bioihbjkbjnl/mcl2 huggingface dataset:
Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study
Condition: Circumscribed Choroidal Haemangioma; Optical Coherence Tomography Angiography; Macular
MeSH terms: Hemangioma
Study type: Observational

Summary: 
      The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with
      exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.
    

Detailed description: 
      Circumscribed choroidal haemangioma (CCH) is an uncommon, potentially congenital benign
      vascular hamartomas which typically manifests as an elevated mass with reddish-orange
      pigmentation located posteriorly to the equator, mostly in the macular and peripapillary
      region. Despite its benign nature, cystoid macular edema (CME) or SRF due to the exudations
      from the exudative CCH can cause visual impairment. Diagnosis is often suspected clinically,
      and multimodal imaging is useful for the differential diagnosis of CCH from other malignant
      tumors such as melanoma. Optical coherence tomography angiography (OCTA) is a rapid,
      non-invasive, new imaging technology which could provide the capillary density (CD) of
      superficial and deep capillary plexus as well as the CD of choriocapillaris of the
      superficial, the latter two of which could not be seen on conventional FA or ICGA. However,
      little knowledge is known about the parafoveal microvasculature changes in eyes with
      exudative CCH on OCTA. Therefore, it is necessary to quantitative evaluation of parafoveal
      microvasculature changes in eyes with exudative CCH compared with healthy eyes without any
      disease. To the best of our knowledge, this is the first cross-sectional, case-control study
      to use OCTA to quantitative evaluation of parafoveal microvasculature changes in Eyes with
      exudative CCH compared with age- and gender-controlled healthy eyes.
    

Intervention name(s): This is observational study with the examination of OCTA
Intervention type(s): Other
Intervention description(s): This is observational study with the examination of OCTA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        There are two groups in this study: one is the exudative CCH group,and the other is the
        healthy eye control group. They performed OCTA at baseline.
Vortioxetine for Menopausal Depression
Condition: Depression; Menopause; Vasomotor Disturbance; Hot Flashes; Sleep
MeSH terms: Hot Flashes; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The broad goal of this study was to examine the efficacy and tolerability of vortioxetine
      (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women
      around the menopausal transition. We hypothesized that an eight-week treatment with
      vortioxetine would promote a significant improvement of depression symptoms and other
      menopause-related physical symptoms.
    

Detailed description: 
      Forty-seven peri- and postmenopausal women were enrolled in this open-label study. This was
      an 8-week intervention using open-label vortioxetine with flexible dose between 5-20 mg,
      dependent on participant response and tolerability. In addition to assessment of depressive
      symptoms, improvement of menopause-related physical and emotional symptoms that occur with
      MDD, including vasomotor symptoms, cognition, fatigue, anxiety, sleep complaints, and quality
      of life, were also examined.
    

Intervention name(s): vortioxetine
Intervention type(s): Drug
Intervention description(s): Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.
Other intervention name(s): Trintellix
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Association Between Smoking, Brain Activity, Genes, and ADHD
Condition: Smoking; Withdrawal Nicotine; ADHD
Study type: Observational

Summary: 
      The study investigated the underlying mechanisms of smoking in young adults by examining the
      associations between smoking, brain activity, dopamine genes, and attention deficit
      hyperactivity disorder (ADHD).
    

Detailed description: 
      The study investigated the underlying mechanisms of smoking in young adults by examining the
      associations between smoking, brain activity, dopamine genes, and attention deficit
      hyperactivity disorder (ADHD). Four groups of young adults were recruited: (1) smokers with
      ADHD; (2) nonsmokers with ADHD; (3) normative control smokers; and (4) normative control
      nonsmokers. Smoking was assessed via questionnaires and salivary cotinine levels. Brain
      activity was examined via functional Magnetic Resonance Imaging (fMRI). Each nonsmoker
      underwent an fMRI scan during an experimental task consisting of mathematical problems.
      Smokers underwent two fMRI scans during similar experimental tasks under the following two
      conditions: (1) after smoking a cigarette and (2) after overnight abstinence. The association
      between the DRD4-7 repeat allele and smoking was explored.
    

Intervention name(s): Cigarette smoking; Abstinence
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.; Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
Sampling method: Non-Probability Sample
Study population: 
        Commuity sample
      
Biospecimen description: 
      Blood samples for genotyping
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Abscess; Wound Infection; Surgical Site Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment
      with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in
      participants with known or suspected Gram-positive acute bacterial skin and skin structure
      infections (ABSSSI) at 48 -72 hours after initiation of treatment.
    


Intervention name(s): Dalbavancin; Dalbavancin-matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dalbavancin IV infusion over 30 minutes.; Dalbavancin-matching placebo IV infusion over 30 minutes.
Other intervention name(s): DALVANCE®
Intervention MeSH terms: Dalbavancin; Teicoplanin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome
Condition: Anovulation
MeSH terms: Polycystic Ovary Syndrome; Anovulation
Study type: Observational

Summary: 
      We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of
      ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary
      Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this
      study, we plan to investigate whether a drop in the serum AMH level would be concomitant to
      the appearance of a dominant follicle induced by administration of mild amounts of exogenous
      FSH in women with PCOS.
    

Detailed description: 
      Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate
      will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum
      levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed
      twice a week until 3 days after appearance of > 1 dominant follicle(s).The starting dose of
      recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days
      at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is
      achieved. Dominance will be defined by the appearance of at least one follicle >10 mm growing
      at least 2 mm/day and serum E2> 100 pg/L. Ultrsound examination will performed with a 7-MHz
      transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized
      protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay
      AMH-EIA.
    

Intervention name(s): usual administration of exogenous recombinant FSH
Intervention type(s): Drug
Observational model: Defined Population
Time perspective: Prospective
Keywords: Polycystic Ovary Syndrome; Follicular Arrest; Anti-Mullerian Hormone; FSH
University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
Condition: Graft Versus Host Disease (GVHD); Acute Myocardial Infarction (AMI)
MeSH terms: Myocardial Infarction; Graft vs Host Disease; Infarction
Study type: Interventional

Summary: 
      The objective of this protocol is to use established standard criteria and methods for the
      collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The
      hMSC collected from the donors will use to develop well-defined and reproducible cell banks.
      Standard manufacturing procedures and quality control testing methods will be used to
      characterize and evaluate the final cell product. After the cell banks are created, these
      cell products will be used in future translational or clinical research.
    

Detailed description: 
      Cell banks will be manufactured and cellular products used for future translational or
      clinical research.
    

Intervention name(s): Bone marrow aspirate
Intervention type(s): Procedure
Intervention description(s): A single bone marrow aspirate procedure is planned.
Other intervention name(s): bone marrow-derived MSC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MSC; Allogeneic; Bone marrow cells; Healthy subject donors; Collection of MSC from bone marrow aspirate; Bronchiolitis obliterans syndrome (BOS)
rTMS for Executive Function Deficits in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      In this study, the investigators will be examining the effects of repetitive transcranial
      magnetic stimulation (rTMS) on executive function deficits in individuals with autism
      spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS
      stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the
      same as active rTMS only there will be no direct brain stimulation. This is necessary to
      ensure that active rTMS is efficacious in the enhancement of executive function in
      individuals with autism spectrum disorder. Based on results from a recently published pilot
      study, the investigators propose that active rTMS treatment will result in a significant
      improvement in working memory performance compared to sham rTMS treatment.
    

Detailed description: 
      This study is a randomized, double blind, sham controlled study to evaluate the efficacy of
      repetitive transcranial magnetic stimulation (rTMS) as a treatment for executive function
      deficits in individuals with autism spectrum disorder between 16 and 25 years of age. The
      study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times
      a week, for about 1 hour each. Several scales will be used to assess for symptom severity and
      adaptive functioning. Cognition will be assessed using a validated battery.

      This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at
      the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of
      rTMS on brain structure and function. Investigators will measure the size and connections of
      different parts of the brain to assess brain structure and blood flow while participants are
      completing some basic tasks to asses brain function.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
Other intervention name(s): MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Executive Function; rTMS (Repetitive Transcranial Magnetic Stimulation); MRI (Magnetic Resonance Imaging); Healthy Subjects
Case Volume and Adenoma Rate During Screening Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Observational

Summary: 
      Screening colonoscopy has been established as the most effective means of colorectal cancer
      prevention. This is based on the fact that colonoscopy detects and removes colonic polyps
      (adenomas) which are known to progress to cancer if left untreated. The present study
      examines the question whether case volume (i.e., the number of colonoscopies performed per
      year) correlates with colonoscopy quality, i.e., adenoma detection rate.
    

Detailed description: 
      21 private practice gastroenterologist endoscopists from Berlin performed a prospective
      quality assessment study including at least 10.000 screening colonoscopies. After informed
      consent, patients data are included (age, sex, family history, colonoscopy performance
      parameters and findings, therapy performed, histology of biopsies and/or polypectomies,
      complications (immediate and late) and patient acceptance. The latter was retrieved by
      patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in
      an anonymized way

      Primary outcome parameter:

        -  Correlation of adenoma detection rate with case volume and other confounding factors
           (e.g., withdrawal time)

      Secondary outcome parameters:

        -  Complications and method of assessment (immediate recording versus later questionnaire
           enquiry)

        -  Quality of bowel preparation in relation to outcome Patient acceptance in relation to
           procedural factors (e.g., sedation)

        -  Quality of pathology reports and histologic outcome of polypectomy

      Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has
      been part of the protocol and patient consent form.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In Germany screening colonoscopy is reimbursed over the age of 55 years. All persons
        willing to undergo screening colonsocopy without contraindications are asked for consent to
        be included
      
Keywords: colorectal cancer; prevention; colonoscopy; screening; quality assessment; colorectal cancer prevention
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a drug trial comparing the post-operative pain control provided by liposomal
      bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the
      local anesthetic) for men undergoing testicular sperm extraction.
    


Intervention name(s): Liposomal Bupivacaine; Standard Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.; After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study model is a randomized double blind control trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral
      solution of BIBV 308 SE following multiple doses, tolerability
    


Intervention name(s): BIBV 308 SE solution; BIBV 308 SE capsule 1; BIBV 308 SE capsule 2
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Association Between Physical Sensations and Thinking Styles
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      The aim of the study is to examine panic-related associations and interpretations in the
      context of Panic Disorder and its treatment. While theoretical accounts of Panic Disorder
      suggest a central role of such associations and interpretations in the onset and maintenance
      of the disorder, research to date in fact leaves many questions about the nature of these
      dysfunctional cognitions and their potential role unanswered. Patients with Panic Disorder
      and a control group of patients with other anxiety disorders will complete measures of
      panic-relevant associations and interpretation bias. The patients with Panic Disorder will be
      randomized to receive either Cognitive Behaviour Therapy (CBT) or a waiting list condition
      (to be followed by CBT after completion of the study procedures). The anxious control group
      will also receive CBT. Panic-relevant associations and interpretations will be measured
      twice, i.e., pre and post CBT/waitlist. Furthermore, relevant symptom measures and
      physiological and biological markers will be assessed and responses to a hyperventilation
      challenge. The study aims to further advance our understanding of cognitions in the etiology
      and maintenance of Panic Disorder, and inform future treatment optimisation.
    

Detailed description: 
      The main purpose of the present study is to look at relationships and changes over time but
      not to compare treatment outcomes (i.e. it is not an efficacy trial). The associations and
      interpretation measures are listed as primary outcomes because these are the measures of main
      interest.
    

Intervention name(s): Cognitive Behaviour Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behaviour Therapy (CBT) for diagnosed anxiety disorder (i.e. CBT for Panic Disorder in the Panic Disorder group, or other diagnosed anxiety disorders in the Anxious Control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants meeting study criteria for Panic Disorder will be randomized to an intervention arm (CBT) or waiting list arm (which is followed by CBT after completion of the study procedures); participants meeting study criteria for the anxious control group will be allocated to an intervention (CBT) arm. The study aims to have equal numbers of participants in each of the 3 arms.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognitive biases; Associations; Interpretations; Physiological and biological markers
Assessing Early Behavioral Indicators of Formula Tolerance
Condition: Tolerance
Study type: Interventional

Summary: 
      The study is intended to assess the amount of crying and fussiness in infants fed an infant
      formula containing probiotics.
    


Intervention name(s): Control; Investigational
Intervention type(s): Other; Other
Intervention description(s): Marketed partially hydrolyzed cow's milk protein infant formula; Partially hydrolyzed cow's milk protein infant formula with a probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for
      SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of
      gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of
      groups A and B, and 20 cases in group C.
    


Intervention name(s): Aspirin、clopidogrel、placebo or SHR2285; Aspirin、clopidogrel、placebo or SHR2285; Aspirin、ticagrelor、placebo or SHR2285
Intervention type(s): Drug; Drug; Drug
Intervention description(s): groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；; groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2); groupC： Aspirin + ticagrelor + placebo or SHR2285
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
Condition: Head and Neck Cancer
MeSH terms: Salivary Gland Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with
      metastatic or recurrent salivary gland cancer.
    

Detailed description: 
      OBJECTIVES: I. Estimate the response rate in patients with metastatic or recurrent salivary
      gland cancer treated with paclitaxel (Taxol, TAX) by 3-hour infusion. II. Describe the
      toxicity of TAX in these patients.

      OUTLINE: Single-Agent Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973.

      PROJECTED ACCRUAL: Up to 32 patients/histology will be entered. If no response is observed in
      the first 14 patients in a particular histology, accrual to that group will close; if after
      18 months annual accrual is less than 10 patients/histology, accrual to that group may close.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Primary purpose: Treatment
Keywords: stage IV salivary gland cancer; recurrent salivary gland cancer; high-grade salivary gland mucoepidermoid carcinoma; salivary gland adenocarcinoma