bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles
Condition: Abdominal Muscles
Study type: Interventional

Summary: 
      This study evaluates the effect of a rotation based exercise program on core muscle
      thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment
      tool to identify muscle thickness changes. Half of participants receive the rotation based
      exercises, while the other half perform a traditional core exercise program. It was
      hypothesized that the rotation based exercises would result in greater changes in muscle
      thickness.
    

Detailed description: 
      A number of exercise programs and assessment tools have been evaluated for their ability to
      influence and measure the core muscles. Inefficient stability and asymmetrical muscle
      activity of the core have been linked to a wide range of lower extremity injuries. Training
      of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is
      a widespread clinical practice, however valid and reliable assessment tools and effective
      intervention protocols are lacking. This study uniquely uses both a clinical assessment tool
      and musculoskeletal ultrasound to measure changes in the core muscles following an exercise
      intervention. The overall purpose of this study was to design a valid and reliable assessment
      tool and an effective training protocol to activate the core muscles.
    

Intervention name(s): Rotation Exercises; Control Exercises
Intervention type(s): Other; Other
Intervention description(s): The subjects received 7 trunk rotation stability exercises x 10 reps each; The subjects received 7 traditional exercises x 10 reps each
Other intervention name(s): Sling Activation Session; Traditional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
Condition: Prostate Cancer; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate
      cancer.

      It is the consequence of penile vascular damage, mainly arterial insufficiency and venous
      leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells,
      including mesenchymal cells, smooth muscle cells and endothelial is believed to play an
      important role in the pathophysiology of post prostatectomy erectile dysfunction.

      Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the
      damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells,
      endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC
      may therefore find application in the treatment of post prostatectomy erectile dysfunction.

      The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC
      injection and to evaluate benefit for the patient concerning recovery of natural erection.
      Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer
      (considered as cured by radical prostatectomy) will be included in this study.

      Four different doses of BMMNC will be tested.
    

Detailed description: 
      We have shown in a rat model of post prostatectomy erectile dysfunction that BMMNC injection
      replace apoptotic cavernous cells and restore erectile function.

      In the pig, the injection of high dose of BMMNC into the corpus cavernosus does not cause
      side effect. Moreover, the BMMNC remains at the injection site.
    

Intervention name(s): injection of bone marrow mononucleated cells
Intervention type(s): Biological
Intervention description(s): Four different concentration of BMMNC will be tested in four groups of 3 patients. In group 5 (n=19): one cell concentration corresponding to the best dose determined by analysis of the previous groups will be tested.
Other intervention name(s): cell therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radical prostatectomy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to monitor clinical status, adverse events and laboratory
      investigations and assess relative safety and tolerance of Atorvastatin formulations under
      fasting conditions.
    

Detailed description: 
      An open-label, randomized, single oral dose, two way crossover bioequivalence study to
      compare Atorvastatin Calcium 40 mg Tablets of Dr.Reddy's with Lipitor® 40 mg Tablets of
      Pfizer in 74 healthy, adult, human study participants under fasting conditions.
    

Intervention name(s): Atorvastatin Calcium Tablets, 40 mg
Intervention type(s): Drug
Intervention description(s): Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Lipitor® 40 mg Tablets
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Atorvastatin calcium; crossover
The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to determine the effects of drinking
      eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal
      blood pressure.
    

Detailed description: 
      Visit 1

      -

      Beginning of the first four weeks:

      Upon arrival, subjects will be given a consent form to sign. The student investigators will
      go over the layoutof the research study such as the procedures, and compliance with them.
      Then, subjects will be asked if they agree with drinking orange juice daily for two months.
      If they agree, they will be asked to relax for five minutes, and the student investigators
      will take their blood pressure reading three times using a blood pressure monitor. The
      subjects will complete the Perceived Stress Scale (PSS) survey before leaving. The subject
      will drink orange juice for 28 days.

      •

      Visits 2, 3, and 4:

      Subjects will meet with the student investigators at a convenient location. Subjects will be
      asked to rest for five minutes. Student investigators will then take their blood pressure
      reading three times using a blood pressure monitor. The subjects will complete the PSS survey
      before leaving.

      •

      Between visit 2 and 3:

      There is a washout period of approximately eight weeks. • During the first and second set of
      the 4

      -week intervention phase, subjects will visit student investigators to retrieve orange juice
      samples every 3 or 4 days.
    

Intervention name(s): fresh orange juice; concentrated orange juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The fresh oranges will be bought from Sysco. They will be squeezed at the kitchen of School of Allied Health Professional with a juicer. They will either be squeezed the night before or on the same day. The juice will not be treated with additional preservatives or sugar. The brand of the juicer is Kitchen Aid. Eight ounces of fresh orange juice needs approximately two and half oranges. They will be put into 32 oz water bottles that were bought from Sysco, and then store them in the refrigerator. They will be given to the subjects every three or four days.; The concentrated orange juice will be bought from Sysco then reconstituted. One part of concentrated orange juice needs four parts of water to reconstitute. Then, it will be measured and the reconstituted orange juice will be put into 32 oz water bottles that we bought from Sysco. They will be stored in the refrigerator. The subjects will need to get the reconstituted orange juice every three or four days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the seropersistence of TBE antibodies in children and
      adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34
      months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations
      during the predecessor study 209), as well as the immune response to a booster vaccination
      with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third
      vaccination (in Study 209).

      Protocol amendment of October 2006: The study has been prolonged for children and adolescents
      who still showed highly positive TBE virus antibody concentrations at approximately 3 years
      after the third vaccination and therefore did not receive a booster vaccination at this time
      point. Further follow-up of TBE antibody persistence is now included for these subjects at 46
      and 58 months after the third vaccination (in Study 209), as well as a booster vaccination
      offered at either 48 or 60 months after the third vaccination (in Study 209), depending on
      individual TBE antibody levels.
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Intervention description(s): Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tick-borne encephalitis
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
Condition: Atherosclerosis of Arteries of the Extremities, Unspecified
MeSH terms: Atherosclerosis; Plaque, Atherosclerotic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical
      use
    

Detailed description: 
      Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is
      a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been
      reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques
      in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been
      investigated in clinical use.
    

Intervention name(s): GSPE; lifestyle intervention
Intervention type(s): Drug; Other
Intervention description(s): GSPE 240 mg/day (120mg bid); dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity
Other intervention name(s): Grape seed proanthocyanidin extrat
Intervention MeSH terms: Proanthocyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: proanthocyanidin,atherosclerosis, carotid plaque
S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Adenocarcinoma, Bronchiolo-Alveolar
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop
      the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with
      bevacizumab may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab
      works in treating patients with stage III or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine overall survival of patients with stage IIIB or IV bronchioloalveolar
           carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride
           and bevacizumab.

      Secondary

        -  Determine the progression-free survival of patients treated with this regimen.

        -  Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed
           by a central computer-assisted image-analysis system in patients with measurable disease
           treated with this regimen.

        -  Assess the frequency and severity of toxicities of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over
      30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; erlotinib hydrochloride
Intervention type(s): Biological; Drug
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; bronchoalveolar cell lung cancer; adenocarcinoma of the lung
The PrEP (Pre-exposure Prophylaxis) SMART Study
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The PrEP SMART study is testing a stepped model of scalable adherence support strategies in
      South African young women who initiate PrEP using a SMART (sequential multiple assignment
      randomized trial) design.
    

Detailed description: 
      Women enrolled in the study will be randomized to standard of care adherence support (brief
      counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP
      initiation, tenofovir drug levels will be measured to determine if participants have achieved
      high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP
      >/=500 fmol/punch from dried blood spots [DBS]) will continue with the adherence support to
      which they were initially randomized. Participants with low adherence (i.e., TFV-DP <500
      fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be
      randomized to more one of two more intensive adherence support interventions - continued
      monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly
      visits between months 3-9 with feedback about adherence based on drug levels at months 3 and
      6.
    

Intervention name(s): WhatsApp Group; 2-way SMS; Drug level feedback; Monthly counseling sessions
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive peer adherence support through WhatsApp groups; Participants will receive healthcare worker adherence support through 2-way SMS; Participants will receive adherence counseling based on tenofovir drug levels; Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential multiple assignment randomized trial (SMART)
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: pre-exposure prophylaxis; young women; HIV infections/prevention; SMART design
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      This study aims to compare the effects of two water-based training models in physiological
      parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will
      be conducted in parallel with the participation of 45 dyslipidemic elderly women.
    

Detailed description: 
      The women will be randomly divided into three groups: water aerobics training (WA),
      resistance aquatic training (WR) and the third is the control group (who will perform
      relaxation sessions under water). The three groups will attend classes during 10 weeks, with
      two weekly sessions of 45 minutes each. The WA and WR groups will use the same four exercises
      in their training.

      The WA group will be trained using the interval method, performing six blocks of five minutes
      each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart
      rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities
      between 80 and 90% HRVT2.

      The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always
      at maximal speed execution of the exercises.

      Will be measured, before and after the period of 10 weeks of intervention, biochemical,
      cardiorespiratory, neuromuscular and hemodynamic variables, parameters of quality of life and
      depressive symptoms in addition to the cardiovascular risk score of the participants of the
      three groups.

      Data will be described by means values and lower and upper limits, with a 95% confidence
      interval. Comparisons between and within groups were performed using the method of
      generalized estimates of equations (GEE), with Bonferroni post hoc, adopting a 0.05
      significance level.
    

Intervention name(s): Water aerobics training.; Water resistance training.; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): The WA group will be trained adopting the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2.; The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises.; The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
Other intervention name(s): WA; WR; CG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dyslipidemias,; aging; water aerobics training; resistance aquatic training; lipid profile
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety
      and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg
      mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
    

Detailed description: 
      This is a double-blind, randomized, multi-center, multi-national, active-control study in
      patients who are experiencing a moderately active flare of UC. Patients will be randomly
      assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg
      tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1
      ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day
      (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population.
      Following successful screening, patients will be randomized to one of the two treatment arms.
      Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.
    

Intervention name(s): Mesalamine
Intervention type(s): Drug
Intervention description(s): Asacol 400g/day (400 mg tablet), oral, for 6 weeks
OR
Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ulcerative colitis, inflammatory bowel disease
The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the effects of combined administration of mosapride
      as modulator of gastrointestinal motility and DPP-4 inhibitor on secretion of gut hormone
      such as glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), and oral
      glucose tolerance. Additionally, change in lipid profile and insulin secretion will be also
      assessed.
    

Detailed description: 
      This is randomized, double-blind, placebo-controlled, cross-over study. After screening and
      enrollment, participants will take 5 mg of linagliptin once a day for one week of run-in
      period (Day 1 to Day 7). Randomization will be done on Day 8 to assign the participants to
      either mosapride arm or placebo arm. If a subject is assigned to mosapride arm, mixed meal
      tolerance test (MMTT) will be performed after taking mosapride with linagliptin. If a subject
      is assigned to placebo arm, he/she will take placebo instead of mosapride before MMTT. On Day
      9, all subjects will be crossed over to the other arm and MMTT will proceed with medication
      depending on their arms. Gastric emptying time measurement with paracetamol will be done
      along with MMTT. Plasma incretin hormone levels in two arms will be compared.
    

Intervention name(s): Mosapride citrate; Linagliptin; Acetaminophen (paracetamol)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On the day of MMTT, 1 tablet (5 mg) of mosapride will be administered orally to participants of 'mosapride' arm. After 1 hour, MMTT will be performed.; During run-in period, 1 tablet (5mg) per day will provided for 7 days. On the day of MMTT, 1 tablet (5 mg) of linagliptin will be administered orally to participants of both arms. After 1 hour, MMTT will be performed.; On the day of MMTT, 3 tablets (1500 mg) of acetaminophen (paracetamol) will be administered orally to participants of both arms at the start of MMTT with manufactured mixed meal (0 min).
Other intervention name(s): Gasmotin®; Trajenta®; Tylenol®
Intervention MeSH terms: Acetaminophen; Linagliptin; Mosapride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Gastric Emptying; Gastrointestinal Motility; Incretins; Glucagon-Like Peptide 1; Diabetes Mellitus