bioihbjkbjnl/mcl2 huggingface dataset:
Triheptanoin Treatment Trial for Patients With Adult Polyglucosan Body Disease
Condition: Adult Polyglucosan Body Disease; Glycogen Brancher Enzyme Deficiency; Glycogen Storage Disease Type IV
MeSH terms: Nervous System Diseases; Glycogen Storage Disease; Glycogen Storage Disease Type IV
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if triheptanoin is an effective treatment for the
      symptoms of Adult Polyglucosan Body Disease.
    

Detailed description: 
      Adult polyglucosan disease is a progressive neurogenetic disorder characterized by neurogenic
      bladder, progressive difficulty with walking, and sensory abnormalities in the lower
      extremities which typically present in the 4th or 5th decade of life. The pathogenesis of the
      disease includes the accumulation of intracellular polyglucosan bodies (amylopectin-like
      polysaccharides) in the peripheral nerves as well as the central nervous system cells and is
      often associated with brancher enzyme deficiency which causes improper glycogen formation. It
      is hypothesized that decreased glycogen degradation leads to energy deficit in the nervous
      system cells. Therefore, anaplerotic therapy may supply needed substrate to the citric acid
      cycle to correct the energy deficit. This intervention may slow, halt or reverse the
      progression of the disease, for which there is no effective treatment. The trial involves 18
      subjects ingesting a diet supplemented with triheptanoin, a 7 carbon triglyceride or a
      placebo of vegetable oil at a dose of 1-2 g/kg/24 hours in a randomized crossover controlled
      double blind study. The study lasts one year with patients receiving triheptanoin for 6 mo
      and the placebo oil for 6 mo. Safety monitoring includes urine organic acids and acyl
      carnitine profile.
    

Intervention name(s): Triheptanoin; Vegetable Oil
Intervention type(s): Drug; Other
Intervention description(s): 1-2 grams triheptanoin (drug)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months followed by 1-2 grams vegetable oil (placebo)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months.; 1-2 grams vegetable oil (placebo)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months followed by 1-2 g triheptanoin (drug)/kilogram body weight for 6 months.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adult Polyglucosan Body Disease (APBD); Glycogen Brancher Enzyme (GBE1) Deficiency
Substrate Oxidation in Children in Response to High and Low Dairy Intake
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators propose a randomized trial comparing higher levels of dairy intake compared
      to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,
      overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each
      participant will be randomized to either higher or lower levels of dairy intake. A baseline
      calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet
      they have been randomized to receive for 6 days and will then have a second calorimeter stay.
      During this 2nd stay, each participant will continue to receive the diet they were randomized
      to receive and will achieve a 300 kcal energy deficit through physical activity. The
      investigators hypothesize that children who receive a 300 kcal energy deficit from the energy
      expenditure of exercise and receive 3 to 4 servings of dairy products will show greater
      increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of
      exercise and receive 1 or fewer servings of dairy products.
    

Detailed description: 
      The study objective was to conduct a randomized clinical trial comparing enhanced levels of
      dairy consumption to lower levels of dairy consumption during an energy deficit resulting
      from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of
      age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less
      than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher
      or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2
      weeks of wash out. The investigators provided all meals and snacks for the participants
      during the higher and lower dairy conditions. During the wash out period, participants were
      instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer
      servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at
      baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured
      substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.
    

Intervention name(s): Dairy Products; Dairy Servings
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy; Continue baseline consumption of one or fewer servings of dairy per day
Other intervention name(s): Recommended dairy servings per day; One or fewer servings of dairy per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy; obesity
Measurement of Eye Movements While Reading a German Text
Condition: Healthy Children
Study type: Observational

Summary: 
      To establish normative value for reading parameters in healthy children of primary school age
      and in grades 2-5.
    

Detailed description: 
      Following initial assessment of feasibility, recruitment is expanded to children attending
      grades 2-5 recruited from 4 different primary schools in German speaking Switzerland. Two
      texts of The New International Reading Speed Test (IReST) of similar difficulty are presented
      on a laptop in randomized order. Children are asked to read the text aloud while eye
      movements are recorded with an eye tracking bar. The following parameters are analysed:
      reading speed (words/minute), number of saccades, number of fixations.
    

Intervention name(s): reading of a text
Intervention type(s): Diagnostic Test
Intervention description(s): Reading of 2 IRest Texts presented on a laptop in randomized order while eye movements are recorded with a tracking bar.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children recruited from 4 primary schools in German speaking Switzerland
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels
      (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this
      newly developed test will be compared to Tysabri® serum levels measured in parallel using an
      independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®,
      receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri®
      serum levels.
    

Detailed description: 
      From a single site, consenting patients with relapsing forms of multiple sclerosis who are
      currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will
      be asked to provide blood samples on the same day, and prior to, a scheduled infusion of
      Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be
      asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data
      points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO)
      questionnaire along with the blood draws
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only patients with multiple sclerosis who have had one or more doses of Tysabri®
        (natalizumab) and are currently being treated with Tysabri® will be included in this study.
RV568 - Viral Challenge With RSV
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic
      rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is
      effective in reducing the inflammation caused by viral infections such as RSV (respiratory
      syncytial virus).
    


Intervention name(s): RV568; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8); Placebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Music on Postoperative Anxiety
Condition: Anxiety Postoperative
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In this study, it is planned to compare the effect of listening to the music preferred by the
      patient and classical music on postoperative anxiety.
    

Detailed description: 
      Preoperative anxiety can be detected via structured and standardized screening by the
      State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia
      surgery for any reason in the age range of 18-70 will be included in our study. Preoperative
      STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients
      will be divided into three groups as preoperative patient preferential music, classical music
      and not played. The patient favorite music track and singer without limiting the kind of
      music or classical music will be played through the headphones. The STAI will be repeated at
      postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at
      postoperative.
    

Intervention name(s): Patient preferential music; Classical music; No music
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will listen to their preferred music through the headphones before surgery.; Patients will listen to classical music through headphones before surgery.; Patients will not listen to music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Patient preferential music; Postoperative anxiety; Classical music
Environmental Contaminants and Infant Development
Condition: Mercury Poisoning; Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning; Mercury Poisoning
Study type: Observational

Summary: 
      This study is designed to examine the effects of prenatal exposure to environmental
      contaminants on cognitive and behavioral development and physical growth in two groups of
      Inuit infants-one in Northern Quebec; the other in Greenland.
    

Detailed description: 
      Due to prevailing weather patterns and ocean currents, certain environmental contaminants are
      transported to the Arctic region. The Inuit are among the most heavily exposed populations on
      earth due to the prevalence of these contaminants in traditional foods that comprise a large
      portion of their diet. The contaminants assessed in this study include polychlorinated
      biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These
      contaminants are measured in umbilical cord blood samples obtained at birth, milk samples
      obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from
      the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine
      the degree to which these nutrients may protect against adverse effects attributable to these
      contaminants.
    

Time perspective: Prospective
Keywords: methylmercury; PCBs; lead; fish consumption; breast-feeding
To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open label, multiple dose, crossover study to compare the safety and
      Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of
      "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.
    


Intervention name(s): Rebamipide SR 150mg; Rebamipide IR 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference Drug
Intervention MeSH terms: Rebamipide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this proposed study is to investigate the pharmacokinetics interaction
      between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug
      interaction study.
    

Detailed description: 
      This clinical trial is a single centre, single dose Phase I study, with a non-randomized,
      open label, one sequence cross-over design.

      A total of 24 healthy male and female are planned to be included.

      Participants will be dosed with CHF6001 before and during co-administration of Itraconazole
      and will act as their own control. The study will be run with a one-sequence crossover
      design, where all subjects will be treated with CHF6001 in the first treatment period and
      CHF6001+Itraconazole in the second treatment period in order to avoid the need of a very long
      washout from the CYP3A4/5 inhibitor.

      Standard safety assessments will be conducted during the Study, including safety blood and
      urine laboratory tests, vital signs, physical examinations, ECGs and observations of any
      adverse events. Blood samples will be also collected for PK analysis.
    

Intervention name(s): CHF6001 DPI; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of CHF6001; Repeated doses of oral Itraconazole
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: one sequence cross-over design
Masking: None (Open Label)
Primary purpose: Other
Preoperative Estetrol in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a single-center, randomized, double-blind, placebo-controlled study
      in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will
      either receive estetrol or placebo during a 2 week treatment period.

      Several biological markers, such as a cellular growth marker and cell death markers, will be
      assessed in the tumor tissue and surrounding normal tissue before and after the treatment
      period. During the 2 week interval between diagnosis of breast cancer and surgical resection,
      no therapy for breast cancer is usually administered.
    

Detailed description: 
      The study is designed as a single-center, randomized, double-blind, placebo-controlled study
      in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will
      either receive estetrol or placebo during a 2 week treatment period.

      Several biological markers, such as a cellular growth marker and cell death markers, will be
      assessed in the tumor tissue and surrounding normal tissue before and after the treatment
      period. In addition, receptor studies will be performed. During the 2 week interval between
      diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually
      administered.
    

Intervention name(s): placebo; Estetrol
Intervention type(s): Drug; Drug
Intervention description(s): once daily for 14 days orally; once daily for 14 days orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Breast cancer (Estrogen Receptor positive)
Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV
Condition: HIV-1-infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of lefitolimod and 3BNC117/10-1074
      in HIV-1-infected individuals on ART and during ATI as intervention to reduce the HIV-1
      reservoir
    


Intervention name(s): Saline; Lefitolimod; 3BNC117 and 10-1074
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; A TLR9 agonist administered s.c. once weekly for 8 weeks.; Broadly neutralizing antibodies against HIV env administered two times with a 3 week interval.
Other intervention name(s): MGN1703; RUhumab-001 and RUhumab-002
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants will be randomized 1:1:1:1 in a blinded fashion to receive:
Arm A: Placebo and Placebo Arm B: Lefitolimod and Placebo Arm C: Placebo and 3BNC117+10-1074 Arm D: Lefitolimod and 3BNC117+10-1074
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of CKR-051 in
      healthy participants.

      This study aiming to develop an agent for skin regeneration; potential treatments include
      acute and chronic wounds (c.f. Diabetic foot ulcers).
    


Intervention name(s): CKR-051 Dose 1; CKR-051 Dose 2; CKR-051 Dose 3; CKR-051 Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be administered 5 g of CKR-051.; Subjects will be administered 10 g of CKR-051.; Subjects will be administered 10 g of CKR-051.; Subjects will be administered 10 g of CKR-051.; Placebo comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
      IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of
      pediatric subjects with acute uncomplicated influenza.
    


Intervention name(s): Peramivir; Oseltamivir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oseltamivir; Peramivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Combined Oral Contraceptive Effects in Female Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of
      coadministered oral contraceptives.
    


Intervention name(s): BMS-955176; Ortho Cyclen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxifloxacin; BMS-955176; Norgestimate, ethinyl estradiol drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose
      Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with
      fever. Results for the Fixed Dose Combination product will be compared to the individual
      components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.
    


Intervention name(s): Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; Acetaminophen 500 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; 1 APAP 500 mg caplet; Placebo tablet
Other intervention name(s): IBU 250 / APAP 500; IBU 250; APAP 500
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ibuprofen; acetaminophen; induced fever; fever
Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and
      extubation, as compared to the combination of fentanyl and midazolam in critically-ill
      patients.
    


Intervention name(s): Morphine infusion; Fentanyl and Midazolam infusion
Intervention type(s): Drug; Drug
Intervention description(s): Conventional dose; Conventional dose
Intervention MeSH terms: Midazolam; Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: sedation; critical care; morphine; fentanyl; analgesic based sedation
TAK-114 Single- and Multiple-Dose Phase 1 Study
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of TAK-114 following
      single and multiple ascending oral doses in healthy Japanese male participants.
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral
      dose study in healthy Caucasian and Japanese male participants.

      The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and
      Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are
      designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort,
      ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect
      Part is designed as a randomized, open-label, 2-period crossover study of a single dose of
      TAK-114.
    

Intervention name(s): TAK-114 10 mg capsule; TAK-114 matched placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment