bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
Condition: Fibrillary Glomerulonephritis
MeSH terms: Glomerulonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study is being done to see if the study medication, Rituximab, preserves kidney
      function after 12 months of taking the drug.
    

Detailed description: 
      This is a Phase II, open-label pilot study to determine if the use of Rituximab reduces
      proteinuria over a 12 month period and is there preservation of kidney function with the use
      of this study drug. Each patient will be treated with 2 intravenous infusions of rituximab
      1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with
      identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first
      infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each
      participant will receive 4 infusions of rituximab.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): 1000 mg infusion
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibrillary glomerulonephritis; rituximab; Rituxan; MabThera; Zytux™
Lifestyle Change to Prevent Diabetes Via African-American Churches
Condition: Diabetes; Weight Loss
MeSH terms: Diabetes Mellitus; Weight Loss
Study type: Interventional

Summary: 
      Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of
      the GLB program compared with a health education intervention.
    


Intervention name(s): Fit Body and Soul; Wellness Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Inferior Vena cavaCollapsibility Index in Patients With Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      This is an observational study that will examine the possibility of determining the type of
      Acute Kidney Injury (AKI) using bedside ultrasound machines.
    

Detailed description: 
      The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal)
      are associated with different inferior vena cava diameters and collapsibility index. The
      investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or
      higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline
      creatinine). Standard of care treatment will not be different for patients taking part in
      this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and
      follow-up data will be collected from medical records.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects ages 18-89 years with AKI (creatinine of 1.7mg/100ml or higher for less than 24
        hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care
        treatment will not be different for patients taking part in this study. Participants will
        have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be
        collected from medical records.
      
Keywords: Inferior vena cava; Kidney injury; Ultrasound
WildCam: A Privacy Conscious Wearable Eating Detection Camera People Will Actually Wear in the Wild
Condition: Wearable Electronic Devices
Study type: Interventional

Summary: 
      WildCam is a wearable device that collects video data of the user's face and upper torso to
      capture eating behaviors. WildCam and its accompanying software is privacy conscious, meaning
      it utilizes a computer vision algorithm that extracts proximal features (the user's body and
      objects-in-hand) from the video and digitally obfuscates the distal features (background
      environment and entities therein) to preserve the privacy of the wearer, as well as any
      bystanders who may be in the device's visual field. The present study tests the impact of 3
      different obfuscation techniques on acceptability, including the willingness of users to wear
      the device. Participants are randomly assigned to 1 of the 3 obfuscation techniques
      (blurring, masking, or cartooning). Participants wear the WildCam during waking hours during
      a 7-day period with the randomly selected obfuscation setting enabled and a 7-day period with
      the raw images (no obfuscation) setting. The order of these periods is counterbalanced, and
      the two periods are separated by a 7-day washout period during which WildCam is not worn.
      Structured feedback, including user burden and acceptability surveys, is collected to
      determine the efficacy of each obfuscation technique on increasing user acceptability,
      including willingness to use the WildCam device, as opposed to a video-collecting device
      without obfuscation.
    


Intervention name(s): Blur Obfuscation; Edge Obfuscation; Cartoon Obfuscation; Raw images
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Blurring is applied to objects and people in the background of images.; Objects and people in the background of images are replaced with an outline of the object.; Blurring is applied to objects and people in the background of images and the wearer's face is concealed with cartoon faces.; No editing is performed on images.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Of the 3 obfuscation settings (blur, mask, cartoon), participants are randomly assigned to 1, which they test for the first or second 7-day test period. During the remaining test period, participants use WildCam with the raw images setting. There is a washout period between each test period. The order of the test sequence is counterbalanced across participants to reduce carryover effects.
Masking: None (Open Label)
Primary purpose: Basic Science
Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of anticoagulation in immune response with
      Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).
    


Intervention name(s): Continuous renal replacement therapy with regional citrate anticoagulation; Continuous renal replacement therapy with no anticoagulation or heparin
Intervention type(s): Procedure; Procedure
Intervention description(s): CRRT with anticoagulant : regional citrate anticoagulation
Filter : AQUAMAX™ (Edwards Lifesciences); CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
Other intervention name(s): Continuous veno-venous hemofiltration; Continuous veno-venous hemofiltration
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Stage I：Neoadjuvant therapy

        -  Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to
           surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and
           Oteracil Potassium Capsules plus oxaliplatin

      Stage II: Perioperative therapy

        -  Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is
           superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
           alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and
           Oteracil Potassium Capsules plus oxaliplatin

        -  A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and
           Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable
           locally advanced or metastatic gastric cancer. The investigators assessed whether the
           addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves
           R0 resection rate and survival among patients with curable locally advanced gastric
           cancer.
    


Intervention name(s): Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin; Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin; Oxaliplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation; Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation; Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
Other intervention name(s): S-1; Oxaliplatin; S-1; Oxaliplatin; Oxaliplatin; Capecitabine
Intervention MeSH terms: Capecitabine; Tegafur; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tegafur，Gimeracil and Oteracil Potassium Capsules; Capecitabine; Oxaliplatin; perioperative Chemotherapy; Gastric Cancer
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, double-blind, placebo-controlled, phase I study with healthy
      male volunteers receiving ascending single dose of GX-P1
    


Intervention name(s): GX-P1 or Placebo (dose level 1); GX-P1 or Placebo (dose level 2); GX-P1 or Placebo (dose level 3)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GX-P1 dose level 1 or placebo; GX-P1 dose level 2 or placebo; GX-P1 dose level 3 or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ovarian Follicle Function in Patients With Primary Ovarian Failure
Condition: Amenorrhea; Hypoaldosteronism; Hypogonadism; Infertility; Premature Ovarian Failure
MeSH terms: Infertility; Primary Ovarian Insufficiency; Menopause, Premature; Hypogonadism; Hypoaldosteronism; Amenorrhea
Study type: Observational

Summary: 
      No proven therapy to restore ovarian function and fertility is available to patients with
      karyotypically normal spontaneous premature ovarian failure. We know that one-half of these
      patients have primordial follicles remaining in the ovary, and these follicles can function
      intermittently. This is a diagnostic omnibus protocol that permits baseline clinical
      evaluation of patients with prematurem ovarian failure. The findings will determine patients'
      suitability for specifically focused therapeutic research protocols.
    

Detailed description: 
      No proven therapy to restore ovarian function and fertility is available to patients with
      karyotypically normal spontaneous primary ovarian insufficiency. We know that more than
      one-half of these patients have primordial follicles remaining in the ovary, and these
      follicles can function intermittently. This protocol permitted baseline clinical evaluation
      of patients with primary ovarian insufficiency and ongoing observation of the natural history
      of the disorder. The protocol is now in the follow up and analysis phase and is not now
      recruiting new patients. Now a major aim of the protocol is to investigate large scale
      medical sequencing as a method by which to uncover mechanisms of primary ovarian
      insufficiency and to assist in the management of women with this condition. This will involve
      a community-based participatory research approach.
    

Keywords: Menopause; Estrogen; Infertility; Ovulation; Amenorrhea; Hypergonadotropic Hypogonadism; Young Women; Gonadal Steroid Deficiency; Mineralocorticoid Deficiency; Premature Ovarian Failure; POF
Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
Condition: Outcome During r-hFSH Stimulation; Outcome During r-hFSH and r-hLH Stimulation
Study type: Interventional

Summary: 
      The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late
      follicular phase of young women undergoing controlled ovarian stimulation for oocyte
      donation.
    

Detailed description: 
      While the role of FSH is considered the fundamental driver of folliculogenesis, the role of
      LH in this process is more controversial. FSH is associated with stimulating growth and
      recruitment of follicles while LH is associated with the selection of dominant follicles
      destined for ovulation. We will use an open, prospective, cross-over study to compare the
      safety and efficacy of two different treatment protocols for controlled ovarian stimulation
      in egg donors.

      20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH
      though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month
      rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient
      response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in
      diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
    

Intervention name(s): r-hFSH; r-hFSH and r-hLH
Intervention type(s): Drug; Drug
Intervention description(s): r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response; Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
Other intervention name(s): Gonal F; r-hFSH; Gonal F; r-hLH; Luveris
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: r-hFSH; r-hLH
A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Most previous clinical trials that addressed exercise for sarcopenic elderly subjects focused
      on community-dwelling older adults who were relatively healthy. There is a notable paucity of
      high-quality research investigating the effects and feasibility of exercise for hospitalized
      or institutionalized older people, who are generally frailer and more severe in functional
      impairment than those living in the community. Moreover, most reported exercise programs were
      of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It
      remains unclear whether short-term exercise would be effective for treating sarcopenia.
      Therefore, the investigators aimed to assess the effectiveness of short-term exercise for
      treating sarcopenia in hospitalized older patients aged 80 years and over.
    


Intervention name(s): balance training; resistance training; aerobic exercise; usual care
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.; Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.; Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.; received usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
Condition: HIV Infections; Lipodystrophy
MeSH terms: Lipodystrophy; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine if Serostim® 4 mg administered daily for
      12 weeks as treatment for the abnormal fat accumulation and distribution associated with
      HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT,
      measured by CT scan) more effectively than placebo.
    


Intervention name(s): Placebo; Serostim® 4 mg; Serostim® 2 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo matched to serostim® as subcutaneous injection.; Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.; Serostim® 2 mg as subcutaneous injection on alternate days.
Other intervention name(s): recombinant human growth hormone (r-hGH); recombinant human growth hormone (r-hGH)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Growth hormone; Serostim®; Human Adipose Redistribution Syndrome; Human Immunodeficiency Virus lipodystrophy
Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group
      study to determine the antihypertensive dose range, efficacy, safety and tolerability of
      TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in
      hypertensive pediatric subjects. The study population included school age children (age 6 to
      < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than
      50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since
      response to some therapies in adult hypertension appears to be different in black and
      non-black populations, recruitment was aimed at a mixture of black and non-black children.
      The design included a 1-week screening period (for treatment naive subjects), a 1-week
      single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible
      subjects were randomized to the double-blind period with a once daily oral dose of metoprolol
      CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight
      adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely
      monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment
      period.
    


Intervention name(s): metoprolol succinate
Intervention type(s): Drug
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pediatric hypertension
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM
      Depot formulation at doses of 400mg in patients with schizophrenia.
    

Detailed description: 
      To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg
      administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive
      weeks
    

Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
Other intervention name(s): ABILIFY MAINTENA
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)
Condition: Hepatitis E
MeSH terms: Hepatitis A; Escherichia coli Infections; Hepatitis E; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia
      Coli) Hecolin®.
    

Detailed description: 
      This study is a mono-center, randomization, double-blind clinical trial in healthy subjects
      between 18 to 50. Under the premise of full informed consent, 360 subjects that meet the
      requirement of clinical trial in the age of 18-50 will be divided into 3 groups and injected
      3 consecutive batches of Hecolin® separately. The main outcome measures are the
      immunogenicity evaluation and safety surveillance after inoculation according to prescribed
      immunization procedure.
    

Intervention name(s): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Intervention type(s): Biological
Intervention description(s): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to verify the superiority in efficacy (American College of
      Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus
      placebo without coadministration of MTX in active RA patients in whom MTX cannot be
      administrated.
    


Intervention name(s): CDP870; Placebo of CDP870
Intervention type(s): Drug; Drug
Intervention description(s): 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC); Placebo given every 2 weeks until Week22 (SC)
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia