bioihbjkbjnl/mcl2 huggingface dataset:
Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Sequential culture media were introduced in order to meet the changing requirements of the
      developing embryo in vitro. However, there has been renewed interest in the use of
      single-step media, which allow the embryo itself to choose the necessary nutrients while
      maintaining a more stable culture environment. Previous studies suggest that sequential media
      do not appear superior to single-step media.
    

Detailed description: 
      Sequential culture media were introduced in order to meet the changing requirements of the
      developing embryo in vitro. However, there has been renewed interest in the use of
      single-step media, which allow the embryo itself to choose the necessary nutrients while
      maintaining a more stable culture environment. Previous studies suggest that sequential media
      do not appear superior to single-step media.

      The current study will include 2 RCTs:

      RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst
      formation rates in the two culture media compared.

      RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy
      rates.
    

Intervention name(s): Global; Origio
Intervention type(s): Other; Other
Intervention description(s): Single medium for the culture of embryos from Day1 to Day 5; Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)
Other intervention name(s): Global medium (LIfeGlobal); ISM1/BlastAssist (Origio)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Assessment of the Safety & Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
Condition: Vitamin D
Study type: Interventional

Summary: 
      This is a pilot study to assess the safety and tolerability of long-term use of patented
      transdermal vitamin D patches in healthy adults.
    

Detailed description: 
      A randomised, parallel, pilot study to assess the safety and tolerability of long-term use of
      patented transdermal patches in healthy adults. The study consists of 4 on-site visits: the
      Screening Visit (Visit 1, Week -2), the Baseline Visit (Visit 2, Week 0), Visit 3 (Week 4),
      and the End of Intervention Visit (Week 8).
    

Intervention name(s): To Better Days Large Patch; To Better Days Small Patch
Intervention type(s): Other; Other
Intervention description(s): Large patch containing vitamin D & Dextrose for transdermal absorption; Small patch containing vitamin D & Dextrose for transdermal absorption
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 Arms with 15 Subjects per group
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD
      of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.
    


Intervention name(s): TI-Inhalation Powder A; TI-Inhalation Powder B
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Insulin; Inhaled Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Condition: Anemia; Pregnancy Complications
MeSH terms: Pregnancy Complications; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of body iron storage replenishment
      between low dose intravenous iron and oral iron in late pregnancy.
    

Detailed description: 
      Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia
      (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently,
      intravenous iron sucrose appears to be safe and efficient in treating within a short period.
      From literature review, no study of intravenous iron for IDA treatment has been carried out
      in the third trimester of pregnancy. This research aims to compare the efficacy of body iron
      storage replenishment at 3 weeks as labor may take place at this point in some women. In this
      study,500 mg intravenous iron has been given weekly instead of every other day for the sake
      of patient's convenience in the hope that parenteral iron may become another alternative for
      treatment of pregnant women with iron deficiency anemia who have difficulties or failures
      with oral iron.
    

Intervention name(s): Ferli-6® (Continental Pharm co., ltd.); Venofer® (Vifor AG, St. Gallen, Switzerland)
Intervention type(s): Drug; Drug
Intervention description(s): In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.; Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron deficiency anemia; pregnancy; third trimester; intravenous iron; efficacy; a randomized trial; Female; Ferric Compounds/therapeutic use*; Infusions, Intravenous; Hematologic/therapy*
Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally
      inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry
      powder containing either lactose alone or lactose and cellobiose octaacetate. However, future
      dry powder GW685698X formulations will contain lactose and magnesium stearate. This study
      will be the first administration of this new GW685698X dry powder formulation in man and will
      provide safety and tolerability data to support the further development of this formulation.
    


Intervention name(s): GW685698X; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS; Subject will receive Placebo matching GW685698X via DISKUS.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Healthy Volunteers
Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
Condition: Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Sexual Trauma
Study type: Interventional

Summary: 
      Our specific aims are:

        1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women
           veterans

        2. To examine the effects of GIFT on fronto-limbic brain function and

        3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.
    

Detailed description: 
      Guided imagery is a complementary and alternative treatment (CAM) modality. This directed
      meditation technique uses healing imagery to promote recovery in a variety of illnesses,
      including cancer, heart disease and, more recently, posttraumatic stress disorder (PTSD).
      PTSD is a severe and disabling anxiety disorder. It is among the most common mental
      disorders, affecting 10% of women in the United States during their lifetime. Sexual assault
      is the most common cause of PTSD. Similarly, military sexual trauma (MST) is disturbingly
      common among women in the armed forces. At least 20% of women veterans using VA services
      report a history of sexual assault. Unfortunately, high rates of MST-related PTSD are
      anticipated among women currently deployed to Iraq and Afghanistan.

      To address this issue, we will evaluate a guided imagery intervention for women veterans who
      have MST-related PTSD. We will evaluate the efficacy of Guided Imagery for Trauma (GIFT) in
      decreasing PTSD symptoms. Using brain-imaging techniques, this research will examine the
      effects of GIFT on brain function in the areas associated with PTSD. We will also examine the
      effects of GIFT on neurosteroids, which are candidate modulators of PTSD symptoms, and may
      also represent novel targets for therapeutic intervention.
    

Intervention name(s): Guided Imagery for Trauma (GIFT)
Intervention type(s): Behavioral
Intervention description(s): Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Guided Imagery for Trauma (GIFT); Posttraumatic Stress Disorder (PTSD); Military Sexual Trauma (MST); Military Sexual Trauma - related PTSD
Sertraline and Cognitive Therapy in Depressed Alcoholics
Condition: Alcoholism; Depression
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess whether individuals treated with sertraline (Zoloft) and cognitive
      behavior therapy will experience improvement with their depression and consume less alcohol
      than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week,
      random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3
      months after treatment.
    


Intervention name(s): sertraline (Zoloft); cognitive behavior therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Sertraline
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given
      weekly in patients with advanced or recurrent head and neck cancer
    


Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Solution, IV, 100 mg/m2, weekly for 6 of 7 weeks, until evidence of disease progression or unacceptable side effects became apparent
Other intervention name(s): Taxol; BMS-181339
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether using a smart phone application to foster
      communication between study participants and their doctor will impact care. Participants must
      have a history of migraine or have recently been prescribed a common medicine to treat
      migraine. The study will last about one year for each participant.
    


Intervention name(s): Migraine App
Intervention type(s): Other
Intervention description(s): Smart phone app used to report migraine burden to the EHR.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is:

        -  To determine whether it is feasible in locally advanced gastric or gastroesophageal
           cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme
           and also to determine what toxicities are involved.

      The secondary objective of this trial are to describe:

        -  The disease free survival at one and two years in that subgroup of patients that has
           undergone a R0 resection.

        -  The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that
           have undergone an R0 resection and progression-free survival and overall survival at one
           and two years.
    


Intervention name(s): DOCETAXEL; S-1; OXALIPLATIN
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.; 80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.; 100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
Intervention MeSH terms: Docetaxel; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
Condition: Pain; Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain
      management a complex task. Several studies have found out that pharmacological interventions
      alone were not enough to provide optimal pain management for these patients. The
      investigators developed a DVD on guided imagery, customized for teenagers, to help them cope
      better with their pain. The investigators believe that this type of intervention combined
      with their usual analgesic medication will help them to control their pain and foster
      rehabilitation.
    


Intervention name(s): Guided imagery intervention
Intervention type(s): Behavioral
Intervention description(s): A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain; Scoliosis; Rehabilitation; Cognitive-behavioral interventions; Adolescents
Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      The purpose of this study will be to evaluate the effect of direct and indirect pick up of
      the locator retentive caps and compare the clinical results with those of the manufacturer
      retentive force.
    

Detailed description: 
      Patient selection:

      For this study, 30 patients were selected from the clinic of Prosthodontic Department,
      Faculty of Dentistry, Mansoura University.

      According to pick up technique for the locator retentive caps, the overdentures will be
      classified into two groups as follows; Group1: The retentive caps will be picked up by
      indirect method on the cast then by the direct method Group2: The retentive caps will be
      picked up in the patient by the direct method first then by the indirect method.

      For both groups, the clinical retention will be measured after using pink and blue retentive
      inserts respectively.

      All implants were inserted using computer-guided implant surgery and conventional loading
      protocol was used.

      Evaluation methods The clinical retention of each insert will be calibrated as regards the
      manufacturer's value.

      Also, the laboratory retention will be assessed for the two groups and calibrated as regards
      the manufacturer's value.

      Measurements will be done immediately, three and six months after each overdenture insertion.
    

Intervention name(s): dental implants in the mandible; locator attachment and overdenture
Intervention type(s): Procedure; Device
Intervention description(s): placement of two interforaminal dental implants in the canine region in the mandible; placement of locator attachment and insertion of mandibular overdenture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Interaction Study of Timolol Eye Drops and Paroxetine Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma
      levels of timolol and its main metabolites after topical application of ophthalmic timolol
      products.

      This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy
      male volunteers aged 18 - 40 years will be enrolled.

      Placebo or paroxetine will be given for three days after which 1 drop of timolol product will
      be administered once in both eyes.

      The duration of the paroxetine or placebo treatment period will be 3 days. There will be four
      different treatment periods. A washout between the study periods will be at least 4 weeks.
    


Intervention name(s): Paroxetine; Placebo; timolol maleate; timolol maleate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.; Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.; Oftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.; Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
Intervention MeSH terms: Timolol; Paroxetine; Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interaction; healthy volunteers; Interaction study for healthy volunteers
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      A major goal in public health is to find effective, feasible and simple programs for
      overweight prevention among children. This controlled intervention study evaluates a simple
      environmental and behavioral modification for its efficacy in preventing overweight of
      children in the school setting. The intervention strategy focuses solely on the promotion of
      drinking tap water. The study was conducted in 32 elementary schools including about 3000
      children in two German cities over 1 school year.
    

Detailed description: 
      Soft drinks and other caloric beverages are supposed to be involved in the development of
      overweight and obesity in children. The intervention strategy of our study was to promote
      water consumption by facilitating access to tap water in schools assuming a concomitant
      decrease in caloric soft drinks at least at school. The environmental modification of
      installing a water dispenser at school and delivering a special bottle to each child in the
      intervention schools was supported by a few educational lessons. These lessons were held by
      the class teachers who received a prepared 6-hour curriculum dealing with the importance of
      water for the body and of water intake. For the study 17 randomly selected schools were
      assigned to the intervention group, 15 schools to the control group that did not receive any
      intervention. Body weight and height to calculate BMI as primary outcome were assessed at
      baseline and after the intervention period of 1 school year. As secondary outcome drinking
      and physical activity habits were evaluated at baseline and after the intervention. The water
      flow of the dispenser was measured at regular intervals. In addition, data of process
      evaluation was collected to measure acceptance and feasibility of the intervention in the
      school setting.

      To analyze the efficacy of this primarily environmental and behavioral intervention,
      incidence and prevalence was compared between intervention and control group.
    

Intervention name(s): environmental and behavioral change
Intervention type(s): Behavioral
Intervention description(s): In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; primary prevention; environmental change; behavioural change; school setting; changing of drinking habits; promotion of drinking tap water
Cardiac Water and Fluoromethane Cardiac PET
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      In this study we are looking at the blood flow to the heart using two different chemical tags
      or tracers that give off a low level of radiation. The tracers used in this study are called
      O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the
      body. The researchers will use positron emission tomography (PET scans)to track the tracers
      as they moe through the heart and chest.
    


Intervention name(s): Cardiac PET imaging- rest and pharmacological stress
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cardiac PET imaging; Radiopharmaceutical tracers
Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
Condition: Gene Expression Profiling; Gastric Intestinal Metaplasia; Duodenum
MeSH terms: Metaplasia
Study type: Observational

Summary: 
      To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal
      Mucosa.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
      
Biospecimen description: 
      The metagenome was obtained from biopsy specimen.