bioihbjkbjnl/mcl2 huggingface dataset:
Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures
Condition: Rupture of Achilles Tendon
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this study is to directly compare traditional plaster treatment with early
      weightbearing in a walking boot for the non operative treatment of acute achilles tendon
      rupture.
    

Detailed description: 
      This injury has traditionally been treated in a plaster cast applied to the leg for a period
      of 10 weeks which allows the tendon to heal, or by an operation to repair the tendon.
      Research undertaken in the investigators department has shown that patients treated with
      surgery or with a plaster had similar chance of re-rupture of the tendon after treatment and
      gain a similar recovery. The investigators therefore now manage these injuries in a plaster.

      More recently, further research has shown that a new type of non-surgical rehabilitation
      programme, which is quicker than the traditional non-surgical programme, gave a tendon
      re-rupture rate that was similar to that after surgical treatment. This new rehabilitation
      programme uses a walking boot fitted with a heel-raise (instead of the traditional plaster).
      The potential benefit of this quicker rehabilitation programme is that it allows the patient
      to put weight through the leg immediately, whereas patients treated with the traditional
      plaster cast non-surgical treatment cannot weight bear (this means that they are kept
      non-weightbearing and therefore have to use crutches) for the first 8 weeks. The time spent
      in the walking boot in this new, quicker rehabilitation programme is 8 weeks while that spent
      in plaster is 10 weeks. This new non-surgical, quicker rehabilitation programme is referred
      to as the accelerated non-surgical programme hereafter. There are no known increased risks
      with the accelerated rehabilitation programme.
    

Intervention name(s): Standard treatment protocol; Accelerated Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Cast Protocol 4 weeks in Full Equinus cast - Non Weight Bearing (NWB) with axillary crutches; 4 weeks in Semi-Equinus cast NWB with axillary crutches; 2 weeks in neutral cast - Full Weight Bearing (FWB); 2 weeks FWB out of cast, with shoe insert heel raise.
Followed by course of physiotherapy; 4 weeks in Ossur Rebound walking boot with 3cm heel raise, worn continuously including in bed. Weight bearing as tolerated (WBAT)/FWB - crutches for balance; 2 weeks in Rebound walking boot with 1.5cm heel raise (WBAT/FWB - crutches for balance; 2 weeks in Rebound walking boot with foot in neutral. At 8 weeks, remove boot and allow FWB out of boot.
At 8 weeks after initiation of treatment, physiotherapy is commenced.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular
      injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.
    

Detailed description: 
      This study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose
      study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients
      diagnosed with painful femoro-tibial osteoarthritis. The study consists of 2 parts: Part A is
      a single ascending dose study, whereas Part B is a single-dose study at a dose that has been
      determined to be safe and tolerable in Part A of the study.

      In Part A, subjects will be randomly allocated to receive UBX0101 or placebo in 3:1
      randomization by dose level (cohort), whereas in Part B subjects will be randomly allocated
      to receive UBX0101 or placebo in a 2:1 randomization.

      The primary objective is to establish the safety and tolerability of UBX0101 given as a
      single intra-articular injection into the femoro-tibial joint of patients with
      osteoarthritis.
    

Intervention name(s): UBX0101; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug intra-articular injection; Diluent intra-articular injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence
Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

Summary: 
      THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION
      OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER
    

Detailed description: 
      The study was conducted experimentally to determine the effect of black mulberry lollipop and
      sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up
      due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared
      to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35
      children were assigned to the experimental group (sodium bicarbonate + black mulberry
      lollipop application), 34 were assigned to the control group (sodium bicarbonate
      application).
    

Intervention name(s): Oral Mucositis
Intervention type(s): Other
Intervention description(s): The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.
Intervention model: Single Group Assignment
Intervention model description: The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology
Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss
Condition: Miscarriage, Recurrent
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Recurrent unexplained spontaneous miscarriage (RSM) is defined as three consecutive pregnancy
      loss prior to 20 weeks from the last menstrual period. 1% to 2% of women experience RSM.
      Treatment of URSM is a challenging issue. The currently available lines of treatment
      according to simplicity of use, reliability and degree of invasiveness include
      corticosteroids, sildenafil citrate, aspirin, heparin and immunoglobulins (besides good
      antenatal care), but up to now there are no prospective randomized studies, powerful enough,
      to determine a significant difference between these therapeutic protocols, with any of the
      above mentioned pharmacological agents.

      Sildenafil Citrate (Viagra®), a vasodilator, is also described as an anti-inflammatory agent.
      While improving uterine blood flow in the proliferative phase, NO may have detrimental
      effects at the level of the endometrium during the implantation window. The NO- mediated
      release of cytokines such as tumour necrosis factor- from activated natural killer cells has
      been implicated as a cause of implantation failure.

      Based on these observations, this study attempts was made to study uterine arteries and
      sub-endometrial blood flow during the luteal phase in normal fertile women and in patients
      with Unexplained recurrent miscarriage
    


Intervention name(s): Sildenafil Citrate; Folic Acid; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period; Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally; Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period
Intervention MeSH terms: Folic Acid; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into two groups: Group (A) folic acid and sildenafil citrate and Group (B) folic acid and placebo.
Folic acid (0.5 mg) will be started 3 months before conception in the two groups. Sildenafil citrate (dose: 25 mg; oral tablets, 4 times/day) or placebo will be started preconception for 24 days
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study was to expand access to buprenorphine using a mobile health care
      system among marginalized populations with or at high risk for HIV and observe longitudinal
      effects of treatment.
    


Intervention name(s): Mobile Access
Intervention type(s): Other
Intervention description(s): Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opiate dependence; buprenorphine
Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition
Condition: Premature Birth; Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to gain information that may be useful in helping to figure out
      better or newer ways to provide nutrition to babies born premature.
    

Detailed description: 
      Babies born premature weigh significantly less at the time of hospital discharge when
      compared to babies born at the corresponding age. The researchers in this study believe that
      the lower body weight at discharge may be due to lower muscle mass. However, there is no such
      information available for that at this time. It is important to have this information as
      babies who weigh less than normal at hospital discharge may develop higher blood pressure and
      higher sugar levels when they are 10-15 years old.

      By doing this study, researchers will be able to have information about the baby's muscle
      mass, which will help the researchers to provide better nutrition to babies who are born
      premature. Researchers will also be able to determine if there are any differences in the
      muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a
      combination of breast milk and formula). This information may be beneficial in helping to
      promote the appropriate type of feeding for babies born premature.
    

Intervention name(s): PEA POD Infant Body Composition System
Intervention type(s): Device
Intervention description(s): The non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study group involves premature infants born between 23 to 32 weeks gestation, while
        babies born at 34 weeks, 36 weeks and ≥37 and ≤ 42 weeks gestational age will serve as
        control groups.
      
Keywords: Pea Pod; Body composition
External Beam Radiotherapy for Muscle Invasive Bladder Cancer
Condition: Toxicity
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase 1 trial, the investigators will prospectively evaluate 3 different external
      beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to
      40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of
      abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of
      fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is
      delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a
      simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3
      different dose levels will be implemented in order to increase the biological equivalent dose
      (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.
    

Detailed description: 
      3 different dose levels will be implemented in order to increase the biological equivalent
      dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

        -  Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.

        -  Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy

        -  Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be
           implanted at the edges of the postoperative bed during the second transurethral
           resection of the bladder to improve visualization of the gross tumor volume (GTV) during
           external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy.
           In order to further improve the treatment accuracy, 5 planning Computed Tomographies and
           plans, with different bladder fillings will be made upfront in our study. During
           treatment the plan corresponding best with bladder filling at time of EBRT will be
           selected and delivered.
    

Intervention name(s): external beam radiotherapy (EBRT)
Intervention type(s): Radiation
Intervention description(s): EBRT: 3 dose escalation levels
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD.
Condition: Obstructive Lung Diseases
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Interventional

Summary: 
      In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is
      severely impaired due to a ventilatory limitation, levelling off the intensity of exercise.
      This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is
      then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity
      and the duration of every training session. In a preliminary study, the investigators showed
      that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of
      post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps
      contractions (TlimQ).

      The aim of this study is to determine the relationship between the prevention of
      post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of
      sessions) during a pulmonary rehabilitation programme. At the beginning of the training
      programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal
      workload) with and without IPS in random order. The training load was then monitored at every
      exercise session of the programme.
    


Intervention name(s): Inspiratory help then sham ventilation; Sham ventilation then Inspiratory help
Intervention type(s): Device; Device
Intervention description(s): The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.; The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether Smecta® is more effective than placebo with
      respect to time to recovery following an acute diarrhoea episode.
    


Intervention name(s): Diosmectite (Smecta®)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare tumor response rate of the test
      arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable
      pancreatic cancer
    

Detailed description: 
      Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is
      difficult to diagnose at its early stage and only 10-20% of patients are candidates for
      resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic
      cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard
      chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8
      months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or
      CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists
      of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP
      (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4
      (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have
      demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%),
      colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic
      cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in
      phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination
      therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares
      efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and
      metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather
      ordinary clinical settings.
    

Intervention name(s): gemcitabine + S-1; gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks; gemcitabine DIV on day one , 8th and 15th
Other intervention name(s): gemzar; TS-1; gemzar
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic carcinoma; gemcitabine; S-1; phaseⅡstudy
Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
Condition: Healthy
Study type: Interventional

Summary: 
      Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to
      decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their
      metabolites have not been explored in details.

      This is an exploratory study aiming at determining the plasma level of MCT and their
      metabolites after oral intake of Peptamen.
    

Detailed description: 
      20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single
      day.

      Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline
    

Intervention name(s): Peptamen 1.5
Intervention type(s): Dietary Supplement
Intervention description(s): Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Medium Chain Triglycerides; Medium Chain Triglycerides metabolites; Peptamen 1.5
Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
Condition: HIV Infections; Acquired Immunodeficiency Syndrome
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to assess retinal nerve fiber layer thickness and macular
      thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus
      without ocular manifestations and to correlate these results with perimetric findings
      assessed by frequency doubling technology perimetry (FDT).
    


Intervention name(s): Optical Coherence Tomography (OCT); Frequency Doubling Technology (FDT) perimeter
Intervention type(s): Device; Device
Intervention description(s): Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls; 24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV infected patients