bioihbjkbjnl/mcl2 huggingface dataset:
Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer
Condition: Cervical Cancer; Ovarian Cancer; Sarcoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Sarcoma; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer
      may help in planning cancer treatment and improve the quality of life of future cancer
      survivors.

      PURPOSE: This research study is looking at ways to improve employment in patients who have
      survived cervical cancer, uterine cancer, or ovarian cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Conduct formative work, including 4 to 5 focus groups, leading to development of a
           structured interview instrument assessing factors related to employment outcomes among
           women with gynecologic cancers.

        -  Pilot a recruitment strategy and administer the interview among a sample of 60 to 70
           gynecologic cancer survivors; and, with each woman's permission, a family member, a key
           health care provider, and her supervisor will be interviewed.

      OUTLINE: This is a multicenter, pilot study.

      Patients complete a survey, meet with a focus group, and undergo a short interview.
      Patient-designated participants are also interviewed; these individuals may include a health
      care provider, a significant other, and/or a work supervisor.

      PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
    

Intervention name(s): counseling intervention; study of socioeconomic and demographic variables
Intervention type(s): Other; Other
Primary purpose: Other
Keywords: recurrent cervical cancer; stage 0 cervical cancer; stage IA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer; recurrent uterine sarcoma; stage I uterine sarcoma; stage II uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma; ovarian stromal cancer; recurrent ovarian epithelial cancer; recurrent ovarian germ cell tumor; stage I ovarian epithelial cancer; stage I ovarian germ cell tumor; stage II ovarian epithelial cancer; stage II ovarian germ cell tumor; stage III ovarian epithelial cancer; stage III ovarian germ cell tumor; stage IV ovarian epithelial cancer; stage IV ovarian germ cell tumor
Upper Limbs Intervention in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact
      and economic consequences. It is caused by damage to the myelin sheath, the protective
      covering that surrounds nerve cells. Different areas are affected, including manual
      dexterity, strength, coordination and function. The objective of this study is to evaluate
      the improvement in these variables in patients with multiple sclerosis after a 8-weeks
      intervention focused on upper limbs.
    

Detailed description: 
      The total estimated prevalence rate of multiple sclerosis has been reported to be 83 per 100
      000 for the past three decades. It is also higher in northern countries and between females
      with a male ratio around 2.0. The highest prevalence rates have been estimated for the age
      group 35-64 years. The estimated European mean annual Multiple Sclerosis incidence rate is
      4.3 cases per 100 000.

      Multiple sclerosis can cause a variety of symptoms: hypoesthesia, muscle weakness, abnormal
      muscle spasms, or difficulty moving; difficulties with coordination and balance; dysarthria,
      dysphagia, visual problems fatigue and acute or chronic pain syndromes, bladder and bowel
      difficulties,cognitive impairment, or emotional symptomatology. The investigators focus on
      the benefits of an intervention on dexterity, strength, coordination and functionality.
    

Intervention name(s): Upper limbs intervention; Usual treatment
Intervention type(s): Other; Other
Intervention description(s): An 8-week intervention with different exercises will be performed. This intervention will focus on upper limbs. The exercises will include plaster of resistance, elastic bands and other exercises.; Occupational therapy and physiotherapy, twice a week, as usual.
Other intervention name(s): Exercise program; Standard treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Dexterity; Upper limbs
Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer; Chemotherapy Effect
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, open-label, single-center prospective phase II study to evaluate the
      efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in
      patients with advanced colorectal cancer. The primary end point is progression free survival
      (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in
      previous treatment and could not receive the target therapy presently are planned for
      recruitment. For patients with metastatic colorectal cancer who met admission criteria,
      oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated
      every 6 weeks. The treatment continues until the disease progression or the untolerable
      adverse reaction.
    

Detailed description: 
      The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.

      Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
    

Intervention name(s): the rechallenge regimen
Intervention type(s): Drug
Intervention description(s): XELOX regimen: Oxaliplatin 130mg/m2, intravenous, on day 1; Capecitabine 1000mg/m2, oral, twice daily, continuously for 14 days; ±bevacizumab 7.5mg/kg, intravenous, on day 1; repeating every 3 weeks. FOLFOX regimen: Oxaliplatin 85mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. FOLFIRI regimen: Irinotecan 180mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours; ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Irinotecan monotherapy regimen: Irinotecan 180mg/m2 on day 1, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Raltitrexed contained regimen: Raltitrexed 3mg/m2 on day 1; ± Bevacizumab 7.5mg/kg, repeating every 3 weeks; Raltitrexed 2mg/m2 on day 1; ± Cetuximab 500mg/m2, repeating every 2 weeks.
Other intervention name(s): reintroduction of the former regimens in the third or later line treatment even after the same treatment had shown drug-resistance in the former setting
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: investigator chose the optimal reintroduction regimen for chemotherapy according to criteria
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy
      Japanese adults.

      The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA
      vaccine candidate against COVID-19:

        -  As 2 doses, separated by 21 days

        -  At a single dose level

        -  In adults 20 to 85 years of age
    

Detailed description: 
      From protocol amendment 3, this study is transitioned from a clinical trial to a
      postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was
      approved by the Ministry of Health, Labour and Welfare on 14 February 2021.
    

Intervention name(s): BNT162b2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): BNT162b2 (intramuscular injection); Placebo (intramuscular injection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Loading Gait in Spatic Cerebral Palsy
Condition: Spastic Hemiplegic Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to observe the behavior of kinematic variables in children with
      spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with
      ankle loading.

      The children underwent a single treadmill training session with ankle loading. The kinematic
      parameters were assessed in three phases: before training (PRE); immediately after training
      (POST); and 5 minutes after the end of training (FOLLOW UP).

      The investigators hypothesized that the treadmill gait training with additional lower limb
      loading would be a disturbance capable of modifying the locomotor strategy of children with
      SHCP, by the increase in kinematic parameters in the swing phase of gait.
    


Intervention name(s): Single treadmill gait training with additional loading
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Gait; Weight Bearing; Rehabilitation
Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, fixed-sequence, Phase 1 study in healthy adult
      participants to evaluate the effect of AGMB-129 200 mg twice daily (BID) on the PK of a
      single dose of MDZ in healthy participants.

      A total of 14 participants will be enrolled and will receive study intervention in a
      fixed-sequence scheme. All IP will be administered orally and in fed conditions.

      The total duration of involvement for each participant, screening through follow-up, will be
      approximately 6 weeks.
    


Intervention name(s): AGMB-129; MDZ
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Pre-filled oral syringes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Brain Energy and Cognition
Condition: Energy Restriction; Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This proposed laboratory study will extend previous findings on relationships between
      cognitive function and nutritional status to conditions that more closely resemble military
      operations where aerobic exercise, inadequate nutritional intake and sleep deprivation
      combine to degrade cognitive function. The investigators will examine cognitive function,
      brain activity and glucose levels in volunteers who are calorie-deprived, performing high
      workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for
      approximately 48 hours. A comprehensive cognitive test battery will be repeatedly
      administered and several cognitive tests will be administered when volunteers are exercising.
      Interstitial glucose levels will be assessed and whole body nitrogen utilization determined.
      The effects of energy restriction and the physiological basis of the relationship between
      peripheral glucose levels and cognitive function will be examined using a state-of-the-art
      imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow
      any key brain regions affected by caloric deprivation to be identified.
    


Intervention name(s): Sleep Deprivation; Energy Restriction
Intervention type(s): Other; Other
Intervention description(s): Sleep Deprivation; Energy Restriction
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: energy restriction; sleep deprivation; cognitive performance; brain function
Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
Condition: Diabetes Melliuts, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a trial in obese subjects who have poor lipid control with and without Type 2
      diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of
      PF-05231023
    


Intervention name(s): Placebo; 25 mg PF-05231023; 50 mg PF-05231023; 100 mg PF-05231023; 150 mg PF-05231023
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks; 25 mg IV once a week for 4 weeks; 50 mg IV once a week for 4 weeks; 100 mg IV once a week for 4 weeks; 150 mg IV once a week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; safety; multiple dose; intravenous
A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study to will compare the blood levels of sildenafil following administration of an
      experimental tablet vs. the conventional oral tablet.
    


Intervention name(s): Sildenafil; Sildenafil; Sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Dose of 50 mg Sildenafil Oral Tablet With Water; Single Dose of 50 mg Sildenafil Experimental Tablet With Water; Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sildenafil, Pharmacokinetics, Healthy Volunteer
Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Condition: Obstetrical Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and
      was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur
      within 4 h of delivery and are a result of problems during third and fourth stages of labor.
      It also contributes significantly to serious maternal morbidity. Obstetric, surgical and
      radiological interventions play central role in the management of obstetric hemorrhage;
      however, pharmacologic management and in particular prohemostatic therapies also play an
      important role in the final maternal outcome. Administration of tranexamic acid (TA),
      intravenously in the third stage of labor may be one of these methods.

      TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly
      inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.
      TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In
      nonobstetric surgery, a systematic review of randomized controlled trails showed that
      tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI
      0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95%
      CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].

      In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and
      is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding
      associated with pregnancy (placental abruption, placenta previa) has also been treated with
      TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum
      hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is available
      evaluating the effect of TA use to prevent bleeding in the postpartum period following
      spontaneous vaginal delivery [12].

      The purpose of our study was to estimate the effect of the addition of intravenous TA to a
      standard active management of the third stage of labor (which includes prophylactic injection
      of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and
      controlled cord traction).
    


Intervention name(s): transamin
Intervention type(s): Drug
Intervention description(s): TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia in Remission
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional

Summary: 
      Sixty patients with AML from both sexes aged from 35-45 years were selected from hematology
      department in Nasser Institute Hospital where the study was conducted. Patients were randomly
      assigned into two groups equal in number. Group (A) underwent aerobic exercises in the form
      of cycling with 50-60% of maximum heart rate. Group (B) underwent resistive training
      conducted in the form of a series of exercises using free weights, and dumbles. Sessions were
      conducted three times /week for eight weeks. Six minutes' walk test (6MWT), 10 repetitions
      maximum test (10 RM), ventilatory function test, fatigue and quality of life (QOL) scales
      were used to assess functional capacity in both groups.
    

Detailed description: 
      Aerobic Ex Group: Included 30 patients who underwent aerobic training with 50 %-60% of
      maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three
      sessions/week.

      Resistive Ex Group: Included 30 patients who underwent a resistive training which were
      conducted in the form of a series of exercises using free weights, and dumbles to increase
      the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients
      carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60
      seconds for each muscle group and rested 1-2 min between series. Sessions were conducted
      three sessions/week for eight weeks.
    

Intervention name(s): Aerobic exercise
Intervention type(s): Other
Intervention description(s): resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.
Other intervention name(s): Resistive exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel randomized single blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Lyme Neuroborreliosis
Condition: Lyme Neuroborreliosis
MeSH terms: Lyme Neuroborreliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine whether four weeks treatment with oral
      doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in
      patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics
      of Lyme neuroborreliosis and further define the manifestations and epidemiology of the
      disease in Finland.
    


Intervention name(s): Doxycycline; Ceftriaxone
Intervention type(s): Drug; Drug
Intervention description(s): Doxycycline: 100mg tablet two times per day, four weeks; 2 g intravenous once a day, three weeks
Intervention MeSH terms: Doxycycline; Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: doxycycline; ceftriaxone
POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, randomized, multi-center, active-controlled parallel-comparison of
      POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary
      open-angle glaucoma.
    


Intervention name(s): POLAT-001; Latanoprost ophthalmic solution
Intervention type(s): Drug; Drug
Intervention description(s): Subconjunctival injection; Latanoprost ophthalmic solution q.d., evening
Intervention MeSH terms: Ophthalmic Solutions; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy
      with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain
      distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower
      extremities, or patients with idiopathic distal predominantly sensory neuropathy participated
      in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful
      diabetic neuropathy or idiopathic distal sensory neuropathy.
    


Intervention name(s): Lidoderm
Intervention type(s): Drug
Intervention description(s): Patients participated in an 8-week treatment period; patients at one site were to continue treatment for the entire 8 weeks while patients at two sites were to terminate treatment after 3 weeks. Commercially available Lidoderm® (lidocaine patch 5%) was provided to each patient with up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain.
Other intervention name(s): Lidocaine Patch 5%
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment