bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the single-dose relative bioavailability study of 1
      mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fasting conditions.
    

Detailed description: 
      Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's
      Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone
      Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fasting Conditions
    

Intervention name(s): Risperidone Orally Disintegrating Tablets
Intervention type(s): Drug
Intervention description(s): Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Risperidone
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with
      carboplatin and weekly taxol in patients with previously untreated advanced non-small cell
      lung cancer. The study hypothesis is that sildenafil may improve the distribution and
      efficacy of cytotoxic anticancer agents.
    

Detailed description: 
      Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the
      degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells
      lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and
      increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall
      smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the
      treatment of pulmonary hypertension.
    

Intervention name(s): sildenafil; placebo; paclitaxel (taxol); carboplatin (palaplatin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg, day1,8 and 15 in each cycle; 1 tab, day 1,8 and 15 in each cycle.; paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days; carboplatin; AUC=6 on day 1, every 28 days
Other intervention name(s): taxol; palaplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; previously untreated
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
Condition: Nociceptive Pain
MeSH terms: Nociceptive Pain
Study type: Interventional

Summary: 
      Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies
      nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore
      provide individual guidance so that patients will be given about the right amount. Patient
      given the right amount will presumably awaken quickly when anesthesia is done, and have good
      initial pain control in the post anesthesia care unit (PACU). To the extent that NOL
      titration facilitates optimal opioid dosing, patients are likely to have better PACU
      experiences - which would be an important outcome that clinicians and regulators are likely
      to take seriously.
    


Intervention name(s): NOL Guided Analgesia; Routine opioid management
Intervention type(s): Device; Other
Intervention description(s): NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends; Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement
Other intervention name(s): Physiological Monitoring Device: PMD-200 system
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: NOL-Guided analgesia vs. Routine Management
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NOL; Nociception
Comparison of Different Amputation Levels
Condition: Amputee; Plantar Pressure Distrubution; Balance
Study type: Observational

Summary: 
      Lower limb amputation is a factor that changes the individual's weight transfer, gait
      pattern, and trunk balance. This change plantar pressure distribution of both side and cause
      a series of problems to be exposed over time according to level of amputation. The aim of
      this study is to reveal the relationship between amputation level-postural balance and
      amputation level-plantar pressure distribution.
    


Intervention name(s): Bipedal with open eyes; Bipedal with closed eyes; Bipedal with open eyes and with platform; Bipedal with closed eyes and with platform
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Standing bipedal with open eyes on force platform; Standing bipedal with closed eyes on force platform; Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform; Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Unilateral transtibial and transfemoral amputees
      
Keywords: amputee,plantar pressure, balance
Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population
Condition: Healthy Individuals
Study type: Observational

Summary: 
      Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes
      in the brain occur. In this long asymptomatic period or preclinical phase, studies with
      populations at risk of developing AD have shown cognitive differences compared to control
      groups without such risk. There is a need for short, sensitive, easily administered,
      reproducible, non-expensive and independent of socio-demographic influences tests enabling
      the detection of pre-symptomatic variations in memory, when the memory decline is still
      within a normal range.

      Study main hypothesis: When evaluated with high-demanding tests of memory and executive
      function, the cognitive performance of cognitive healthy people aged between 45 and 65 and,
      extensively, to a group of up to 75 years, will vary significantly depending on clinical,
      socio-demographic and genetic features
    

Detailed description: 
      The purpose of Study 45-65 is to assess if:

        -  Endogenous factors (clinical history, risk factors, genetic factors APOE4, etc…),
           exogenous (socio-demographic, ambient and lifestyle variables) and cognitive reserve
           (including bilingualism) influence cognitive performance.

        -  New and/or updated tests translated and validated in Spanish and Catalan when needed,
           will provide accurate and sensitive measurements of the variability of cognitive
           performance in this target population, representative of the preclinical phase of
           Alzheimer's disease.

      An optional visit is offered to study participants that includes: cerebral magnetic
      resonance, vascular ultrasound and olfactory testing.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cognitive normal men and woman aged 45-75 years
      
Biospecimen description: 
      serum; white cells
    
Keywords: Preclinical phase of Alzheimer's disease; Asymptomatic phase of Alzheimer's disease; Cognitive normal; Exogenous factors; Endogenous factors; Episodic memory test; Executive function test; Memory binding test validation into Spanish; Memory binding test validation into Catalan
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
Condition: Whiplash Associated Disorder
MeSH terms: Whiplash Injuries
Study type: Interventional

Summary: 
      Today there is evidence for that neck specific exercises reduce neck pain problems in
      patients with mechanical neck pain. However, there is a lack of consensus on how to optimize
      neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine
      which and how muscles are activated in exercises thought to be neck-specific. There is
      neither enough knowledge of differences in neck muscle activation between patients with long
      standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle
      function improved with specific neck exercises. One approach would be a real time study of
      deformation and deformation rate in different layers of neck muscles in patients with
      residual long-term neck pain and disability after a whiplash trauma. The purpose of the
      present study was to investigate deformation and deformation rate in different layers of
      dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during
      rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion
      until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder
      elevation. Forty patients with long standing (more than 6 months but less than 3
      years)patients and 40 controls matched for age and gender will be included for comparisons
      between patients and healthy in neck muscle activation. The investigators also include 60
      patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific
      exercises in a 3 months period and B. will 30 be on a waiting list for 3 months. Measurements
      are performed at baseline and at 3 months follow-up. Those patients who fulfilled the 3
      months period of neck specific exercises will also be asked for a 6 months follow-up.
    


Intervention name(s): Neck specific exercises
Intervention type(s): Other
Intervention description(s): Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
Other intervention name(s): Physiotherapy with neck specific exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Neck; Spine; Muscles; Activity; Coordination
Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
Condition: Endodontic Disease
MeSH terms: Pulpitis; Dental Pulp Diseases; Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a
      newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis
      at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s]
      it aims to answer are:

      • In patients with symptomatic irreversible pulpitis does the use of bioceramic material in
      partial pulpotomy decrease amount of post operative pain in comparison to conventional root
      canal treatment?

      Participants will record the intensity of pain at 24,48, 72 hours postoperatively.
    


Intervention name(s): Partial pulpotomy
Intervention type(s): Procedure
Intervention description(s): Use of newly introduced bioceramic putty in partial pulpotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bioceramic material, pulpitis, partial pulpotomy
Chemotherapy With DNA Damaging Agents In Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy
      combined with surgery in colorectal cancer (CRC) avoiding surgery complications.
    


Intervention name(s): Treatment with chemotherapy; Only chemotherapy treatment for study cohort; surgery
Intervention type(s): Other; Other; Procedure
Intervention description(s): Control patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy
Primary purpose: Treatment
Keywords: DNA damaging agents
Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether bismuth subsalicylate can reduce use of
      antibiotics among adults with diarrhea in Pakistan.
    


Intervention name(s): Bismuth subsalicylate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
Other intervention name(s): Pepto-Bismol
Intervention MeSH terms: Bismuth; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: diarrhea; gastroenteritis; antimicrobial drug resistance; antimicrobial agents; Pakistan; ambulatory care; bismuth
Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material
Condition: Extraction Tooth Socket
Study type: Interventional

Summary: 
      Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the
      deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the
      socket shield technique with autogenous dentine was introduced to preserve the periodontal
      ligaments.

      this study aim to evaluate of socket preservation using alloplast with socket shield versus
      Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone
      dimension change and mean bone density in addition to histological and histomorphometric
      analysis for the quality of the formed bone.
    


Intervention name(s): Modified socket shield technique with autogenous dentin graft material (in one side); Modified socket shield technique with alloplast graft material (in contralateral side)
Intervention type(s): Procedure; Procedure
Intervention description(s): The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix.; The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A single group in a split-mouth design, right and left sides are randomly allocated to the intervention group (16 sides in 8 patients)
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to clinically compare post-operative pain levels after ultrasonic
      activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients
      with symptomatic irreversible pulpitis related to mandibular premolar teeth.
    

Detailed description: 
      To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal
      bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic
      irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal
      bioceramic sealer for 20 seconds using non cutting ultrasonic tip.
    

Intervention name(s): ultrasonic activation of bioceramic sealer
Intervention type(s): Other
Intervention description(s): activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
Condition: Mobile Applications; Secondary Prevention; Stroke
MeSH terms: Neoplasm Metastasis; Stroke
Study type: Observational [Patient Registry]

Summary: 
      The aim of the present study was to quantitatively assess the risk factors that may affect
      the re-occurrence of a CVD event and the use of a commercially available mobile application
      Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace
      Base II application for the assessment of cardiological parameters.
    

Detailed description: 
      In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair
      Climb Test) were preceded by a 10-minute rest in sitting position. The time of test
      performance, the walked distance and steps made as well as the mean and maximum gait velocity
      and the calories burned were assessed using the above-mentioned Samsung Health application .
      ECG results were assessed with the use of ECG M-Trace Base II application described above. In
      addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood
      pressure (DBP), heart rate (HR) and arterial blood saturation were assessed. The measurements
      were performed at rest and directly after SCMT and SCT. Additionally, after the tests, the
      level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom
        ischaemic stroke occurred within 14 days before the admission to the Clinical Department.

        The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from
        the hospital staff who did not experience stroke.
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
Condition: Gallstone Disease
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional

Summary: 
      Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical
      techniques for the management of symptomatic gallstone disease and both techiques have shown
      to be feasible for day surgery. However, to our knowledge the long-term outcome between these
      approaches has not been compared in randomised trials as day surgery procedures.
    


Intervention name(s): Cholecystectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 5-year outcome after cholecystectomy
Safer Conception for Women - Understanding Use of Periconception PrEP
Condition: HIV Prevention; Conception
Study type: Interventional
Phase: Phase 4

Summary: 
      Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic
      settings need prevention strategies to reduce periconception HIV acquisition risk. Women at
      high risk for acquiring HIV during pregnancy need risk reduction strategies to protect
      themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as
      pre-exposure prophylaxis in this population is crucial to understanding whether and how this
      novel prevention strategy should be incorporated into HIV-risk reduction packages for at-
      risk women planning or with pregnancy.
    

Detailed description: 
      In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or
      unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and
      adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the
      risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a
      woman's risk of HIV-acquisition and is the only female-controlled option for reducing the
      risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible
      for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and
      their children.

      Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use.
      However, women are eager for prevention strategies that allow for conception, and we
      hypothesize that adherence to a proven prevention strategy, for a limited time with the
      motivation to have a healthy child, will confer drug levels required to prevent HIV
      transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention
      strategy for South African women who intend to conceive with risky partners. Given the
      repercussions of acquiring HIV during conception and pregnancy, this is an important step
      towards providing a key prevention strategy to women and their children.
    

Intervention name(s): PrEP for Safer Conception
Intervention type(s): Behavioral
Intervention description(s): Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.
Intervention model: Single Group Assignment
Intervention model description: All participants are assigned to the Safer Conception study intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV risk reduction; Safer Conception; Pre-exposure prophylaxis; South Africa; Women; Reproductive Health