bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5
      mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse
      events and ensure safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two treatment, two-sequence, two-period, single-dose,
      crossover comparative bioequivalence study of Olanzapine 5 mg OD Tablets, of Dr. Reddy's
      Laboratories Limited and Zyprexa Zydis 5 mg Tablets of Cardinal Health in healthy, human
      subjects under fasting conditions.
    

Intervention name(s): Olanzapine OD Tablets 5 mg
Intervention type(s): Drug
Intervention description(s): Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Zyprexa Zydis
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination
Condition: Alveolar Socket Preservations
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to compare post-extraction augmented sockets using Atorvastatin
      loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct
      application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and
      spontaneously healed socket (Control) both clinically and by histomorphometric analysis of
      formed bone quality.
    

Detailed description: 
      Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft
      tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as
      part of the natural physiological healing process. There are many techniques in the
      literature used for socket preservation as bone grafts, barrier membranes, immediate implant
      and socket shield. Many other techniques also are used such as bone and tissue healing
      promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However
      Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth
      factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the
      widely used group of cholesterol lowering drugs which also increase normal bone formation by
      promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In
      addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins
      increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area
      of growth factors, there is no high-quality evidence to either support or refuse their use.

      This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its
      biocompatibility, ease of use, stimulation of production of growth factors and its effect on
      the already differentiated osteoblasts, when combined with statin with its effect on
      progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts,
      prevent bone resorption and stimulate bone formation at the extraction socket.
    

Intervention name(s): PRGF/ATV; ATV gel; PRF; PRGF
Intervention type(s): Combination Product; Drug; Biological; Biological
Intervention description(s): Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold; Atorvastatin gel; Platelet rich fibrin; plasma rich in growth factor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Treadmill Training With Lower Extremity Amputees
Condition: Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      Many people with a leg amputation have difficulty walking even after they have finished their
      rehabilitation. The purpose of this study is to see if a large amount of walking practice on
      a treadmill can improve functional abilities.
    


Intervention name(s): Treadmill Training
Intervention type(s): Other
Intervention description(s): The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amputees
A Randomized Study of Approaches in Total Hip Arthroplasty
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      The primary aim of the study is to compare the results of an established, successful
      procedure, which is total hip arthroplasty through a mini-posterior approach to a less
      studied - increasingly popular procedure, which is total hip replacement through the direct
      anterior approach utilizing the orthopedic table.
    


Intervention name(s): Direct Anterior Approach; Mini-Posterior Approach
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a four-way crossover (non-parallel) study with each subject receiving three of the
      four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75
      inclusive.

      Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind
      placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will
      include three treatment assignments for each of three treatment Periods according to the
      randomization scheme.
    

Detailed description: 
      Following the screening, eligible subjects entered a 3-day, single-blind placebo run-in. On
      Day 4, each subject was randomized to a treatment sequence that included three treatment
      assignments for each of three treatment Periods according to the randomization scheme.

      Pre-assignment Details The number of participants receiving each Intervention, in each
      Period, is reported.

      Subjects received the randomized treatment from Day 4 through Day 8. There was a 24-hour
      single-blind placebo washout on Day 9. Each subject received placebo for one of the three
      treatment periods. Each subject also received 1 of the 3 active doses randomly in each of the
      two other treatment periods respectively. The dosing order is random.
    

Intervention name(s): ORMD-0801 (qd); ORMD-0801 (bid); ORMD-0801 (tid); Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Dose 1 = ORMD-0801 (qd); Dose 2 = ORMD-0801 (bid); Dose 3 = ORMD-0801 (tid); fish oil placebo
Other intervention name(s): Oral Insulin; Oral Insulin; Oral Insulin; fish oil
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral Insulin; DM T2 (Diabetes Mellitus Type 2)
Cardiac Vulnerability in Potentially Susceptible Patients
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This project is part of a program project directed toward assessing cardiac effects of
      particulate and other ambient air pollutants. In this project patient who have recently
      suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times
      during the year following their cardiac event. Similarly a second group of patients with
      moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice
      a week separated by 3 months. In both sets of patients home indoor pollution measures will be
      continuously made and used to correlate with measures of heart rate variability.
    

Detailed description: 
      Approximately 50 patients in each group will be studied. In addition to cardiac monitoring
      for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be
      monitored in both groups. The exposure monitoring will include both particle mass of PM2.5
      along with detailed assessment to determine that portion of the particulate exposure from
      outdoor vs. indoor sources.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Cardiac event; Heart disease; Particulate Matter
Qol Following Management for Pediatric UI
Condition: Quality of Life; Incontinence
Study type: Interventional

Summary: 
      A comparison of changes between symptoms of incontinence and pediatric quality of life will
      be used to draw conclusions about whether differences in quality of life are noted with
      changes in symptoms of incontinence.
    

Detailed description: 
      Although positive physiological results are associated with successful treatment for bowel
      and bladder dysfunction and daytime incontinence (BD-UI), there are few studies examining the
      effects of treatment on quality of life (QoL) for children. The purpose of our study is to
      determine whether successful physical therapy treatment improves QoL for children with BD-UI.

      Consent will be obtained from parents and assent from children. Children will be asked to
      complete a global, age appropriate quality of life assessment and a quality of life
      instrument specific to incontinence. Information will be provided by the parent through
      completion of a parent report instrument matched to the child's global quality of life tool
      as well as completion of an instrument depicting child symptoms. Clinicians will report
      general information about related physiological changes and progress with established
      outcomes individualized to the child. A repeated measures MANOVA will be used to analyze the
      results.
    

Intervention name(s): Physical Therapy
Intervention type(s): Behavioral
Intervention description(s): Management of urinary incontinence by a physical therapist will include but is not limited to biofeedback, dietary management, alleviation of constipation, and neuromuscular re-education.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Pediatric; Incontinence
Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
Condition: Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Robotic rectal cancer resection with natural orifice extraction is a recently developed
      minimally invasive surgery for patients with rectal cancer. However, it's safety and
      feasibility remain undiscussed and controversial. This study reported the clinical outcomes
      and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal
      cancer resection with natural orifice extraction to discuss aforementioned question.
    

Detailed description: 
      Robotic rectal cancer resection with natural orifice extraction is a recently developed
      minimally invasive surgery for patients with rectal cancer. However, it's safety and
      feasibility remain undiscussed and controversial. This study reported the clinical outcomes
      and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal
      cancer resection with natural orifice extraction to discuss aforementioned question. From
      January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal
      cancer resection with natural orifice extraction and 49 matched patients underwent
      conventional robotic assisted rectal cancer resection were systematically analyzed in this
      study.
    

Intervention name(s): Robotic Assisted Rectal Cancer Resection Alone; Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.; participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From January 2015 to November 2016, a consecutive wave of patients with rectal cancer
        underwent conventional robotic assisted rectal cancer resection and robotic rectal cancer
        resection with natural orifice extraction were invited to participate in this study.
      
Biospecimen description: 
      The resected specimens were kept and sent to the laboratory for pathological examination
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the combination of two new drugs, cetuximab
      (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and
      neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that
      is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab
      is also approved by the FDA for the treatment of colorectal cancer
    

Detailed description: 
      Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United
      States 1. Squamous cell carcinomas account for more than 90% of head and neck cancer cases.
      Patients with squamous cell carcinoma of the head and neck (HNSCC) usually present with
      locoregionally advanced disease. Initial presentation with distant metastasis may occur in
      about 10% of all patients. However, recurrence of disease either in local or distant sites
      after potentially curative treatment with surgery, radiation, and/or chemotherapy occurs in
      more than 50% of patients. Therefore, the majority of patients with HNSCC develop recurrent
      or metastatic disease during the course of their illness. These patients have a dismal
      prognosis with a median survival of 6-9 months 2-4.

      Active single agents in head and neck squamous cell carcinoma include methotrexate,
      bleomycin, cisplatin, carboplatin, 5-FU, paclitaxel, docetaxel, and CPT-11. A small
      randomized study showed that cisplatin monotherapy prolongs survival compared with best
      supportive care 5. Response rates for single agents range between 10-40% 2, 4, 6, 7.
      Combination chemotherapy with platinum agents, in spite of achieving higher response rates
      (about 30% in phase III trials), has not been shown to produce a survival benefit compared to
      single agents in randomized comparisons in recurrent/metastatic head and neck cancer 2, 4.
    

Intervention name(s): Cetuximab; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations; Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
Other intervention name(s): Erbitux, C225; (rhuMAb VEGF, Avastin) (NSC 704865; IND 7921)
Intervention MeSH terms: Bevacizumab; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: head and neck cancer; cetuximab; bevacizumab; squamous cell carcinoma; SCCHN; Squamous Cell Carcinoma of the Head and Neck
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    


Intervention name(s): ADX-N05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg once a day for seven days followed by 300 mg once a day for seven days; Placebo to match ADX-N05 once a day for 2 consecutive weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Kinesio Tape on Motor Function in Subjects With ACL Rupture
Condition: ACL Rupture; Rehabilitation
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Thirty-two participants with ACL rupture were included in the study. All participants were
      divided in two groups - control and experimental. In the experimental group (n=16)
      participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control
      group - standardized physiotherapy.

      Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic
      balance, proprioception, knee flexion and extension muscle torque, level of activity
    


Intervention name(s): standardized physiotherapy program and Kinesio tape
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Foley's Catheter Balloon for Induction of Mid Trimester Abortion in Nulliparous Women With or Without Tension Applied
Condition: Induction of Abortion
Study type: Interventional

Summary: 
      Induction of abortion is a hot subject that has complex and emotional controversy. The most
      common time of abortion is the second trimester which represent about 10-15% of all induced
      abortions over the world. As well as, two-thirds of all serious abortion-related
      complications are related to induced second trimester abortion.

      There are many causes for induction of abortion in the second trimester such as missed
      abortion, serious fetal abnormalities such as central nervous system or skeletal malformation
      and lastly some women do not wish to continue a pregnancy and will often seek out termination
      of pregnancy.

      Termination of second trimester is more risky than the first trimester. So many lines have
      been emerged to achieve safe and effective method of termination of second trimester.

      Pharmacologic management seems to be an appealing method for induction of abortion. The
      combing between mifepristone and misoprostol is the effective regimen for termination of
      second trimester abortion with success rate reaching about 97-99% within 24 hours.

      However, mifepristone is not available or affordable in many countries worldwide so
      misoprostol have been used alone but it needs higher total dose with lower effectiveness and
      higher percentage of side effects rate than the combined regimens.

      The optimal method for inducing second trimester nulliparous women with an unfavorable cervix
      is not known. Several studies in literature have described the effectiveness of Foley's
      catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices
      . It may act in addition to its mechanical effect by increasing the release of prostaglandin
      and/or oxytocin release secondary to localized inflammation.

      In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying
      tension in trial to shorten the time between the insertion and expulsion of the fetus,
      however; this tension adds more pain for the pregnant women with higher rate of vaginal
      bleeding and dissatisfaction.

      Gary et al in 2016 concluded that the application of tension did not result in faster
      delivery times, but did result in faster times to catheter expulsion.
    


Intervention name(s): Tension group; No tension group; Foley catheter Balloon
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare disease-free survival (DFS) of patients
      with triple negative breast cancer randomised to treatment with standard adjuvant
      chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine
      (Xeloda) metronomic therapy.
    

Detailed description: 
      Triple negative breast cancer (TNBC) is an aggressive disease without tumor-specific
      treatment options. Patients with triple-negative disease had an increased likelihood of
      distant recurrence and death within 5 years of diagnosis. Median time to distant recurrence
      was significantly shorter. This study will evaluate the efficacy and safety of the addition
      of Capecitabine to standard adjuvant therapy in patients with triple negative breast cancer.
      Patients will be randomized to receive either standard chemotherapy (according to NCCN
      guideline), or standard chemotherapy followed by 1 year of metronomic Capecitabine (650mg/m2,
      twice every day). The anticipated time on study treatment is 12 months, and the target sample
      size is 432 individuals.Disease-free Survival (DFS) will be primary end point.
    

Intervention name(s): Capecitabine
Intervention type(s): Drug
Intervention description(s): capecitabine 650 mg/m2 twice every day for 1 year.
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple-negative breast cancer; metronomic chemotherapy; capecitabine (xeloda)