bioihbjkbjnl/mcl2 huggingface dataset:
Using Magnetic Resonance Imaging to Predict People Who Are Likely to Develop Flash Pulmonary Edema (The PREDICT Study)
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Flash pulmonary edema is a sudden, abnormal build-up of fluid in the lungs. It is usually
      caused by heart failure and can be life threatening. The purpose of this study is to
      determine if a new form of magnetic resonance imaging (MRI) can identify abnormal blood flow
      to the lungs and predict increased risk of developing flash pulmonary edema among older
      adults.
    

Detailed description: 
      Pulmonary edema is a condition in which an abnormal build-up of fluid occurs in the lungs,
      which then leads to swelling. Symptoms include shortness of breath, breathing difficulty, and
      coughing. Flash pulmonary edema, which develops suddenly and can be life-threatening, is
      usually caused by heart failure. It occurs when the left ventricle of the heart is weakened
      and does not function properly, potentially impeding the flow of blood from the heart to the
      rest of the body. Blood pressure and fluid volume then increase, and excess blood accumulates
      in the blood vessels and tissues of the lungs. Flash pulmonary edema requires immediate
      treatment, including supplemental oxygen, mechanical ventilation, or medication. This study
      will determine if a new form of MRI testing can be used to identify probable abnormalities in
      blood flow to the lungs and predict increased risk of developing flash pulmonary edema among
      older adults.

      This study will enroll people who are at risk of developing flash pulmonary edema. At a
      baseline study visit, participants will undergo a medical record review, a physical exam,
      blood collection, questions about cardiovascular health, and an MRI stress test. For the
      stress test, participants will first receive the medication dobutamine, which will increase
      their heart rate and reduce the blood supply to their heart. Participants will then be placed
      in an MRI machine and images of their heart will be taken. All participants will complete
      follow-up cardiovascular health questionnaires three times a year for 1 to 10 years,
      depending on when participants are enrolled into the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with diabetes, high blood pressure, or coronary artery disease
      
Keywords: Cardiac Outcomes; MRI; Cardiac Stress Testing
External Ankle Supports - 3D Motion Analysis
Condition: Chronic Ankle Instability
Study type: Interventional

Summary: 
      Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim
      of our study is to quantify the stabilizing effect of different devices. Through the use of a
      foot measurement model in 3D motion analysis the influence of the devices with respect to a
      mechanical effect is examined by means of different tests. The dynamic postural control is
      quantified. The hypothesis was that the devices would stabilize differently the foot
      segments.
    


Intervention name(s): Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
MRI and Biomarkers in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer has been the most common neoplastic disease in men in Finland over the last
      ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate
      cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.
      Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)
      guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed
      instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there
      is an increasing interest in developing more accurate non-invasive imaging modalities.

      This prospective multi-institutional study will enroll 400 men with clinical suspicion of
      prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital
      rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted
      imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to
      non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided
      biopsy based on MRI findings will be performed in addition to routine twelve core TRUS
      biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from
      fresh biopsy sample will be collected and correlated with the presence or absence of prostate
      cancer.
    


Intervention name(s): prostate biopsy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: prostate cancer; PSA; MRI; biopsy; biomarker
Needs Assessment After Cancer in Patients Treated for Breast Cancer
Condition: Breast Neoplasm Female; Quality of Life; Fear Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      observational monocentric study
    

Detailed description: 
      observational monocentric study

      Primary objective :

      Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for
      breast cancer after completion of treatment and 2 years later.

      Secondary objective :

        -  Correlation between needs after cancer and the fear of recidivism assessed by the scale
           of the inventory of fear.

        -  Compare the need for supportive care between the end of treatment and 2 years after.

        -  Assess needs after cancer according to the stage of the disease

        -  Evaluate the needs after cancer according to the treatments received:
           surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.

        -  Assess needs after cancer according to age and socio-professional category.

      Schedule :

      The selected patients then received a letter including an information and non-objection note,
      the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and
      the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a
      phone call after 15 days for an analysis of responses in February 2019.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients who completed breast cancer treatment between January 1 and May 31, 2017, and
        between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset,
        patients with a history of breast cancer or any other location, selection of 20 patients
        with breast cancer in situ at random in each of the 2 cohorts.
Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients
    

Detailed description: 
      Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in
      psoriatic patients as case control study by dividing patients into 3 groups: group 1 include
      patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin
      (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving
      those interventions.
    

Intervention name(s): Narrowband Ultraviolet B; Acitretin
Intervention type(s): Radiation; Drug
Intervention description(s): patients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months; patients will received acitretin in dose 0.5-1 mg/kg daily for 3 months
Other intervention name(s): NB-UVB phototherapy
Intervention MeSH terms: Acitretin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Condition: Postoperative Pain; Complications; Satisfaction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country
      hemorrhoidectomy usually be performed under general anesthesia, however there may be the
      complications resulted from general anesthesia together with associated diseases in advanced
      age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA)
      for hemorrhoid surgery but they all require a trained anesthetist and have numerous known
      complications. Since, anesthesiologists are not always available then local anesthesia is an
      alternative mode of anesthesia that surgeon can safely carry out by their own. Local
      anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body
      by localized effect on peripheral nerve endings. The local anesthesia is able to provide
      fully relaxation of the anal canal which is an ideal setting for various anal surgical
      procedures. The results of hemorrhoid surgery under this mode of anesthesia have been
      demonstrated in many publications. Local anesthesia is a safe and effective technique while
      fewer risks and complications compared with general or spinal anesthesia. In Thailand both
      spinal anesthesia and local perianal block have routinely been used for various kinds of
      anorectal surgery. However, so far there has no any trial conducting to compare between these
      two techniques.
    

Detailed description: 
      Objectives: To study analgesic efficacy, postoperative voiding problems, patients'
      satisfaction, and other complications after closed hemorrhoidectomy comparison between local
      perianal block and spinal anesthesia.

      Research design: Randomized controlled trial Setting: Phramongkutklao Hospital Research
      methodology: A total of 64 subjects (32 males and 32 females) underwent elective
      hemorrhoidectomy were randomly allocated into two groups. Thirty-two patients were randomly
      allocated to receive spinal anesthesia (SA group) while 32 patients received local perianal
      block (LA group). Duration of analgesic effect, pain measurement with visual analogue scale
      (VAS) at 6 and 24 hours, quantity of analgesic medication administered, postoperative
      complication, and patient's satisfaction with the anesthetic technique were recorded.
    

Intervention name(s): spinal block; Perianal block
Intervention type(s): Procedure; Procedure
Intervention description(s): 0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space; 0.25% bupivacaine injected at perianal region
Other intervention name(s): marcaine 0.5%; Marcaine 0.25%
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemorrhoidectomy; perianal block; local anesthesia; spinal anesthesia
A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the safety and tolerability of AMG 167
      following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men
      and postmenopausal women.
    


Intervention name(s): AMG 167; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.; Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; Phase 1; First in Human; Postmenopausal
Neighborhoods, Networks, Depression, and HIV Risk
Condition: HIV; Depression; Drug Use
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to examine how social networks, neighborhood, and depression are
      related to HIV risk. The intervention is designed to train individuals to cope with feelings
      of depression or stress as a way to reduce their risk for HIV.
    

Detailed description: 
      This study included implementation and evaluation of a small group, randomized controlled,
      phase II intervention to reduce depressive symptoms and HIV risk behaviors among inner city
      drug users. The intervention included elements of cognitive behavioral therapy (CBT) for
      depression among impoverished individuals, emphasizing depressive cognitions and behaviors
      theorized to be associated with depression and with HIV risk behaviors among mildly to
      moderately depressed drug users. In addition, the study examined active drug users' social
      and environmental pathways to depression and subsequent HIV risk behaviors. Specifically, we
      will hypothesized mediating/moderating effects of neighborhood characteristics, social
      network factors, and individual level factors on depressive symptoms and HIV risk behaviors.
    

Intervention name(s): Workshop; Workshop control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 session intervention; 1 session intervention on standard HIV/STD information
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; depression; drug use,; risk reduction
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
Condition: Mouth Protectors; Quality of Life
Study type: Interventional

Summary: 
      This study assessed the influence of a reduction of the palate extension of a custom-made
      mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo
      players wore a custom-made conventional mouthguard or a reduced palate extension mouthguard
      during the training sessions and for competing for two weeks. The sequence was randomized to
      obtain one-half of the participants started the first week wearing the conventional
      mouthguard, and the other half wearing the shortened mouthguard. The participants rated the
      degree of discomfort in reference to speech, breathing, swallowing, nauseas/vomiting,
      pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale,
      considering 0 no discomfort and 10 maximum discomfort. After each session, players also rated
      the perception of protection and the degree of satisfaction in a 10-point scale, considering
      0 no protection/satisfaction and 10 maximum protection/satisfaction.
    

Detailed description: 
      This crossover intervention study aimed to assess the influence of a reduction of the palate
      extension of a custom-made mouthguard on the degree of satisfaction of elite water polo
      players. Eighteen water polo players participated in this study. Two different custom-made
      mouthguards were made, a conventional one and a reduced palate extension mouthguard. They
      wore them during the training sessions and for competing one type of mouthguard for the first
      and fourth week and the other type of mouthguard for the second and third week. The sequence
      was randomized to obtain one-half of the participants started the first week wearing the
      conventional mouthguard, and the other half wearing the shortened mouthguard. The
      participants rated the degree of discomfort or inconvenience in reference to speech,
      breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic
      performance, in a 10-point scale, considering 0 no discomfort/inconvenience and 10 maximum
      discomfort/inconvenience. After each session, players also rated the perception of protection
      and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction
      and 10 maximum protection/satisfaction.
    

Intervention name(s): Use of conventional mouthguard; Use of shortened mouthguard
Intervention type(s): Device; Device
Intervention description(s): Use of a conventional custom-made mouthguard while playing water polo; Use of a shortened custom-made mouthguard while playing water polo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pedometers for the Enhancement of Post Cesarean Mobility
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      This is a randomized controlled trial, planned to study the effects of pedometers (digital
      step counters) on patient mobility following cesarean delivery. The investigators plan to
      randomize patients at high risk for thromboembolic events to participants with a personalized
      repeated feedback approach based on pedometer results, versus participants with no feedback
      to pedometer results.
    


Intervention name(s): personalized repeated feedback approach
Intervention type(s): Other
Intervention description(s): Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keratinocyte Growth Factor to Prevent Acute GVHD
Condition: Graft-vs-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to
      prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow
      (BM) or peripheral blood progenitor cell (PBPC) transplantation.
    

Detailed description: 
      GVHD remains the major complication of allogeneic BM transplantation and is initiated during
      the conditioning of the recipient for transplant when the host tissues are damaged. Research
      has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD
      pathophysiology. Agents that protect the GI tract may provide prophylaxis against the
      cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein
      that stimulates the growth of epithelial cells including those of the GI tract. KGF can
      protect the GI tract, prevent GVHD, and preserve donor T-cell function.

      Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD
      will be graded weekly during the first 2 months after transplant, then every other week to
      Day 100. Response to therapy will be measured through the use of severity indices, physical
      exam, and laboratory serum values.
    

Intervention name(s): Recombinant Human Keratinocyte Growth Factor (rHuKGF)
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: Keratinocyte growth factor; Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation; HLA Antigens; Transplantation, Homologous; Recombinant Proteins
Kaletra in Combination With Antiretroviral Agents
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir)
      in combination with new substances such as integrase inhibitors (INIs), C-C chemokine
      receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors
      (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even
      personal reasons) which may result in a change from the daily clinical routine and lead to
      the use of a newly approved antiretroviral agent in combination with Kaletra.
    

Detailed description: 
      This study was designed as a non-interventional observational study. Kaletra was prescribed
      in the usual manner in accordance with the terms of the local market authorization with
      regards to dose, population and indication as well as local guidelines.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample: HIV-positive patients
      
Keywords: Infection; Rilpivirine; CCR5 antagonists; Etravirine; Human Immunodeficiency Virus; Maraviroc; Safety and efficacy; Non nucleoside reverse transcriptase inhibitors (NNRTIs); Integrase inhibitors; Raltegravir; Kaletra