bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
Condition: Healthy Volunteers; Mass Balance Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, non-randomized, absorption, metabolism, and excretion study
      to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of
      [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing
      approximately 150 µCi) oral dose (as an oral solution)
    

Detailed description: 
      This study will be an open-label, non-randomized,absorption, metabolism, and excretion study
      to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of
      [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing
      approximately 150 µCi) oral dose (as an oral solution) following at least an 8-hour fast from
      food (not including water). Seven healthy male subjects will be enrolled in the study at a
      single study site to complete a minimum of 6 subjects. The study will consist of 2 visits.
    

Intervention name(s): AZD3293
Intervention type(s): Drug
Intervention description(s): 7 subjects will receive AZD3293
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Beta secretase inhibitor; Alzheimer disease
Paternal Psychosis After Baby Born
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      A large number of studies have investigated the psychological disorders occurred in
      postpartum women, and found that postpartum psychosis is common in new mothers.

      However, the situation of paternal psychological status after they had their first baby is
      not assessed. The investigators hypothesized that they had a high occurrence of paternal
      psychosis after first baby born. In addition, different factors might influence its onset and
      development in new fathers.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fathers with their first baby born
      
Keywords: Paternity; Psychology; Risk factor
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of 2 rotigotine transdermal patches from 2 different
      manufacturing processes.
    


Intervention name(s): Rotigotine transdermal patch
Intervention type(s): Drug
Intervention description(s): Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
Other intervention name(s): Neupro®
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rotigotine; Neupro®; Transdermal Patch
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Condition: Genetic Disorders
MeSH terms: Angioedema; Angioedemas, Hereditary; Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this multi-center study is to explore the efficacy, safety, tolerability and
      pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute
      attacks in patients with hereditary angioedema.
    


Intervention name(s): i.v. recombinant human C1 inhibitor
Intervention type(s): Drug
Other intervention name(s): rhC1INH
Intervention MeSH terms: Complement C1 Inhibitor Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of hydrolyzed
      ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).
    

Detailed description: 
      This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects
      were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles
      during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
    

Intervention name(s): HGE (hydrolyzed ginseng extract); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HGE, impaired fasting glucose, clinical trial
Antioxidant Functions of Lipoic Acid
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine whether a short treatment with lipoic acid, an
      antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity
      and decreases oxidant stress in persons with elevated blood cholesterol.
    

Detailed description: 
      As per Brief Summary
    

Intervention name(s): lipoic acid
Intervention type(s): Drug
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Lipoic acid; F2-isoprostanes; endothelial dysfunction; natural product
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery
Condition: Morphine
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in
      postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind,
      placebo-controlled study
    


Intervention name(s): 1 mg morphine soak in epidural oxidized cellulose; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.; During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.
Intervention MeSH terms: Morphine; Cellulose, Oxidized
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study will develop and test the effectiveness of a cell phone-based text messaging
      program to encourage abstinence, monogamy, or condom use among black urban males in
      Philadelphia, Pennsylvania.
    

Detailed description: 
      Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread
      through unprotected sexual intercourse. STDs are a primary health issue, especially among
      young ethnic minorities in the United States. The rate of STDs is significantly greater in
      urban areas where ethnic minorities, particularly African-American males, are commonly
      represented. Despite this information, safe sexual practices, including correct condom use,
      are not commonly followed among minority males. It is believed that educational outreach
      designed to motivate and inform on the correct use of condoms will be effective in
      encouraging safer sex practices. A cell phone-based text messaging program designed to
      promote safer sex practices may provide an effective and easy means of delivery of treatment.
      This study will develop and test the effectiveness of a cell phone-based text messaging
      program to sustain abstinence, monogamy, or condom use among black urban males in
      Philadelphia, Pennsylvania.

      Participation in this study will be divided into two phases. In the first study phase,
      participants will partake in a 90-minute focus group to help develop text message content and
      plans for treatment delivery. The next study phase will be a pilot test of the program
      developed in the first phase. Participants will be assigned to receive text messages
      concerning either HIV prevention or general nutrition. Participants receiving the HIV
      prevention text messages will be sent up to 90 text messages related to abstinence, monogamy,
      and condom use over a 3-month period. Participants will also be able to join interactive
      phone activities related to HIV. Participants receiving the nutritional text messages will be
      sent up to 30 messages about nutrition and healthy eating over the same period of time.
      Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will
      assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and
      risk behaviors.
    

Intervention name(s): HIV-related text messaging; Nutrition-related text messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.; Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Mobile Phone; Technology-Based Intervention; HIV; HIV Seronegativity
Biodentine Vital Pulpotomy in Immature Molars
Condition: Pulp Exposure, Dental
MeSH terms: Dental Pulp Exposure
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously
      exposed vital immature first permanent molars using calcium hydroxide and calcium
      silicate-based material (Biodentine ™). After a 12 months postoperative period, Biodentine ™
      proved very useful as a successful pulpotomy agent in young permanent teeth.
    

Detailed description: 
      Objective: This study aimed to evaluate the clinical and radiographic success of pulpotomy in
      cariously exposed vital immature first permanent molars using calcium hydroxide and calcium
      silicate-based material (Biodentine ™).

      Participants and methods:

      This study was carried out on patients attending an outpatient clinic in Pediatric Dentistry
      and Dental Public Health Department - Faculty of Dentistry - Cairo University - Egypt. A
      total of thirty-five patients had thirty-eight vital immature first permanent molar with deep
      caries, who satisfied the eligibility criteria and completed the follow-up period. Their age
      ranged between six years to nine years old with a mean age of 7.5+/-1 years. All teeth were
      mandibular. In this study, pulpotomy was performed to preserve the vitality and function of
      the remaining radicular pulp tissue, followed by applying one of the investigated pulp
      capping materials.
    

Intervention name(s): pulpotomy
Intervention type(s): Procedure
Intervention description(s): Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed
Other intervention name(s): vital pulp therapy; apexogensis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial (RCT), parallel group with 1:1 allocation ratio and equivalence framework. Triple blinded (patient, radiographic assessors of results and statistician) Ethics approval by the Human Research Ethics committee at Faculty of Dentistry- Cairo University was taken.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
High Image Matrix CT Reconstruction
Condition: Healthy Subjects; Pulmonary-Related Conditions; Cardiac-Related Conditions
MeSH terms: Disease
Study type: Observational

Summary: 
      Background:

      Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make
      pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3
      million of them occurred in the United States. Researchers think CT images can be made better
      using new techniques. Higher resolution images can be derived from the original scan.

      Objective:

      To learn if new ways of obtaining and processing pictures of the body from a regular CT scan
      can produce images with higher resolution (pixels) and more information than standard
      methods.

      Eligibility:

      People ages 18 and older who are scheduled to have a CT scan and are not pregnant

      Design:

      Participants will be screened with a review of their medical records.

      Participants will have their scheduled CT scan.

      The CT scanner used in this study provides enhanced images of inside the body. Researchers
      may use the CT scanner in a research mode to test and improve the pictures.

      Images from the CT scan will be reviewed.

      Any clinical findings from the CT test will be shared with the participant s doctor.

      Participants will continue to receive their medical care from their regular doctor.

      The CT images will be entered into an NIH research database. In the future, they may be used
      for research purposes.
    

Detailed description: 
      Computed Tomography (CT) images the body. Different methods of creating CT pictures are
      avilable on a research basis that enables higher resolution imaging using the same
      aquisition. The purpose of this research study is to learn wheteher these new high resolution
      images derived from the original CT scan provide similar or perhaps more information than the
      current standard clinical method.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be enrolled at the NIH Clinical CenterUp to 500 subjects will be
        enrolled. Subjects will be recruited from the NIH Clinical Center radiology department from
        subjects scheduled to have a CT scan
      
Keywords: Computed Tomography; Image Reconstruction; Iterative Reconstruction; Natural History
Evaluation of the Ulthera System for the Treatment of the Decolletage
Condition: Chest Wrinkles
Study type: Interventional

Summary: 
      This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera®
      treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following
      treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at
      each follow-up visit.
    


Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Micro-focused Ultrasound with Visualization (MFU-V)
Microsurgical Breast Reconstruction & VTE
Condition: Breast Reconstruction; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis
      (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.
      Significant morbidity and mortality is associated with VTE events. This disease entity
      represents the most common cause of preventable in-hospital death as evidenced by over
      100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,
      with annual costs to the U.S. healthcare system in excess of $7 billion.

      Cancer patients have been identified as a particularly vulnerable patient population. Of
      these, breast cancer patients represent the largest group treated by plastic surgeons. An
      increasing number of breast reconstructions are performed in the U.S. with a documented 35%
      increase in the annual number of breast reconstructions since 2000. Over 106,000 breast
      reconstructions were performed in 2015 alone.

      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is
      associated with the highest risk for VTE. We believe that a key element rendering these
      patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is
      supported by the observation that VTE risk remains elevated for up to 12 weeks
      postoperatively. We hypothesize that lower extremity deep venous system stasis is a
      procedure-specific key contributing factor to postoperative VTE risk.

      This study examines the duration of postoperative lower extremity venous stasis to identify
      patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging
      technology to examine the lower extremity deep venous system preoperatively, on postoperative
      day 1, and on the day of discharge to determine if patients display radiographic evidence of
      lower extremity venous stasis at the time of hospital discharge.

      A better understanding of pathophysiologic mechanisms that contribute to the development of
      VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE
      prophylaxis, thus, favorably impacting clinical outcome in a large patient population.
    


Intervention name(s): Duplex ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Duplex ultrasound of lower extremity venous system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult (age ≥18 years) female patients who are scheduled to undergo autologous breast
        reconstruction following mastectomy. Only patients who undergo breast reconstruction with
        free abdominal flaps that require violation of the anterior rectus sheath, i.e. MS-TRAM and
        DIEP flaps, will be included in the study.
The Physiological Impact of N95 Masks on Medical Staff
Condition: Hypoxemia; Hypercapnia
MeSH terms: Hypoxia; Hypercapnia
Study type: Interventional

Summary: 
      Wearing N95 masks may have adverse physical effect on medical staff
    

Detailed description: 
      Wearing N95 masks results in hypooxygenemia and hypercapnia which reduce working efficiency
      and the ability to make correct decision.

      Medical staff are at increased risk of getting 'Severe acute respiratory syndrome'(SARS), and
      wearing N95 masks is highly recommended by experts worldwide. However, dizziness, headache,
      and short of breath are commonly experienced by the medical staff wearing N95 masks. The
      ability to make correct decision may be hampered, too. The purpose of the study was therefore
      to evaluate the physiological impact of N95 mask on medical staff.
    

Intervention name(s): wearing N95 masks
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: N95 mask; medical staff; hypoxemia; hypercapnia; neurological study
Medtronic Treat to Range (TTR) Closed-Loop Control
Condition: Diabetes Mellitus; Type 1 Diabetes; Metabolic and Nutritional Disorders
MeSH terms: Diabetes Mellitus; Nutrition Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a treat-to-range automated insulin management system
      using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in
      individuals with type 1 diabetes.
    

Detailed description: 
      The purpose of this study is to demonstrate the safety and efficacy of a closed-loop
      "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR
      system only effects insulin delivery when the glucose is projected to be above or below
      specified target ranges. These initial studies will assess the safety of this algorithm
      (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal
      over-insulinization. This is a "hybrid" system, which allows the research team to deliver
      insulin boluses manually with the TTR controller only becoming active when blood glucose
      levels are projected to be out of the specified range.
    

Intervention name(s): TTR controller (Medtronic)
Intervention type(s): Device
Intervention description(s): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormone; Diabetes; Mellitus; Type 1; Immune; Metabolic disorder