bioihbjkbjnl/mcl2 huggingface dataset:
GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients
Condition: Pancreatic Cancer; Chemotherapy Effect; Chemotherapeutic Toxicity
MeSH terms: Pancreatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved
      objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with
      locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen
      exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To
      assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line
      chemotherapy in Chinese patients with advanced PC, we designed this prospective study.
    


Intervention name(s): GS
Intervention type(s): Drug
Intervention description(s): Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All advanced pancreatic cancer patients are diagnosed by histology to have pancreatic
        adenocarcinoma after a biopsy and received first-line GS chemotherapy at the Cancer
        Biotherapy Center of the First Affiliated Hospital.
Chordate System Prophylactic Migraine Clinical Investigation
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the performance of the Chordate System, in
      terms of the prophylactic effect and tolerability of treatment in patients diagnosed with
      migraine.
    

Detailed description: 
      This was a prospective, interventional, randomized, placebo-controlled, double-blind,
      multi-center clinical investigation of a medical device system.

      A pilot study in which patients with frequent migraine attacks received intranasal KOS or
      placebo using the Chordate System S200 on two occasions.
    

Intervention name(s): Chordate System S200 + CT100 (active treatment); Chordate System S200 + CT100 (placebo treatment)
Intervention type(s): Device; Device
Intervention description(s): Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).; Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Extracorporal shock wave therapy is performed prior to cell therapy for induction of
      therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in
      patients with chronic ischemic heart disease following anterior myocardial infarction.

      Shock waves can induce growth factor expression in the ischemic myocardium and might augment
      homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h
      following shock wave therapy
    

Detailed description: 
      Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised
      trial (Cell therapy), single blind (Shockwave)
    

Intervention name(s): intracoronary stem cell therapy
Intervention type(s): Procedure
Intervention description(s): extracorporal shock waves prior to intracoronary cell therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Extracorporal shock wave therapy; Cell therapy
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal participants. Until recently, the search for medicines to activate pharyngeal
      muscles in sleeping humans has been discouraging. However, exciting new animal research has
      shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle
      activity to waking levels. In this protocol the investigators will test the effect of
      desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)
      on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.
    

Detailed description: 
      Two overnight sleep studies, a placebo night and a drug night, will be performed
      approximately one week apart in random order. The placebo or drug will be administered 2
      hours before lights out. At least 15 minutes of quiet wakefulness will be recorded to
      quantify the participant's awake EMG GG activity. Participants will then sleep in the lateral
      position to minimize pharyngeal resistance similar to previous studies of this kind.

      The same will be done for stable non-rapid eye movement (NREM) and rapid eye movement (REM)
      sleep (free of arousals and other artifacts). Both NREM and REM sleep will be analyzed,
      recognizing that REM is less frequent on these drugs.

      During the second part of the night, the participants will be connected to a modified
      continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide
      a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure
      and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).
    

Intervention name(s): Desipramine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg administered 2 hours before normal sleep time; Placebo-matching desipramine administered 2 hours before normal sleep time
Other intervention name(s): Norpramine
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Adjuvant FEC Versus EP in Breast Cancer (MIG5)
Condition: Breast Cancer; Chemotherapy, Adjuvant
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In this multicenter, randomized phase III trial, node positive early breast cancer patients
      are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin
      60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP
      (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary
      study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free
      survival (EFS).
    

Detailed description: 
      At the time the Gruppo Oncologico Nord-Ovest- Mammella Intergruppo trial 5 (GONO-MIG5) was
      designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast
      cancer, but its role was still to be established in the adjuvant setting. Therefore the
      GONO-MIG5 trial was designed to compare a standard anthracycline-containing chemotherapy
      regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (FEC), given for 6 cycles to a new
      regimen containing both epirubicin and paclitaxel (EP), given concurrently, for 4 cycles.
      This latter regimen was chosen on the basis of the results obtained in metastatic breast
      cancer patients, where the combination of doxorubicin and paclitaxel was associated with more
      than 90% of objective response . Only four cycles of the new regimen were planned since the
      expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration
      was hoped to be the best strategy to obtain a favourable balance between the toxicity and the
      expected high efficacy.
    

Intervention name(s): 5-fluorouracil; epirubicin; cyclophosphamide; epirubicin; paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 600 mg/m2 intravenously on day 1, every 21 days for six cycles; 60 mg/m2 intravenously on day 1, every 21 days for six cyles; 600 mg/m2, intravenously on day 1, every 21 days for six cycles; 90 mg/m2 on day 1, every 21 days for four cycles; 175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: early breast cancer; adjuvant chemotherapy; FEC; paclitaxel
Personalizing Interventions Using Real-World Interactions
Condition: Social Interaction; Schizophrenia Spectrum and Other Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      Social functioning deficits are among the most disabling and difficult to treat aspects of
      schizophrenia. An essential component of social functioning is metacognition-a process that
      is profoundly disrupted in schizophrenia and represents the ability to reflect upon the
      mental states of oneself and others. To date, treatment efforts in schizophrenia have been
      hindered by barriers in accurately monitoring client's real-world social interactions.
      Recently, wearable technologies have evolved to provide therapists with innovative,
      ecologically-valid tools. The Electronically Activated Recorder is a wearable audio recorder
      that collects behavioral samples at pre-programmed intervals; it holds great promise as a
      method for yielding concrete, real-world examples of social interactions that can be used by
      therapists in session to enhance metacognition. Despite the immense costs of social
      functioning deficits, no previous studies have investigated whether functioning can be
      improved by integrating wearable audio recorders with psychosocial interventions.

      By enhancing therapy using a wearable recording device, this proposal's primary goal is to
      implement a novel intervention that targets metacognitive deficits to improve social
      functioning. The novel intervention will be tailored to individual clients-based on the
      content of recorded social interactions-in a way that is not possible using traditional
      psychotherapy. This will allow clients and therapists to step out of the therapy room by
      offering a window into how clients process material in real-world interactions. In this
      study, a randomized controlled trial will be conducted with two schizophrenia groups
      receiving six months of individualized: 1) Metacognition Reflection and Insight Therapy
      (MERIT) alone (Standard MERIT); and 2) Tailored MERIT using wearable audio recorders. In this
      study, our specific aims will test feasibility, effectiveness, and acceptability of Tailored
      MERIT.
    


Intervention name(s): Tailored MERIT; Standard MERIT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): see arm description; see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of an MK 0974 for
      migraine headache and to identify an appropriate dose range for further study.
    


Intervention name(s): Comparator: Placebo; MK0974; MK0974; MK0974; MK0974; MK0974; MK0974; MK0974; Rizatriptan
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo to match assigned treatment arm; one orally-administered dose; MK0974 25 mg; one orally-administered dose; MK0974 50 mg; one orally-administered dose; MK0974 100 mg; one orally-administered dose; MK0974 200 mg; one orally-administered dose; MK0974 300 mg; one orally-administered dose; MK0974 400 mg; one orally-administered dose; MK0974 600 mg; one orally-administered dose; Rizatriptan 10 mg; one orally-administered dose
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed
      world. Because OA gradually worsens over time, the sooner treatment is started, the more
      likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration,
      and an increase in disability. Multiple treatments are used to manage the degenerating hip as
      well as the associated pain. These include physiotherapy and rehabilitation, bracing, other
      walking aids, oral medications, injections, and in severe cases, surgery. Prior research has
      shown that injection of hyaluronic acid (HA) and corticosteroids can slow down OA
      degradation. This study will look at the effects of injecting Cingal into the hip, which
      expands on its current approved use in the treatment of knee OA.
    


Intervention name(s): Cingal
Intervention type(s): Device
Intervention description(s): Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chemotherapy in Treating Patients With Advanced Sarcoma
Condition: Ovarian Cancer; Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of
      ifosfamide and doxorubicin in patients with advanced sarcoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in
      patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide
      and doxorubicin.

      OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days
      1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after
      completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood
      counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease
      progression or unacceptable toxicity. Patients are followed at treatment failure and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.
    

Intervention name(s): filgrastim; doxorubicin hydrochloride; ifosfamide
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; ovarian sarcoma; stage IV adult soft tissue sarcoma
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the efficacy of embryo transfer procedure guided
      by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as
      the advantages and disadvantages of the new technique.
    


Intervention name(s): ultrasound-guided embryo transfer
Intervention type(s): Procedure
Intervention description(s): Embryo transfer in oocyte recipients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female infertility with indication of oocyte reception
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
Condition: Renal Insufficiency; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the influence of moderate renal
      impairment on the pharmacokinetics of multiple doses in comparison to a matched control group
      with normal renal function.
    


Intervention name(s): BI 1467335
Intervention type(s): Drug
Intervention description(s): 28 day treatment period
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın
Condition: Neck Pain; Low Back Pain; Cognitive Level; COVID-19 Pandemic
MeSH terms: COVID-19; Low Back Pain; Neck Pain
Study type: Observational

Summary: 
      There are a limited number of studies examining the difficulty of reaching treatment related
      to the pandemic process and the general effects of the process in patients with chronic low
      back and neck pain. However, no study has been found that compares the effects of individuals
      actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study
      is to examine the effects of the pandemic process on the cognitive level, pain
      catastrophization, physical activity level and quality of life in individuals with chronic
      low back and neck pain.
    


Intervention name(s): assessment of cognitive level, pain catastrophe, physical activity level and quality of life
Intervention type(s): Other
Intervention description(s): assessment of cognitive level, pain catastrophe, physical activity level and quality of life
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic low back and neck pain
Psychological Effects of Bone Marrow Transplants in Children
Condition: Psychological
Study type: Observational

Summary: 
      This study is designed to examine the psychological effects of bone marrow transplants on
      children and their families. The investigators hypothesis is that families who show signs of
      psychological distress before transplant will continue those signs post transplant. The
      investigators are examining cognitive placement, emotional placement and other psychological
      factors in both the child undergoing transplant and his or her parent.
    

Detailed description: 
      Previous research on bone marrow transplants has conflicting results concerning the effects
      of maladjustment. The current research is conducted in consortium with DeVos Children's
      Hospital. Children receiving bone marrow transplants are assessed using the Child Behavior
      Check List (CBCL) and Cognitive based testing. Parents are assessed using the Parenting
      Stress Index (PSI). Children and parents are evaluated prior to transplant and then 50 days,
      6 months, and one year post transplant. Descriptive statistics are currently being used to
      determine results.
    

Intervention name(s): protein and calorie controlled diet and self-hypnotic relaxation
Intervention type(s): Behavioral
Intervention description(s): daily
Intervention MeSH terms: Hypnotics and Sedatives
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients under the age of 18
      
Keywords: Bone Marrow; Bone Marrow Transplant; Pediatric; Psychological Impact; Psychology
A Study of a Whole-Body Balm on Newborn Babies
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and
      perceived product efficacy of a whole-body balm on newborns (0-28 days old).
    


Intervention name(s): Whole-body Balm; Wash and Shampoo
Intervention type(s): Other; Other
Intervention description(s): Balm will be applied to cover newborn's entire body (while avoiding the mouth, eyes, diaper area, and scalp), and gently massaged onto the skin until the balm is fully absorbed.; Wash and shampoo will be used to cleanse newborn baby using an "in tub" bathing method.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other