bioihbjkbjnl/mcl2 huggingface dataset:
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Condition: Human Papilloma Virus; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts
MeSH terms: Condylomata Acuminata; Papilloma; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV)
      L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS)
      and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s)
      of IMX for further studies of the octavalent HPV L1 VLP vaccine.
    

Detailed description: 
      The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants
      were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg
      IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B,
      participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV
      with 120 mcg IMX/AAHS.
    

Intervention name(s): Octavalent HPV with 15 mcg IMX / AAHS; Octavalent HPV with 30 mcg IMX / AAHS; Octavalent HPV with 60 mcg IMX / AAHS; Octavalent HPV with 120 mcg IMX / AAHS; Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other intervention name(s): V502; V502; V502; V502; V502-002
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
the Value of Transanal Endoscopic ISR
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The Intersphincteric resection (ISR) technique is an alternative for anal preservation in
      ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might
      compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field
      exposure. Thus, we decided to perform ISR through a transanal endoscopic approach (taE-ISR),
      seeking to evaluate the value of this innovative technique in extreme anal preservation in
      ultra-low rectal cancer.
    


Intervention name(s): transanal endoscopic ISR
Intervention type(s): Procedure
Intervention description(s): perform ISR using laparoscopy through transanal port
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patient with low and ultra-low rectal cancer
The Effects of Gum Chewing on Energy Intake and Expenditure
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if chewing gum increases energy expenditure and
      decreases food intake.
    


Intervention name(s): Chewing gum; Water
Intervention type(s): Other; Other
Intervention description(s): Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.; Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection
Condition: Rescue Therapy for Helicobacter Pylori
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not
      satisfactory. The study aims to compare the efficacy and safety between quadruple therapy
      with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.
    


Intervention name(s): RBLF; RA
Intervention type(s): Drug; Drug
Intervention description(s): The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).; The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori, rescue, quadruple therapy，dual therapy
AGE - Functional Reserve
Condition: Kidney Function Tests
Study type: Interventional

Summary: 
      Renal functional reserve is defined as the glomerular hyper filtration induced by a protein
      load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein
      load. Renal functional reserve loss is associated with a persistent hyper filtration state,
      seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney
      Disease (CKD). This observation has lead to larger clinical studies that demonstrated the
      positive effects of protein restriction on kidney function, and allowed the scientific
      community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD
      progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and
      metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that
      renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation
      End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the
      demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat),
      were in fact responsible for an AGEs load, based on recent published data.

      The aim of this study is to determine whether AGEs alone or proteins in general are
      responsible for the mobilization of renal functional reserve, leading to the progression of
      CKD.
    


Intervention name(s): low AGE meal; High AGE meal
Intervention type(s): Other; Other
Intervention description(s): Patients will receive a low AGE (eggs) meal; Patients will receive a high (mixed nuggets) AGE (eggs) meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention Post-Cesarean Section Infection
Condition: Post Cesarean Infectious Morbidity
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Maternal infectious morbidity is a common complication of cesarean delivery, especially in a
      poor recourse setting like ours. This study was done to compare the effectiveness of
      preoperative vaginal cleansing with immediate postoperative vaginal cleansing with
      chlorhexidine solution in preventing post-cesarean infectious morbidities. Randomized trial
      involving 120 consented women who had elective or emergency cesarean sections at term, 60 in
      each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with
      1% chlorhexidine.
    

Detailed description: 
      Background: Maternal infectious morbidity is a common complication of cesarean delivery,
      especially in a poor recourse setting like ours. This study was done in a tertiary hospital
      in Abakaliki, Ebonyi State, Southeast Nigeria over a period of 5 months. The State is
      inhabited mainly by rural farmers and petty traders. Literacy is low and poverty is common
      with poor maternal health indices.

      Aim: To compare the effectiveness of preoperative vaginal cleansing with immediate
      postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean
      infectious morbidities.

      Method: Randomized trial involving 120 consented women who had elective or emergency cesarean
      sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative
      vaginal cleansing with 1% chlorhexidine. Research Randomizer software was used to generate
      120 numbers. Sixty numbers were randomly generated from a pool of 120 numbers and were
      assigned to group 1 while the remaining 60 numbers were automatically assigned to group 2.
      Both groups received antibiotics and anterior abdominal wall scrubbing. There were monitored
      for symptoms and signs of endometritis, wound infection and pyrexia till discharge.
    

Intervention name(s): Chlorhexidine
Intervention type(s): Procedure
Intervention description(s): Pre-operative and post-operative vaginal cleansing.
Other intervention name(s): Antibiotic prophylaxis
Intervention MeSH terms: Anti-Bacterial Agents; Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Condition: Stage IIIC Ovarian Cancer
MeSH terms: Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will
      be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs.
      neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point
      is the evaluation and comparison of the surgical complications of primary surgery and IDS and
      the evaluation of the progression free survival (PFS)
    


Intervention name(s): Neoadjuvant chemotherapy + Interval Debulking Surgery; Primary Debulking Surgery + Adjuvant Chemotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo only to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. After neoadjuvant chemotherapy interval debulking surgery will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.; Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. Then, an attempt of laparotomic cytoreduction will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned (1:1 ratio) to undergo either PDS followed by systemic adjuvant chemotherapy, or NACT followed by IDS. Random assignment will be centralised at the Institutional clinical trial center using a block-randomisation computer-generated list (maximum allowable percentage deviation = 10%). Allocation will be concealed to patients and investigators. Patients and investigators will not be masked to group assignment.
Masking: None (Open Label)
Primary purpose: Treatment
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
Condition: Chronic Hepatitis C; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no
      treatment for the prevention of disease progression in adult subjects with compensated
      cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a
      interferon plus ribavirin.
    


Intervention name(s): peginterferon alfa-2b (SCH 54031)
Intervention type(s): Biological
Intervention description(s): 0.5 µg/kg subcutaneously once weekly for 60 months
Other intervention name(s): PegIntron
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cirrhosis
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety
      profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
    


Intervention name(s): Inotuzumab ozogamicin [CMC-544]
Intervention type(s): Drug
Intervention description(s): CMC-544, IV, dose escalation trial
Intervention MeSH terms: Inotuzumab Ozogamicin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-Cell; Non-Hodgkin's; Lymphoma
Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure
Condition: Pain
Study type: Observational

Summary: 
      Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing
      temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to
      compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in
      patients with uncomplicated chronic anal fissure.
    

Detailed description: 
      consecutive patients with uncomplicated chronic anal fissure who had failed conservative
      treatment were randomized to receive either intra-sphincteric injection of botulinum toxin
      (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure,
      continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.
    

Intervention name(s): conservative lateral internal sphincterotomy; Intra-sphincteric Botulinum-toxin injection
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Botulinum Toxins
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This trial included consecutive adult patients presenting with symptomatic chronic anal
        fissure in which conservative treatment had failed.
      
Keywords: Pain after treatment; healing of fissure after treatment; continence scores after treatment
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of stable coadministered oxcarbazepine
      (OXC), on the pharmacokinetics (PK), safety, tolerability of padsevonil (PSL) and the plasma
      PK of PSL metabolites, UCB1431322-000 and UCB1447499-000, in study participants with epilepsy
      compared with study participants co-medicated with stable doses of levetiracetam (LEV),
      lamotrigine (LTG) or brivaracetam (BRV) therapy.
    


Intervention name(s): Padsevonil; Oxcarbazepine; Levetiracetam; Lamotrigine; Brivaracetam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Padsevonil (PSL) will be dosed to steady state and the effect of background therapies on pharmacokinetics will be assessed; Concomitant administration of oxcarbazepine (OXC) at therapeutic dosage; Concomitant administration of levetiracetam (LEV) at therapeutic dosage; Concomitant administration of lamotrigine (LTG) at therapeutic dosage; Concomitant administration of brivaracetam (BRV) at therapeutic dosage
Other intervention name(s): PSL; UCB0942; OXC; LEV; LTG; BRV
Intervention MeSH terms: Lamotrigine; Oxcarbazepine; Levetiracetam; Brivaracetam; Padsevonil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epilepsy; Phase 1; padsevonil
Comparative Bioavailability Study of Codeine Sulfate
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to assess the comparative bioavailability of codeine from
      Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with
      codeine phosphate 30mg) under fasted conditions
    


Intervention name(s): Codeine Sulfate
Intervention type(s): Drug
Intervention description(s): 30 mg Tablet
Other intervention name(s): Tylenol #3 Tablets
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg
      Lefradafiban tid
    


Intervention name(s): Lefradafiban; Clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Chinese Prescription on Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription
      on Ulcerative Colitis.
    


Intervention name(s): bascial prescription plus or minus herbs depend on symptoms
Intervention type(s): Drug
Intervention description(s): Decoction ,two times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alternative medicine; traditional Chinese medicine
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment
Condition: Amputation; Traumatic, Hand
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      State-of-the-art myoelectric prostheses provide upper limb amputees with a remarkable variety
      of grip patterns but lack proper feedback from touch sensation. This restriction limits the
      controllability of multi-articulated robotic hands, resulting in the rejection of the device
      in many cases.

      Amputees have often reminiscing sensations in the stump, i.e. by touching certain regions, it
      feels as if no longer existing fingers were touched. These regions form a phantom map and
      show promising results for touch feedback. However, not every amputee has one and the socket
      of a prosthesis offers limited space for additional devices. Thus, the investigators
      developed a feedback display which is worn in the shoe instead of the prosthesis itself. The
      investigators want to assess the viability of vibrotactile feedback stimulus on the foot as a
      substitution for pressure on the fingers of an artificial hand in a clinical study. The
      efforts are based on the hypothesis that a hand prosthesis with tactile feedback has better
      performance in manipulating fragile and heavy objects, compared with a standard commercial
      hand prosthesis without tactile feedback.
    


Intervention name(s): FeetBack System Active; FeetBack System Passive
Intervention type(s): Device; Device
Intervention description(s): Commercially available hand prosthesis with feedback device turned on; Commercially available hand prosthesis with feedback device turned off
Intervention model: Single Group Assignment
Intervention model description: The two interventions are commercially available myoelectric hand prostheses either with or without an additional feedback device.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: myoelectric prostheses; closed-loop control; vibrotactile feedback; feedback display
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Condition: PBC; Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a
      13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect
      of daily dosing with UDCA in combination with LUM001 or placebo.
    


Intervention name(s): LUM001; Placebo; Ursodeoxycholic Acid
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): UDCA
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PBC
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how SHP626 is absorbed and excreted from the body
      in healthy males.
    


Intervention name(s): SHP626; 5.95 μCi RAD
Intervention type(s): Drug; Radiation
Intervention description(s): single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
Intervention MeSH terms: Volixibat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADME