bioihbjkbjnl/mcl2 huggingface dataset:
The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to estimate the drug interaction between RIF and ABT. This will be a
      single-center, open-label, parallel study in healthy adult subjects.
    

Detailed description: 
      The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following
      administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8
      (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and
      receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).
    

Intervention name(s): ABT; RIF
Intervention type(s): Drug; Drug
Intervention description(s): 320 mg, Intravenous infusion; 600mg q.d.
Other intervention name(s): albuvirtide; rifampicin
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore the efficacy of paliperidone palmitate administered
      as a once monthly injection in patients with an acute exacerbation of schizophrenia.
    

Detailed description: 
      This is an open-label (patients and study staff will know the identity of treatments
      assigned) study of paliperidone palmitate in patients with acute an exacerbation of
      schizophrenia. The total duration of the study will be approximately 4 months. Eligible
      patients without a documented history of exposure to oral risperidone or paliperidone
      extended-release (ER), or intramuscular (IM) RISPERDAL CONSTA or paliperidone palmitate will
      receive oral risperidone 1 mg/day or extended release (ER) OROS paliperidone 3 mg/day for at
      least 3 days before the first injection of the study drug (paliperidone palmitate) for
      tolerability testing. Paliperidone palmitate will be administered to patients as an
      intramuscular (IM) injection in the deltoid (upper arm) or gluteal (buttocks) muscle.
    

Intervention name(s): Paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): Type=exact number, unit=mg, number=150, 100, 75 mg equivalent (eq), form=suspension for injection, route=intramuscular use. One IM injection of 150 mq on Day 1, 100 mg eq. on Day 8 (+/- 4 days), and 75 mg eq. is recommended on Days 36, 64, and 92.
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone palmitate; Long-acting injectable antipsychotic medication
Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma
Condition: Ovarian Adenocarcinoma; Fallopian Tube Adenocarcinoma; Primary Peritoneal Carcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few
      studies have been published on the use of HCIP in peritoneal carcinosis from ovarian
      background but most of them were non-randomized phase II studies on a small population using
      different type of drugs and dosage. before this heterogeneity it seems necessary to
      standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian
      background
    


Intervention name(s): Cisplatin; Bevacizumab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Corpus Luteum and Uterine Artery Doppler With Serum P and CA125 in Threatened Abortion
Condition: Threatened Abortion
MeSH terms: Abortion, Threatened
Study type: Observational

Summary: 
      The purpose of this study is to determine whether assessing color doppler of corpus luteum
      and uterine artery is useful in predicting patients who will complete pregnancy. The
      investigators will add to this the usefulness of serum progesterone and CA125 in prediction.
    

Detailed description: 
      The introduction of Doppler ultrasound in obstetrics has allowed evaluating hemodynamic
      characteristics from the first trimester of pregnancy. For example, Kurjak et al.,in one of
      the first studies using transvaginal pulsed-wave Doppler ultrasound in early pregnancies,
      identified the uterine arteries in 100% of the patients. The flow blood of the corpus luteum
      was identified in 75% patients. The measures obtained by Doppler ultrasonography that may
      have prognostic value to the evolution of pregnancy include uteroplacental blood flow, also
      known as trophoblastic flow. Jaffe et al. reported that abnormal Doppler findings were
      associated with a significantly higher prevalence of complicated pregnancies, among women
      with abnormal Doppler findings, 43% ended in miscarriage, whereas among women with normal
      findings only 1.4% of women miscarried.Progesterone plays a crucial role in the maintenance
      of pregnancy. In the presence of sufficient progesterone levels during pregnancy, lymphocytes
      synthesize a mediator called progesterone induced blocking factor (PIBF), which is
      anti-abortive in mice . Besides inducing secretary changes in the endometrium and supporting
      early pregnancy, it modulates the maternal immune response to prevent fetal rejection and
      relaxes the uterine smooth muscles .CA-125, well-known as a tumor marker for epithelial
      ovarian cancer , is a high molecular weight glycoprotein that is produced not only by ovarian
      cancer, but also by nonovarian tumors, normal epithelia of the peritoneum, the endometrium,
      the fallopian tube, and the ovary. Because CA-125 is also produced by the endometrium, some
      authors suggest that CA-125 can be used as a marker for endometrial receptivity in patients
      undergoing IVF . Its role as a predictor for pregnancy outcome is controversial .
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant females >8 weeks but < 20 weeks gestation. They are presenting with a complaint of
        threatened abortion to our outpatient ANC clinic.
      
Keywords: CA 125; Progesterone; Doppler; Corpus Luteum
The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise
Condition: Osteoporosis; Osteopenia; Sarcopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Sarcopenia
Study type: Interventional

Summary: 
      Performing adduction and abduction resistance exercise will increase hip bone density and
      strength to a greater extent than doing squat and deadlift exercise.

      Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16
      weeks improves spine bone mineral density and hip bone mineral density and strength as
      determined by finite element modeling.

      Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift
      exercise with respect to potential changes in hip bone mineral density and strength.

      Aim #3: To determine if the addition of adduction and abduction exercise to squat and
      deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral
      density and hip bone mineral density and bone strength.
    

Detailed description: 
      The investigators will carry out a 16-week exercise training study (n=24) consisting of 3
      groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55
      years). Our aim is to determine if hip adduction and abduction resistance exercise is more
      effective than squat and deadlift exercise with respect to changes in the whole bone strength
      and density of the proximal femur and spine.

      Group A will do only hip adduction and abduction exercises. Group B will do only squat and
      deadlift exercise Group C will do a combination of hip adduction and abduction and squat and
      deadlift exercise

      Subjects will be imaged with quantitative computed tomography (QCT) of the proximal femur and
      spine, pre-training and post-training, to determine changes in spinal bone density and
      proximal femoral bone density and strength.

      Serum assays of bone formation (osteocalcin) and bone resorption (serum CTX type I) will be
      performed four times during the study at 4 week intervals.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): Adduction, Abduction and Squat exercise three times a week for 16 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Condition: Obesity
MeSH terms: Obesity; Diabetes Mellitus; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the weight loss effect of lorcaserin during and at the
      end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus
      treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral
      hypoglycemic agents.
    


Intervention name(s): Lorcaserin 10 mg once daily (QD); Lorcaserin 10 mg twice a day (BID); Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.; Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.; Matching placebo tablet each morning and evening for a duration of 52 weeks.
Other intervention name(s): APD356; APD356
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; weight loss; lorcaserin; APD356; BLOOM-DM; hypertension; dyslipidemia; sleep apnea; glucose tolerance; cardiovascular disease; Arena
PMZ-1620 (Sovateltide) in Acute Ischemic Stroke Patients
Condition: Acute Stroke; Cerebral Ischemia
MeSH terms: Stroke; Ischemic Stroke; Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a prospective, multicentric, randomized, double blind, parallel, saline controlled
      Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide)
      therapy along with standard supportive care in patients of acute ischemic stroke.
    

Detailed description: 
      There are hidden stem cells in the brain, which becomes active following injury to the brain.
      Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal
      progenitor cells in the brain to repair the damage by formation of new mature neurons and
      blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral
      blood flow when administered following ischemia.
    

Intervention name(s): Normal Saline along with standard treatment; PMZ-1620 along with standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.; PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
Other intervention name(s): Vehicle; Sovateltide (IRL-1620) along with standard treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
In both treatment groups, subjects will be provided the best available standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mid-term Follow-up for Tailored ATVM
Condition: Lower Urinary Tract Symptoms
MeSH terms: Pelvic Organ Prolapse; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of
      this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the
      changes in values of urodynamic parameters between baseline and after pelvic organ prolapse
      surgery.
    

Detailed description: 
      Between November 2011 and December 2015, medical records of all consecutive women who
      underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral
      sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and
      urodynamic parameters were compared. The bladder outlet obstruction was defined when the
      detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate
      was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder
      oversensitivity and urodynamic stress incontinence were also recognized as international
      continence society definition. STATA software was used for statistical analysis. Wilcoxon
      signed-rank test or McNemar's test was used for statistical analysis as appropriate. P < 0.05
      was considered as statistically significant.
    

Intervention name(s): ATVM
Intervention type(s): Procedure
Intervention description(s): Tailored anterior transvaginal mesh for pelvic organ prolapse
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Between November 2011 and December 2015, medical records of all consecutive women who
        underwent anterior transvaginal mesh surgery for their advanced pelvic organ prolapse were
        reviewed.
      
Keywords: Pelvic organ prolapse; Transvaginal mesh; lower urinary tract symptoms; Urodynamic study
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA)
      administration in follicular phase prevents premature luteinization with equal efficiency as
      GnRH antagonists and otains similar clinical results in oocyte donation.
    

Detailed description: 
      Within the new guidelines for stimulation, the use of oral progesterone in follicular phase
      allows GnRH analogue administration, resulting in greater comfort for patients as well as a
      reduction in cost. Obtained results are similar to those from conventional protocols in terms
      of: early luteinization, number of oocytes, embryos number and rate of implantation and
      gestation or appearance of congenital malformations. Another advantage is the lower incidence
      of OHSS (Ovarian Hyperstimulation Syndrome).

      From a scientific point of view, it would allow a better understanding of folliculogenesis,
      of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and
      later embryonic level.

      From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by
      reducing the number of medication administered subcutaneously and their possible side effects
      on both systemic and local levels. It would be of special interest in 2 groups of patients,
      for example, oocyte donors and patients undergoing preservation of fertility. To date, there
      is a lack of studies along these lines.
    

Intervention name(s): Provera 10 mg.; Ganirelix (GnRH antagonist)
Intervention type(s): Drug; Drug
Intervention description(s): One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.; One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.
Intervention MeSH terms: Medroxyprogesterone Acetate; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Condition: Type 2 Diabetes Mellitus With Circulatory Complciation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study is to assess the safety and feasibility of chemical denervation of multiple artery
      beds for the treatment of Type 2 diabetes (T2DM) and its comorbidities.
    

Detailed description: 
      Diabetes mellitus is among the most prevalent chronic diseases, affecting 435 million persons
      as of 2015 with an annual death toll of 1.5 million, and the overwhelming majority of these
      have Type 2 diabetes mellitus (T2DM). Hypertension is a common comorbidity of diabetes and
      present in more than 50% of diabetic patients. The risk for cardiovascular disease (CVD) is
      four-fold higher in patients with both DM and hypertension as compared to the normotensive
      non-diabetic controls. Obesity, with a prevalence of over 500 million, is another common
      comorbidity of diabetes. These are chronic diseases associated with increased risks of
      cardiovascular disease, stroke, and decreased quality of life.

      Neurotronic developed a novel catheter for denervation procedure. Chemical agent is delivered
      locally into the adventitial space and ablates the sympathetic nerve and nerve endings in the
      adventitial space of the target arteries.

      The purpose of the study is to assess the safety and feasibility of chemical denervation of
      the target arteries for the treatment of Type 2 diabetes (T2DM) and its comorbidities.
    

Intervention name(s): The Neurotronic arterial ablation catheter
Intervention type(s): Device
Intervention description(s): a sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation.
Other intervention name(s): NAA
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single-center, non-randomized, open label first-in-human (FIH) study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Denervation; T2DM; Hypertension; Obesity
Medial Forefoot Block for Analgesia After Foot Surgery
Condition: Hallux Valgus
MeSH terms: Hallux Valgus
Study type: Interventional

Summary: 
      Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and
      is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this
      work. The purpose of this study is to compare two techniques: one using anatomical landmarks
      alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation
      to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques
      will be compared for reliability of postoperative analgesia.
    

Detailed description: 
      More extensive description not desired.
    

Intervention name(s): Landmark guided ankle block.; PNS guided block.
Intervention type(s): Procedure; Procedure
Intervention description(s): 25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.; This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
Other intervention name(s): Other names not required; Other names not required
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: regional anaesthetic techniques; surgery orthopaedic
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
Condition: Tear Trough Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Prospective single center study to evaluate the safety and effectiveness of Restylane Silk
      for treatment of tear trough correction.
    


Intervention name(s): Restylane Silk
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment