bioihbjkbjnl/mcl2 huggingface dataset:
Cognitively-Based Compassion Training and Mindfulness Attention Training Program
Condition: Behavioral Resilience; Biological Resilience
Study type: Interventional
Phase: Phase 3

Summary: 
      This project will explore the effect of Cognitively-Based Compassion Training or mindfulness
      training on behavior and saliva stress hormones in elementary school-age children.
    

Detailed description: 
      This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or
      mindfulness training (MT) on different aspects of behavior and stress-related biology in
      elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and
      various social behavioral assessments will be conducted. Participants will also provide
      saliva in which concentrations of stress hormones including cortisol and the inflammatory
      biomarkers C-reactive protein will be measured.
    

Intervention name(s): Cognitively-Based Compassion Training (CBCT); Mindfulness training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBCT is a 12 week program that begins by teaching mindfulness and attention. It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies.; Mindfulness training will consist of 6 weeks training in mindfulness meditation.
Other intervention name(s): Compassion Meditation; Mindfulness meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: meditation, inflammation, children, attention
Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol
Condition: Suppression of Ovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study was to evaluate the ability of several doses of NOMAC in
      combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and
      ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal
      women.

      The study was also designed to check whether the combined administration of E2 and NOMAC at
      the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when
      it is given alone.
    


Intervention name(s): NOMAC
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability and efficacy of RO4607381 in patients with
      coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive
      either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by
      flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time
      on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
    


Intervention name(s): Placebo; dalcetrapib
Intervention type(s): Drug; Drug
Intervention description(s): po daily for 36 weeks; 600mg po daily for 36 weeks
Intervention MeSH terms: Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Research of the Effect of Reservoir Oxygen Mask Application on Respiratory Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      With the oxygen mask with reservoir, oxygen can be given to patients with FiO2 values that
      can reach 80-100%. Reservoir oxygen mask is superior to other oxygen treatment methods with
      the high oxygen rate applied.Our hypothesis is that the use of an oxygen mask with a
      reservoir will reduce the incidence of respiratory complications in adult patients who will
      undergo sedation in the endoscopy unit.
    

Detailed description: 
      During the sedation procedure in the endoscopy unit, patients who used a reservoir oxygen
      mask will be examined. Patients over the age of 18 and under the age of 70, with ASA 1-2 risk
      score, who are planned to be operated under sedation in the endoscopy unit of our hospital
      will be included. Patients who do not have verbal and written consent to participate in the
      study, have an ASA3-4 risk score, and are scheduled for emergency procedures will be excluded
      from the study. No premedication will be applied to patients admitted to the endoscopy unit.
      As a standard, intravenous vascular access will be established with a 22 gauge intraket on
      the back of the left hand in all patients, 6-10 lt/minute oxygen therapy will be started with
      a reservoir mask, and peripheral oxygen saturation, end-tidal CO2, blood pressure arterial
      values will be monitored and recorded. These parameters will be monitored and recorded every
      five minutes during the procedure. In addition, the sedative agents applied to the patients
      and their doses will be recorded. After the procedure, all patients will be taken to the
      recovery room, where they will be observed until the modified aldrete score is 9 or higher.
      The recovery times of the patients, nausea, vomiting and similar symptoms will be followed
      and recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who used an oxygen mask with a reservoir during the sedation procedure in the
        endoscopy unit will be examined.
Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women
Condition: HIV; Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether increasing the dose of the levonorgestrel
      subdermal contraceptive implant will overcome a detrimental drug-drug interaction with
      efavirenz based antiretroviral therapy.
    

Detailed description: 
      The investigators research team recently demonstrated that combined use of efavirenz (EFV)
      based antiretroviral therapy (ART), the only preferred first-line ART regimen in low and
      middle income countries, with a levonorgestrel (LNG)-releasing implant for one year reduced
      LNG plasma concentrations by approximately 50% compared to women not on ART. Importantly, the
      investigators also observed three unintended pregnancies (15%) in the investigators study
      group of women on EFV-based ART plus the LNG implant, in contrast to the <1% expected failure
      rate of the implant for women without drug interactions.

      This study will determine if increasing the dose of the LNG-releasing subdermal implant
      effectively overcomes the known pharmacokinetic interaction with EFV- based ART. LNG
      pharmacokinetic results from the participants enrolled in this dose escalation study (n=28)
      will be compared to HIV-infected Ugandan women on standard dose LNG without concomitant
      EFV-based ART.
    

Intervention name(s): Levonorgestrel; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): Increased dose levonorgestrel implant plus efavirenz-based antiretroviral therapy.; Participants will receive efavirenz-based ART as part of standard of care
Other intervention name(s): Jadelle; SinoImplant; Sustiva; Stocrin; Atripla; EFV
Intervention MeSH terms: Efavirenz; Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efavirenz; levonorgestrel; contraceptive implant
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multi-center event-driven study in non-dialysis (ND) participants with
      anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of
      daprodustat compared to darbepoetin alfa.
    


Intervention name(s): Daprodustat; Darbepoetin alfa; Placebo; Iron Therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.; The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.; Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).; Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1278863; hemoglobin; anemia; non-dialysis; erythropoiesis stimulating agents; daprodustat; chronic kidney disease
Study of Key Electro-acupuncture Technique on Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture
      formula, and to analysis the regulation of the intensity-effects and to observe the
      peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture
      treatment.
    

Detailed description: 
      acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control
      group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.
    

Intervention name(s): electro-acupuncture; flunarizine hydrochloride
Intervention type(s): Device; Drug
Intervention description(s): electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.; flunarizine hydrochloride ，10mg/day，for 20 days。
Other intervention name(s): flunarizine
Intervention MeSH terms: Flunarizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electroacupuncture therapy; Migraine; Acupuncture Therapy
Evaluation of Upper Extremity Prosthesis
Condition: Transradial Amputation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able
      to fit a multitude of individuals. This may offer an off the shelf item for those that cannot
      afford a customized prosthesis, or wish to have an inexpensive spare.
    

Detailed description: 
      A prospective study will be done on an inexpensive below elbow upper extremity prosthesis.
      Prestige Healthcare Technologies Ltd. has developed a prosthesis that is easily and
      inexpensively fabricated. The prosthesis is similar to a fitting frame used by some
      prosthetists in trial fits to ensure proper length and angulation of the terminal device. The
      prosthesis consists of two pieces of aluminum bar stock running midline the length of the
      residual limb. One bar is located anteriorly, the other posteriorly. A terminal device will
      be placed in the receiver on the distal end of the prosthesis. An aluminum band will connect
      the anterior and posterior bar stock for structural stability. A finished figure of eight
      harness will be utilized for control and suspension of the prosthesis. The research performed
      will be noninvasive. The check out will be based on the New York University (NYU)
      trans-radial prosthesis checkout form. Prestige Healthcare Technologies has donated an adult
      size trans-radial prosthesis to be utilized for this study.

      Each patient will serve as their own control group. The control group will be considered
      using the same guidelines for testing function of the patient's current prosthesis, which we
      will refer to as alpha P. The patient will then be fitted with the inexpensive model, which
      we will refer to as beta P. The results will be compared to the NYU standard as well as
      comparing between the results of alpha P and beta P. Beta P will be the same prosthesis
      personalized for subjects with the harness adjusted to properly fit each individual.

      The benefit of this study may provide an inexpensive versatile alternative to the current
      below elbow prosthesis. This version may be utilized as a spare prosthesis while the patient
      is unable to use his primary prosthesis.
    

Intervention name(s): Alpha P Control; Beta P Experimental
Intervention type(s): Device; Device
Intervention description(s): Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.; Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
Other intervention name(s): Standard/Current Prosthesis; Inexpensive Prosthesis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transradial amputation; prosthesis; prefabricated prosthesis; inexpensive; custom prosthesis; adult transradial amputation
Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in
      intact tablet form in the fasted and fed states in healthy volunteers.
    

Detailed description: 
      The effect of food on dexpramipexole bioavailability following administration of the proposed
      commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg
      twice daily) has not been studied. Therefore, this study has been designed to evaluate the
      effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following
      administration of a single 150 mg dose in healthy volunteers, consistent with US Food and
      Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.

      Additionally, patients with ALS can have difficulty swallowing tablets, necessitating
      alternative methods of administration for the drug. Therefore, this study has also been
      designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in
      soft food (applesauce).
    

Intervention name(s): Dexpramipexole
Intervention type(s): Drug
Intervention description(s): 150 mg single dose
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
Condition: Vasomotor Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and
      estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor
      symptoms) and uro-genital complaints.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): Estradiol/DRSP (Angeliq, BAY86-4891); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.; Same administration.
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Work of Breathing in Premature Infants at Discharge
Condition: Bronchopulmonary Dysplasia; Very Low Birth Weight Infant; Prematurity
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Study type: Observational

Summary: 
      The purpose of this study is to compare how premature infants who required oxygen for at
      least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at
      discharge compared to premature infants who did not require oxygen for at least 28 days
      during their time in the NICU.
    

Detailed description: 
      Work of breathing tests will be performed on premature infants who required oxygen for at
      least 28 days during their time in NICU. These same work of breathing tests will be performed
      in another group of premature infants who did not require oxygen for at least 28 days during
      their time in the NICU. The two groups will be compared.
    

Intervention name(s): Enrollment
Intervention type(s): Other
Intervention description(s): All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born greater than 26 weeks gestation, weighing less than 1500 grams at
        birth. Work of breathing indices will be compared between the group of babies who were
        diagnosed with BPD and the group that was not diagnosed with BPD.
Safety and Efficacity of NFL101 as Tobacco Therapy
Condition: Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
    

Detailed description: 
      Tobacco addiction is one of the biggest public health threats the world has ever faced,
      killing nearly six million people a year. There are more than 1 billion smokers in the world,
      up to half will eventually die of a tobacco-related disease. Nicotine replacement treatments
      were the first pharmacological treatments approved for use in smoking cessation therapy and
      include nicotine gums, transdermal patches, tablets, nasal sprays, and inhalation systems.
      More recently, buproprion and varenicline were approved but showed limiting side effects. The
      development of safe and efficient alternatives for this indication is now called for.

      Tobacco cessation cases were observed concomitantly with the administration of a
      desensitization treatment against tobacco allergy. Based on these observations, NFL
      Biosciences developed a drug candidate for tobacco cessation. This new drug (NFL 101) was
      assessed in preclinical studies. Notably, regulatory genotoxicity (Institut Pasteur de Lille)
      and toxicity studies in rats (Ricerca, Wil Research, Lyon) showed no toxicity. The NFL 101
      composition and the low doses injected led to propose a mechanism of action based on an
      immune response. Immunogenicity studies conducted with the European Georges Pompidou Hospital
      (HEGP) on peripheral blood mononuclear cells and rodents have supported such hypotheses.
      Therefore, the objective of this Phase I study is to investigate the safety of two dose
      levels of NFL-101 in smokers.
    

Intervention name(s): NFL101
Intervention type(s): Drug
Intervention description(s): Level 1: 100 µg
50 µg per injection (in each arm), two injections at day 1 and two injections at day 29
The 140 µg must be diluted in 2.8 mL of dilution solution in order to obtain a 50 µg.mL-1 concentration.
Level 2: 200 µg
100 µg per injection (in each arm), two injections at day 1 and two injections at day 29
The 140 µg must be diluted in 1.4 mL of dilution solution in order to obtain a 100 µg.mL-1 concentration. Therefore, for this level only, two vials are needed to inject 2 x 1.0 mL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera
      (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting
      multiple sclerosis (MS) under routine clinical practice.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): This is a non-interventional study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Korean participants with relapsing-remitting MS will be included in this study.
      
Keywords: MS0008; Dimethyl Fumarate; Multiple sclerosis; Tecfidera; Korean participants