bioihbjkbjnl/mcl2 huggingface dataset:
Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether the of vaginal progesterone replacement for frozen embryo transfer
      results in equivalent live birth rates to intramuscular injection progesterone replacement.
    

Detailed description: 
      The purpose of this ongoing study is to look at whether Endometrin® (vaginal micronized
      progesterone tablets) supplemented by intramuscular injection of progesterone in oil (PIO)
      work as well as PIO alone for women undergoing transfer of frozen-thawed blastocyst(s).
      Another goal of the study is to determine whether patients prefer Endometrin or PIO.
      Endometrin® has been approved by the United States Food and Drug Administration, or FDA, "to
      support embryo implantation and early pregnancy by supplementation of corpus luteal function
      as part of an Assisted Reproductive Technology (ART) treatment program for infertile women."
      (FDA New Drug Approval Letter, Endometrin®, 2007). The use of Endometrin® (vaginal micronized
      progesterone tablets) in this study is investigational. An investigational use is one that is
      not approved by the U.S. Food and Drug Administration (FDA).

      Approximately 1170 women between the ages of 18-48 who are having difficulty becoming
      pregnant and wish to undergo frozen embryo transfer will be asked to participate. The
      participants will be recruited from among patients of Shady Grove Fertility.

      One-half of the participants who qualify and wish to take part in the ongoing study will be
      randomized (assigned by chance, like the flip of a coin) to receive Endometrin® and an
      intramuscular injection of PIO every third day. One-half will be randomized to receive an
      intramuscular injection of PIO every day. This study is a type of study called an "open
      label," assessor-blind study. This means that you and your doctor will know which treatment
      you are assigned and receive; however, the person analyzing the information obtained from the
      study will not know which patients received which study treatments.

      Patients enrolling in the study will receive the medications for their frozen embryo transfer
      cycle free of charge.
    

Intervention name(s): Endometrin® plus Progesterone in Oil (PIO); Progesterone in Oil (PIO) Only
Intervention type(s): Drug; Drug
Other intervention name(s): Vaginal Micronized Progesterone Tablet; Progesterone in Sesame Oil Injection; Progesterone in Sesame Oil Injection
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Progesterone; ART; IVF; FET; FBT; Frozen Embryo Transfer
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Condition: Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Disorders of Excessive Somnolence; Syndrome; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess patient reported outcomes with armodafinil treatment
      in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to
      engage in life activities (ie, daily or work and family and/or social activities), and
      effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also
      be assessed.
    


Intervention name(s): Armodafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin
      in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group
      will receive HMS5552 plus Metformin, while the other group will receive placebo plus
      Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.
    

Detailed description: 
      This study is a phase III study in subjects with T2DM. As designed, the study will start with
      a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for
      screening eligible subjects, meanwhile, subjects are treated with Metformin (Glucophage) at
      1500mg/day as basic therapy throughout the treatment period. 3 weeks after run-in,
      eligibility is confirmed with required laboratory tests at -5±2 days prior to randomization.
      The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group
      with ratio 1:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week
      open-label treatment of HMS5552 75mg BID add-on to Metformin. After 52-week treatment, all
      investigational drugs should be discontinued, followed by 1 week for safety evaluation. The
      dosage of Metformin (Glucophage) should be maintained at 1500 mg/day from run-in period to
      treatment completion.
    

Intervention name(s): HMS5552; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BID oral administration; BID oral administration
Other intervention name(s): Glucokinase Activator (GKA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GKA; T2DM; HMS5552; Add-on therapy; Metformin
Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy is one of the most important source of disability among children and its
      incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with
      ambulatory difficulties.The current study highlights the effect of treadmill training as
      compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The
      present study would add to the clinical knowledge of physical therapists by promoting the
      implementation of treadmill training and DeLorme resistance exercises for this prevalent
      pediatric neurodevelopmental disorder. The study would decrease the burden of disease among
      community and enhance the social participation of cerebral palsy children. This in turn would
      improve the quality of living of these disabling diseased children.
    


Intervention name(s): Treadmill training; traditional physical therapy; Delorme resistance exercise
Intervention type(s): Other; Other; Other
Intervention description(s): The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.; Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes; Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
Other intervention name(s): traditional physical therapy; traditional physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Delorme resistance exercises; treadmill training; locomotor abilities; tendon of achilles lengthening
Experience of Arab American Women With Breast Cancer: In-depth Interviews
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The investigators are conducting a study entitled 'Experience of Arab American Women with
      Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's
      experience with breast cancer.
    


Intervention name(s): one-time qualitative assessment
Intervention type(s): Behavioral
Intervention description(s): The study involves a one-time qualitative assessment to explore key cultural influences on AMBER breast cancer survivors' health behavior. We will focus on self-efficacy in healthcare, coping with breast cancer, social networks of support, and culturally-sensitive support groups. The study investigator will administer questions from the structured interview guide, estimated to take 90 minutes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is open to current and previous AMBER support group participants held at the MSK
        Brooklyn Infusion Center.
      
Keywords: support group; 15-246; The Arab American Breast Cancer Education and Referral Program (AMBER)
Brown Fat Activity and White Fat Accumulation
Condition: Hodgkins Lymphoma; Non-hodgkins Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      White and brown adipocytes differ in their expression of hormones, cytokines, and
      inflammatory factors, and they modulate different biological functions. While white adipose
      tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead
      metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all
      humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered
      longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging
      conditions, BAT is detected more frequently in children and teenagers than in adults with
      malignancy. Since most children with cancer have significantly shorter treatment courses and
      greater survival rates compared to adult patients, the investigators have the ability to
      examine the relation of repeated measures of body composition and BAT by selecting pediatric
      patients. In this study, the investigators will longitudinally examine whether BAT activity
      is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children
      successfully treated for pediatric cancer.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with a history of malignancy such that they are required to undergo
        PET/CT exams.
      
Keywords: Brown adipose tissue
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study aims to explore the efficacy and acceptability of a clinician-guided
      internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression,
      in Singapore.
    

Detailed description: 
      All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a
      primary diagosis of mild to moderate depression and were referred to the Psychology
      Department for therapy were invited to take part in this research. Participants were
      randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The
      four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician
      and six online modules).The treatment group is hypothesised to exhibit pre-post improvements
      in depressive symptoms, compared to the control group.
    

Intervention name(s): Internet-delivered Cognitive Behavioural Therapy
Intervention type(s): Behavioral
Intervention description(s): The iCBT programme comprised on 6 online modules. Module 1 provided an introduction to the symptoms of depression, its causes and information on CBT. Module 2 covered problem-solving strategies. Module 3 provided information on problematic thought patterns and beliefs in depression. Module 4 entailed identifying problematic thought patterns and using various techniques to counter problematic thoughts. Module 5 covered pleasurable activities scheduling to help increase activity levels.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial
      magnetic stimulation device for treatment-resistant depression. In this open label study, all
      participants will receive accelerated theta-burst stimulation.
    

Detailed description: 
      Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy
      for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for
      40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC) for a 6 week treatment
      course. This methodology has been successful for many people with treatment-resistant
      depression. One of the limitations of this approach is the long duration of the treatment
      course (approximately a 6 weeks per treatment course). Recently, researchers have
      aggressively pursued modifying the treatment parameters to reduce treatment course time with
      some preliminary success. This study intends to further modify the parameters to create a
      more rapid form of the treatment. This study will also look at the change in neuroimaging
      biomarkers associated with this treatment.
    

Intervention name(s): Accelerated theta-burst stimulation treatment
Intervention type(s): Device
Intervention description(s): All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Treatment-Resistant Depression; Transcranial Magnetic Stimulation (TMS); Theta-Burst Stimulation
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
Condition: Hyperphagia in Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097
      in children and adults with Prader-Willi Syndrome.
    


Intervention name(s): FE 992097; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE)
      following a single dose administration of INP104 (DHE administered by I123 Precision
      Olfactory Delivery (POD) Device Nasal Spray) to that of D.H.E. 45 for Injection (Intravenous)
      and Migranal Nasal Spray in healthy adult subjects.

      It is hypothesized that INP104 will address the current variability in nasal administration
      and give more reproducible dose delivery compared to Migranal nasal spray.

      Blood concentrations of all three investigational products will be compared for 48 hours
      following dosing. The safety and tolerability of INP104 will be monitored throughout the
      study.

      INP104 has been developed for the treatment of acute migraine headache. The device in which
      the drug will be delivered has been designed to deliver the medication to the upper nasal
      cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the
      dose being swallowed.

      Approximately 36 participants in general good health (equal ratio of males and females
      desired) will be enrolled and will be allocated to receive 3 treatments in a randomized
      sequence. They will receive a single dose of INP104, a single dose of DHE via intravenous
      injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where
      no treatment will be administered for 7 days in between each treatment. Participants are
      required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be
      in the study for up to 43 days.
    


Intervention name(s): INP104; Dihydroergotamine Mesylate (DHE); Migranal Nasal Spray
Intervention type(s): Combination Product; Drug; Combination Product
Intervention description(s): Dihydroergotamine Mesylate (DHE) administered via I123 Precision Olfactory Delivery (POD) Device; Dihydroergotamine Mesylate (DHE) injection (intravenous); Dihydroergotamine Mesylate (DHE) delivered via Migranal Nasal Spray pump
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Pain After Root Canal Disinfection Via Diode Laser
Condition: Root Canal Infection; Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The prevention and control of post-treatment pain is of great importance for the comfort of
      the patient as well as for the clinician's prestige. In this study, the effect of 940 nm
      diode laser disinfection on the postoperative pain of retreatment cases was evaluated.
    

Detailed description: 
      From the fact that microorganisms are the most common factors causing pain, this study aimed
      to evaluate effect of 940 nm diode laser disinfection performed in addition to conventional
      irrigation on postoperative pain of retreatment cases. Eighty-four patients with chronic
      apical periodontitis were treated. Root canal fillings were removed using rotary files. Root
      canals were irrigated using sodium hypochlorite between instrument changes. Final irrigation
      was performed using sodium hypochlorite and ethylenediaminetetraacetic acid (EDTA). The cases
      were randomly allocated into 2 groups: Group 1: Diode laser disinfection group, Group 2:
      control group. Root canal fillings were applied and crowns were restored. All treatments were
      completed in a single appointment. Patients were given a pain scale and they were requested
      to mark the code that reflects their pain intensity during 3 days.
    

Intervention name(s): Diode laser disinfection; Pseudo diode laser disinfection
Intervention type(s): Device; Device
Intervention description(s): Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.; Without activating laser energy, same procedure as experimental group was performed (Sham laser application)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postoperative pain; Diode laser; retreatment
Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa
Condition: Immune System Diseases
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective is to evaluate the concentration of allergen extract of Betula verrucosa
      that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride
      10 mg / ml in size.
    

Detailed description: 
      Open, prospective, unblinded and non-randomized biological assay. Each patient was tested
      with four concentrations of allergen and with a histamine and saline solution as positive and
      negative controls, respectively.
    

Intervention name(s): 10 HEP/mL Betula verrucosa allergen extract; 25 HEP/mL Betula verrucosa allergen extract; 50 HEP/mL Betula verrucosa allergen extract; 100 HEP/mL Betula verrucosa allergen extract
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): The investigational product contained 10 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.; The investigational product contained 25 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.; The investigational product contained 50 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.; The investigational product contained 100 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immune System Diseases; Prick Test; Betula verrucosa
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether an investigational malaria vaccine is safe
      and induces an immune response against malaria when tested in adults living in the United
      States.
    

Detailed description: 
      Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate
      Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be
      enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen
      (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by
      Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent
      (sterile water) for injection.
    

Intervention name(s): Plasmodium falciparum Malaria Protein 010 (FMP010); Rabipur
Intervention type(s): Biological; Biological
Intervention description(s): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK; Rabipur is a licensed rabies vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention