bioihbjkbjnl/mcl2 huggingface dataset:
Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the ability of a new design of brachytherapy seed for prostate seed
      implants for treatment of prostate cancer to maintain their intended position in the prostate
      after being deposited. Standard seeds, especially in apical locations, have a tendency to
      migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is
      designed to prevent migration. 40 patients who are eligible and suitable for prostate
      brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.
    

Detailed description: 
      Standard post implant prostate brachytherapy quality assurance at the Center for the Southern
      Interior is usually performed at one month after the procedure with CT and MR imaging. In
      order to test the ability of the new design of prostate brachytherapy seeds (AnchorSeeds) to
      hold their position in the prostate, 40 men who have been randomly assigned to receive either
      standard seeds or AnchorSeeds will have an additional CT scan immediately after the procedure
      to record seed position for comparison to positions one month later. The magnitude and
      frequency of seed displacement will be determined.
    

Intervention name(s): Iodine 125 standard loose brachytherapy seeds; AnchorSeed Iodine 125 brachytherapy prostate implant
Intervention type(s): Radiation; Radiation
Intervention description(s): radioactivity 0.4 U per seed, prescribed dose 144 Gy; activity 0.4 U per seed, prescribed dose 144 Gy
Other intervention name(s): BrachySciences; BrachySciences
Intervention MeSH terms: Iodine; Cadexomer iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; Iodine 125 brachytherapy; seed migration; seed migration in the first month after brachytherapy
Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor
Condition: Adult Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a open-label, phase I, dose escalation clinical study to evaluate the safety
      and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic
      solid tumors.
    

Detailed description: 
      This study is a open-label, phase I, dose escalation clinical study to evaluate the safety
      and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic
      solid tumors. In this study, a 3 + 3 dose escalation design was used. The patients will be
      given different doses(500mg, 800mg Q3W) of HLX26 Plus fixed dose of HLX10(300mg)
      intravenously. Observation period of DLT lasts for 3 weeks after the first administration of
      HLX26.
    

Intervention name(s): HLX26; HLX10
Intervention type(s): Drug; Drug
Intervention description(s): Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody; Humanized Anti-Programmed Death-1 Monoclonal Antibody
Other intervention name(s): Anti-LAG-3 Monoclonal Antibody; Anti-PD-1 Humanized Monoclonal Antibody; SERPLULIMAB
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LAG-3
Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Condition: Chronic Pain; Opioid Use Disorders
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery
      Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic
      pain to prescription opioid misuse and addiction. The investigators plan to conduct a full
      scale clinical trial to determine whether MORE (relative to a support group control
      condition) can reduce symptoms of chronic pain and opioid misuse among patients who are
      receiving pain management in primary care via long-term opioid analgesic therapy.
    


Intervention name(s): Mindfulness-Oriented Recovery Enhancement; Support Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.; A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rotation and Movement System, Postpartum Cesarean Sections
Condition: Breast Feeding, Exclusive
Study type: Interventional

Summary: 
      In the first half hour of a cesarean advertisement, the service-oriented mother will not be
      mobile and will need support to get fit in bed and start getting started. The patient turning
      and movement system will provide a lot of convenience to the mother who does not have enough
      support.

      With the remote control system, the mother will be easily turned to the desired side in the
      bed and it will be ensured that she takes the desired position with less pain and more
      comfort.
    

Detailed description: 
      While studies on the Patient Turning and Movement System have been conducted on long-term
      bedridden patients, there is no scientific study examining its effects in the obstetric
      field. For the reasons mentioned above, the aim of this research is; The aim of this study is
      to investigate the effect of Patient Turning and Movement System on postpartum early
      postpartum breastfeeding success, pain and postpartum comfort in puerperant women who
      delivered by cesarean section and to contribute to the literature.
    

Intervention name(s): Giving side position with patient turning and movement system
Intervention type(s): Other
Intervention description(s): To provide effective breastfeeding by placing the mother in position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; midwife; breast-feeding; movement; comfort
Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow
Condition: Vasospastic Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the
      vasospastic syndrome (VS)?

      The main questions are:

      Do women with VS exhibit...

        -  a different basal metabolic rate

        -  a reduced choroidal blood flow

        -  a reduced increase of oxygen consumption after intake of ice-water

        -  a different oxygen consumption after melatonin intake

        -  a different choroidal blood flow after melatonin intake

        -  a different oxygen consumption after melatonin intake and after intake of ice-water….?
    

Detailed description: 
      Study description:

      Melatonin, a natural hormone of the pineal gland exclusively released during the dark phase,
      exhibits vasodilatatory effects in distal skin regions and reduces core body temperature.
      This study investigates whether exogenous melatonin (5mg p.o. at 2p.m.) in the afternoon,
      when no endogenous melatonin is secreted, increases not only distal skin blood flow, but also
      choroidal blood flow and changes oxygen consumption. Two subject groups were studied, women
      with vasospastic syndrome (VS) and controls. The main hypothesis is: melatonin normalizes
      distal vasoconstriction in VS.

      Further questions will also be answered:

      Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the
      vasospastic syndrome (VS)?

      Do women with VS exhibit:

        -  a different basal metabolic rate

        -  a reduced choroidal blood flow

        -  a reduced increase of oxygen consumption after intake of ice-water

        -  a different oxygen consumption after melatonin intake

        -  a different choroidal blood flow after melatonin intake

        -  a different oxygen consumption after melatonin intake and after intake of ice-water....?
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg per os; per os
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: melatonin; skin blood flow; choroidal blood flow; vasospastic subjects; normal subjects
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
Condition: Diabetes Mellitus, Type 2; Healthy Participants
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug
      concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug
      concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug
      Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the
      drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The
      objective of the study is to compare the amount of investigational drug taken up in the body
      for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A
      will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the
      first study period; and will receive a single dose of 0.5 mg semaglutide of the drug
      concentration 0.68 mg/mL in the second study period. Participants assigned to group B will
      receive the two drug concentrations in the reverse order. Participants will get 1
      subcutaneous injection on Day 1 of each of the two study periods. The two injections are
      separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each
      participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks),
      washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study,
      participant should not get vaccinations. Participant should agree on timing of vaccination
      with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant
      during the study period.
    


Intervention name(s): Semaglutide B, 1.34 mg/mL; Semaglutide B, 0.68 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.; Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      This study investigates whether risk criteria based on MRI features could identify a cohort
      of patients with a good prognosis among those recommended for preoperative treatment by NCCN
      guidelines to avoid preoperative treatment with the likely good survival outcomes by primary
      surgery and more accurately indicate the response to the treatment and predict prognosis
      after neoadjuvant treatmen than radiographic TNM staging in the patients who received
      neoadjuvant therapy.
    

Detailed description: 
      There is a lack of international consensus on the choice of preoperative treatment for
      patients with rectal cancer. Existing guidelines decide whether to administer preoperative
      therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC,
      however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients
      with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less
      accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance
      imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD
      and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant
      recurrence as well as poor overall survival. This retrospective study is designed to was to
      evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant
      treatment decisions and more accurately indicate the response to the treatment and predict
      prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with
      MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion
      (EMVI), or tumor deposits (TD) were defined as MRI high-risk.
    

Intervention name(s): total mesorectal excision
Intervention type(s): Procedure
Intervention description(s): patients must underwent total mesorectal excision
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Rectal cancer patients with T3Nx or T1-3N+ at initial diagnosis.
      
Keywords: Rectal cancer; Neoadjuvant treatment; Mesorectal fascia; Extramural vascular invasion
An Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Condition: Contraception
Study type: Interventional

Summary: 
      This randomised controlled trial will establish the effect a contraceptive intervention
      delivered by mobile phone text message on the acceptability of effective contraception in
      Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4
      months (intervention) or a monthly text message not about contraception (control).
      Participants will complete a questionnaire at baseline and 4 month follow-up.
    


Intervention name(s): Contraceptive text messages; Text messages not about contraception
Intervention type(s): Behavioral; Other
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Reproductive health
Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis.
      The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses
      of AIN457 10 mg/kg administered three weeks apart.
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.; Matching placebo to AIN457
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriatic arthritis; IgG1K monoclonal antibody; Interleukin -17A neutralizing
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the absolute oral bioavailability of BI
      425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as
      intravenous microtracer (Reference, R).
    


Intervention name(s): BI 425809; BI 425809 mixed with [C-14]-BI 425809
Intervention type(s): Drug; Drug
Intervention description(s): Treatment T; Treatment R
Intervention MeSH terms: BI 425809
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Cherry Concentrate on Vascular Function
Condition: Healthy
Study type: Interventional

Summary: 
      Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young
      men
    


Intervention name(s): Cherry versus placebo concentrate
Intervention type(s): Dietary Supplement
Intervention description(s): Acute cherry concentrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
Condition: Ventricular Tachycardia; Premature Ventricular Contraction; Stroke
MeSH terms: Stroke; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn if taking a drug called direct oral anticoagulant after
      an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke
      in patients with ventricular tachycardia or arrhythmia (VT).
    

Detailed description: 
      Ventricular tachycardia (VT) or fast heart rhythm is a condition where the lower chambers
      (ventricles) of the heart beat too fast. This condition can be life threatening because these
      ventricles are the main pumping chambers of the heart. The fast heartbeat is caused by
      electrical impulses that travel incorrectly in your heart.

      One way to treat VT is to have a catheter ablation procedure. A catheter ablation is a
      procedure that creates scar tissue in the heart to interrupt the electrical impulses that
      create irregular heart rhythms.

      It is possible that the ablation procedure might cause a blood clot to form. The blood clot
      can stop blood flow to the brain and cause a stroke. When blood flow is interrupted to a
      certain part of the brain, that part does not receive enough oxygen. As a result of the
      stroke the affected areas of the brain are unable to function normally.

      Direct oral anticoagulant (DOAC) is a blood thinning drug, also called an anticoagulant. It
      interferes with the body's natural blood clotting ability by inactivating a specific enzyme
      that the body needs to form blood clots.

      Participation in this study will last about 30 days.
    

Intervention name(s): DOAC; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): DOAC is a blood thinning drug, also called direct oral anticoagulant. These group of drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of stroke prophylaxis in atrial fibrillation and deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs.; Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.
Other intervention name(s): Direct Oral Anti Coagulants; Rivaroxaban; Apixiban; Dabigatran; Edoxaban
Intervention MeSH terms: Aspirin; Rivaroxaban; Edoxaban; Dabigatran; Anticoagulants; Coagulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Radiofrequency ablation; anticoagulation; Direct oral anticoagulants; Aspirin; Ventricular arrhythmia
Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable
      healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to
      observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in
      groups of healthy individuals and to compare the side effects and tolerability of a single
      dose of fenobam with placebo.
    

Detailed description: 
      Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine)
      urea hydrate], oral administration of one 50 mg gelatin capsule.

      Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.

      Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.

      Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
    

Intervention name(s): Fenobam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose); Oral administration of placebo or lactose 150 mg
Other intervention name(s): N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea; Lactose
Intervention MeSH terms: Imidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Fenobam,; Pharmacokinetics; side effects
A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the
      immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men
      (MSM)
    

Detailed description: 
      The investigators estimate that 166 participants will need to be included in the study to
      evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection
      who have sex with men, by evaluating in two age groups and the seroconversion rate for each
      of the HPV genotypes included in the vaccine from baseline to month 7 and 24.
    

Intervention name(s): HPV9v
Intervention type(s): Biological
Intervention description(s): Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24
Other intervention name(s): Gardasil9
Intervention model: Single Group Assignment
Intervention model description: A phase IV, open-label and single-arm clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
Condition: Total Hip Replacement
Study type: Observational

Summary: 
      Does having a large diameter metal on polyethylene total hip replacement increase metal ion
      release. Larger metal heads are thought to have increased torsional forces on the trunion
      which would like release more metal ions. Increased metal ion levels have been associated
      with adverse local tissue reactions. Are there any differences comparing these groups to a
      dual mobility type total hip replacement.
    


Intervention name(s): Metal Ion Levels
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Orthopedic patients with prior hip replacement.
      
Keywords: Total Hip Replacement; Metal Ion; 2-5 years after surgery; Asymptomatic