bioihbjkbjnl/mcl2 huggingface dataset:
OTO-104 for Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral
      Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease
      will also be evaluated.
    

Detailed description: 
      Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as
      vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an
      imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help
      manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting
      corticosteroid which could provide significant benefit to patients with Meniere's disease.
    

Intervention name(s): OTO-104 (steroid) 3 mg; Placebo; OTO-104 (steroid) 12 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OTO-104 3 mg dose cohort, single intratympanic injection.; Placebo arm will be conducted in parallel with each OTO-104 dose cohort.; Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's Disease; Vertigo; Definitive vertigo; Vertigo episodes; Vertigo frequency; Tinnitus; Hearing loss; Aural Fullness
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of photoirritation and photosensitization potential of the product
      Dermacyd PHDESILSTYFL.

      Secondary Objective:

      None.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 5 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections
Condition: Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Intraabdominal Infections
Study type: Interventional

Summary: 
      The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually
      avoided in infected or critical colonized wounds. To our observation, the additional
      continuous irrigation tube attached beside the suction tube in the NPWT system could provide
      the effective drainage by reducing the occlusion of suction tube, enable effective
      debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by
      providing relatively moist ambient. At our institutions, the modified system combined with a
      "triple-tube" device to allow a continuous instillation became more active and efficient. The
      study is to investigate if a continuous triple-tube instillation and suction could improve
      the outcomes of acute severely infected open abdomen.
    

Detailed description: 
      This study was performed on the patients with a severely complicated infected open abdomen
      treated with topical triple-tube irrigation and suction, compared with a control group of the
      patients treated with standard NPWT without topical irrigation. The clinical outcomes were
      recorded. Profiles of cytokines/proteinase in wound fluid were quantified weekly.
    

Intervention name(s): Continuous topical triple-tube irrigation and suction; SOC
Intervention type(s): Device; Device
Intervention description(s): The triple-tube device was continuous operated: instilled the topical solution through the "washing tube", delivered negative pressure therapy at 100 - 125 mmHg continuously through the inner tube of "sleeve tubes" through the central negative pressure device in the wall of the ward. The outer tube was used for normalize and balance the distribution of the negative pressure around the inner tube to allow the solution to penetrate through the dressing to cover the wound, and protecting the inner tube from getting stuck with the sucked tissue. All tubes are all commercially available (Medical Silicone Tubing, Forbest Manufacturing Co., Ltd, China).; Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.
Other intervention name(s): standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Negative pressure wound therapy; Acute wound infection; complicated abdominal infection; Cytokines; Matrix metalloproteinase
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neuromuscular Diseases
Study type: Observational

Summary: 
      The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and
      study its reliability and ability to differentiate ALS patients from healthy controls.
    

Detailed description: 
      Investigators will study 10 ALS patients and at least 10 age-matched healthy controls between
      the ages of 21 and 85 years old. For all subjects, EIM measurements will be performed on four
      muscles: two in the upper and two in the lower extremities, using 8 different EIM sensors.
      Measurements will be repeated one time.
    

Intervention name(s): EIM Measurements
Intervention type(s): Device
Intervention description(s): EIM measurements are taken by applying saline to the skin and placing a sensor on patients' muscles that will record electrical activity. Electrical current is generated by this machine, but patients will not be able to feel it. The electrical activity recorded is returned to the machine and analyzed by a computer.
Other intervention name(s): Electrical Impedance Myography Measurements
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ALS Patients
      
Keywords: ALS; EIM
Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
Condition: Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional

Summary: 
      The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock
      with posterolateral internal sphincterotomy at 5 o'clock in regards healing time,
      postoperative recurrence and complications, particularly fecal incontinence.
    

Detailed description: 
      The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock
      with posterolateral internal sphincterotomy at 5 o'clock in regards healing time,
      postoperative recurrence and complications, particularly fecal incontinence. We hypothesized
      that performing internal sphincterotomy in a point midway between the standard lateral
      position and the posterior midline position would confer better healing and relief of
      symptoms with less incidence of fecal incontinence while avoiding the development of keyhole
      deformity.
    

Intervention name(s): posterolateral sphincterotomy; lateral sphincterotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm; Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Total Hip Prosthesis Assisted by Computer
Condition: Clinic Hip Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery:
      Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of
      hip navigation in lateral decubitus while maintaining the accuracy of the technique
    

Detailed description: 
      Hip navigation based on preoperative EOS(TM) imaging could help to improve the accuracy of
      cup positioning like other computer assisted hip surgery, but it would also simplify the
      procedure in lateral decubitus. Indeed, the registration of the controlateral antero superior
      iliac spine and the pubis is not necessary with this technique. The target population of the
      study is the one affected with primitive hip osteoarthritis for which an indication of
      prosthesis of total hip has been chosen Expected Result: Simplification of the procedure of
      navigation of the cup. Decrease in the number of cups positioned out of the "security zone"
      compared to the standard manual technique of cup positioning. A result of 50% of good
      positioning is expected with the manual technique versus 80% with the technique of navigation
      based on EOS(TM).

      MAIN OBJECTIVE: Compare the surgical treatment of total hip prosthesis without assistance by
      computer and total hip prosthesis with navigation based on imaging EOSTM pre-operative
      Comparative clinical trial of superiority, randomized in single blind, in 2 parallel groups:
      -Group 1: Installation of hip prosthesis without assistance by computer -Group 2:
      Installation of hip prosthesis with assistance by computer based on imaging EOS(TM)
    

Intervention name(s): Prosthetic hip surgery, operated under manual control; Prosthetic hip surgery operated under navigation based on EOS imaging
Intervention type(s): Procedure; Procedure
Intervention description(s): : Hip replacement is performed in supine side position. Cup is positioned under manual control with the aid of a manual ancillary.; The patient will be installed in supine side position. The cup will be navigated with the technique based on EOS imaging. This technique requires the registration of the homolateral antero superior iliac spine and the homolateral postero superior iliac spine only. It does not require the registration of the pubis or any other controlateral points which are poorly accessible in the supine side position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hip arthroplasty; navigation
Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Condition: Healthy
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess safety, tolerability of the different vaccine
      schedules (different regimen durations and different number of dose administrations) with
      Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody
      (Ab) responses of the different vaccine schedules.
    

Detailed description: 
      This is a phase 1 single-center, randomized (the study drug is assigned by chance), parallel
      group (each group of participants will be treated at the same time), placebo-controlled
      (study in which the experimental treatment or procedure is compared to a pretend treatment
      with no drug in it to test if the drug has a real effect), and double-blind (neither
      physician nor participant knows the treatment that the participant receives) study.
      Participants will be randomized in to 3 groups and will receive study vaccines or placebo.
      Group 1 will have 4 vaccination time points during 48 weeks, Groups 2 and 3 will have 3
      vaccination time points during 24 weeks. The study comprises a Screening Period (up to 4
      weeks), a Vaccination Period (maximum 48 weeks), and a Follow-up Period (up to 72 weeks).
      Participants' safety will be monitored throughout the study. An optional Long-term Extension
      (LTE) phase (approximately 1 year after Week 72) will be performed for participants
      randomized to receive study vaccine, who have received all planned vaccinations and are
      negative for HIV infection at Week 72. The duration of the participation will be
      approximately 124 weeks for participants participating to the optional LTE phase.
    

Intervention name(s): Ad26.Mos.HIV; Clade C gp140; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.; The Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.; Normal saline, 0.5 mL injection administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Human Immunodeficiency Virus; adenovirus serotype 26; Ad26.Mos.HIV; Vaccine; Placebo; Glycoprotein; IPCAVD010
Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce
      the risk of metabolic syndrome in patients with serious mental illness who receive treatment
      with antipsychotic medications.

      The hypothesis of the study is that: the application of a physical health promotion program
      in people with serious mental illness, who receive treatment with antipsychotic medications,
      carried out by a mental health nurse, will decrease the presence of metabolic syndrome and
      contribute to improve their quality of life.
    


Intervention name(s): Physical health promotion program
Intervention type(s): Behavioral
Intervention description(s): The program has 24 sessions. Each session has two parts:
first part: half an hour of theoretical content, about the Metabolic syndrome, the effect of unhealthy lifestyle, toxic habits such as smoking or drinking alcohol, dietary habits or physical activity.
Second part: 1 hour of physical activity (walk)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: metabolic syndrome; lifestyle intervention; health promotion; mental health nurse; serious mental illness
Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients
Condition: Chronic Obstructive Pulmonary Disease; Alpha-1-antitrypsin-deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and
      Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation
      in regard to improvement of 6-minute-walking distance. The aim of this study is to
      investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency
      patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with
      strength and endurance training. In addition to conventional diagnostic procedures, muscle
      biopsies from the M. vastus lateralis will be conducted before and after rehabilitation
      program followed by biochemical, histochemical and immunohistochemical analysis of the
      probes.
    


Intervention name(s): exercise training
Intervention type(s): Procedure
Intervention description(s): strength and endurance training, 5 time per week.
Other intervention name(s): endurance training; strength training
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: alpha-1-antitrypsin-deficiency; COPD; exercise training; muscle biopsy
A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      The purpose of this investigator-initiated study is to compare new bone formation through
      histomorphometric analysis following maxillary sinus augmentation using two different bone
      graft materials. A total of twenty, sinus augmentation via a lateral approach will be
      performed for subjects requiring sinus augmentation for implant placement and randomly
      divided into 2 groups. These subjects will receive one of two different bone graft materials:
      1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss
      (Group B). At the time of implant placement (eight months after the sinus augmentation
      procedure), two bone biopsies will be collected from augmented site for the histomorphometric
      analysis. The percentage of vital bone will be measured and analyzed statistically, also the
      following will be measured: percentage of non-vital bone, percentage of non-bone material
      (xenograft), and the percentage of connective tissue.
    


Intervention name(s): InterOss; Bio-oss
Intervention type(s): Device; Device
Intervention description(s): Anorganic bovine bone mineral - Xenograft; Anorganic bovine bone mineral ( Xenograft)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Phase I Clinical Trial of Meplazumab in Healthy Volunteer
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy
      volunteer of meplazumab for injection. The primary objective of this phase I trial is to
      evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy
      characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and
      provide a reference for the dosage of meplazumab in phase II clinical trial.
    


Intervention name(s): meplazumab for injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose: 6 dose level, multiple dose: 0.3mg/kg/dose; placebo
Intervention MeSH terms: Meplazumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
Condition: Malaria, Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed to assess the effect of food on the extent and rate of absorption of
      Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose
      combination (Eurartesim™).
    


Intervention name(s): Eurartesim
Intervention type(s): Drug
Intervention description(s): Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Tomotherapy in Patients With Benign Brain Tumour
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Although malignant brain tumors are the most common type of primary brain tumor, there are a
      number of other benign brain tumors that exist. Many difficulties exist with treating these
      tumors that have led to controversies in the best treatment. A common issue among these brain
      tumors is the risk of long term side effects from treatment. What limits the use of curative
      radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the
      amount of radiation to the normal structures in the brain. A new method of delivering
      radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will
      be used in this study. It has the ability to deliver a high dose of radiation to the tumor
      while minimizing the amount of radiation to normal brain structures. This study will use this
      method of radiation therapy to deliver radiation and see if the long term side effects from
      radiation therapy can be reduced.
    


Intervention name(s): Tomotherapy
Intervention type(s): Procedure
Intervention description(s): 3T MRS scans (3T magnetic resonance spectroscopy)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiotherapy; brain
Bioequivalence Study of Cephalexin Tablets 1g
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of cephalexin tablets are
      bioequivalent.

      Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1
      g Cephalexin; Eli Lilly). The single dosage was one tablet.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 26 healthy volunteers, both genders, adults between 18-40
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Cephalexin 1g tablets; Cephalexin 1g tablets
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Keflex; KEFLEX® is a trademark of ELI LILLY; Ceporex; CEPOREX® is a trademark of GLAXOSMITHKLINE
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Bioequivalence; Mexico; Cephalexin