bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in
      treating patients with acute promyelocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into
           cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by
           tretinoin maintenance therapy in patients receiving induction tretinoin and daunorubicin
           hydrochloride with acute promyelocytic leukemia (APL) induced into remission with
           tretinoin and daunorubicin hydrochloride.

        -  Determine, preliminarily, the efficacy of this strategy in inducing and maintaining
           molecular remissions in patients treated with this regimen.

      OUTLINE: This is a pilot, multicenter study.

        -  Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and
           daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days
           60-67 and proceed to consolidation therapy.

        -  Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3,
           daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once
           daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with
           clinical and/or cytogenic, but not molecular, remission receive additional arsenic
           trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical
           and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed to
           maintenance therapy.

        -  Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment
           repeats every 3 months for 8 courses (2 years).

      After completion of study treatment, patients are followed periodically for up to 5 years.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
    

Intervention name(s): arsenic trioxide; cytarabine; daunorubicin hydrochloride; mercaptopurine; methotrexate; tretinoin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Methotrexate; Mercaptopurine; Daunorubicin; Arsenic Trioxide; Tretinoin
Primary purpose: Treatment
Keywords: untreated adult acute myeloid leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; adult acute promyelocytic leukemia (M3); childhood acute promyelocytic leukemia (M3); adult acute myeloid leukemia with t(15;17)(q22;q12)
Sitagliptin and Glucagon Counterregulation
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at
      moderate hypoglycemia in metformin-treated subjects with T2DM
    

Detailed description: 
      The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by
      sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to
      explore whether DPP-4 inhibition affects glucagon counter-regulation.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg daily; Placebo one tablet daily
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting
Condition: Anxiety State; Pain; Vomiting; Nausea
MeSH terms: Pain, Postoperative; Nausea; Vomiting; Anxiety Disorders
Study type: Interventional

Summary: 
      The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital
      between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group
      and 30 in the control group, who met the inclusion and exclusion criteria.
    

Detailed description: 
      In the study, 60 patients were randomly assigned to the study and control groups. The study
      group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian
      located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris
      tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the
      thumb and the LI4 points located in the space between the index finger (between the 1st and
      2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial
      side) were applied for an average of 15 minutes. No intervention didn't made to the control
      group (n = 30). The primary outcome of the study is the effect of acupressure on the state
      and trait anxiety level of patients. The secondary outcome of the study is the effect of
      acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients
      were evaluated before and 15 minutes after acupressure application; pain levels were
      evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in
      the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first
      24 hours after surgery.
    

Intervention name(s): Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points). During the application, the most appropriate position in which the individual would be comfortable was preferred, taking into account the privacy of the individual. First of all, the supine position was preferred, and alternatively, the sitting position was preferred. At the end of the application, it was ensured that the person was in a position that he/she was comfortable.
Other intervention name(s): Acupress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain; ENT patients
Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)
Condition: Ectasia
MeSH terms: Dilatation, Pathologic
Study type: Observational

Summary: 
      To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to
      correct keratoconus on eyes with prior refractive surgery.
    

Detailed description: 
      Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery
      were studied in a nonrandomized, retrospective, observational case series. Mean age at the
      time of ICRS implantation was 30,5 years.
    

Intervention name(s): INTRASTROMAL CORNEAL RING SEGMENT
Intervention type(s): Procedure
Intervention description(s): Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients residents in Brazil with ectasia after refractive surgery
      
Keywords: INTRASTROMAL CORNEAL RING; ASTIGMATISM
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the
      effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.
    

Detailed description: 
      A total of approximately 12 healthy male and/or female participants will be enrolled in the
      study to obtain at least 10 evaluable participants who complete the study. This is an
      open-label study not requiring an assessment of efficacy or pharmacodynamics markers, but it
      will include pharmacokinetic estimation drug-drug interactions.
    

Intervention name(s): Ritlecitinib; Tolbutamide
Intervention type(s): Drug; Drug
Intervention description(s): Ritlecitinib 200 mg provided as four 50 mg oral capsules; Tolbutamide 500 mg provided as one 500 mg oral tablet
Other intervention name(s): PF-06651600
Intervention MeSH terms: Tolbutamide
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics (PK)
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with
      allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen
      that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at
      12 weeks compared to baseline will be evaluated.
    


Intervention name(s): QGE031; omalizumab; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug administered by subcutaneous injection; Drug administered by subcutaneous injection; Drug administered by subcutaneous injection
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergies, asthma, IgE
Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men
Condition: Sterility, Reproductive
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study was designed to assess the responsiveness of the hypothalamic pituitary
      gonadal axis to kisspeptin administration with increasing age in men.
    

Detailed description: 
      Little is known about the involvement of kisspeptin signalling in the causation of
      senescence-basal modulation of the GnRH-LH unit in any model and particularly in advance age
      men. The present study was therefore designed to assess the response of hypothalamic
      pituitary gonadal axis to kisspeptin administration with increasing age in healthy men.
      Sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes
      post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120).
      Kisspeptin-10 was administered (1 µg/kg BW) as an intravenous bolus, immediately after
      collecting 0 min sample to assess the response of GnRH neurons to kisspeptin-10 with
      increasing age in men by determining plasma levels of LH and testosterone.
    

Intervention name(s): Human kisspeptin-10 (metastin 45-54)
Intervention type(s): Biological
Intervention description(s): Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy men, 15 in number were selected. These individuals were classified on the basis of their ages in three groups: adult, middle age and advanced aged. Each group comprised of five participants.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aging
Parecoxib for Treatment of Catheter Related Bladder Discomfort
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the
      supra-pubic region; reported postoperatively in patients who have had urinary catheterization
      intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for
      preventing CRBD in patients undergoing catheterization after transurethral resection of
      bladder tumor (TURBT).
    

Detailed description: 
      Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous
      parecoxib 30 min before surgery and Control Group C: an equal volume of saline.

      Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg
      Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's
      catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at
      0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD
      was graded as none, mild, moderate and severe.
    

Intervention name(s): Parecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg of intravenous parecoxib 30 min before surgery; An equal volume of saline
Other intervention name(s): DYNASTAT; Saline
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Parecoxib; Bladder Discomfort
Effectiveness of Neuromuscular Kinesiology Taping in Plantar Fasciitis
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      One of the pathologies most studied and treated with kinesiotape (KT) is plantar fasciitis
      (PF). In most of the studies reviewed, it is concluded that there is an improvement in the
      symptoms of PF when treated with KT: either combined with other therapies or as a single
      treatment compared to placebo. However, most current studies have limitations because the
      sample is small, the effect size is small, and the evidence is insufficient or of low
      quality.

      In the present work, the aim is to study the effectiveness of KT in PF, and to compare the
      results with those obtained in a placebo group, which is treated with tape. The researchers
      will assess the decrease in symptoms prior to performing other definitive treatments. In
      addition, the variability of the painful symptoms and the durability of the bandage will be
      studied, in order to determine whether it can be used in the short or long period of time,
      being able to take it into account and supposing a supplement to the pharmacological
      treatment.
    


Intervention name(s): Kinesiotaping; Tape
Intervention type(s): Other; Other
Intervention description(s): Perform a neuromuscular bandage with kinesiotape in patients with plantar fasciitis; Perform a neuromuscular bandage with tape (Hipofix(R)) in patients with plantar fasciitis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery
Condition: Enhanced Recovery After Surgery; Anesthesia; Surgery-Complications; Colorectal; Early Mobilization
Study type: Observational

Summary: 
      Early mobilization is an important factor in increasing postoperative colorectal surgeries
      outcome. There are four components held by anesthesiologist in Enhanced Recovery After
      Surgery protocol for colorectal surgery in our hospital: post operative nausea and vomiting
      (PONV) prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and
      postoperative opioid-free pain management. Although early mobilization affected by
      postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is
      no clear evidence of how much each of these components will affect early mobilization.
    

Detailed description: 
      Early mobilization is an important factor in increasing postoperative colorectal surgeries
      outcome. There are four components held by anesthesiologist in ERAS protocol for colorectal
      surgery in our hospital: PONV prophylaxis, intraoperative fluid management, intraoperative
      multimodal analgesia, and postoperative opioid-free pain management. Although early
      mobilization affected by postoperative pain, vomiting and nausea, and fluid balance
      management, nonetheless, there is no clear evidence of how much each of these components will
      affect early mobilization. This study was a retrospective cohort study by collecting
      secondary data from patients underwent elective colorectal surgery in our hospital from
      January 2020 to December 2022. The outcomes assessed were early mobilization rate and factors
      affecting it (PONV prophylaxis, intraoperative fluid management, intraoperative multimodal
      analgesia, and postoperative opioid-free pain management).
    

Intervention name(s): Early mobilization; No early mobilization
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients who received early mobilization in postoperative period; Patients who did not receive early mobilization in postoperative period
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients underwent colorectal surgery in Cipto Mangunkusumo Hospital during 2020 to
        2022
      
Keywords: early mobilization; Enhanced Recovery After Surgery; PONV prophylaxis; fluid management; pain management
Educational Video's Impact on Knowledge Regarding Cervical Cancer Screening
Condition: Human Papilloma Virus; Cervical Dysplasia
MeSH terms: Uterine Cervical Neoplasms; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      The researchers will be conducting a prospective randomized trial where the researchers will
      be introducing an educational video to see whether there is an increase in knowledge scores
      surrounding cervical cancer, cervical cancer screening, and prevention with HPV vaccinations.
    

Detailed description: 
      The researchers are conducting a single-blinded randomized controlled trial. All patients who
      meet exclusion criteria will be recruited at the time of their visit where a Pap smear will
      be collected at an ob/gyn clinic. If patients agree to participate in the study, they will be
      randomized into one of two arms. A control arm or an interventional arm. The control arm just
      includes physician counseling regarding cervical cancer screening/prevention, while the
      interventional arm includes patient's watching a video on cervical cancer
      screening/prevention as well as physician counseling. Patient will be administered a survey
      before and after to assess knowledge and satisfaction scores.
    

Intervention name(s): Educational video
Intervention type(s): Other
Intervention description(s): Intervention is a 10-minute animated video that explains cervical cancer screening and prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: cervical cancer screening; pap smear; HPV vaccination
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to
      Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced
      Migraine-like Attacks in Migraine Patients.
    


Intervention name(s): Erenumab; Placebo; PACAP-38 Challenge Agent
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered once on day 1 of Part B of the study by intravenous infusion.; Administered once on day 1 of Part B of the study by intravenous infusion.; Administered by intravenous infusion during Part A of the study for dose selection for Part B.
Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
Other intervention name(s): AMG 334; Aimovig™; Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide; Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Migraine; Headache; Migraine Headache; Headache, Migraine; Amgen
Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, caused by dengue viruses, is a major health problem in the tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of
      morbidity and mortality in several of the world's tropical and subtropical regions. The
      rDEN2/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective
      against dengue virus serotype 2 (DEN2). The purpose of this study is to evaluate the safety
      and immunogenicity of the rDEN2/4delta30(ME) vaccine in healthy adults.

      This study will last approximately 5 to 7 months with 25 study visits. Participants will be
      randomly assigned into one of two cohorts. Participants in Cohort 1 will receive an injection
      of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 180. Participants in Cohort 2 will
      receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 120. Participants
      will be asked to record their temperature in a diary for 16 days after each vaccination. At
      each study visit a physical examination, symptom history, and blood and urine collection will
      occur.
    

Intervention name(s): rDEN2/4delta30(ME) vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10^3 PFU dose; placebo for rDEN2/4delta30(ME) vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK)
Condition: ADHD
Study type: Observational

Summary: 
      Investigate the hypothesis that children with ADHD have difficulty with the allocation of
      visio-spatial attention related to an inability to control posterior alpha brain
      oscillations. A paradigm will be used in which the aim is to address covert attention as
      similar recent studies did in adults with ADHD.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ADHD vs no ADHD
      
Keywords: Alpha; Lateralization; Attention; ADHD; Oscillation