bioihbjkbjnl/mcl2 huggingface dataset:
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open label, Phase III, randomized, controlled, parallel arm multicentre
      non-inferiority clinical trial to compare the efficacy and safety of two combination regimens
      of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult
      and children VL patients in Eastern Africa.
    

Detailed description: 
      The 2 treatment regimens to be tested are:

        -  Arm 1: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric
           dosing for 14 days

        -  Arm 2: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric
           dosing for 28 days (recruitment in this arm was discontinued under protocol v4.0 dated
           22 Jul 2019)

      The reference arm is the current standard treatment for VL:

      • Arm 3: Sodium Stibogluconate 20 mg/kg/day IM/IV combined with Paromomycin 15 mg/kg/day IM
      for 17 days

      The target population will be VL patients from 4 to 50 years old in order to cover both
      paediatric and adult population.

      Patients will be hospitalized for 14 days of PM and MF treatment for both arm 1 and arm 2. MF
      treatment will start at the same time as PM treatment and for arm 2 it will continue on an
      out-patient basis until completion of the 28 days treatment.

      SSG&PM combination therapy will be administered for 17 days according to routine VL treatment
      guidelines and patients will remain hospitalized for the entire duration of the treatment.

      All patients will be asked to return to the hospital for a full assessment on day 28, and for
      followup visits on day 56 and at six months.

      To respond to the objectives, study assessments will be carried out at screening and on days
      1, 3, 7, 14, 21, 28, 56 (one-month post-treatment) and 210 (six-month post-treatment). These
      assessments will include clinical, parasitological, haematological, biochemistry, safety,
      pharmacokinetic and pharmacodynamics assessments.
    

Intervention name(s): Miltefosine; Paromomycin; Sodium stibogluconate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Miltefosine 10mg and 50mg capsules; Paromomycin sulfate equiv to 750mg paromomycin / 2ml amp; Sodium stibogluconate 33% 30 ml inj.
Other intervention name(s): Impavido; Paromomycin sulfate; SSG
Intervention MeSH terms: Paromomycin; Miltefosine; Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Left Elective Colectomy in Renal Transplanted Patients
Condition: Left Elective Colectomy; Renal Transplanted Patients
Study type: Observational

Summary: 
      Aim of the study :

      To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted
      population.

      Methods :

      From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a
      referral center were prospectively collected.

      Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was
      separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted
      patients (C-group) Short and longterm outcomes were compared between the two groups.

      Primary outcome :

      90 days postoperative anastomotic leak rate
    

Detailed description: 
      From January 2010 to December 2015, data from patients requiring an elective left colectomy
      for benign or malignant indication were collected prospectively in our colorectal surgery
      database.

      According to our exclusion criterial patients were retrospectively divided into two groups:
      kidney transplant recipients (KTR-group) and control group (C-group).

      The surgical indication for an oncologic left colectomy was retained by the expert surgeon,
      after a multidisciplinary conversation meeting comprising at least one surgeon, one
      gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical
      indication for diverticular disease was based on French guidelines.

      Demographic, clinical, intraoperative and postoperative, histological, length of hospital
      stay and mortality data were collected over a 90-day period following the intervention.
    

Intervention name(s): Left elective colectomy
Intervention type(s): Procedure
Intervention description(s): Open or laparoscopic left elective colectomy with colo-rectal anastomosis
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis
      
Keywords: Benign or malign pathology; Renal transplanted patients; Anastomotic leakage
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
Condition: Purpura, Thrombocytopenic, Idiopathic; Acute Idiopathic Thrombocytopenic Purpura; Chronic Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, four-group, two-period, replicate design study to
      evaluate the effect of food on within and between subject variability in second generation
      formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single
      doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a
      reduction in either the within or between subject variability (coefficient of variation
      [CV]%) of approximately 35%.
    

Detailed description: 
      This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging,
      parallel-group study. The PK and PK/PD relationship of AKR-501 will also be studied.
      Approximately 65 eligible patients will be randomized in a 3:3:3:3:1 ratio in a
      double-blinded fashion into one of five parallel treatment groups to receive daily doses of
      either AKR-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each AKR-501 dosing
      group will consist of 15 patients while the placebo group will consist of 5 patients. All
      study patients will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy,
      and (Days 7, 14, 21, and 28) AKR-501 pharmacokinetics while receiving study treatment with a
      final assessment for safety and effectiveness to be done 2 weeks after the last study dose
      (Day 42).
    

Intervention name(s): E5501 40 mg 2 x 20-mg tablets, orally, fasted; E5501 40 mg 2 x 20-mg tablets, orally, with food; E5501 40mg 2 x 20-mg tablets, orally, fasted; E5501 40 mg 2 x 20-mg tablets, orally, with food
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition; single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition; single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition; single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic Thrombocytopenia Purpura(ITP); Acute and Chronic Thrombocytopenia Associated with Chronic Liver Disease; TLD
Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the effect of treatment with glatiramer acetate (GA)
      compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the
      occurrence of the second clinical attack) during the double-blind period. The secondary
      objective is to assess, within the time frame of the up to 3-year double-blind,
      placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging
      (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to
      assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed
      treatment with GA as reflected by clinical and MRI parameters measuring the accumulated
      irreversible brain tissue damage.

      A pre-planned interim analysis was performed on all efficacy and safety data accumulated in
      the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the
      double-blind, placebo-controlled period had been collected. Upon review of the interim
      analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind
      portion of the study be stopped and that subjects be switched to the 2-year Open-label
      period, during which time they would have the option of receiving GA therapy. The sponsor
      (Teva) adopted the DMC recommendations and took the necessary action towards its
      implementation.
    


Intervention name(s): Glatiramer Acetate (DB); Placebo; Glatiramer Acetate (OL)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS).; Double blind period (DB): subcutaneous injection of placebo, once daily, for up to 36 months or until conversion to CDMS; Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months.
Other intervention name(s): Copaxone®; Copaxone®
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinically Definite Multiple Sclerosis; Clinically Isolated Syndrome; Multiple Sclerosis
Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study intends to carry out pain neuroscience education intervention for TKA patients to
      clarify the effect of this method on the degree of postoperative pain, the incidence of pain
      catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as
      to provide a basis for clinical nursing of such patients.
    


Intervention name(s): Pain Neuroscience Education; Routine Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Carry out pain neuroscience education intervention for TKA patients; Carry out routine education intervention for TKA patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to assess the efficacy of adding pentoxifylline to losartan in
      comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.
      also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and
      C-reactive protein
    

Detailed description: 
      Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes
      patients with nephropathy that might relate to its effect on N terminal brain natriuretic
      peptide (NT-pro BNP) and C-reactive protein.

      Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used
      in type 2 diabetes patients with nephropathy for treatment of diabetes complications.

      NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a
      diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2
      diabetes.
    

Intervention name(s): Pentoxifylline; Losartan
Intervention type(s): Drug; Drug
Intervention description(s): pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.; losartan arm took 100mg losartan daily for 12 weeks.
Other intervention name(s): oxpentifylline; Cozaar
Intervention MeSH terms: Losartan; Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Condition: Pudendal Neuralgia
MeSH terms: Neuralgia; Pudendal Neuralgia
Study type: Interventional

Summary: 
      Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were
      randomly assigned either into experimental group (26 patients) received TENS plus the
      traditional physical therapy program( including range of motion exercise, stretching exercise
      of obturator internus muscle, clam shell exercise, relaxation exercise and underwater
      exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received
      only the traditional physical therapy exercise for the same period of time. Intensity of pain
      by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake
      are measured pre and post treatment.
    


Intervention name(s): Trans-cutaneous Electrical Nerve Stimulation; Conventional physical therapy exercise
Intervention type(s): Device; Procedure
Intervention description(s): TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode; physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times
Other intervention name(s): Conventional physical therapy exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pistachios Blood Sugar Control, Heart and Gut Health
Condition: Type 2 Diabetes; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-period randomized crossover study will be conducted to evaluate the effect of nighttime
      pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels,
      longer-term blood sugar control, and risk factors for heart disease. This study will also
      investigate how pistachios affects gut health.
    

Detailed description: 
      A two-period randomized crossover trial will be conducted. Participants will be randomized to
      receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the
      pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an
      evening snack. During the control phase subjects will be given advice to consume 1-2
      exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers
      of glycemic control, cardiovascular risk factors and gut health will be assessed at the
      beginning and the end of each treatment period.
    

Intervention name(s): Pistachio; Usual care
Intervention type(s): Drug; Other
Intervention description(s): Unsalted pistachios; Advice and resources will be provided
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of
      ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve
      participants with genotype 1, 2 or 3 chronic HCV infection.
    

Detailed description: 
      This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts:
      one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and
      a post-treatment phase. The treatment phase was designed to explore the antiviral activity,
      safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without
      RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate
      Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral
      resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who
      have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.
    

Intervention name(s): ABT-450; ABT-267; ribavirin; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets; tablets; tablets; capsules
Other intervention name(s): paritaprevir; ombitasvir; Norvir
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1; Genotype 2; Genotype 3; Hepatitis C Virus; ABT-450/r; Ribavirin; ABT-267; Ombitasvir; Paritaprevir
Wellness and Weight Family Group Project
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of the current study is examine the feasibility and efficacy of providing a
      behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending
      a multidisciplinary pediatric obesity clinic and their parents. Participating families will
      complete assessments consisting of weight status, dietary intake, physical activity,
      health-related quality of life, psychological functioning, home-food environment, parenting
      skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month
      post-treatment follow-up (Month 5). Family attendance data will be collected during the
      behavioral family intervention and children and parents will complete a treatment
      satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C,
      glucose) routinely assessed through standard medical care in the multidisciplinary pediatric
      obesity clinic will be obtained from child medical charts.
    


Intervention name(s): Behavioral Family Intervention (BFI)
Intervention type(s): Behavioral
Intervention description(s): Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an
      antiinflammatory and modulating activity on immunological processes, with positive results on
      different inflammatory and atopic conditions.
    

Detailed description: 
      In this study the investigators evaluate the safety and efficacy of a probiotic formulation
      in the reduction of symptoms and use of topic and systemic corticosteroids and antihistamines
      in the treatment of mild atopic dermatitis according to Hanifin and Rajka diagnostic criteria
      for atopic dermatitis, with a SCORAD (Scoring Atopic Dermatitis) index of 20 to 40, in
      patients 4 to 18 years old, that require the use of said drugs due to disease flare-ups, and
      to whom the usage of topic corticoids to control said flare-ups is indicated.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of 1 capsule probiotic; daily intake of 1 capsule containing placebo
Other intervention name(s): Active formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Analgesia in Children Using Caudal Epidural Ropivacaine
Condition: Inguinal Hernia; Circumcision
MeSH terms: Hernia, Inguinal
Study type: Observational

Summary: 
      Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It
      has been shown to be effective in managing postoperative pain in children undergoing
      abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown
      that children receiving caudal blocks have secondary benefits such as lower narcotic and
      anesthetic requirements, more rapid awakening from general anesthesia, decreased time to
      discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias
      et al 1995, Tobias 1996).

      This proposed study involves the use of a caudal block in children undergoing elective
      inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in
      pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a
      caudal block before the onset of a painful stimulus, we can decrease central nervous system
      sensitization and reduce postoperative analgesic requirements
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.
      
Keywords: caudal epidural analgesia; elective circumcision; elective inguinal herniorrhaphy