bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of simeprevir in combination with
      sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of
      participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in
      the overall population.
    

Detailed description: 
      This is a partly randomized, open-label (identity of study drug will be known to volunteer
      and study staff), multicenter (when more than one hospital or medical school team work on a
      medical research study) study. The study will consist of a screening period of up to 4 weeks,
      an open-label treatment period of 8 weeks or 12 weeks, and a post-treatment follow-up period
      until 24 weeks after end of treatment (EOT). Participants without cirrhosis will be assigned
      to Group A wherein half of the participants will receive 8 week treatment in Group A1 and
      remaining participants will receive 12 week treatment in Group A2. Participants with
      cirrhosis, will be assigned to Group B to receive simeprevir in combination with sofosbuvir
      for 12 weeks. The duration of participation for each participant, including the screening
      period, will be approximately 36 or 40 weeks for 8 or 12 week treatment, respectively.
      Efficacy will be primarily assessed by percentage of participants with SVR12. Participants'
      safety will be evaluated throughout the study.
    

Intervention name(s): Simeprevir; Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.; Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Simeprevir; Sofosbuvir; Healthy
Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill)
      based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy
      volunteers after 12 days consumption, the aim in this study is to investigate whether same
      effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin
      an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal
      inflammation will be measured in blood and feces of these patients.
    


Intervention name(s): AndoSan
Intervention type(s): Dietary Supplement
Intervention description(s): AndoSan, 20mlx3, 12 days
Other intervention name(s): Agaricus blazei Murill
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory; AbM; IBD
A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine the long-term safety of asoprisnil 10 mg in women with
      one or more uterine fibroids after an initial 12 weeks in study M99-144.
    

Detailed description: 
      No medical therapy is currently available for the long-term treatment of uterine fibroids.
      The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily
      for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine
      fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will
      be based on ultrasound and endometrial biopsy results, adverse events, and any changes from
      baseline laboratory values and vital signs.
    

Intervention name(s): Asoprisnil
Intervention type(s): Drug
Intervention description(s): 10mg Tablet, oral Daily for 6 months
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibroid Uterus; Leiomyoma; Uterine Fibroids; asoprisnil
A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      to prospectively assess the health-related quality of life (HRQOL) changes during the first
      year after different treatment modalities for localized prostate cancer.
    

Detailed description: 
      Quality of life is of great concern to patients considering treatment options for prostate
      cancer. Patients with clinically localized prostate cancer treated with active surveillance,
      radical prostatectomy, external radiotherapy and high intensity focused ultrasound were
      included. All men completed the questionnaires of Functional Assessment of Cancer
      Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and
      International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after
      treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with clinically localized prostate cancer at single tertiary institution
      
Keywords: quality of life; localized prostate cancer; FACT-P
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the induction effect of multiple doses of
      BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.
    


Intervention name(s): BI 1015550; midazolam
Intervention type(s): Drug; Drug
Intervention description(s): BI 1015550; midazolam
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Italy)
Condition: Mildly Hypercholesterolemic Subjects
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the cholesterol lowering effect of a drinkable
      low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in
      mildly hypercholesterolemic people treated or not by statins
    


Intervention name(s): 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
Intervention type(s): Other; Other
Intervention description(s): 1 = Intervention 1 (1 test product/day); 2 = Intervention 2 (1 control product/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Plant sterol - Hypercholesterolemia - diet - dairy
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
Condition: Obesity
Study type: Interventional

Summary: 
      This project is a randomized controlled trial to compare the efficacy of two interventions-
      one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)-
      and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All
      participants will first participate in an initial 4-month standard behavioral weight loss
      program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop;
      the ACT workshop will teach ACT skills including acceptance and mindfulness techniques
      designed to promote behavior change and health behavior persistence consistent with one's
      core values. The SR program will focus on self-regulation, regular weighing, and modeling
      behavior on successful maintainers. The WLO group will receive a control workshop focused on
      cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24
      months. The secondary outcome is change in psychological flexibility, a critical component of
      ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24
      months, the ACT group will show significantly greater weight loss as compared to the SR and
      WLO groups.
    


Intervention name(s): ACT; SR; WLO
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Treatment is based on Acceptance and Commitment Therapy; Treatment is based on Self-Regulation theory.; Treatment is based on cooking tips and demonstrations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease
Condition: Sanfilippo Syndrome
MeSH terms: Mucopolysaccharidosis III; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage
      disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence
      of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting
      in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of
      life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5
      years. The disease is characterized by developmental delays initially, followed by
      neurological developmental arrest, then regression. These developmental deficits are
      typically associated with severe behavioral disturbances. Patients have a significantly
      reduced lifespan, with few surviving beyond the 2nd or 3rd decade.

      The purpose of this study is to evaluate the safety and efficacy of recombinant human
      heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type
      III A Disease.
    

Detailed description: 
      No effective, disease-modifying therapies are currently approved as treatments for this
      devastating and disabling disease.

      Shire Human Genetic Therapies (Shire HGT) is developing an enzyme replacement therapy (ERT)
      recombinant human heparan-N-sulfatase (rhHNS) for patients with MPS IIIA. rhHNS is being
      administered into the cerebrospinal fluid (CSF) via an surgically implanted intrathecal drug
      delivery device (IDDD), because when administered intravenously (IV) it does not cross the
      blood brain barrier (BBB).

      This study will evaluate the effect of 48 weeks of rhHNS treatment on the clinical course of
      MPS IIIA, using cognitive function as the primary outcome measure. The trial will evaluate 2
      dosing regimens of rhHNS administered via an IDDD in comparison with a no treatment control
      group. Patients will be randomized 1:1:1 to either of the treatment groups or the no
      treatment group. Treatment will be administered in an open-label manner. The safety and
      tolerability profile of rhHNS will continue to be evaluated in this study.
    

Intervention name(s): Recombinant human heparan N-sulfatase [rhHNS]
Intervention type(s): Drug
Intervention description(s): Recombinant human heparan N-sulfatase [rhHNS]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sulfoglucosamine sulfohydrolase (SGSH); recombinant human heparan N-sulfatase (rhHNS); Hunter's Syndrome; Shire HGT; Lysosomal Storage Disease (LSD); Sanfilippo Syndrome Type A (Sanfilippo A); enzyme replacement therapy (ERT)
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
Condition: Bile Leakage
Study type: Interventional

Summary: 
      Bile leakage after liver transection is treated by external drainage. The question addressed
      is whether downstream control by transpapillary stent insertion into distal bile duct can
      enhance healing.
    

Detailed description: 
      All patients who present with clinically significant bile leakage after liver resection at
      postoperative day two or longer are offered the opportunity to become randomized to either
      continuous external drainage or the addition of transpapillary stent.
    

Intervention name(s): Transpapillary plastic stent (7-10 Fr)
Intervention type(s): Device
Intervention description(s): Duodenoscopy plus transpapillary bile cannulation plus stent insertion.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Levonorgestrel Intrauterine System and Adenomyosis
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional

Summary: 
      Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the
      myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not
      yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It
      is a common condition in women aged 40-50 years and is considered an important cause of
      dysmenorrhea and menorrhagia in around 65 % of cases.

      Until past few years; hysterectomy was the suggested definitive treatment, however; this may
      not be acceptable to women not willing to loss their fertility. Many treatment lines were
      studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol,
      combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these
      line of treatment are not commonly used because high incidence of side effects and relatively
      high cost of some of them.

      The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line
      for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to
      12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to
      decidualization and atrophy of the adenomyosis .

      In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and
      satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to
      remove it and start a new medical or surgical option for treatment.

      However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well
      available. Only one report states that a large uterine volume could be a factor associated
      with LNG-IUS treatment discontinuation in adenomyotic patient.

      For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which
      should be addressed. The present study examines the hypothesis that patient's data reported
      at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help
      the prediction of the responsiveness for this important line of treatment at 6 months follow
      up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict
      the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.
    


Intervention name(s): Levonorgestrel intrauterine system
Intervention type(s): Device
Intervention description(s): Levonorgestrel intrauterine system for adenomyosis
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Technique To Control Postpartum Hemorrhage
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to
      the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality
      due to hemorrhage, infection, or other surgical complications such as those resulting from
      hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is
      increasing due to the rise in the rate of deliveries by Cesarean section.

      Placenta accreta is a potentially life-threatening obstetric condition that requires a
      multidisciplinary approach to management. The incidence of placenta accreta has increased and
      seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta
      accreta are those who have myometrial damage caused by a previous cesarean delivery with
      either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of
      placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize
      potential maternal or neonatal morbidity and mortality.
    


Intervention name(s): Modified surgical technique for placenta accreta
Intervention type(s): Procedure
Intervention description(s): suturing of the myometrium splitted by the placenta in cases presented by placenta accreta
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Investigation of a Customized Femoral Resurfacing Implant
Condition: Articular Cartilage Disorder
MeSH terms: Cartilage Diseases
Study type: Interventional

Summary: 
      The purpose is to assess the safety profile and performance of a femoral resurfacing implant
      for localized chondral lesions.
    

Detailed description: 
      The implant's safety profile will be assessed by incidence of any subject having any of the
      seven identified implant-related clinical undesirable side effects. This will be analyzed
      with a one-side exact binomial test on significance level 0.05, at 24 months
      post-operatively.
    

Intervention name(s): Implant surgery
Intervention type(s): Device
Intervention description(s): surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-ERCP Pancreatitis Prevention by Stent Insertion
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      The presented study is designed to analyze the efficacy of pancreatic stent insertion in
      patients undergoing ERCP with accidental cannulation of the pancreatic duct.
    


Intervention name(s): Stent insertion into the main pancreatic duct
Intervention type(s): Device
Intervention description(s): Stent insertion into the main pancreatic duct
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: ERCP; endoscopy; pancreatitis
Examining the Effects of a Team-based Running Program
Condition: Memory; Learning; Mood; Attention; Stress; Sleep
Study type: Interventional

Summary: 
      The investigators are interested in finding accessible interventions for youth and young
      adults that help promote long-term positive mental health functioning. They will be
      investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on
      mental health symptoms, memory, and attention. This intervention will hopefully improve
      mental health functioning in youth aged 17-25 that are at high risk of developing mental
      health disorders. Sessions will consist of 30 minutes of running under the supervision of
      group leaders and coaches. The group will steadily increase the distance and time spent
      running versus walking, with the goal of having everyone run a 5 km race together at the end
      of 13 weeks. Once a week, youth will be provided with education on a variety of topics
      related to health and running. Youth will complete measures before, during, and after the
      program to assess outcomes.
    


Intervention name(s): Running
Intervention type(s): Other
Intervention description(s): A 13-week running program where youth run for 30 minutes twice weekly.
Other intervention name(s): Exercise
Intervention model: Single Group Assignment
Intervention model description: This is an open-label pilot study examining the effects of exercise on mood, learning, memory, attention, stress, and sleeping habits.
Masking: None (Open Label)
Primary purpose: Other
SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigator's goal is to address the need for the development of social interventions
      for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends
      established behavioral strategies with theatre techniques that emphasize the involvement of
      peers, play and performance. The resulting synergy extends promising pilot studies in a
      randomized group experiment.
    

Detailed description: 
      The investigator's goal is to address the need for the development of social interventions
      for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends
      established behavioral strategies with theatre techniques that emphasize the involvement of
      peers, play and performance. The resulting synergy extends promising pilot studies in a
      randomized group experiment.

      Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated,
      theatre-based intervention on children with ASD with an emphasis on social functioning. The
      10-session program incorporates theatrical approaches, trained typically developing peers and
      established behavioral strategies. Previous studies using pre-post designs have reported
      improvement in several skills, such as face memory, theory of mind and social cognition. A
      primary objective of this investigation is to utilize a true experimental design while
      evaluating social ability across multiple levels of analysis including neuropsychological,
      cognitive, behavioral, and functional outcomes.
    

Intervention name(s): SENSE Theatre; Delayed Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A peer-mediated, theatre-based intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This extension study is designed to assess the long-tem tolerability and safety of
      licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
    


Intervention name(s): licarbazepine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder, manic episode/treatment/licarbazepine