bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Heat Transfer With the Esophageal Cooling Device
Condition: Non-cardiac Surgery
Study type: Interventional

Summary: 
      An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each
      patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of
      warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be
      heat transfer, determined from inflow and outflow temperatures and fluid flow rate for
      cooling and warming modes.
    

Detailed description: 
      The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central
      port. The coolant ports of the ECD are connected to external heat exchanger while a third,
      central lumen simultaneously allows gastric decompression and drainage. The ECD can be
      inserted like a standard gastric tube.

      The aim of this prospective, interventional study is to quantify heat transfer during warming
      and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac
      surgery.

      An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each
      will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming
      (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be
      randomized. The primary outcome will be heat transfer, determined from inflow and outflow
      fluid temperatures and fluid flow rate assessed for both cooling and warming modes.
    

Intervention name(s): Esophageal Warming; Esophageal Cooling
Intervention type(s): Device; Device
Intervention description(s): 30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.; 30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Cross-over.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Treatment of Hepatitis C in Psychiatric Patients
Condition: Mental Disorders; Drug Addiction
MeSH terms: Hepatitis C; Hepatitis; Substance-Related Disorders; Behavior, Addictive; Mental Disorders
Study type: Observational

Summary: 
      Psychiatric disorders or drug addiction are often regarded as contraindications against the
      use of Interferon-alpha in patients with chronic hepatitis C. The investigators aim is/was to
      get prospective data about adherence, efficacy and mental side effects of IFN-alpha treatment
      in different psychiatric risk groups compared to controls. In a prospective trial, 81
      patients with chronic hepatitis C (positive HCV-RNA and elevated ALT) and psychiatric
      disorders (n=16), methadone substitution (n=21), former drug addiction (n=21) or controls
      without psychiatric history or addiction (n=23) should be/were treated with a combination of
      IFN-alpha-2a 3 x 3 Mio U/week and ribavirin (1000-1200 mg/day).
    

Detailed description: 
      Patients from the Munich University outpatient department of psychiatry or gastroenterology
      as well as inpatients with elevated transaminases were tested for HCV-infection and
      considered for our trial to avoid a positive or negative selection. Medical inclusion
      criteria were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche
      Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase
      (ALT > 30 U/L, normal <24 U/L). General exclusion criteria were the presence of other liver
      disease, Child B or C cirrhosis, severe cardiac or neurological disease, co-infection with
      hepatitis B or HIV, hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein,
      autoimmune disorders, a neutrophil count below 1500 per cubic millimetre, and a platelet
      count below 75000 per cubic millimetre.
    

Study population: 
        HCV-infected Controls, Psychiatric patients, Patients with former drug addiction and
        patients with methadone substitution
      
Keywords: Interferon-alpha; hepatitis c; Drug addiction; methadone; psychiatric disorder; Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.
A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
Condition: Anxiety; Depression; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This virtual, open-label, three-group, randomized-controlled trial will last six weeks.
      Participants will be allocated into three groups; the Intervention Group, Spotify Group, and
      Control Group. All participants will complete a baseline questionnaire before completing
      their designated regime daily for six weeks. In addition, participants will complete
      study-specific surveys and validated questionnaires at the end of each week (Week 1, 2, 3, 4,
      5 & 6). The study will include 75 [participants in total, 25 per group, who all have
      self-reported concerns around anxiety, stress, or depression.

      Questionnaires will be used to monitor sleep, cognitive ability, and changes in symptoms of
      anxiety, depression, and stress. Both study-specific questionnaires and validated
      questionnaires will be utilized, including the Generalized Anxiety Disorder Assessment
      (GAD-7), the 9-question Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS),
      and The World Health Organisation- Five Well-Being Index (WHO-5). Likert scale responses will
      be examined from baseline to each check-in. Participant responses on product feedback will be
      presented as % scores.
    


Intervention name(s): SoundMind App; Spotify Playlist
Intervention type(s): Other; Other
Intervention description(s): he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.; Participants will listen to a "calm vibes" playlist by Spotify.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-group study.
Masking: None (Open Label)
Primary purpose: Other
Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)
Condition: Perianal Fistula; Cryptoglandular Perianal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
      using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20
      million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will
      be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection
      and placement of a draining seton. Six weeks post placement of the draining seton, the seton
      will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical
      practice. The subjects will be subsequently followed for fistula response and closure for 24
      months. This is an autologous product derived from the patient and used only for the same
      patient.
    

Detailed description: 
      The investigators propose to study the safety of autologous mesenchymal stromal cell transfer
      using a biomatrix (the Gore&#174; Bio-A&#174; Fistula Plug) in a Phase I study using a single
      dose of 20 million cells. 15 adult patients (age &gt; 18 years) with cryptoglandular fistulas
      will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of
      infection and placement of a draining seton. Six weeks post placement of the draining seton,
      the seton will be replaced with the MSC loaded Gore&#174; fistula plug as per current
      clinical practice. The subjects will be subsequently followed for fistula response and
      closure for 24 months. Study visits are Day 1, Week 2, Week 4, Week 8, Week 12, Week 24, Week
      52, and Week 104. This is an autologous product derived from the patient and used only for
      the same patient.
    

Intervention name(s): MSC-AFP
Intervention type(s): Drug
Intervention description(s): Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.
Other intervention name(s): mesenchymal stromal cell coated fistula plug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cryptoglandular; perianal fistula; cryptoglandular perianal fistulas
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients
Condition: Early Stage Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primarily, this clinical investigation compared overall survival and recurrence-free survival
      in patients with hormone receptor-negative breast cancer treated with pre- and postoperative
      chemotherapy vs. conventional postoperative treatment.
    


Intervention name(s): Cyclophosphamide; Methotrexate; Fluorouracil; Epirubicin; Surgery
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Cyclophosphamide 600mg/m2; Methotrexate 40mg/m2; Fluorouracil 600mg/m2; Epirubucin 60mg/m2 (only node-positive patients); Surgery
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Methotrexate; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclophosphamide; Methotrexate; Fluorouracil; Epirubicine; Breast Cancer
Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine
      hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the overall response rate (partial and complete response) in patients with
           relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine
           hydrochloride.

      Secondary

        -  Determine the safety and toxic effects of this regimen in these patients.

        -  Determine the time to progression in patients treated with this regimen.

        -  Correlate NF-kB inhibition and proteasome activity with response in patients treated
           with this regimen.

      OUTLINE: This is a multicenter, pilot study.

      Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over
      30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 2 years and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): bortezomib; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult Hodgkin lymphoma
Supported Exercise Programme for Adults With Congenital Heart Disease
Condition: Congenital Disorder; Heart Diseases
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      This study will evaluate if the introduction of a supported exercise programme can improve
      physical and psychological well-being for adults with congenital heart disease.
    

Detailed description: 
      Congenital heart disease (CHD) describes heart defects present from birth. The majority of
      affected patients will require lifelong care to not only manage their medical condition, but
      also to offer support and guidance on living with their specific heart condition. Exercise
      and physical activity is one such area where patients often require support and advice.
      Recommendations are in place for health care providers to promote physical activity for this
      patient population. However, many health care providers find it difficult to know what level
      of exercise is reasonable or how to escalate current exercise programmes.

      The benefits of regular exercise are well known and evidence suggests that even a modest
      increase in physical activity can reduce morbidity, improve psychological wellbeing and
      protect against cardiovascular disease.

      This pilot study will determine the feasibility of introducing a supported exercise programme
      to clinical practice. The investigators aim to assess if improvements can be made in both
      physical and psychological well-being for adults with CHD who are living in Scotland. After
      initial assessment and baseline measurements are obtained, participants will follow a twelve
      week individualised programme. The investigators will keep in regular contact with the
      participant throughout and arrange interval and final assessments. The baseline measurements
      will be repeated during the final assessment at 12 weeks. Investigators anticipate that the
      study will also help to establish a programme that will help to improve the way adults who
      were born with a heart condition can be supported with physical activity on a long term
      basis.
    

Intervention name(s): Exercise Programme
Intervention type(s): Other
Intervention description(s): Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants compete a six minute walk test (6MWT). Those who achieve less than 450 metres will be assigned to study group one. Participants who achieve greater than 450 metres on 6MWT will be assigned to study group two.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exercise; Physical Activity
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Intervention study in malnourished adults to assess whether a nutritional supplement given
      for 8 weeks in addition to the subject's usual diet improves body weight, body composition,
      biochemical and immune parameters.
    

Detailed description: 
      Criteria to be included in this study include:

      BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any
      malabsorption disorders

      Description:

      We are studying whether adding nutritional shakes will help participants gain weight and
      improve their health and immunity. This study lasts about 8 weeks and has a total of 7
      visits.
    

Intervention name(s): Quaker Complete Nutrition Supplements
Intervention type(s): Dietary Supplement
Intervention description(s): 3-6 250ml cans of Quaker Complete Nutrition Supplements per day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malnutrition; underweight; low body weight; BMI under 19; under nourished; malnourished
Effect of Melatonin on Reduction of Pelvic Pain
Condition: Dysmenorrhea; Endometriosis
MeSH terms: Endometriosis; Pelvic Pain; Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      In two double blinded randomized controlled trials (RCT) we will study the effect of pain
      reduction of melatonin vs placebo in women with severe dysmenorrhea and women with
      endometriosis.The aim is to find an effective method for pelvic pain caused by dysmenorrhea
      and endometriosis.The primary outcome is reduction of pain in patients with dysmenorrhea and
      endometriosis respectively when treated with melatonin vs placebo. Secondary outcomes include
      the effect on daily life, quality of life and cognition. Sleep will also be assessed to
      evaluate its potential relation to quality of life and cognition.
    

Detailed description: 
      Two substudies will be performed. Forty women with severe dysmenorrhea will be randomized to
      treatment with 10 mg melatonin daily or placebo during the menstruation for 2 menstrual
      cycles. Another 40 women with endometriosis will be randomized to treatment with 20 mg or
      placebo daily during 8 weeks. Participants will report drug intake, bleeding details
      (duration and amount) and pain as well as possible side effects. They will also perform a
      test for sleep quality and cognition before and after completion of the study.

      See protocol for more details
    

Intervention name(s): Melatonin 10 mg; Placebo; Melatonin 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Melatonin capsule; Sugar pill manufactured to mimic Melatonin capsule; Melatonin capsule
Other intervention name(s): N-acetyl-5-methoxy tryptamine; Sugar pill; N-acetyl-5-methoxy tryptamine
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Project BEST: Buprenorphine Entry Into Substance Abuse Treatment
Condition: Opioid-related Disorders; HIV Infections; Hepatitis C, Chronic; Depression
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Substance-Related Disorders; Opioid-Related Disorders
Study type: Observational

Summary: 
      Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services
      Administration (SAMHSA) to increase treatment to opiate dependent patients with mental
      illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care
      for as long as the individual takes buprenorphine to track the success of buprenorphine for
      the maintenance of opiate dependence.
    

Detailed description: 
      The investigators propose to create a prospective cohort that will track outcomes for an
      opiate dependent population on buprenorphine maintenance. Individuals who have already
      decided to undergo buprenorphine treatment in Project BEST will be invited to participate in
      the following data collection process. The investigators propose the following series of data
      collection to assess clients during their time in the cohort:

      GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology.

      Patients who are enrolled will enter a standardized, manual based weekly counseling regimen.
      Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same
      times monthly to decrease the probability of sampling error.

      This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The
      goal of this prospective cohort is to generate thoughtful observations. Specific items of
      interest which will be compared with age, race matched historical controls on methadone will
      be:

        1. Changes in addiction severity over treatment time

        2. Changes in sexual risk behaviors and injection practices

        3. Improvements in urine toxicology

        4. Co-occurring mental illness
    

Intervention name(s): MET/CBT based individualized counseling; Buprenorphine
Intervention type(s): Behavioral; Drug
Intervention description(s): Manualized counseling with the first four week being MET followed by 8 weeks of CBT; Target dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily.
Intervention MeSH terms: Buprenorphine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective cohort of opioid dependent patients at risk for HIV or with HIV
        seeking treatment with buprenorphine. Subjects may have severe mental illness and other
        co-morbid medical conditions.
      
Keywords: Opioid dependence; HIV/AIDS; Hepatitis C; Severe mental illness; Injection Drug Use
N-methylglycine (Sarcosine) Treatment for Depression
Condition: Major Depressive Disorder; Depression; Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Major depressive disorder is a complex disease and most currently available antidepressants
      aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects.
      N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in
      learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine
      (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved
      not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm
      its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine
      in efficacy for major depressive patients.
    

Detailed description: 
      Major depressive disorder is a complex disease and most currently available antidepressants
      aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. Novel
      therapies via manipulating other neurotransmission (e.g. glutamate receptor) are being
      developed.

      NMDA enhancing agents, such as sarcosine have been demonstrated to improve negative symptoms
      and depressive symptoms of schizophrenic patients. The purpose of this study is to compare
      citalopram and sarcosine in aspects of efficacy, safety in major depressive patients.

      In the study, 40 major depressive patients are recruited into the 6-week trial and randomly
      assigned into the two groups (20-60 mg/d citalopram, or 500 - 1500 mg/d sarcosine) with a
      double-blind manner. Hamilton Depression Rating Scale(17-item), CGI(Clinical Global
      Impression), GAF(Global Assessment of Function)and side effects are evaluated every two weeks
      during the trial. The efficacies of two groups are compared.
    

Intervention name(s): citalopram; sarcosine
Intervention type(s): Drug; Drug
Intervention description(s): 20-60 mg/day, oral, for 6 weeks; 500-1500 mg/day, oral, for 6 weeks
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; Depression; Sarcosine; N-methylglycine; NMDA