bioihbjkbjnl/mcl2 huggingface dataset:
COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
Condition: First-episode Psychosis; Cannabis Abuse
MeSH terms: Marijuana Abuse; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      General objective:

      To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive
      behavioral treatment + pharmacological treatment) compared to standard treatment
      (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP)
      cannabis users.

      Design A multicenter single-blind randomized study with 1 year of follow-up. The
      effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral
      treatment + pharmacological treatment) compared to standard treatment (pharmacological
      treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users
      will be assessed.

      Patients will be randomly assigned to one of two treatments:

        1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse +
           pharmacological treatment

        2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment
    


Intervention name(s): Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention.; The aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
Condition: Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal
      spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of
      perennial allergic rhinitis.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Allergy; Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever
Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
Condition: Blastic Phase Chronic Myelogenous Leukemia; Childhood Acute Promyelocytic Leukemia (M3); Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis; Leukemia, Promyelocytic, Acute; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of bortezomib in treating young
      patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer
      cells by blocking the enzymes necessary for their growth.
    

Detailed description: 
      OBJECTIVES: Primary I. Determine the maximum tolerated dose and recommended phase II dose of
      bortezomib in children with refractory or recurrent leukemia.

      II. Determine the toxic effects of this drug in these patients. III. Determine the
      pharmacokinetics of this drug in these patients.

      Secondary I. Determine, preliminarily, the antitumor activity of this drug in these patients.

      II. Determine, preliminarily, the biologic activity of this drug in these patients.

      OUTLINE: This is a dose-escalation, open-label, multicenter study.

      Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every
      21 days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1.5-36
      months.
    

Intervention name(s): bortezomib; pharmacological study; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other
Intervention description(s): Given IV; Correlative studies; Correlative studies
Other intervention name(s): LDP 341; MLN341; VELCADE; pharmacological studies
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This First-In-Human trial will be conducted in healthy male subjects to explore the safety,
      tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of
      M6495.
    


Intervention name(s): M6495; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive M6495 on Day 1; Subjects will receive placebo matched to M6495 on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: M6495; anti-A disintegrin and metalloproteinase with thrombospondin motifs-5 nanobody; Osteoarthritis
An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There
      are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more
      effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by
      6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and
      increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The
      objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by
      comparison with non-acupoint group.
    

Detailed description: 
      efficacy here means specific effect(or active ingredient) of the point BL33.
    

Intervention name(s): needle
Intervention type(s): Device
Intervention description(s): For the acupoint group,needle on bilateral BL33 60-80mm with a 45°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.
Other intervention name(s): acupuncture; electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Mild and moderate BPH
Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence
Condition: Conflict Resolution
Study type: Observational

Summary: 
      Nurses are being challenged to provide increasingly complex care with more inexperienced
      nurses due to higher rates of retirement and registered nurse (RN) turnover in general.

      High-performing charge nurses with excellent interpersonal, conflict management,
      communication, and leadership competencies are vital to achieving optimal outcomes.
      Implementing a charge nurse leadership development program focused on improving communication
      competencies in conflict management situations can support a healthy work environment.
    

Detailed description: 
      Freedman (2019) asserts that "interpersonal conflict in nursing workplaces is a pervasive and
      complex phenomenon, with implications for patient safety and quality of care" (p.594).
      First-time leaders seldom receive adequate training for effective transition to leadership
      roles, with 60% reporting having no training (Gentry, Logan, & Tonidandel, 2014).
      Furthermore, many novice leaders struggle with transitioning from peer to leader,
      specifically related to interpersonal and communication skills (Basogul, 2020; Radovich, et
      al., 2011).
    

Intervention name(s): Orai: Master Public Speaking
Intervention type(s): Behavioral
Intervention description(s): Participants will access the Orai: Master Public Speaking (Sani, Dhamani, & Gupta, 2020) platform with mobile and web-based applications. Communication skill-building moduleswill be assigned using exercises, case scenarios, and AI-assisted feedback debriefing through the Orai application.
Participants will also complete case scenarios created with specific nursing conflict issues a charge nurse may encounter in an acute care facility. Upon completion of the competency development program, participants will complete the CMCSS to determine the effect on confidence levels and a brief survey (Appendix C) to assess the amicability of the program.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        • RN Clinical Team Leader or Charge Nurse employed at MMMC
THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory
      multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at
      investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double
      autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly
      diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then
      continued throughout the subsequent treatment phases until the day before the second
      autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are
      response rates to the different treatment phases (induction, first and second ASCT), best
      response whenever achieved, duration of response (DOR), time to progression (TTP),
      progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as
      evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes
      (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities
      and imaging features, as detected by 18F-FDG PET/CT.
    


Intervention name(s): Thalidomide; Dexamethasone; Zoledronic acid; Cyclophosphamide; Melphalan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-120 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)
AFTER PBSC COLLECTION: 200 mg/d from day after last PBSC collection until the day before first course of MEL-200
AFTER FIRST TRANSPLANTATION: 200 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200; INDUCTION THERAPY: 40 mg/d days 1-4, 9-12 and 17-20 (cycles 1 and 3, 30 days each); 40 mg/d days 1-4 (cycles 2 and 4, 30 days each)
AFTER PBSC COLLECTION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide)
AFTER FIRST TRANSPLANTATION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each); INDUCTION THERAPY: 4 mg i.v. once a cycle for 4 cycles (30 days each)
AFTER PBSC COLLECTION: 4 mg i.v. once (the same day of resumption of Thalidomide)
AFTER FIRST TRANSPLANTATION: 4 mg i.v. once a cycle (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each); Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation; Melphalan 200 mg/sqm on day -1 for first and second ASCT
Intervention MeSH terms: Zoledronic Acid; Thalidomide; Dexamethasone; Cyclophosphamide; Melphalan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous stem cell transplantation; thalidomide; induction therapy
Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
Condition: Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose is to examine the additional effect of either yoga or resistance exercise on
      weight loss weight combined with a standard behavioral weight loss intervention.
    


Intervention name(s): behavioral weight loss
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in
      adult population will be determined. It will provide insights into the influence of
      formulation on vitamin D absorption.

      A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65
      years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in
      Part 1 of the study, after completion of winter sampling.

      Study subjects will be randomised into four study groups (at least 18 subjects per study
      group). Three different treatments will be compared with a control group, which will not
      receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment
      groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C)
      Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are
      commercially available. Prior to study, actual level of vitamin D will be determined using
      appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two
      months, in all three groups. Second serum vitamin D level will be determined on last day of
      the treatment, and compared with pre-treatment vitamin D level.
    


Intervention name(s): Oil-based vitamin D; Water-based vitamin D; Vitamin D capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.; Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.; Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Condition: Locked-In Syndrome
MeSH terms: Locked-In Syndrome
Study type: Interventional

Summary: 
      In this study a new means of communication for people with locked-in syndrome will be tested.
      The investigators will record brain signals directly from the surface of the brain by means
      of a completely implantable system. These brain signals are fed wirelessly into an assistive
      technology device and will control this device for communication and environmental control at
      the users home.
    

Detailed description: 
      In this pilot study we will provide locked-in people with a new means of communication which
      has not been possible up to now. For the first time, we will test whether we can record and
      decode neural signals obtained directly from the brain, for control over a computer. The
      target population is people with locked-in syndrome. For these patients there is no technique
      available to allow them to communicate unaided. We have developed a brain-computer interface
      (BCI) system that can read activity directly from the brain, and can convert the activity to
      a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an
      implantable amplifier for electrical brain signals, a set of electrodes positioned on the
      surface of the brain and a wireless receiver, placed outside of the body. A dedicated
      computer will convert the signals to electrical pulses for standard Assistive Technology
      devices. The UNP can in principle enable the patient to engage in any activity that is
      offered by commercial Assistive Technology companies that can be performed with switch
      signals, for instance operating home apparatus or writing text. Most importantly, we aim to
      achieve unsupervised function of the BCI, meaning that the patient will be able to use it at
      home without the aid of researchers or other experts (but with minimal caregiver assistance).
    

Intervention name(s): ECoG (electrocorticography) sensing
Intervention type(s): Device
Intervention description(s): Implant electrodes and sensing device and use for control of Assistive Technology
Other intervention name(s): Activa PC + S
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Brain-Computer Interface; Motor Cortex; Dorsolateral Prefrontal Cortex; Quality of Life
Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Condition: Relapsed or Refractory Hodgkin Lymphoma; Primary Mediastinal Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is that ruxolitinib may be a possible treatment option for relapsed
      or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.
    

Detailed description: 
      Patients will take ruxolitinib 20 mg orally twice a day, 40mg in total per day, for 4 weeks.4
      weeks is 1 cycle. Treatment will be continued until documented disease progression or
      unacceptable toxicity and the maximum period of treatment is 16 cycles.
    

Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Other intervention name(s): jakavi
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ezetrol Post-Marketing Study
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.
    


Intervention name(s): simvastatin; Ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): simvastatin 20 mg/QD for 6 Weeks.; Ezetimibe 10 mg/QD for 8 weeks.
Other intervention name(s): MK0733; Zocor®; Ezetrol; Zetia; MK0653
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
Condition: Hepatobiliary Malignancies
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      This study is a prospective, multicenter study aimed to develop and validate the performance
      of combined assays for cfDNA methylation markers and serum tumor markers in early
      hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA
      markers and tissue will also be evaluated. The study will enroll approximately 496
      participants, including participants with malignant or benign diseases of the hepatobiliary
      system.
    


Intervention name(s): Multi-cancer early detection test
Intervention type(s): Device
Intervention description(s): Blood collection and multi-cancer early detection testing
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible participants will be recruited from medical centers and assigned into two arms,
        including participants with new diagnosis of hepatobiliary malignancies and benign diseases
        of the hepatobiliary system.
      
Keywords: Hepatobiliary malignancies; Liquid biopsy; Cell-free DNA; Early detection
Breast, Omega 3 Free Fatty Acid, Ph 0
Condition: Breastcancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Assess the impact of dietary omega 3 free fatty acids breast cancer patients.
    

Detailed description: 
      Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred
      (200) newly diagnosed breast cancer patients will be recruited to participate in a short term
      (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be
      receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).
    

Intervention name(s): Omega-3 FFA
Intervention type(s): Dietary Supplement
Intervention description(s): Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
Other intervention name(s): Omacor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment