria in patients undergoing cervical cerclage.
      The hypothesis is that chloroprocaine will result in faster resolution of motor block.
    

Detailed description: 
      Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed
      under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their
      use impacts clinical care, in particular patient flow, is not well studied.

      This is a prospective, randomized, double blind, controlled trial. Participants meeting
      inclusion criteria will be randomly allocated to receive spinal anesthesia with either
      chloroprocaine or bupivacaine.

      Patients will then be assessed for motor block and sensory level until they are discharged
      from the recovery room.
    

Intervention name(s): Chloroprocaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.; The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
Other intervention name(s): Sensorcaine; Marcaine
Intervention MeSH terms: Bupivacaine; Chloroprocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double blinded clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical Cerclage; Bupivacaine; Chloroprocaine; spinal anesthesia
Physiological Responses to Maximal 4-s Sprint Interval Cycling
Condition: Exercise, Cardiovascular Function, Fatigue, Muscular Power
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The optimal recovery duration depends on the intensity of exercise and in the present study
      the intensity was maximal power for 4-s while cycling an 'Inertial Load' ergometer (ILE).
      Recovery duration of 15, 30 and 45-s were given between 30 successive sprints.
    

Detailed description: 
      All subjects completed an informed consent for this study that was approved by the
      Institutional Review Board of the University of Texas at Austin.

      Study Overview. A randomized, cross-over experimental design was conducted. Each participant
      visited the laboratory on four occasions which were separated by two to five days.
      Measurement of body mass, familiarization with experimental procedures and cycling peak
      oxygen consumption test (VO2peak) were performed on the first visit. Participants took part
      in inertial-load exercise (ILE) on the remaining test days. On each separate session, a
      different inter-sprint recovery duration was employed (i.e. 15, 30 or 45-s). Cycling power
      output, pulmonary gas exchange, vastus lateralis de-oxygenation status, heart rate and blood
      lactate were measured.
    

Intervention name(s): inertial-load exercise (ILE)
Intervention type(s): Other
Intervention description(s): Length of time between exercise bouts
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Repeated measures, cross-over
Masking: None (Open Label)
Primary purpose: Basic Science