bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Water Biking in Hot Versus Neutral Water for Heat Acclimatation
Condition: Healthy; Heat Exposure
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the efficiency of water biking training in hot
      (35°C) versus neutral (25°C) temperature water to elicite heat acclimation in healthy
      recreative athletes.
    

Detailed description: 
      The goal of this clinical trial is to compare the efficiency of water biking training in hot
      (35°C) versus neutral (25°C) temperature water to elicite heat acclimation in healthy
      recreative athletes. The main questions it aims to answer are:

        -  Does the water biking training protocol in hot versus neutral temperature water improve
           the time trial in an artificially hot and humid indoor environment?

        -  Does the water biking training protocol in hot versus neutral temperature water improve
           the VO2 max performance and force/velocity profile in neutral indoor environment?

        -  What are the main acclimation adaptations (central and cutaneous temperature), heart
           rate, cardiac function, sweating quality, sleep quality, haematologic profile.

      Participants will have to do pre and post training tests in both normal environment
      (cardiorespiratory stress test, force/velocity profile test, echocardiography) and
      artificially hot and humid indoor environment (time trial). The training protocols consists
      in 10 sessions of 1 hour of water bike aerobic training (5 times a week for 2 weeks) at an
      intensity based on the heart rate corresponding to the 1st respiratory threshold, in hot
      (interventional group IG: 35°C) versus neutral (control group CG: 25°C) water.
    

Intervention name(s): Water Biking in hot water condition; Water Biking in neutral water condition
Intervention type(s): Other; Other
Intervention description(s): Training protocol includes 10 water biking sessions in hot water temperature (35°C) for this group; Training protocol includes 10 water biking sessions in neutral water temperature (25°C) for this group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Water biking; Acclimatization
Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study was to compare the single-dose relative bioavailability
      of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30
      mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed
      conditions.

      The secondary objective of this study was to evaluate the adverse events associated with each
      of these 2 different morphine sulfate modified-release commercial formulations
    


Intervention name(s): KADIAN (morphine sulfate sustained-release) capsules; Avinza (morphine sulfate sustained-release) capsules
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 30 mg; Capsules, 30 mg
Other intervention name(s): Test product A; Reference product B
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: KADIAN; morphine; Avinza; 30 mg; bioequivalence; fed
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
Condition: Acute Coronary Syndromes
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the combination of aspirin plus clopidogrel is
      more effective than aspirin alone in preventing another heart attack, chest pain, stroke or
      death in people who have already had a heart attack that was treated with fibrinolytic
      therapy.
    


Intervention name(s): Clopidogrel (SR25990); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): plus acetylsalicylic acid (ASA); plus acetylsalicylic acid (ASA)
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
Condition: Enteropathy
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc
      therapy and de-worming albendazole as separate interventions in restoring normal gut
      absorptive and immunological function as measured by the dual sugar permeability test and
      additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental
      Enteropathy.
    


Intervention name(s): Albendazole; Placebo; High-dose Zinc
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age; Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.; Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating an Online Wellness Intervention for Indian College Students
Condition: Depressive Symptoms; Anxiety; Happiness
MeSH terms: Depression
Study type: Interventional

Summary: 
      We are evaluating the effects of an online single-session mental health intervention (the
      Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled
      trial with Indian college students. Students will be randomized to the COMET condition or to
      a wait-list control condition.

      Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being)
      will be measures at two weeks post-intervention, four weeks post-intervention, and twelve
      weeks post-intervention.

      We will evaluate COMET as a universal intervention (using the full sample) and as a targeted
      intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms
      at baseline).
    


Intervention name(s): Common Elements Toolbox; Wait-list control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.; Participants in the control condition will receive access to the intervention after data collection for the study has been completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Condition: Metabolic Impact
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Prospective study of 6 months of evolution in people with type 1 diabetes with insulin
      multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological
      baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control
      (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI),
      treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R),
      quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.
    


Intervention name(s): telemedicine
Intervention type(s): Device
Intervention description(s): The study population corresponds to patients> 18 and <65 years with DM1 of> 1 year of evolution, and treated with MDI HbA1c> 7%. It is changing one group of subjects between two observation times due to any intervention in this case the addition of a tele
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to determine the relative bioavailability of a BI 10773
      / metformin fixed dose combination tablet compared to single tablets of BI 10773 and
      metformin when administered together and to assess the effect of food on the bioavailability
      the fixed dose combination tablet
    


Intervention name(s): C: BI 10773 / metformin tablet; B: BI 10773 tablet and metformin tablet; A: BI 10773 / metformin tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal; BI 10773 and metformin single tablets, administered together in fasted state; BI 10773 / metformin fixed dose combination tablet in fasted state
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial
Condition: Pain, Post Operative; Arthroplasty Complications
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This research aim to improve postoperative outcome in total hip arthroplasty(THA) by using
      local mixture infiltration as bupivacaine + NSAID + epinephrine + tranxemic acid. In the
      present time these mixture components has shown to improve THA outcome by aspect of
      postoperative pain control, postoperative opioid consumption, postoperative bleeding, LOS and
      postoperative rehabilitation without increasing complication but the accuracy of infiltration
      technique which gives the best outcome has not been yet discovered.Recently study by
      Hashimoto et al has risen that these technique can be administrated by both periarticular and
      intra-articular approach.By considering the complexity of human anatomy around the hip tissue
      we assume that the intra-articular(transarticular) may given equivalence (may be better)
      outcome with lowering procedural related complication comparing to periarticular infiltration
      approach.
    


Intervention name(s): transarticular multimodal drug infiltration
Intervention type(s): Procedure
Intervention description(s): as described previously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total hip arthroplasty; transarticular multimodal drug infiltration; periarticular multimodal drug infiltration
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Condition: Diffuse Large B-Cell Lymphoma; POOR PROGNOSIS
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to
      dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT)
      as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI
      score
    


Intervention name(s): Rituximab; Epirubicin; Cyclophosphamide; Vincristine; Prednisone; Granulocyte-colony-stimulating factor; Mitoxantrone; Cytarabine ARA-C; Dexamethasone; Carmustine BCNU; Etoposide; Melphalan; Radiotherapy; PBSC reinfusion
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation; Procedure
Intervention description(s): 375 mg/m2 on day 1; 110 mg/m2 on day 3; 1200 mg/m2 on day 3; 1.4 mg/m2 (maximum 2 mg) on day 3; 40 mg/m2 from day 1 to 5; (G-CSF 5 μg/Kg/day) from day 5 to day 11; 8 mg/m2 for 3-day; 2 g/m2/12 hours for six doses in 3-hour infusion; 4 mg/m2/12 hours before ARA-C administration; 300 mg/m2 on day -7; 100 mg/m2/12 hours; 140 mg/m2 on day -2; Involved Field Radiotherapy (IF-RT); ASCT
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Melphalan; Carmustine; Rituximab; Etoposide; Vincristine; Epirubicin; Mitoxantrone; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Large B-cell Lymphoma; Rituximab; ASCT
Self-System Therapy for Older Adults With Lung Cancer
Condition: Lung Cancer Stage III; Lung Cancer Stage IV
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study to use Self-system therapy (SST), to treat depression and
      lung-cancer-related distress in older adults (65 years and older).
    

Detailed description: 
      The investigator will examine whether delivering the SST intervention will be both feasible
      and acceptable to study participants. The investigator will also examine whether
      participation in SST can help alleviate symptoms of depression and distress while helping
      improve overall functioning in older adults with advanced lung cancer.
    

Intervention name(s): Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
Intervention type(s): Behavioral
Intervention description(s): The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Condition: Malignant Melanoma, Neoplasms
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of
      multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of
      tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies.
      Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice
      daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will
      have the option to continue treatment with vemurafenib as part of an extension study
      (NCT01739764).
    


Intervention name(s): Tizanidine; Vemurafenib
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive tizanidine as single oral doses, 2 milligrams (mg) on Day 1 and repeated on Day 22, each following an overnight fast >/= 10 hours.; Participants will receive vemurafenib as multiple oral doses, 960 mg twice daily on Days 2 to 22.
Intervention MeSH terms: Vemurafenib; Tizanidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of a single dose of PT003 compared with
      single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two
      separate single doses in healthy subjects.
    


Intervention name(s): PT001; PT005; PT003; PT001 + PT005
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled PT001, single dose; Inhaled PT005, single dose; Inhaled PT003, single dose; Inhaled PT001 + PT005, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers
the Effect of Ozone Oil on the Postoperative Sequalae After Surgical Removal of Third Molar
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to evaluate the effectiveness of intra socket application of Ozone oil on
      postoperative pain, trismus and facial swelling following the surgical extraction of impacted
      mandibular third molars.
    

Detailed description: 
      Background: Surgical removal of impacted teeth is frequently encountered in dental clinic.
      Pain, trismus, and swelling are common postoperative sequelae for third molar surgery.
      Different methods have been used to prevent or decrease these postoperative sequelae, one of
      them is the application of Ozone oil that shows many advantages in controlling the
      inflammation, thus reducing pain, trismus and swelling. There is an evidence to suggest that
      it may have significant effects in the synthesis, release, and metabolism of a series of
      biochemical substances.

      Aim of the study: This study aimed to evaluate the effects of local application of Ozone oil
      on postoperative pain, trismus and facial swelling following the surgical removal of
      mandibular third molars.

      Materials and Methods: This triple blind randomized prospective clinical trial was performed
      during period from January 2021 until the end of July 2021, on (40) patients, age range was
      between (18-35) years, with impacted mandibular third molar in similar positions (Class I-II
      and position B, Pell and Gregory's classification). They were randomly assigned into two
      groups, 20 patients for Ozone oil group treated with topical application of Ozone oil in
      their socket, and 20 patients into the control group in which the Ozone oil syringe was
      inserted inside the patient mouth without applying the treatment. Assessment of trismus was
      done by measuring the maximum mouth opening and the swelling was assessed by measuring
      distance between five predetermined points (tragus, angle of mouth, pogonion, lateral angle
      of eye and angle of mandible). These measurements were done before surgery as a baseline
      record as well as at the second and seventh postoperative days. Pain was evaluated using
      numeric rating scale from the day of surgery until the seventh day.
    

Intervention name(s): Ozone-Based Agent; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap; In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil
Other intervention name(s): ozone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: third molar; ozone oil
An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of Spanish Black Radish on phase I and phase II enzyme
      activity in healthy adult males. The primary objective is to determine the effect on phase I
      and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite
      concentrations prior to and after a 28 day supplementation period with Spanish black radish
      product.
    


Intervention name(s): Spanish Black Radish product
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Spanish Black Radish; Phase I detoxification enzymes; Phase II detoxification enzymes; Acetaminophen
Water Drinking Test in Patients With Occludable Angle
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The water drinking test (WDT), is a predictive test that has been used to detect primary open
      angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension
      curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior
      chambers and narrow angles are highly desirable to detect patients prone to angle closure
      glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking test
      in patients with narrow angles who are scheduled for prophylactic laser iridotomy.
    

Detailed description: 
      This prospective case series will investigate the effects of the WDT on subjects with narrow
      anterior chamber angles on the day of their scheduled laser iridotomy. The angle
      configuration and IOP will be monitored following the WDT. Twenty patients with occludable
      angles will be enrolled in this study. After measuring the baseline IOP, weight and height,
      the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately
      0.33 ounces of water for every 2.2 pounds of weight or 2 ½ cups for a 150 lb. individual) and
      their IOP will be checked every 15 minutes up to one hour after drinking the water. This will
      be repeated after performing a laser iridotomy. The data obtained, mainly IOP and gonioscopic
      findings, will be analyzed using statistical tests and compared to historical controls of the
      WDT without narrow angles, and laser iridotomy subjects without the WDT.
    

Intervention name(s): Intra-ocular pressure measurement (IOP)
Intervention type(s): Other
Intervention description(s): Subjects will be given 10ml/kg of water over 15 min prior to laser peripheral iridotomy (LPI) surgery and Intra-ocular pressure (IOP) is tested every 15 min before and after surgical procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Orthostatic Hypotension Among Veterans
Condition: Hypotension, Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Hypotension
Study type: Observational

Summary: 
      Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several
      different underlying diseases, conditions, or combinations of medicines may contribute to OH;
      therefore the cause of the condition varies among individuals. Some studies have shown that
      OH is associated with an increase in the rate of death, but it is not clear what role OH
      plays in increased morbidity. By studying what the prevalence of OH is in a generalized
      veteran population we expect increase clinical awareness of the degree of the problem so that
      patient care might be improved.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Any able-bodied veteran (able to independently stand for 10 minutes) that presents for a
        routine clinical visit or a neurological clinic visit at the James J. Peters VA Medical
        Center and does not have an acute illness or infection is eligible to participate in the
        study.
      
Keywords: Hypotension, Orthostatic Hypotension