bioihbjkbjnl/mcl2 huggingface dataset:
Almonds: Digestive Health and Immune Function of Adults and Children
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether incorporating almonds into the diets of
      families with young children will induce beneficial changes in gastrointestinal function, the
      fecal microbiota profile, and immune and inflammatory processes of the adults and children
      resulting in improved quality of life. The investigators anticipate finding an increase in
      beneficial bacteria, improved intestinal function, and decreased inflammation during the
      almond intervention.
    

Detailed description: 
      This is a randomized, crossover study. After obtaining informed consent, healthy adults aged
      18-40 years with children aged 3-6 years will be randomized to either consume almonds and
      almond paste during the first arm of the study or during the second arm of the study. During
      the intervention period, adult participants will consume 1.5 ounces of almonds per day, and
      children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout
      period, participants will be crossed to the other treatment (no almond consumption or almond
      consumption).

      Participants will complete daily questionnaires throughout the intervention period, and one
      week before and after each intervention period. Blood samples will be collected from adults
      at the baseline and final time points of each intervention. Stool samples will be collected
      during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed
      weekly during each intervention period. Gastrointestinal symptoms questionnaires will be
      completed weekly during each intervention.
    

Intervention name(s): Almonds, Then no almonds; No Almonds, Then almonds
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.; No almonds will be consumed by participants for 3 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: almonds; inflammation; immunity; gut microbiota; stress; diet quality
S9005 Mifepristone in Meningioma
Condition: Meningioma
MeSH terms: Meningioma
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare daily oral mifepristone vs placebo with respect to time to treatment failure in
      patients with unresectable meningioma.
    

Detailed description: 
      To compare daily oral mifepristone vs placebo with respect to time to treatment failure in
      patients with unresectable meningioma and to address issues of safety in this patient
      population.
    

Intervention name(s): Mifepristone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor; placebo matching mifepristone
Other intervention name(s): RU-486
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unresectable
Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
Condition: Liver Fibroses; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      The study "Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients
      With Liver Fibrosis" is designed to test the accuracy of non-interventional radiological
      imaging and compare its results with the "gold standard" liver biopsy. This is prospective
      non-randomized single patient group study.
    


Intervention name(s): Liver elastography (2D-SWE); Liver scintigraphy with 99mTc-mebrofenin
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.; All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.
Intervention MeSH terms: Liver Extracts; Technetium Tc 99m mebrofenin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary diagnosis of chronic viral liver disease who are referred treating
        gastroenterologist/infectologist for liver biopsy prior to treatment.
      
Keywords: Liver fibrosis; Liver cirrhosis; Liver biopsy; Shear wave imaging; Dynamic liver scintigraphy
Treating IBD With Inulin
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to see how the prebiotic inulin changes the gut bacteria
      (microbiome) of children and young adults with IBD and determine if this dietary intervention
      can help reduce disease activity.
    

Detailed description: 
      The pathogenesis of inflammatory bowel disease (IBD) is thought to be due to a combination of
      genetic, environmental and immunological factors. From a clinical stand point, there is great
      interest in determining if manipulation of the gut microbiota may be a viable therapeutic
      strategy in IBD patients. One such strategy involves the use of prebiotic. Prebiotics are
      oligosaccharides that cannot be enzymatically hydrolyzed in the small intestine, however
      serve as substrates for fermentation by commensal bacteria in the colon.

      Investigators propose to evaluate the modulatory effects of the prebiotic inulin on the
      composition and function of the microbiota of children with IBD and determine the efficacy of
      this dietary intervention in reducing disease activity.
    

Intervention name(s): Oligofructose-enriched Inulin OI; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.; Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.
Other intervention name(s): Orafti®Synergy1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diet; inulin; prebiotic; IBD; Inflammatory Bowel Disease
A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in
      combination with metformin and sitagliptin against placebo in combination with metformin and
      sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with
      inadequate glycemic control on metformin and sitagliptin.
    


Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ipragliflozin; Suglat
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP1941; Type 2 diabetes mellitus
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine
      succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and
      postmenopausal women with major depressive disorder
    


Intervention name(s): desvenlafaxine succinate sustained-release; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50-mg DVS SR tablets taken orally once daily.; Placebo tablets taken orally once daily.
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction of SHR1459 With a Strong CYP3A Index Inducer (Rifampicin)
Condition: Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, SHR1459
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction (DDI) study had been designed to investigate the effect of a
      strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese
      healthy volunteers.
    


Intervention name(s): Rifampin; SHR1459
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose, 600 mg, fasted.; single oral dose, 200 mg, fasted.
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: To observe the effect of rifampicin on the pharmacokinetics of SHR1459 and to evaluate the safety of SHR1459, rifampicin and their coadministration in Chinese healthy subjects. The subjects will take SHR1459 at first single dose, then washout period, and take it at second single dose after multiple administration of rifampicin to get a full induction condition.
Masking: None (Open Label)
Primary purpose: Treatment
Psychological Interventions to Prevent Late Effects in Breast Cancer
Condition: Pain, Postoperative; Fatigue; Breast Cancer
MeSH terms: Breast Neoplasms; Fatigue; Pain, Postoperative
Study type: Interventional

Summary: 
      The study aims to investigate whether a combined pre-operative medical hypnosis plus a
      post-operative internet-based acceptance and commitment intervention are more effective in
      preventing post-surgical pain and fatigue following breast cancer surgery compared with
      pre-operative mindfulness plus treatment as usual.
    

Detailed description: 
      The trial will include 200 patients undergoing breast cancer surgery at Oslo University
      Hospital. The patients will be randomized into two groups. One group will receive a 20 minute
      pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a
      post-surgical internet-based acceptance and commitment intervention. The control group will
      receive a 20 minute pre-surgical mindfulness session delivered through an audio recording
      plus treatment as usual. The primary outcomes of the study are quantitative measures of
      post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and
      subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples.
      The study uses a longitudinal design with baseline measures obtained pre-surgery and follow
      up measures obtained 3 and 12 months post-surgery.
    

Intervention name(s): Medical hypnosis; Internet-based Acceptance and Commitment Therapy (iACT); Mindfulness session; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.; Access to an online platform developed to this study containing video clips and audio files with ACT consistent material; Single session mindfulness session delivered by audio file; Treatment as usual as part of post-surical care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast cancer; Post-surgical pain; Fatigue; Hypnosis; Acceptance and commitment therapy
Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa followed by
      peripheral stem cell transplantation in treating patients with stage III or stage IV
      epithelial ovarian cancer in complete remission.
    

Detailed description: 
      OBJECTIVES: I. Assess the toxic effects of combined high dose melphalan and thiotepa
      chemotherapy followed by stem cell rescue in patients with stage III or IV ovarian epithelial
      cancer in complete remission. II. Determine the maximum tolerated dose of thiotepa that can
      be given with melphalan in these patients. III. Evaluate the interpatient blood level
      variability and pharmacokinetics of melphalan given intravenously.

      OUTLINE: This is a dose escalation study of thiotepa. Patients receive cytoreduction and
      mobilization of peripheral blood stem cells (PBSC) with filgrastim (G-CSF) and
      cyclophosphamide/paclitaxel, cyclophosphamide/etoposide or
      cyclophosphamide/etoposide/cisplatin within 30-90 days of last dose of standard therapy. PBSC
      are then collected. Patients then receive melphalan IV over 30 minutes on days -6 and -5 and
      thiotepa IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. G-CSF is
      administered on days 0-21. Cohorts of 5-15 patients each receive escalating doses of thiotepa
      until the maximum tolerated dose (MTD) is reached. The MTD is determined as the dose at which
      2-5 of 4-15 patients experience dose limiting toxicity. Patients are followed at 100 days,
      then at 6, 12, and 24 months.

      PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study over 2 years.
    

Intervention name(s): filgrastim; melphalan; thiotepa; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Melphalan; Thiotepa
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; ovarian undifferentiated adenocarcinoma; ovarian mixed epithelial carcinoma; ovarian serous cystadenocarcinoma; ovarian mucinous cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian clear cell cystadenocarcinoma; Brenner tumor
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic
      cleaning and fulguration of pilonidal sinus inner surfaca followed by application of
      crystallized phenol into the sinus.
    

Detailed description: 
      Endoscopic treatment and crytallized phenol application are two sovereign treatments
      described for pilonidal disease. The curative rate may be as low as 65 % and the recurrence
      rate is at least 10 % after crystallized phenol alone application for pilonidal disease. The
      experience with endoscopic treatment of pilonidal sinus is only limited but at least 4 %
      recurrence rate was reported.

      In this study a preliminary group of 23 patients were treated with combination of these two
      modalities between February to May 2014 and at the end of 6-9 months follow up, there was no
      recurrence after excellent cosmetic results. Patients were all operated and mild sedation and
      local anesthesia. There was no serious complication but only some skin irritation was noticed
      secondary to phenol burn. Some patients felt mild pain and the pain was self limited in most
      cases where only a few needed oral pain killers. Some patients were observed to have mild
      drainage from the sinus but only two of them needed further application of phenol crystals.
    

Intervention name(s): EAPA
Intervention type(s): Procedure
Intervention description(s): Under sedation and local anesthesia, a pit of pilonidal disease is widened, hair and debris removed and cavity first ablated by endoscopy assisted diathermy the filled with crystallized phenol. The remaining pits were also fulgurated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional

Summary: 
      The purpose of this research is to study an investigational medical device that is designed
      to produce lung volume reduction in diseased areas of the lungs in patients with severe
      emphysema.
    

Detailed description: 
      The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to
      decrease volume in targeted regions of the lung. It is indicated for the treatment of
      patients with severe emphysema. The EBV are placed in the diseased region of the lung using
      bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on
      the end. As the diseased region of the lung shrinks in size, healthier regions may expand and
      function more efficiently, resulting in improved breathing.

      The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random
      to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the
      Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control'
      group will receive optimal medical therapy alone. For every three participants in the study,
      two will go into the 'Treatment' group and one will go into the 'Control' group.

      It is hypothesized that after placement of the EBV, lung function will be improved as
      compared to standard medical therapy alone.

      Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve
      System was approved by the FDA for the treatment of severe emphysema in June 2018. Following
      this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5
      years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under
      the auspices of the "LIBERATE Extension Study". This is an administrative change with
      absolutely no change to the design or conduct of the study and, therefore has no material
      impact to the study participants or the study sites. All annual follow-up visits and
      evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the
      LIBERATE Extension Study.
    

Intervention name(s): EBV; Optimal Medical Management
Intervention type(s): Device; Other
Intervention description(s): This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.; This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: emphysema; endobronchial valve; treatments; pulmonary rehabilitation; lung volume reduction
Hypoxia in Flight Simulation in Obese Patients
Condition: Obesity, COPD, OHS
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2)
      with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under
      flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic
      chamber test.
    


Intervention name(s): flight simulationin obese healthy adults or obese patients with or without COPD, OHS
Intervention type(s): Other
Other intervention name(s): flight simulation
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        obese (BMI>30 kg/m2) healthy adults, obese patients with obesity hypoventilation Syndrome,
        obese patients with COPD
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving
      DVS-233 SR versus subjects receiving placebo.

      Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical
      global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton
      Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus
      those subjects receiving placebo.
    


Intervention name(s): DVS-233 SR
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
Condition: Fluid Responsiveness; Modified Prone Position
Study type: Observational

Summary: 
      To investigate whether PVI predicts the fluid responsiveness in modified prone position
      undergoing posterior approach cervical operation. Furthermore, modified prone position could
      influence on dynamic variables including stroke volume variation(SVV), pulse pressure
      variation(PPV) and PVI.
    

Detailed description: 
      Objective :

      To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and
      stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or
      knee-chest position (concord position) for cervical operation.

      To identify Influence of the modified prone position (concord position) on these variables.

      Method

        1. To assess influence of the position change on PVI and other variables(PPV, SVV)

        2. To assess PVI to predict fluid responsiveness at modified prone position
    

Intervention name(s): volume expansion
Intervention type(s): Other
Intervention description(s): To assess fluid responsiveness
Other intervention name(s): If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients received cervical operation at modified prone position (concord position)
      
Keywords: Pleth variability index