bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
Condition: Hypertension; Menopause
Study type: Interventional

Summary: 
      We used a parallel experimental design. Following an initial screening and familiarization
      session of study tests and procedures, eligible postmenopausal women were randomly assigned
      to a stair climbing (SC) group or non-exercising control group. SC training session was
      progressive program, and was performed 4 days a week for 12 weeks. Measurements were
      collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning
      following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48
      and 72 hours after the last exercise session.
    


Intervention name(s): Stair climbing
Intervention type(s): Behavioral
Intervention description(s): Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Text Message Reminder-Recalls For Early Childhood Vaccination
Condition: Vaccination
Study type: Interventional

Summary: 
      Although the investigators have reached the Healthy People 2010 goal of 80% coverage among
      U.S. children 19-35 months of age for the primary immunization series, 20% of children still
      remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of
      vaccine preventable disease persist. Immunization reminder-recalls have been shown to be
      successful, but have been limited by the ability to identify and reach large target
      populations in a real-time, automated fashion. Reminder-recalls via text message may offer an
      innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a
      cell phone. Prior research by our team suggests that text messages reminder recalls may be an
      effective tool to remind parents about their children's vaccines. In this study, the
      investigators will demonstrate the effectiveness of tailored text message appointment and
      immunization reminders linked to a well-established and functional immunization registry to
      increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The
      investigators will target parents of young children from an underserved population that is
      primarily Latino, with low socioeconomic status.
    


Intervention name(s): Text message
Intervention type(s): Other
Intervention description(s): text message appointment and immunization reminders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Underimmunization, text message, vaccination; Underimmunization
Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy
Condition: Subacromial Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of high intensity laser therapy in
      the treatment of subacromial impingement syndrome.
    

Detailed description: 
      Shoulder pain has a high prevalence in our society, several studies estimate an annual
      prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain,
      particularly in third place, after the low back pain and neck pain.

      Symptoms of pathologies of subacromial space impingement syndrome, where, regardless of
      origin, pain is the number one symptom for the patient, which emanates functional impairment
      and the impact on quality of life. Because of the need to implement research to assess the
      effectiveness of high intensity laser therapy with new studies mayor methodological quality
      of obtaining conclusive results, and based on the scientific evidence supporting the
      low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we
      consider very interesting the realization of this research project.
    

Intervention name(s): iLux Laser; Sham ilux Laser
Intervention type(s): Device; Device
Intervention description(s): Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy)
+ Physical Therapy protocol.; Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
PERFECT Project - Part 2 - Study 1
Condition: Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objectives are to test the acute effects of different extruded pulse snacks on: 1)
      aerobic endurance and substrate oxidation during exercise 2) response of blood glucose,
      insulin and appetite on an aerobic exercise session, and 3) food intake two hours following
      the exercise session. The investigators hypothesize that consumption of food products
      containing pulse ingredients 60 minutes before exercise will increase aerobic endurance
      (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient),
      and a reduction in lactate production during compared to the same exercise session following
      the ingestion of a non-pulse food. The investigators also hypothesize that consumption of
      extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake,
      suggesting lower calorie compensation, following a 60-minute aerobic exercise session
      compared to the same exercise session following the ingestion of a non-pulse food.
    


Intervention name(s): Control; Small particle size pea flour; Large particle size pea flour; Lentil flour; Navy bean flour; Pinto bean flour
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Non pulse extruded snack; Pulse extruded snack; Pulse extruded snack; Pulse extruded snack; Pulse extruded snack; Pulse extruded snack
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes Prevention; Obesity Prevention
A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
Condition: NSCLC
Study type: Interventional
Phase: Phase 2

Summary: 
      JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced
      non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression
      on EGFR-TKI treatment：a multi-center, single arm phase II study
    


Intervention name(s): Drug intervention
Intervention type(s): Combination Product
Intervention description(s): anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess two types of new malaria vaccines in different
      combinations. The study will enable us to assess:

        1. The ability of the vaccines to prevent malaria infection.

        2. The safety of the vaccines in healthy participants.

        3. The response of the human immune system to the vaccines.

      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then
      exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under
      carefully regulated conditions. We will follow participants closely to observe if and when
      they develop malaria. If the vaccine combination provides some protection against malaria,
      participants will take longer to develop malaria than usual or will not develop malaria at
      all. We will also recruit 4 individuals to be control subjects - these participants won't
      receive any vaccinations but will be challenged with malaria.

      Vaccinated volunteers who do not develop malaria infection in the blood after being infected
      with malaria by mosquito bite the first time may be invited back to be again infected with
      malaria in a repeat challenge experiment. This would happen approximately 5-7 months after
      the first challenge. The purpose of this second challenge will be to see how long the
      protection of the investigational vaccine against malaria lasts.
    


Intervention name(s): RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01); RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01); ChAd63 ME-TRAP (5 x 10^10 vp); MVA ME-TRAP (2 x 10^8 pfu)
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Plasmodium Falciparum; Malaria; Vaccine; Plasmodium; Falciparum
Remifentanil Requirement for Acceptable Intubating Condition
Condition: Intubating Condition
MeSH terms: Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Ketamine and opioid are known to improve the intubating condition, respectively. Combination
      of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in
      complementary manner. Therefore, the combination use of ketamine and remifentanil could be
      useful for acceptable intubating condition in the general anesthesia without the use of
      neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2
      mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine
      induction dose for intubation without neuromuscular blocking agent. The investigators focus
      on remifentanil dose using Dixon's up and down method.
    


Intervention name(s): Ketamine 1; Ketamine 2; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anesthesia induction is performed with 1 mg ketamine.; Anesthesia induction is performed with 2 mg ketamine.; After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
Intervention MeSH terms: Ketamine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Achilles Tendon Length Measure (ATLM) - Development and Validation
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      The purpose of this study is 1) to develop and validate a new measurement to assess the
      length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of
      the ankle joint is a better method.
    

Detailed description: 
      It has been shown that an Achilles tendon elongation compared to the un-injured leg is
      negatively associated with the clinical outcome and strength of the gastrocnemius muscle.
      Despite this knowledge, there is a lack of a valid score system that can measure the length
      of the Achilles tendon in daily clinical practice. Patients, who follow a rehabilitation
      program at the Department of Physiotherapy, also have their Achilles tendon examined for
      lengthening by physiotherapists, to evaluate if the heeling progresses as planned. Of
      concern, this examination is based on measures, which have not been thoroughly validated.

      The ATLM test use the same test position of the lower limb as being used in Matles test.
      Besides observing the foot's position, we will measure the distance from a point of reference
      on the foot to the examination coach. Reproducibility and responsiveness of the ATLM will be
      examined, while concurrent validity will be examined against ultrasound and a goniometry
      measure. The ultrasound is considered the most precise, secure and objective measure.

      The ATLM and goniometer measures will be conducted at 8 and 16 weeks after the injury. At 8
      weeks there will be two physiotherapists conducting these measures (to investigate
      inter-tester reliability). The ruler and goniometer will have the numbers hidden. A third
      physiotherapist will read the results at 8 and 16 weeks, so that the physiotherapists will be
      blinded towards the results. A person blinded to these results will conduct the ultrasound.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an acute achilles tendon rupture, between week 8 and 16 after injury. The
        patients are participating in a rehabilitation exercise group led by a physiotherapist 2
        times a week for one hour at the time. Therefore, the patients in this study will be
        recruited from this program, and if they accept, they will be followed through the program,
        during the 2 examinations.
      
Keywords: Achilles tendon rupture, lengthening, validity, goniometer.
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
Condition: Bladder Carcinoma
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized phase II/III trial studies gabapentin in reducing the need for pain
      medication in patients with bladder cancer undergoing surgery to remove the bladder and
      nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after
      surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements
      within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured
      morphine equivalents.

      SECONDARY OBJECTIVES:

      I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24
      and 48 hours.

      II. To assess time to return of bowel function (ROBF).

      III. To assess length of stay (LOS) following RC.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery.

      ARM II: Patients receive placebo PO TID for 48 hours after surgery.
    

Intervention name(s): Gabapentin; Placebo; Questionnaire Administration
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Given PO; Ancillary studies
Other intervention name(s): Gralise; Neurontin; placebo therapy; PLCB; sham therapy
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Zostavax in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for
      the development of shingles, a painful reactivation of the varicella zoster virus that causes
      chicken pox.

      The investigators propose to study the immune response to commercially available Zostavax
      vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and
      are on mild immunosuppressant medications, and to compare the immune response to that seen in
      healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the
      study are those felt to be safe according to Centers for Disease Control guidelines.

      Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to
      receive a single, standard dose of Zostavax. Blood samples and physical examination will be
      performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants
      will receive active vaccine, there is no placebo group.
    


Intervention name(s): Zostavax vaccine
Intervention type(s): Drug
Intervention description(s): Commercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Systemic Lupus Erythematosus; Lupus; SLE; Zostavax; shingles
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
Condition: Lymphoma, Lymphoblastic
MeSH terms: Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma
      (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year
      of intensive cyclical chemotherapy with additional prophylaxis for central nervous system
      (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation
      after induction chemotherapy.
    


Intervention name(s): Dexamethasone/Prednisolone; Cyclophosphamide; Vincristine; Daunorubicin; Asparaginase; G-CSF; Mercaptopurine; Cytarabine; Methotrexate; VP16; Vindesine; Adriamycin; Thioguanine; HDARAC; CNS irradiation; Mediastinal irradiation; Cladribine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Drug
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Methotrexate; Vincristine; Doxorubicin; Daunorubicin; Asparaginase; Mercaptopurine; Thioguanine; Cladribine; Vindesine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T-LBL; Treatment; De novo; Chemotherapy; Adult; Lymphoma, lymphoblastic, T-cell
Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products
      cardiovascular risk factors in hypertriglyceridemic patients.
    

Detailed description: 
      Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart
      diseases.

      As a precondition for participating in this study, the patients were provided information in
      writing and verbally about the details of the study. Informed consent was obtained from all
      volunteers. Before the beginning of the study, all participants were subject to a medical
      examination by their general practitioners. Fifty-one hypertriglyceridemic patients (25 f, 26
      m; with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) entered the study.

      The placebo-controlled, randomized double-blind cross-over study consisted of two
      investigation periods of 15 weeks, with a ten-week washout period in between. After the
      washout period the intervention was crossed between the groups and the respective products
      were consumed for another 15 weeks. Patients received about 40 g fat daily (200 g yoghurt
      with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The
      milk fat was partially exchanged by special oils (fish oil, rapeseed oil) with high amounts
      of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA).
      The daily dose of n-3 FA amounted to 3.3 g, consisting of 1.5 g EPA, 1.2 g DHA, 0.2 g DPA,
      and 0.2 g ALA.

      Venous blood and 24h urine were collected at the beginning and at the end of each period.
    

Intervention name(s): n-3 LC-PUFA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d; dairy products without special oils
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n-3 LC-PUFA; hypertriglyceridemic; human; TAG
Effect of Passive Smoking on Platelet Function and Endothelial Function
Condition: Endothelial Function; Platelet Aggregation
Study type: Interventional

Summary: 
      Passive smoking is associated with an increased risk for cardiovascular events. However, the
      exact mechanisms by which passive smoking affects cardiovascular health are not entirely
      understood. In the present study, the researchers investigate the effects of short-term
      exposure to secondhand smoke on platelet function and peripheral microvascular endothelial
      function in healthy individuals. For this purpose, platelet function and endothelial function
      are measured before and after a 1-hour exposure to secondhand smoke in a concentration that
      is encountered in bars and restaurants without smoke-free policies. The researchers'
      hypothesis is that short-term exposure leads to platelet activation and impairment of
      endothelial function.
    


Intervention name(s): secondhand smoke exposure
Intervention type(s): Other
Intervention description(s): Participants will be exposed to secondhand smoke for one hour. As a measure of secondhand smoke exposition, room carbon monoxide concentration will be continuously measured using an Ambient Carbon Monoxide Monitor APMA-360 and kept constant between 4.5-6.0 ppm. Levels in this magnitude are typically seen in smoking areas of restaurants and bars.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Secondhand smoke; passive smoking; platelet function; endothelial function