bioihbjkbjnl/mcl2 huggingface dataset:
Biomechanical Relationship Between Trunk Flexion and Mouth Opening: Pilot Study
Condition: Hamstring Injury; Temporomandibular Joint Disorders; Stretch
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of the present study is to analyze if there is a biomechanical relationship between
      trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion
      by performing the "sit and reach" test when stretching the masticatory muscles.
    

Detailed description: 
      The study design is made up of a double-blind clinical trial with 60 participants randomly
      divided into two groups of 30 people each (Treatment group and Control group). Basal
      measurements of the mouth opening were taken with a vernier caliper and the trunk flexion
      measurements were taken by means of the "sit and reach" test. These measurements were carried
      out again after the intervention, which consisted of self-stretching of the masticatory
      muscles for the Treatment group and an occlusion of the mouth for the Control group. In the
      results there was an increase in the trunk flexion compared to the initial values in both
      groups (Treatment group 2.8 (1.51), Control group 1.97 (2.31) and this increase was greater
      in the Treatment group even though the difference with the Control group was not
      statistically significant. Therefore, the stretching of the masticatory muscles does not
      cause an immediate increase in the degree of trunk flexion measured by the "sit and reach"
      test. As a consequence, we cannot confirm the existence of a biomechanical relationship
      between trunk flexion and mouth opening.
    

Intervention name(s): Self-stretching of the masticatory musculature; Control group intervention
Intervention type(s): Other; Other
Intervention description(s): If the subject belonged to the Treatment group, he was instructed to self-stretch the masticatory muscle.
This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting.; The control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The study is a prospective, multi-center, randomized, open, parallel positive control,
      non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or
      Axium Detachable Coil(Medtronic).

      The purpose of this study is to assess the safety and effectiveness of the Coil
      System(Ton-bridgeMT) in the treatment of intracranial aneurysms.
    


Intervention name(s): Coil system(Ton-bridgeMT); Axium Detachable Coil(Medtronic)
Intervention type(s): Device; Device
Intervention description(s): 1. It consists of a push system with a development mark, and a Detachable platinum-tungsten alloy coil which is connected to the push system. It can be used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.; 2. It is made up of a push system with a development mark, a platinum-tungsten alloy embolized coil connected to the push system and a manual release device for releasing the coil from the distal end of the push system. It is mainly used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem inClinical Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy
      volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ clinical
      study.
    

Detailed description: 
      A single-center, randomized, open-label, and dose escalation trial design is used in the
      multiple-dose tolerability and pharmacokinetic studies. The tolerability and pharmacokinetic
      studies are performed simultaneously. Three doses, 250 mg, 500 mg, and 1000 mg are proposed
      for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two
      groups, 12 subjects in each group, half males and half females. 250 mg group is performed
      firstly. After completion of observation and confirming that the drug can be safely
      tolerated, study on 500 mg group is then performed. After completion of observation and
      confirming that the drug can be safely tolerated, study on 1000 mg group is then performed.
      Each subject only receives one dose, intravenous drip, once daily, for 7 consecutive days.
      During the trial, close attention is paid to the tolerability of subjects, and blood samples
      4 mL is collected from cubital vein respectively before dosing, 0.25 h, 0.5 h, 0.75 h, 1 h,
      1.5 h, 2 h, 3 h, 5h, 8 h, 12 h, and 24 h after dosing on Day 1 (0 h); before dosing (0 h),
      0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 3 h, 5 h, 8 h, 12 h, 24 h, 36 h, and 48 h after
      dosing on Day 7 for pharmacokinetic study. Blood samples are collected before dosing on Day
      4, 5 and 6 to determine the trough concentration for observing the pharmacokinetic profiles
      of benapenem and its major metabolites in the body after continuous dosing. The next dose
      group can be studied only when the observation of the previous dose group is completed and it
      is confirmed that the drug is safely tolerated
    

Intervention name(s): Banapenem
Intervention type(s): Drug
Intervention description(s): Banapenem to be used anti-infection
Other intervention name(s): 5081
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 250 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed. After completion of observation and confirming that the drug can be safely tolerated, study on 1000 mg group is then performed
Masking: None (Open Label)
Primary purpose: Treatment
Beta-hCG + Erythropoietin in Acute Stroke
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients
      with acute ischemic stroke.
    

Detailed description: 
      Patients with a new stroke will be evaluated at the University of California Irvine Medical
      Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian.
      Standard stroke pathways will be used to identify such patients and to initiate standard of
      care therapy. Patients potentially eligible for study enrollment will be identified,
      screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion
      criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E
      therapy will then begin, always within 48 hours after stroke onset. This therapy will consist
      of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of
      study participation), followed by a one day washout period (day 6), followed by Epo (three
      once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation).
      Patients will be examined at several time points during therapy, as well as 6 weeks and 3
      months after stroke onset. The primary outcome measures are related to safety, while
      secondary outcome measures are related to disability, neurological status, and MRI measures.
    

Intervention name(s): Dual Growth Factor
Intervention type(s): Drug
Intervention description(s): 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Intervention MeSH terms: Mitogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke
A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of
      investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe
      pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety.
      Approximately 150 patients from the US will be enrolled in this study.
    


Intervention name(s): ARRY-371797, p38 inhibitor; oral; Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral; Placebo; oral
Intervention type(s): Drug; Drug; Drug
Intervention description(s): multiple dose, single schedule; multiple dose, single schedule; matching placebo
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; pain; NSAID
Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict
      how patients will respond to treatment and help plan the best treatment.

      PURPOSE: This clinical trial is studying lung function testing in patients with locally
      advanced or metastatic solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To obtain the distribution of DLCO, FVC, and FEV_1 by pulmonary function testing (PFT)
           in patients with heavily pretreated locally advanced or metastatic solid tumors referred
           to the Karmanos Cancer Institute (KCI) Phase I Clinical Trials Program.

        -  To estimate the mean DLCO to within 4 units (% of predicted) of the true mean with 95%
           confidence.

      Secondary

        -  To estimate the percentage of patients who meet the defined eligibility criteria
           (including PFT levels, especially DLCO) from the entire population enrolled in the KCI
           Phase I Clinical Trials Program.

      OUTLINE: Patients undergo pulmonary function testing comprising spirometry test, lung
      volumes, and DLCO measurement utilizing the single-breath breath-holding technique. Patients
      then proceed to treatment on a phase I clinical trial.
    

Intervention name(s): pulmonary function testing
Intervention type(s): Procedure
Intervention description(s): After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization.
Other intervention name(s): PFT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: unspecified adult solid tumor, protocol specific
Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
Condition: Miscarriage, Recurrent
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      To compare the abv3-integrin expression in endometrium tissue among RIF women between the
      GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B)
      and GnRH analogue alone as control group (Group C)
    

Detailed description: 
      i. To determine the abv3-integrin expression isolated from endometrium tissue from women with
      RIF prior to medical therapy.

      ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A,
      Group B and Group C following the medical therapy.

      iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B
      and C following the medical therapy.

      iv. To compare the implantation rates among Group A, B and C following the medical therapy.

      v. To compare the ongoing pregnancy among Group A, B and C following the medical therapy
    

Intervention name(s): GNRH Analoge, Duphaston, Letrozole
Intervention type(s): Drug
Intervention description(s): GNRH Analoge, Duphaston, Letrozole
Intervention MeSH terms: Letrozole; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B & C equally by using the auto-randomized program in SPSS version 21.0.
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The safety and performance of the Elaspine™ Implant System in the treatment of lower back
      pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing
      clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5
      clinical centres, including in average 10 patients per centre. The study is conducted in
      accordance with the Standard ISO 14155, where applicable on clinical investigation of medical
      devices for human subjects and other legal requirements.
    


Intervention name(s): Elaspine™
Intervention type(s): Device
Intervention description(s): Implantation of device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back Pain,; Back Pains, Low; Low Back Pains; Pain, Low Back; Pains, Low Back; Lumbago; Lower Back Pain; Back Pain, Lower; Back Pains, Lower; Lower Back Pains; Pain, Lower Back; Pains, Lower Back; Low Back Ache; Ache, Low Back; Aches, Low Back; Back Ache, Low; Back Aches, Low; Low Back Aches; Low Backache; Backache, Low; Backaches, Low; Low Backaches; Low Back Pain, Recurrent; Recurrent Low Back Pain; Low Back Pain, Postural; Postural Low Back Pain; Low Back Pain, Mechanical; Mechanical Low Back Pain; Low Back Pain, Posterior Compartment
Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is
      approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are
      equal to Glucophage is unclear.
    

Detailed description: 
      To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets
      made in Conquer pharmaceutical co., LTD and Glucophage .
    

Intervention name(s): Metformin SR Tablet
Intervention type(s): Drug
Intervention description(s): Metformin SR Tablet made in Conquer pharmaceutical co., LTD
Other intervention name(s): DuLeNing
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      post operative nausea and vomiting are very common after tympanomastoid operations, in this
      study we are investigating the effect of superficial cervical plexus block on the incidence
      and severity of those post operative complications.
    

Detailed description: 
      various treatments and regimens have been tried to overcome the problem of postoperative
      nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so
      promising in this regards as it may reduce the incidence and severity of PONV through 3
      mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the
      vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally
      through decreasing intra and post operative opioid consumption due to adequate analgesia
      which in turn avoids opioids side effects including PONV.

      the study group will receive superficial cervical plexus block while the control will receive
      the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and
      severity of PONV will be recoded according to a scale to find the difference between both
      groups.
    

Intervention name(s): ultrasound guided superficial cervical plexus block
Intervention type(s): Procedure
Intervention description(s): SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) are injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel needle Echogenic Needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study group receives superficial cervical plexus block with lidocaine and bupivacaine control group receives superficial cervical plexus block using normal saline as a placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nause, vomiting, tympanomastoid operations
Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      To investigate whether administration of calcitonin gene-related peptide (CGRP) binding
      monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating
      polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.
    

Detailed description: 
      The aim of the present study is to investigate whether

      - CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks
      in migraine without aura patients.

      Clinical and basic research have established calcitonin gene-related peptide (CGRP) as
      central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such
      as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of
      migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both
      activate adenylate cyclase upon receptor binding which causes increased formation of cyclic
      AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for
      PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP
      binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in
      migraine without aura patients is yet to be investigated.
    

Intervention name(s): Eptinezumab; PACAP-38
Intervention type(s): Drug; Drug
Intervention description(s): Eptinezumab or ALD403 is a humanized anti-calcitonin gene-related peptide IgG1 monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). It selectively binds human CGRP ligand to prevent activation of the CGRP receptor and blocks its binding to the receptor for the prevention of migraine.; PACAP-38 is a naturally occurring peptide diffusely expressed throughout the body. The Danish Headache Center has used infusion of PACAP-38 for several years and the first time in 2007 where infusion of PACAP-38 triggered headaches and migraines in migraine patients.
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled design in migraine without aura patients.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Headache; Vascular effect
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
Condition: Recurrent Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back
      into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different
      ways and stop tumor cells from growing. Giving laboratory-treated T cells together with
      aldesleukin after cyclophosphamide may be an effective treatment for melanoma.

      PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T
      cells together with aldesleukin after cyclophosphamide and to see how well they work in
      treating patients with stage IV melanoma.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients
      using autologous CD4+ and CD8+ antigen-specific T cell clones.

      II. To evaluate the antitumor effects of CD4+ and CD8+ antigen-specific T cells in patients
      with metastatic melanoma.

      III. To determine the duration of in vivo persistence of adoptively transferred CD8+
      antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells.

      SECONDARY OBJECTIVES:

      I. To assess the in vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T
      cells.

      OUTLINE: This is a phase I study followed by a phase II study.

      Beginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients
      then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2
      hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13.
      Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up weekly for 8 weeks, and then
      periodically thereafter.
    

Intervention name(s): therapeutic autologous lymphocytes; aldesleukin; cyclophosphamide; biopsy; immunohistochemistry staining method; flow cytometry; polymerase chain reaction
Intervention type(s): Biological; Biological; Drug; Procedure; Other; Other; Genetic
Intervention description(s): Given IV; Given subcutaneously; Given IV; Optional correlative studies; Optional correlative studies; Correlative studies; Correlative studies
Other intervention name(s): AL; Autologous Lymphocytes; autologous T cells; IL-2; interleukin II; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; TCGF, interleukin; CPM; CTX; Cytoxan; Endoxan; Endoxana; Enduxan; biopsies; immunohistochemistry; PCR
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment