bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
Condition: Impotence; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is
      being assessed to see if it can help preserve erectile function after prostatectomy.
    

Detailed description: 
      This drug has been tested in animals, and was shown to protect nerves from damage and to
      regrow damaged nerves in these animal studies. Participants will receive either GPI 1485 or a
      placebo (inactive pill). Participants will begin study medication 3 full days prior to their
      scheduled surgery.

      GPI 1485 will be supplied as an oral tablet formulation to men who are candidates for
      bilateral nerve-sparing prostatectomies. Participants randomly assigned to receive GPI 1485
      will be required to take four tablets four times a day by mouth.

      GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants
      randomly assigned to placebo will be required to take 4 placebo tablets four times a day by
      mouth.

      Viagra® will be supplied as oral tablets beginning 1 month post-surgery. Patients can begin
      Viagra® 1 month post-surgery and may continue use until the end of the study, as needed.

      The duration of this study is 12 months which includes 5 office visits to your doctor in
      addition to the surgery day. During this study you will also have other clinical evaluations
      including a physical exam, blood work, ECG (tracing of your heart rhythm) and urinalysis.

      Participants enrolled in this study will also carry a handheld diary that is loaded with
      special protocol-specific software, which will be referred to as the patient experience diary
      (PED). Over the duration of this study, participants will complete their questionnaires and
      answer questions about their medication compliance in the electronic PED.
    

Intervention name(s): GPI 1485
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Impotence; Prostate Cancer; Prostatectomy
Special Survey for Long Term Application
Condition: Genetic Disorder; Achondroplasia
MeSH terms: Achondroplasia; Genetic Diseases, Inborn
Study type: Observational

Summary: 
      This study is conducted in Japan. The aim of this study is to assess the incidence rate of
      adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for
      achondroplasia without epiphyseal line closure under normal clinical practice conditions.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Intervention description(s): Prescription of somatropin at the discretion of the physician
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients being treated with somatropin for achondroplasia without epiphyseal line closure
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research is to determine if a subject's own bone marrow tissue can help
      regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair
      Cell (TRC) Therapy.
    

Detailed description: 
      A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where
      it will be processed to form cells. The new cells are transplanted into the tooth socket
      after the tooth has been removed. The researchers are testing to see if these cells (TRC)
      will help form bone. The research will also determine if the implant the subject receives
      will be more stable in the area with new bone growth.
    

Intervention name(s): Tissue Repair Cells (TRC); Control
Intervention type(s): Biological; Device
Intervention description(s): 30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.; Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Other intervention name(s): Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t; Gelfoam
Intervention MeSH terms: Gelatin Sponge, Absorbable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dental; tooth; implant; extraction; Oral; Surgical; Procedures
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, multi-center, double-blind, randomized, placebo-controlled,
      dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and
      immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all
      clinical presentations of MS.
    


Intervention name(s): rHIgM22
Intervention type(s): Drug
Intervention description(s): Administered via IV infusion
Other intervention name(s): M22
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; Multiple Sclerosis
Myfortic Conversion Trial in OLT Recipients With GI Intolerance
Condition: GI Disturbance
Study type: Observational

Summary: 
      Liver transplant patients often require multimodal immunosuppressive therapy to minimize
      their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower
      the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up
      to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of
      patients have intolerance to MMF, thereby mitigating our ability to use this agent. The
      primary objective of this study is to assess the tolerability of myfortic in combination with
      Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after
      conversion from MMF in maintenance liver transplant patients with GI intolerance within 3
      months.
    


Intervention name(s): Mycophenolic Acid (Myfortic)
Intervention type(s): Drug
Intervention description(s): Equimolar conversion from mycophenolate mofetil to mycophenolic acid
Other intervention name(s): Cellcept; Myfortic
Intervention MeSH terms: Mycophenolic Acid
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recipients of Orthotopic Liver Transplants
      
Keywords: Orthotopic Liver Transplant Recipients with GI disturbance
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      This is a prospective trial of single incision versus standard 3-port laparoscopic
      appendectomy.

      The hypothesis is that there may a difference in wound infection rates, operative time, doses
      of analgesics post-operatively, and patient/parent perception of scars.
    

Detailed description: 
      This is a prospective, randomized clinical trial involving patients who present to the
      hospital with non-perforated appendicitis. We will offer enrollment to several institutions
      provided they receive institutional approval.

      There are likely several parameters that will show small differences between groups, and this
      study will precisely quantify them to allow for adequate consultation from surgeons to
      families dealing with acute appendicitis. One theoretical concern over the SILS approach is
      that the exposure of the appendix to the wound could increase the rate of infectious
      complications; therefore, this is the primary outcome variable. The documented rate of
      infectious complications at our institution in patients with non-perforated appendicitis is
      0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new
      technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or
      180 in each arm.

      After the procedure, both groups will be managed in the same manner per routine care. They
      will be discharged when tolerating a regular diet and their pain is well-controlled on oral
      pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.
    

Intervention name(s): Single Incision Laparoscopic Appendectomy; 3 port laparoscopic appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): A single incision through the umbilicus to remove the appendix; Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Other intervention name(s): SILS; Laparoscopic Appendectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Appendicitis; Appendectomy; Children; Laparoscopic; SILS
Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to compare surgical treatment of periodontal infrabony defects with
      and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase
      responses, in systemic healthy patients.
    


Intervention name(s): Periodontal surgery; EMD application
Intervention type(s): Procedure; Procedure
Intervention description(s): After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.; Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface
Other intervention name(s): Open Flap Debridement; Amelogenins application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a pilot randomized controlled trial involving a sleep education intervention in women
      with gestational diabetes to study whether sleep education during pregnancy leads to
      improvement in glycemic control in women with gestational diabetes and improvement in sleep
      duration.
    

Detailed description: 
      Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal
      Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients
      with gestational diabetes will be recruited following general education regarding gestational
      diabetes in pregnancy which is universally done for all patients at the time of their
      diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual
      care vs. sleep education program).
    

Intervention name(s): Sleep Education for Pregnancy
Intervention type(s): Behavioral
Intervention description(s): Sleep education specific to pregnancy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gestational Diabetes Mellitus; Sleep education
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
Condition: Microbial Disease; Cataract Senile
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 1

Summary: 
      Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival
      microbiota as a prophylactic measure in patients scheduled for cataract surgery.
    

Detailed description: 
      Randomized double-blind clinical trial. Study carried out in a single center between January
      and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two
      groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the
      second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a
      conjunctival cul-de-sac culture before and after treatment.
    

Intervention name(s): Besifloxacin Ophthalmic; Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): Prophylaxis for endophthalmitis; Placebo
Other intervention name(s): Besivance ophthalmic suspension 0.6%; Artelac eye drops
Intervention MeSH terms: Besifloxacin; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Besifloxacin; prophylaxis; cataract surgery
Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
Condition: Enteric Fever; Typhoid Fever
MeSH terms: Typhoid Fever; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three
      hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned
      to one of the two treatments by chance and followed for 6 months. The two treatment groups
      will be compared to see which treatment is more likely to make the patient better.
    

Detailed description: 
      With the study hypothesis that Gatifloxacin is superior to Ceftriaxone in terms of treatment
      failure in patients with enteric fever, a comparative study will be conducted at Patan
      Hospital. 300 patients who are diagnosed with enteric fever will be enrolled into the study.
      The patients will be randomized to one of two groups. One group will receive treatment with
      Gatifloxacin for 7 days, and the other with Ceftriaxone. The patients will be followed during
      the treatment courses and at several points of 6 months after initial presentation. The
      endpoints then will be compared between two groups.
    

Intervention name(s): Ceftriaxone; Gatifloxacin
Intervention type(s): Drug; Drug
Intervention description(s): ≥2-<14 years - 60mg/kg/ once daily for 7 days
14 years and older - 2g once daily for 7 days
Intravenous infusion. Vials of crystalline powder.; Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
Intervention MeSH terms: Ceftriaxone; Gatifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gatifloxacin; Ceftriaxone; Enteric fever; Typhoid fever
Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser,
      Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard
      mechanical debridement to ablate the infected tissue around the dental implant and detoxify
      the contaminated implant surface for resolving peri-implant infection and enhance bone
      regeneration of peri-implant defects.
    

Detailed description: 
      The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits
      to the conventional standard mechanical debridement to ablate the infected tissue around the
      dental implant and detoxify the contaminated implant surface for resolving peri-implant
      infection and enhance bone regeneration of peri-implant defects.

      This study involves one center and a double-blinded randomized controlled clinical trial is
      planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis
      will be included. Six visits are needed for each patient including a 24 week follow-up visit.

      Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect
      debridement and surface detoxification with conventional mechanical debridement for
      regenerative therapy

      Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can
      decrease bacterial load and alter microbial profile

      Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can
      impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of
      the treatment
    

Intervention name(s): Standard mechanical debridement; Er:YAG laser-assisted debridement
Intervention type(s): Other; Device
Intervention description(s): Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy; Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser
Study on Mastocytosis for Rupatadine Treatment
Condition: Mastocytosis
MeSH terms: Mastocytosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study title:

      An exploratory, randomised, double-blind, placebo controlled crossover study to assess the
      efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.

      Study code:

      SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40
      Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,
      Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,
      D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical
      Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring
      Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin,
      Charitéplatz 1, D-10117 Berlin Clinical phase Phase II

      Primary objective:

      Reduction of wheal and flare type skin reaction after standardised provocation testing
      assessed by volumetric and thermographic measurements.

      Secondary objectives:

      Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as
      assessed by symptom score, DLQI, Itchy-QoL and VAS.

      Study design:

      An exploratory, randomised, double-blind, placebo controlled crossover study

      Type and number of patients:

      Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic
      mastocytosis with skin involvement

      Main criteria for inclusion:

      Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or
      other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of
      administration 20 mg Rupatadine or placebo before provocation testing, oral administration
      (tablets)

      Duration of treatment:

      28 days (testing will be done at the day of last treatment)

      Assessment of efficacy:

        1. Assessment of wheal and flare development by planimetric analyses of digital
           photographic, volumetric, and thermographic imaging (time lapse) before and after
           treatment with study medication,

        2. Additional assessment of symptoms,

        3. Assessment of life quality

      Main criteria of evaluation:

      Efficacy
    


Intervention name(s): Rupatadin
Intervention type(s): Drug
Intervention description(s): 20 mg, 28 days over 60 days
Other intervention name(s): Each tablet contains 10 mg RUP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Assessment of wheal and flare development; Assessment of life quality
STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention
Condition: Hepatitis C; HepatoCellular Carcinoma
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies
      to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons
      born between 1945-1965): inreach with electronic medical record alerts and provider education
      vs. combination of inreach and provider education plus mailed outreach and patient
      navigation.

      Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up
      testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before
      1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up
      viral load testing or b) HCV viral load positive and who have not completed in-clinic
      treatment evaluation.
    


Intervention name(s): Mailed outreach
Intervention type(s): Behavioral
Intervention description(s): The investigators will randomize all baby boomer patients (~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Screening
Effect of Ginger Supplement on Non-alcoholic Fatty Liver
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis of this study was that ginger supplement consumption can be introduced as a
      new therapeutic strategy for non-alcoholic fatty liver disease through the improved body
      antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized
      double-blind study was designed to evaluate this hypothesis in order to examine the
      effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.
    


Intervention name(s): Ginger supplement; Placebo (starch)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment