bioihbjkbjnl/mcl2 huggingface dataset:
Second Generation Human Milk Oligosaccharides Blend Study
Condition: Healthy Infants
Study type: Interventional

Summary: 
      The aim of this trial is to show that infants fed these new formulas, containing a blend of 5
      Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas
      without HMOs.

      There will be different groups in the trial: three formula-fed groups and a breastfed group.
    

Detailed description: 
      These 5 HMOs are identical to the ones found naturally in human milk. They are natural
      prebiotics (or complex sugars) with potential health benefits. Prebiotics are natural
      compounds that help the establishment of beneficial gut bacteria (such as bifidobacteria),
      while preventing bad bacteria from doing harm. Supplementing diets with certain prebiotics
      has been shown to be well tolerated in adults and infants and to provide potential
      benefits.Therefore, the trial also aims to understand if consuming HMOs supplemented formulas
      could strengthen immunity and prevent common illnesses (for example, respiratory illnesses)
      in infants and toddlers. Furthermore, stool frequency and consistency will be monitored, so
      as to evaluate digestive tolerance to the formula.
    

Intervention name(s): Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides; Breast-feeding; Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
Intervention type(s): Other; Other; Other
Intervention description(s): Study formulas are administered orally, ad libitum, from enrollment until 15 months of age; Exclusive Breast-feeding up to 4 months of age; Standard Study formulas are administered orally, ad libitum, from enrollment until 15 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Improving Ambulation Post Stroke With Robotic Training
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this research study is to look at a new rehabilitation technique for
      individuals who have suffered a stroke and have difficulties walking. This study is designed
      to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in
      order to improve walking post-stroke. This research project will be conducted as a pilot
      randomized controlled trial that compares the effectiveness of Lokomat versus conventional
      physical therapy in improving the ambulation and gait of chronic stroke patients. The project
      will provide important pilot data that could indicate whether or not the effectiveness of
      Lokomat training is superior to that of standard physical therapy and if a definitive and
      larger clinical trial is warranted.
    


Intervention name(s): Physical Therapy; Lokomat
Intervention type(s): Other; Device
Intervention description(s): Conventional physical therapy; Robotic-assisted walking device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
Condition: Sagital Cervical Disorientation
MeSH terms: Confusion
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of clinical pilates exercises and home
      exercise program on postural disorders, pain intensity, normal range of motion, muscle
      strength, endurance, muscle shortness, joint position sense and functional status in desk
      workers with sagittal cervical disorientation.
    


Intervention name(s): clinical pilates exercises; home exercises program
Intervention type(s): Other; Other
Intervention description(s): servikal, deep flexor muscles, posture exercsises; stretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening.
Other intervention name(s): exercise program; classical exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clinical pilates; exercise; Sagital Cervical Disorientation; Disorientation; Forward Head Posture
Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      High intensity motion improves motor functions and quality of life in a neurologist. The
      investigators want to improve the clinical condition and quality of life of post-STROKE
      participants with a special sensory motor and visual motor agility therapy.
    

Detailed description: 
      High intensity motion improves engine function and quality of life in a neurologist. With
      special sensory motor and visual motility, investigaters want to improve the clinical
      condition and quality of life of STROKE participants.

      The investigaters randomly select participants who only perform the rehabilitation treatment
      have performed. The other group that will receive the study's control group will receive the
      traditional rehabilitation physiotherapy treatment.

      The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel
      index, MRS test) The ivestigaters examine the functional movement and equilibrium variables
      of patients. (6MWT, Berg balance test, postgraduation) After that, participants are
      undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke.

      Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test).
      Functional tests show progress 6MWT, Berg balance test and postural control testing with
      posturography. The results are compared and evaluated among the groups.

      The expected hypothesis is that visual and acoustic stimulation produces a better physical
      state at higher intensity.
    

Intervention name(s): Exergaming group; Physiotherapy; Exergaming group 2/day
Intervention type(s): Other; Other; Other
Intervention description(s): Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day); Physiotherapy 4-week-long.; Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)
Other intervention name(s): EXE group; Physio group; EXE2 group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: balance; movement; exergaming; posture; quality of life; gait
Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
Condition: Marijuana Abuse; Substance-Related Disorders
MeSH terms: Marijuana Abuse; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy
      marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms
      associated with tobacco use. The purpose of this study is to determine if bupropion will help
      individuals stop using marijuana.
    

Detailed description: 
      A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy
      marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive
      performance. Many of nicotine's withdrawal symptoms are similar to those observed with
      marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine
      addiction.The purpose of this study is to determine if bupropion is effective in treating
      marijuana dependent individuals. Specifically, this study will determine if bupropion
      alleviates withdrawal symptoms associated with marijuana abuse.

      Participants in this 21-day, double-blind study will be randomly assigned to receive either
      bupropion or placebo. Treatment with bupropion will occur for one week before stopping
      marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days,
      followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at
      which time participants will be required to remain abstinent from marijuana for the duration
      of the study. Participants will provide daily urine specimens. Changes in vigilance, memory,
      reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention description(s): 150 mg, twice a day
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: marijuana; treatment
Internet Telehealth for Pediatric Asthma Case Management
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The original and primary aim of this study is to evaluate the effects of CHESS with Nurse
      Case Management on asthma control (symptom-free days), and adherence factors of children aged
      4-12. The investigators have expanded the scope of the specific aims. The criteria for their
      expanded aim is to also interview low-income African-American caregivers to gain an
      understanding of how they conceptualize their child's asthma, and what they consider to be
      barriers or facilitators to managing their child's asthma. There is no change in the
      investigators' original aim.
    


Intervention name(s): CHESS Internet telehealth
Intervention type(s): Behavioral
Intervention description(s): CHESS Internet telehealth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric asthma
A Study of Selexipag in Healthy Male Participant
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679
      following single oral administration of the matrix tablet and the encapsulated pellets of
      selexipag, each with 3 different release profiles, as compared to selexipag immediate release
      (IR) tablets in healthy male participants.
    


Intervention name(s): Selexipag matrix tablet; Selexipag encapsulated pellets; Selexipag Immediate-release (IR) tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.; Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.; Participants will receive Selexipag immediate-release tablet orally under fasted condition.
Other intervention name(s): JNJ-67896049; JNJ-67896049; JNJ-67896049
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Acceptability of Carraguard® in HIV Positive Women and Men
Condition: HIV Infections
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The study objectives were to assess the mucosal safety of Carraguard® gel when applied
      vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive
      women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to
      evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these
      women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per
      day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported
      by female and male participants during the study may be related to the use of Carraguard®
      gel; and to examine dimensions of the acceptability of, and compliance with, the study and
      placebo products.
    

Detailed description: 
      We proposed a safety study of the Council's lead candidate microbicide, Carraguard® in three
      cohorts in Durban, South Africa: sexually abstinent HIV-positive women, sexually abstinent
      HIV-positive men, and sexually active HIV-positive women. Sexually active women must be in an
      HIV-positive seroconcordant relationship (confirmed by HIV testing of the woman and her male
      partner) and written informed consent was obtained from the male partners. Women and men in
      each cohort were randomized to one of three study groups: Carraguard® gel, its matching
      placebo methyl-cellulose gel, or no product.

      The main objectives of this study were to investigate changes in the vulvar, vaginal, and
      cervical epithelia, the vaginal flora, and HIV-1 shedding in the genital tract of female
      participants, and changes of the penile skin and epithelia of male participants. We also
      evaluated symptoms reported by participants, and several dimensions of the acceptability of
      and compliance with the study or placebo gel. Reactions to a non-contraceptive microbicide
      were assessed, as well as reasons for voluntary discontinuation and non-use of Carraguard® or
      the placebo (determined by review of daily diary) was recorded. Exit focus group discussions
      were held with male and female participants to discuss aspects of acceptability and
      compliance. Self-reported symptoms were also investigated by clinical examination as needed
      and study endpoints included genital itching or burning, frequent urination, burning while
      urinating, genital pain, pain during sex, and abnormal vaginal or penile discharge.
    

Intervention name(s): Carraguard (PC-515)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Microbicides; HIV prevention; HIV positive; carrageenan; safety trial; Treatment Experienced; HIV
Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity
      Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current
      medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.
      We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This
      study will also help us to understand the mechanism of ADHD and give a way to develop new
      drug and also a more possible way to treat ADHD children under 6 years old.
    

Detailed description: 
      The accumulated neuro-image, hereditary and animal studies showed the correlation between
      glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical
      trial to testify the effect of modulating the NMDA receptor function of glutamate to treat
      ADHD.

      GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic
      synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study
      aims to explore the effect of GlyTI-M among children with ADHD.
    

Intervention name(s): GlyTI-M; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Comparator: starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; GlyTI-M
Controlling and Lowering Blood Pressure With The MOBIUSHD™
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To evaluate the safety and performance of the MobiusHD system in subjects with resistant
      hypertension.
    

Detailed description: 
      This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the
      United States. Eligible subjects with stage 2 resistant systemic arterial hypertension
      currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to
      study participation will be assigned to treatment with the MobiusHD system.

      Potential study participants will be consented and then screened at two (2) baseline visits
      beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo
      placement of the MobiusHD under angiographic visualization, and will then be followed for 36
      months.
    

Intervention name(s): MobiusHD™
Intervention type(s): Device
Intervention description(s): Implant that is placed in the carotid sinus to control hypertension.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Carotid Sinus
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of terbinafine
      hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet
      under fasting conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Terbinafine hydrochloride 250 mg tablets
      and Lamisil® 250 mg Tablets administered as 1 x 250 mg tablet in healthy subjects under
      fasting conditions.
    

Intervention name(s): Terbinafine Hydrochloride Tablets, 250 mg
Intervention type(s): Drug
Intervention description(s): Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
Other intervention name(s): Lamisil® 250 mg Tablets
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; crossover; Terbinafine hydrochloride; Fasting
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Condition: Hyperinsulinemic Hypoglycemia
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and
      tolerability of Glucagon RTU when administered to subjects with a history of bariatric
      surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be
      randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research
      center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will
      be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week
      Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a
      subject's last dose of study drug.
    


Intervention name(s): Glucagon RTU; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.; The placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).
Other intervention name(s): glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, placebo-controlled, double-blind, two-treatment, 2-period, crossover in-patient phase followed by a placebo-controlled, double-blind, parallel two-treatment outpatient stage..
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glucagon; post-bariatric hypoglycemia
The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy
Condition: Breast Cancer; Angiogenesis
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Changes in major angiogenic proteins have been seen following initiation of tamoxifen and
      aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the
      circulating platelet pool. The investigators hypothesize that in addition to their
      anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis
      therapy. The investigators will determine the influence of aspirin on the release of
      angiogenic proteins from platelets in 35 patients with breast cancer.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): 325 mg tablets, once daily for 45 days
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Angiogenesis; Aspirin; Tamoxifen