bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Condition: HIV/AIDS; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to compare different ways to deliver the couples HIV Testing and
      Counseling (CHTC) intervention that is suited for adolescents and young adults.
    

Detailed description: 
      Investigators will conduct a comparative effectiveness trial (CET) of CHTC for adolescent-age
      (15-24 years) same-sex male couples. This design tests the added benefits of adjunct
      intervention components delivered prior to receipt of CHTC-Assertive Communication Training
      (ACT) videos viewed by the individual or couple together and individually delivered
      Motivational Interviewing-based Communication Skills Training (MI-CST). These target the
      development of communication skills necessary to participate fully in HIV prevention and
      sexual safety discussions inherent to CHTC. Youth will be randomized to receive one of two
      conditions: Condition 1: watch videos on ACT, participate in Communication Skills Training
      (MI-CST), and complete an individual HIV test, or if participating as a couple will receive
      CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of
      attending the baseline visit alone or with their partner and have the option to bring their
      partner in later after completing the baseline alone. Youth in this CET will complete
      follow-up assessments at 1, 3, and 6 months.
    

Intervention name(s): We Test; IHTC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.; Individual HIV Testing and Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At baseline participants will be randomized to one of two conditions: Condition 1: MI-CST + observation of ACT videos + CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.
Masking: None (Open Label)
Primary purpose: Other
Observational Study of Vision Improvement in Patients With Retinal Disorders
Condition: Age-related Macular Degeneration; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Retinal Diseases
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to assess the vision improvement achieved by patients with
      retinal disorders who received corneal treatments by a low vision aid device.
    

Detailed description: 
      The purpose of this study is to assess the vision improvement achieved by patients with
      retinal disorders, including age-related macular degeneration and diabetic macular edema, who
      received corneal treatments by a low vision aid device. Patient records will be analyzed to
      determine measures of vision improvement including best spectacle-corrected distance visual
      acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes
      and baseline characteristics.
    

Intervention name(s): Corneal treatment by a low vision aid device
Intervention type(s): Device
Intervention description(s): Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with vision impairment due to retinal disorders involving central vision loss
      
Keywords: Age-related macular degeneration; Diabetic macular edema
Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.
Condition: Survival; Embryo Quality
Study type: Interventional

Summary: 
      The survival rate (and embryo quality) of donor oocytes with two commercially available
      devices.
    

Detailed description: 
      Donor sibling oocytes will be vitrified with two commercially available devices. The first
      device is closed vitrification with closed storage and the second device is open
      vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With
      the increase in cooling rate generated by the open vitrification (second device), we expect
      to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed
      with oocytes obtained from both devices.
    

Intervention name(s): CBSvit HS device; Cryotop SC device
Intervention type(s): Device; Device
Intervention description(s): closed vitrification with closed storage; open vitrification with closed storage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitrification; oocyte; donor; open; closed
Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.
Condition: Dentist-Patient Relations
Study type: Interventional
Phase: Phase 1

Summary: 
      We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral
      decontamination agent. It was also shown that SDS surfactant improves the antibacterial
      action of APDT when using Curcumin as the photosensitizer. The decontamination levels
      obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The
      clinical relevancy is the control of oral microbial load which will improve the patients'
      quality of life and will decrease the possibility of cross contamination in the dental
      office.
    

Detailed description: 
      The installation of the orthodontic appliances promotes an increase in the retentive area
      available for microbial aggregation, difficult the oral health promotion and, in addition,
      promotes the artificial selection of biofilms containing a higher load of pathogenic
      microorganisms. In this way, it becomes of critical importance, the development of techniques
      that might aid in the reduction of the oral microbial load. One possible approach is the use
      of the Antimicrobial Photodynamic Therapy (APDT). In this direction, the objective of this
      study was to assess the clinical utility of the APDT and the association of the APDT with the
      SDS surfactant as oral decontamination agents in orthodontic patients. The selected patients
      (n=24) were randomly distributed within seven experimental groups: G1 - Negative control, G2
      - Curcumin mouthwash, G3 - Curcumin mouthwash+SDS, G4 - light irradiation, G5 - APDT, G6 -
      APDT+SDS and G7 - Positive Control (Chlorhexidine mouthwash). Nonstimulated saliva samples
      were collected from each one of the patients in three steps (S), as follows: S1- Initial
      condition, S2 - Treatment with mouthwashes (water, Chlorhexidine or Curcumin) and S3 - After
      APDT treatment. The efficacy of the proposed treatment protocols was assessed in function of
      the survival fraction observed in each group. The obtained results were statistically
      analyzed using variance analysis (ANOVA) and the Kruskal-Wallis test.
    

Intervention name(s): Curcumin; LED; Surfactant; DMSO + water; Chlorhexidine gluconate
Intervention type(s): Drug; Device; Drug; Drug; Drug
Other intervention name(s): Curcumin salt
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Curcumin; Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orthodontic, Photochemoterapy
Exercise & Overweight Children's Cognition
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This research focuses on overweight, sedentary children whose health, cognition, and academic
      performance are therefore at risk, and who may be particularly responsive to exercise
      interventions.

      This study will determine whether regular exercise per se (i.e. compared to attention
      control, or placebo, condition) benefits children's cognition and achievement, and will
      provide insight into neural mechanisms. A substudy will examine exercise-induced changes in
      brain structure.

      Provision of comprehensive evidence for the benefits of exercise on children's health may
      reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by
      persuading policymakers, schools and communities that time spent in physical activity
      enhances, rather than detracts from, learning.
    

Detailed description: 
      An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1,
      http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&icde=20104167)
    

Intervention name(s): Exercise; After-school program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Heart rate monitors worn by each child at each session; Supervised recreational program with token economy
Other intervention name(s): Aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see how much study drug is in the blood of children with
      pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further
      clinical research.
    

Detailed description: 
      During Period I, tadalafil will be administered orally, once daily, at a low dose for
      approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are
      calculated based on body weight cohorts. Heavy weight cohort >=40 kg, middle weight cohort
      >=25 kg to <40 kg. Light weight cohort<25 kg. Participants who complete Period 1 may continue
      taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum
      weight range dose established in Period 1 and after the first 3 months of Period 2, the dose
      may be adjusted based on available safety and efficacy information.
    

Intervention name(s): Tadalafil- Tablet or Oral suspension
Intervention type(s): Drug
Intervention description(s): Tadalafil Tablets administered orally. Tadalafil Oral suspension: An aqueous, ready-to-use suspension for oral administration.
Other intervention name(s): LY450190
Intervention MeSH terms: Tadalafil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery
Condition: Lung Cancer; Thoracic Surgery; Anesthesia, Epidural; Neoplasm Recurrence, Local; Neoplasm Metastasis
MeSH terms: Lung Neoplasms; Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local; Recurrence
Study type: Interventional

Summary: 
      Available studies suggest that regional anesthesia-analgesia may decrease the occurrence of
      recurrence/metastasis in patients after cancer surgery. However, evidences from prospective
      studies are still lacking. The purpose of this randomized controlled trial is to investigate
      the effect of epidural anesthesia-analgesia on recurrence-free survival in patients
      undergoing lung cancer surgery.
    

Detailed description: 
      Lung cancer is increasing and is the leading cause of cancer death. Surgical resection is the
      mainstay of treatment for early stage non-small cell lung cancer. However, long-term survival
      after lung cancer surgery is far from optimal, and cancer recurrence or metastasis is the
      main reason leading to cancer death in these patients.

      The development of cancer recurrence/metastasis largely depends on the balance between
      tumor-promoting factors and immune function of the body. Studies showed that surgical
      manipulation releases cancer cells into circulation; and stress response induced by surgery
      inhibits the cell-mediated immunity. In addition, volatile anesthetics and opioids may also
      aggravate immunosuppression and potentially worsen long-term outcome. On the other hand,
      regional anesthesia can blunt surgical stress and reduce anesthetic consumption. These
      effects may help to preserve immune function and reduce recurrence/metastasis. However,
      existing evidences are insufficient to draw conclusion in this topic.

      The purpose of this randomized controlled trial is to test the hypothesize that regional
      anesthesia-analgesia may reduce recurrence/metastasis and improve long-term survival in
      patients after lung cancer surgery.
    

Intervention name(s): General anesthesia alone; Combined epidural-general anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.; Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lung Cancer; Surgical Resection; Epidural Anesthesia and Analgesia; Cancer recurrence/metastasis; Long-Term Outcome
Study to Investigate Dose-related Efficacy of LAS41004 in the Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004
      in a Psoriasis Plaque Test (PPT)
    


Intervention name(s): LAS 41004; LAS 41004; LAS 41004; LAS 41004; LAS 41004; LAS 41004 dosage 6; Placebo; Reference
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): LAS 41004 dosage 1, once daily; LAS 41004 dosage 2, once daily; LAS 41004 dosage 3, once daily; LAS 41004 dosage 4, once daily; LAS 41004 , dosage 5, once daily; LAS 41004, dosage 6, once daily; Placebo, once daily; Reference, once daily
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: psoriasis; topical; psoriasis plaques test
A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomised, 2-period, single-dose crossover study to determine
      the comparative bioavailability of cytisine following single-dose administration in healthy
      male and female subjects under fed and fasted conditions.

      The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2)
      and a post-study follow-up.
    


Intervention name(s): Cytisine
Intervention type(s): Drug
Intervention description(s): Cytisine 1.5 mg Film-Coated Tablets
Other intervention name(s): Tabex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide additional information on safety and tolerability
      after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331
      study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this
      study.
    


Intervention name(s): pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety
Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
Condition: Lower Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Observational

Summary: 
      Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children
      with lower respiratory tract infections.
    


Intervention name(s): clarithromycin (Klacid) granules for oral suspension
Intervention type(s): Drug
Intervention description(s): clarithromycin (Klacid) Granules for Oral Suspension
Other intervention name(s): clarithromycin; Klacid Granules for Oral Suspension; Biaxin XL
Intervention MeSH terms: Clarithromycin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Out-patients in Thailand
      
Keywords: Post-marketing observational study; Lower respiratory tract infections; Klacid Granules for Oral Suspension
2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy
Condition: Cervix Cancer; Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy
      treatment and assess whether tridimensional dosimetry relates more faithfully with the
      occurrence of adverse effects.
    

Detailed description: 
      Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using
      ionizing radiation to cause damage in tumor cells. After radical surgical treatment of
      gynecological tumors, pathological findings, such as extension of the myometrium invasion,
      histologic grade, and vascular- lymphatic invasion predict the risk of locoregional
      recurrence of disease and, consequently, the need for adjuvant treatment. There are two main
      methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or
      endometrium: external beam radiotherapy with or without booster dose of vaginal vault
      brachytherapy or brachytherapy alone. There are few data in the literature and clinical
      experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .

      Objective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant
      brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully
      with the occurrence of adverse effect.

      Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo
      Cancer Center will be developed with an expected duration of 14 months and will include 60
      patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to
      influence the incidence of adverse effects will be evaluated. Computed tomography for
      planning of external beam radiotherapy and brachytherapy planning will be used, after
      placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two
      fast acquisition sequences, one with a urinary catheter not pulled and pulled another with
      the probe will be obtained. The prescription dose obey the standard indication of document of
      the International Commission on Radiation Units & Measurements (ICRU 38).
    

Intervention name(s): 2D HDR planning; 3D HDR planning
Intervention type(s): Other; Other
Intervention description(s): HDR planning using simple radiograph (2D); HDR planning using computed tomography (3D)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3D Brachytherapy; cervical cancer; endometrial cancer; vaginal vault brachytherapy
Registration of Skin-Temperatures and Sleep-Wake Behaviour
Condition: Vasospastic Syndrome
Study type: Observational

Summary: 
      We study the skin-temperature (skin temperature measurement on different skin regions) and
      circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.

      This project will provide further information at which circadian phase vasospasms occur in
      daily routine life (one week recordings). Special interest lays on the time before sleep. The
      attained results could be used to establish a therapy with few side effects for people with
      difficulties initiating sleep because of vasospasm.
    

Detailed description: 
      We study the skin-temperature and circadian rest-activity cycles of 40 women in their daily
      life.

      20 women with vasospasm and difficulties of initiating sleep and 20 women without vasospasm
      and no difficulties of initiating sleep.

      Women without contraceptives will be examined in the luteal phase (i.e. in the two weeks
      before menstruation). The ambulant registry will be done continuously during one week with so
      called i-Buttons (IButtonTM, Maxim, USA). These will be fixed to various parts of the body
      (i.e. wrist, ankle, …) with Fixomull, a medical bond. Also the subjects have to wear a
      instrument for registration activity, the so called Actiwatch (Cambridge, UK). The data that
      will be gained from these instruments, shall help us to objectify sleep-latency and
      sleep-fragmentation ("sleeping-through").

      Furthermore, the subjects obtain a sleep-and activity-dairy, that has to be filled before and
      after sleeping. At one day, that the proband can choose, saliva samples have to be taken by
      the subjects themselves. In the saliva, the concentration of melatonin will be qualified. The
      attained results could be used to establish a therapy with few side effects for people with
      difficulties of initiating sleep because of vasospasm.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women with vasospasm and difficulties of initiating sleep and women without vasospasm and
        no difficulties of initiating sleep
      
Keywords: vasospasm; circadian; sleep-disorders
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis
Condition: Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis
Study type: Interventional

Summary: 
      This observational study investigates the efficacy and safety of immunoadsorption versus
      plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated
      syndrome who do not fully recover after a high doses of intravenous corticosteroids.
    


Intervention name(s): Immunoadsorption; Plasmapheresis
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunoadsorption; Plasmapheresis