bioihbjkbjnl/mcl2 huggingface dataset:
The Role of the Upper Colliculus in the Idiopathic Blepharospasm
Condition: Blepharospasm, Benign Essential
MeSH terms: Blepharospasm
Study type: Interventional

Summary: 
      This pilot study aims at investigating the role of superior colliculus in patients with
      idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.
    

Detailed description: 
      The objective of the study is to investigate the function of the superior colliculus (SC)
      related to visual stimulation by means of fMRI (functional magnetic resonance imaging) in
      patients with idiopathic BSP compared to healthy subjects. The hypothesis is that SC function
      is impaired in BSP (role of biomarker of SC).
    

Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): bold signal in visual pathway
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Superior colliculus; fMRI
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
Condition: Bleeding
MeSH terms: Hemorrhage; Colonic Polyps
Study type: Interventional

Summary: 
      Although endoscopic colonic polypectomy has been an established procedure for two decades,
      the risk of bleeding is still higher after resecting of pedunculated polyps, because of the
      presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine
      injection have been proposed in the management of postpolypectomy bleeding in large colonic
      polyps. For prophylactic clip, there was no randomized controlled study assessing the
      efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So
      the investigators designed a randomized controlled trial to confirm the efficacy of
      application of prophylactic clip in the prevention of postpolypectomy bleeding in large
      polyps.
    

Detailed description: 
      Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks
      larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base
      of the stalk, followed by conventional snare polypectomy. In conventional group, conventional
      snare polypectomy was done without any preventive management. Immediate and delayed bleeding
      complications were assessed.
    

Intervention name(s): Prophylactic clip; No prophylactic management
Intervention type(s): Procedure; Procedure
Intervention description(s): Prophylactic clipping; No prophylaxis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the percentage of patients who would reach a
      cholesterol goal after atorvastatin treatment.
    


Intervention name(s): Atorvastatin; Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.; Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.; Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Ziprasidone for Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed with the aim to evaluate the clinical effect of the overlapped
      switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.
    

Detailed description: 
      Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week,
      multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be
      maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily
      measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks,
      and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity
      (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding
      the metabolic effects of switching to ziprasidone, weight, body mass index (BMI),
      waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density
      lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured
      at each follow-up visit.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): 100% of the past antipsychotic dose will be maintained in week 1, using flexible dosing of 0-100% during next 3 weeks and then discontinued. Ziprasidone will be maintained with flexible dosing of 40-160mg/day during the study period.
Other intervention name(s): Zeldox
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Ziprasidone; Switch; Metabolic syndrome
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
Condition: Knee Injuries; Knee Osteoarthritis; Patellofemoral Syndrome
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Patellofemoral Pain Syndrome; Wounds and Injuries; Knee Injuries
Study type: Interventional

Summary: 
      Knee pain is one of the most prevalent musculoskeletal disorders in the United States.
      Conservative treatments generally consist of pharmacological agents and physical therapy.
      Unfortunately, such conservative care is often mismanaged, and little data is collected on
      clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile
      application (DETP) to guide an at-home exercise therapy program for non-operative knee pain.
      The purpose of this study is conducting a single-blind randomized, controlled, superiority
      study to compare the DETP to conventional physical therapy (PT). The investigators will seek
      to determine improvement in pain and function in PROMIS measures as the primary outcome. The
      investigators will also evaluate satisfaction with the application as a secondary outcome.
    


Intervention name(s): Limber Digital Application; Physical therapy Therapy
Intervention type(s): Device; Behavioral
Intervention description(s): A mobile application was recently developed to address these needs. The application provides evidence-based, symptom specific home-exercise video programs for MSK conditions, as well as clinically-validated outcome measures for tracking progress.; Therapy prescription 2 x a week for 8 weeks (specified by physician)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: knee pain; knee osteoarthritis; patellofemoral syndrome; physical therapy; digital health
Plasticizers and in Vitro Fertilization Outcomes
Condition: Fertilization in Vitro
Study type: Observational

Summary: 
      To investigate the effect of Plasticizer metabolites concentration on the in vitro
      fertilization outcomes
    

Detailed description: 
      This study was conducted in a medical center in southern Taiwan. 80 infertile female
      patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in
      the infertility outpatient were enrolled in this study. The participates were divided into
      two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle
      (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey.
      Additionally, environmental dust and urine were sampled and analyzed the concentration of
      plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer
      metabolites concentration on the in vitro fertilization outcomes.
    

Intervention name(s): Phthalate metabolites measurement
Intervention type(s): Other
Intervention description(s): To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups
Other intervention name(s): diethylhexyl phthalate
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was conducted in a medical center in southern Taiwan. 80 infertile female
        patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in
        the infertility outpatient were enrolled in this study. The participates were divided into
        two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF
        cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire
        survey. Additionally, environmental dust and urine were sampled and analyzed the
        concentration of plasticizers metabolites.
Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and
      rifaximin are effective in the prevention of the development of hepatic encephalopathy in
      cirrhotic patients with acute variceal bleeding
    


Intervention name(s): Lactulose; L-ornithine L-aspartate; Rifaximin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days; 10 grams by intravenous way for 24 hours. Duration of therapy: 7 days; 2 tablets (400mg) three times daily. Duration of therapy: 7 days; Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days.
Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days.
Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days.
Intervention MeSH terms: Rifaximin; Lactulose; N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatic Encephalopathy; Acute Variceal Bleeding; Cirrhosis
Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie
      before the daily taking dose of duloxetine) in patients relieved of at least 30% of their
      neuropathic pain with duloxetine treatment.

      The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6
      hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain
      with duloxetine treatment.

      Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the
      degree of pain relief and to evaluate the sensation of the global improvement experienced by
      the patient.
    


Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Neuropathic pain; Antidepressant; Duloxetine; Liquid Chromatography; Mass Spectrometry
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma
Condition: Recurrent Glioblastoma Planned for Reoperation
MeSH terms: Glioblastoma; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patupilone trial for patients with recurrent glioblastoma, which are planned for
      re-operation. Objectives: prolongation of PFS compared to patients with re-operation only,
      Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone.
      Translational research of tumor tissue exposed to patupilone.

        -  Trial with medicinal product
    

Detailed description: 
      Prior to and after re-operation patients with recurrent glioblastoma receive the
      investigational drug Patupilone, a tubulin-inhibitor.

      The purpose of the trial is to prolong PFS in this patient population. Patupilone is already
      used in clinical trials of other tumor entities such as ovarian cancer, breast and lung
      cancer. Side effects are expected to be manageable.
    

Intervention name(s): Patupilone
Intervention type(s): Drug
Intervention description(s): Patupilone
Intervention MeSH terms: Epothilone B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent Glioblastoma
Taste of Medicines in Children
Condition: Medication Adherence; Medication Reaction
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      Some but not all children will refuse to take medicine because of its taste, which can lead
      to substantial worsening of disease, antibiotic resistance, increased health care costs, and
      even death. The investigators are systematically assessing individual variation in the taste
      of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard
      of care treatment, to determine whether (1) genetic variation underlies differences in taste
      ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood
      of side effects and medication non-adherence.
    

Detailed description: 
      Taste plays an integral role in whether a child accepts a medicine. Some children will like
      the taste of a given medicine and complete the full course of treatment, whereas others will
      strongly reject its taste, suffer taste-modulated side effects, or both. This study will
      systematically measure initial palatability and reactions to the first dose of an antibiotic
      (clindamycin, liquid formulation) by pediatric patients who are receiving clindamycin as part
      of their standard of care treatment. Saliva will be collected from all patients for GWAS.
      Taste response, tolerance of the medication, adherence and clinical outcomes will be
      assessed. Subjects will be followed to determine if they complete the prescribed medication
      regimen (adherence) and/or experience side effects (tolerability). Because
      medication-specific side effects have patient-specific variability, the investigators will
      determine whether the child's initial taste responses, genes, or both predict subsequent side
      effects and medication adherence.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of
        Philadelphia (CHOP).
      
Biospecimen description: 
      Salivary DNA
    
Keywords: pediatrics; personalized medicine; GWAS; Taste; Side effects; clindamycin
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
Condition: Stomach Neoplasm; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The median survival at progression after first-line chemotherapy for metastatic gastric
      cancer is about 2.5 months. There are no data which a possible benefit of second line
      therapy. for this reason a trial which investigates a possible benefit or chemotherapy
      compared to best supportive care as second line treatment is urgently necessary.

      Irinotecan shows response rates of 20% in the first line therapy with high rates od disease
      stabilization. There are few trials investigating irinotecan in the second line setting.
      Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from
      the company Pfizer.
    

Detailed description: 
      Metastatic gastric cancer, progressive disease after one palliative chemotherapy

      Arm A:

      Irinotecan 250/350 mg/m2 q3w

        1. Cycle:250mg/m2/ 30min

        2. Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to
           350mg/m2 Arm B. Best supportive care
    

Intervention name(s): Irinotecan
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Keywords: gastric cancer; metastatic; irinotecan
Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune system response to the
      ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm.
      The goal is to determine if injecting the vaccine into the groin area produces a better
      immune response in the lining of the rectum.
    

Detailed description: 
      HIV is most commonly transmitted via a mucosal surface. The mucosal lining is a potential
      site of both humoral and cellular protection through the activity of B lymphocytes, activated
      memory T lymphocytes, secretory IgA, and antigen presenting cells. In addition to systemic
      immunity, a preventive HIV vaccine should induce immune responses at the mucosal surfaces
      that are portals of HIV entry into the body.

      Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near
      a lymph node. This strategy has proven effective in the simian immunodeficiency virus
      (SIV)/rhesus macaque model. The iliac and inguinal lymph nodes in the groin are the primary
      draining lymph nodes of the genitourinary and rectal tracts. This study will evaluate and
      compare the safety and immunogenicity of ALVAC-HIV (vCP205) when administered subcutaneously
      in the groin and intramuscularly in the deltoid region. ALVAC-HIV (vCP205) is a canarypox
      virus vector vaccine expressing portions of the gp120, Gag, and Pol genes.

      Participants in this study will be randomly assigned to receive vaccine or placebo injections
      in the groin area or the upper arm. All participants will have three baseline visits for
      blood tests and sigmoidoscopies to measure baseline immune functions. After these visits,
      participants will receive weekly injections for 4 weeks. Groin injections will be given
      subcutaneously (under the skin) and upper arm injections will be given intramuscularly (into
      the muscle). Participants will have follow-up visits 5 and 11 months after the last
      immunization. Participants will have blood draws and sigmoidoscopies and will receive HIV
      risk reduction counseling throughout the study. Total length of participation will be
      approximately 14 months. Participants may continue to contact the study for HIV testing and
      study-related concerns for 1 year after study participation.
    

Intervention name(s): ALVAC-HIV (vCP205); ALVAC-HIV (vCP205)
Intervention type(s): Biological; Biological
Intervention description(s): Canarypox virus vector vaccine; Canarypox virus vector vaccine placbo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine; ALVAC Vaccine; Immunization Site; Deltoid; Groin; Targeted Inguinal Lymph Node; TILN
Contrast-enhanced MRI in Children 2 Months to <2 Years
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist
      in children 2 months to < 2 years of age
    

Detailed description: 
      Safety issues are addressed in the AE section
    

Intervention name(s): Gadopentetate dimeglumine (Magnevist, BAY86-6661)
Intervention type(s): Drug
Intervention description(s): For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MRI agents; Magnevist