bioihbjkbjnl/mcl2 huggingface dataset:
DBS for Treatment Resistant Depression
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep
      brain stimulation (DBS) in patients with treatment resistant depression (TRD).

      The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to
      improvements in TRD patients, and specific neuroimaging biomarkers will correlate with
      response to DBS; the functional recovery will be enhanced with concurrent cognitive
      behavioural therapy (CBT).
    

Detailed description: 
      The aim is to collect data on prediction, optimization and augmentation of DBS for TRD and
      develop tools for DBS surgery. It is a biological pilot study designed to provide informative
      data for future work.
    

Intervention name(s): deep brain stimulation with short & long pulse width
Intervention type(s): Device
Intervention description(s): surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder (MDD); Bi-polar disorder (BP)
Investigating Minimal Residual Disease in Autopreserved Ovarian Tissue in Cases of Neoplastic Pathology
Condition: Neoplastic Pathology; Autopreserved Ovarian Tissue
MeSH terms: Neoplasm, Residual
Study type: Observational

Summary: 
      Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have
      to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The
      main part of the ovary is preserved, as primordial and primary follicles are resistant to
      freezing / thawing protocols. In the absence of other techniques (in vivo maturation,
      injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is
      currently the only technique allowing fertility to be restored. Autograft is possible only if
      the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant
      pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies,
      particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of
      any codified technique for evaluating residual disease (MRD). The team has for two years been
      developing and validating a technique to look for residual disease in fragments of ovarian
      cortex in cases of acute leukemia. This technique is based on an original protocol for
      dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be
      analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have
      been demonstrated in an experimental model. This model consists in using 8 color flow
      cytometry to look for characterizable leukemia cells added in different dilutions to a
      population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of
      10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR
      (Real-Time Quantitative Polymerase Chain Reaction) with the same dilutions. The model tissue
      came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. The main
      objective of this project is to validate techniques that have been previously codified with
      different populations of leukemia cells that may be characterized. We then aim to adapt and
      validate this technique to look for MRD using 8 color flow cytometry on cryopreserved
      fragments of ovarian cortex from leukemia patients that are at risk of metastasis. Secondary
      objectives will be to implement procedures for oncological qualification of grafts in cases
      of malignant pathology and to consider the recommendations for using this cryopreserved
      ovarian tissue through the autograft technique for these indications.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients likely to re-use their cryopreserved ovarian tissue by autograft
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment
      in reducing the number of migraine headaches when added to a person's usual medications for
      acute migraine headache relief.
    


Intervention name(s): RWJ-333369
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Headaches; Migraine headaches; Head pain
A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function
Condition: Normal Healthy Subjects
Study type: Interventional

Summary: 
      This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of
      Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.
    

Detailed description: 
      This study will evaluate Bio-Germanium's efficacy on immune function and immune cell
      activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK
      cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).
    

Intervention name(s): Investigational Product (Bio-Germanium); Control Group - Placebo Product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingredient: Bio-Germanium
Type: HPMC capsule
Weight: 300mg/capsule
Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
Storage: Room temperature (below 25℃)
Duration of use: 8 weeks; Ingredient: Corn starch
Type: HPMC capsule
Weight: 300mg/capsule
Directions: 2 capsules, twice a day
Storage: Room temperature (below 25℃)
Duration of use: 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
Condition: Intubation; Difficult or Failed; Preterm Infant; Term Infant
Study type: Interventional

Summary: 
      This is a randomized controlled pilot study investigating a new intubation method in newborn
      infants. In contrast to the conventional intubation method, in the new method the respirator
      is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose
      (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube
      during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral
      tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and
      control groups during intubation.

      Hypothesis

        -  The new intubation method is safe

        -  The new intubation method leads to a reduction in the number of intubation attempts

        -  The new intubation method leads to a reduction of desaturations and bradycardia during
           intubation

        -  In the long term, it could lead to a reduction in morbidity and mortality
    


Intervention name(s): New intubation method; Conventional intubation method
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
Condition: Postprandial Lipaemia; Postprandial Incretins; Postprandial Inflammation
MeSH terms: Hyperlipidemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of dietary protein on blood lipids and
      gut hormones after a fat-rich meal.

      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream
      following a fat rich meal. The effect is dependant of both the quality and the quantity of
      protein ingested.
    


Intervention name(s): Casein; Whey Isolate; Whey Hydrolysate; Alphalact-Albumin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postprandial Period; Postprandial Lipaemia; Incretins; Subclinical Inflammation; Obesity; Atherosclerosis; Triglyceride; Lipoproteins
Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study compares the efficacy of bowel preparation between the face-to-face
      re-education(FFRE group) and normal education (no-FFRE group) in patients.
    

Detailed description: 
      Despite advances in bowel preparation methods,bowel preparation is inadequate in up to
      one-third of all colonoscopies in reported series.Inadequate bowel cleansing results in
      negative consequences for the examination, including incomplete visualisation of the colon,
      missed lesions, procedural difficulties, prolonged procedure time and reduced time interval
      until follow-up, and an estimated 12-22% increase in overall colonoscopy cost.

      The adequacy of a bowel preparation is closely linked to patient compliance with both dietary
      and purge instructions.One study performed in Asia showed that non-compliance with bowel
      preparation instructions, lower education level, and a long wait for the colonoscopy
      appointment were independent risk factors for poor bowel preparation. Another study performed
      in China showed that telephone re-education（TRE) about the details of bowel preparation on
      the day before colonoscopy significantly improved the quality of bowel preparation and PDR.
      So,it is reasonable to hypothesise that efforts to improve education and maximise patient
      compliance during the preparatory period will enhance the efficacy of bowel preparation.

      The study compares the efficacy of bowel preparation between the face-to-face re-education
      (FFRE group) and telephone re-education (TRE group) in patients.
    

Intervention name(s): telephone re-education(TRE); face-to-face re-education (FFRE)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by one investigator at 15:00-17:00 on the day before colonoscopy.; Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: bowel preparation; polyethylene glycol; face-to-face re-education; telephone re-education; Boston Bowel Preparation Scale
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week
      run-in period will be followed by a median of 6 years of treatment with study medication in
      addition to continuation of background glucose lowering therapy. Patients inadequately
      controlled on background metformin will be randomised to receive, in addition to metformin,
      either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio
      of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in
      addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of
      patients receiving background metformin and SU at entry will be entered into the study.
    

Detailed description: 
      A RECORD follow-up study is being performed to monitor the incidence of cancer and bone
      fractures in RECORD patients for a period of 4 years after the end of the main RECORD study
      (2008 - 2012).
    

Intervention name(s): Rosiglitazone; Sulfonylurea; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rosiglitazone maximum 8 mg per day; Sulfonylurea (SU) maximum permitted daily dose; Metformin maximum permitted daily dose .
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; CV outcomes; rosiglitazone; Type II diabetes; sulfonylurea; RECORD; metformin
to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the drug interaction of pharmacokinetics of
      rosuvastatin and ezetimibe.
    

Detailed description: 
      drug interaction : rosuvastatin, ezetimibe
    

Intervention name(s): Crestor+Ezetrol; Ezetrol; Crestor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rosuvastatin+ezetimibe; ezetimibe; rosuvastatin
Other intervention name(s): rosuvatatin+ezetimibe; ezetimibe; rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized study was designed to evaluate the efficacy and safety of IPu-infused
      liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic,
      levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period
      followed by implantation of the IPu delivery system and then a 6-month double-blind treatment
      period.
    


Intervention name(s): Liatermin (r-metHuGDNF)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bilateral, Idiopathic Parkinson's Disease
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of
      biphasic insulin aspart 30 on postprandial glycaemic control.
    


Intervention name(s): biphasic insulin aspart; biphasic human insulin
Intervention type(s): Drug; Drug
Other intervention name(s): BIASP
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the
      effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite
      following a single oral dose of 33mg/kg Ferriprox®.
    

Detailed description: 
      Post-marketing study to evaluate the effect of impaired renal function on the
      pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of
      Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy
      volunteers.
    

Intervention name(s): Deferiprone
Intervention type(s): Drug
Intervention description(s): Oral iron chelator
Other intervention name(s): Ferriprox; L1; DFP
Intervention MeSH terms: Deferiprone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Renal Impairment; Kidney Impairment; Kidney Disease; Ferriprox; Deferiprone; DFP (deferiprone); L1
Training Model on Insertion Techniques for Postplacental Intra Uterine Device
Condition: Intra-uterine Device Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to compare special guided training model with standard procedure on
      insertion technique for post-placental intra uterine device that provides IUD location close
      enough to fundal part of uterus to prevent expulsion
    

Detailed description: 
      The standard of insertion IUD postplacental can not provide prevention of expulsion. Special
      techniques on insertion IUD is needed for preventing expulsion. This training model is
      consisted of the special techniques to provide intra uterine device post placental close
      enough to fundal part of uterus to prevent expulsion
    

Intervention name(s): Training; No Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.; Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Huperzine for Cognitive and Functional Impairment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Huperzine is a natural plant product with procognitive properties in patients with
      Alzheimer's disease. Cognitive difficulties hamper functioning in schizophrenia as well. The
      present study will investigate whether huperzine improves cognition and functioning in
      patients with schizophrenia.
    


Intervention name(s): placebo; huperzine 0.2 mg BID; huperzine 0.4 mg BID; huperzine 0.8 mg BID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): matching pill placebo; huperzine rising doses up to 0.2 mg BID; huperzine rising doses up to 0.4 mg BID; huperzine rising doses up to 0.8 mg BID
Intervention MeSH terms: Huperzine A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; cognition; functioning
School Located Adolescent Vaccination Study
Condition: School Located Vaccine Program
Study type: Interventional

Summary: 
      The provision of adolescent vaccination in a school setting will be feasible and acceptable
      to parents as evidenced by the number and percentage of students immunized within each school
      compared to those in schools without a program. The likelihood of vaccination for diphtheria,
      tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate
      vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a
      comprehensive school-based immunization program will be significantly higher than that of
      students enrolled in schools without a school-based immunization program.
    


Intervention name(s): School Located Vaccine (SLV) Program
Intervention type(s): Behavioral
Intervention description(s): A community vaccinator will administer vaccines to students whose parents consent for their child to participate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: school located vaccine program
Comparative Study Between Porcine and Autologous Cortical Plates
Condition: Bone Regeneration
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the outcome of three-dimensional bone regeneration
      procedures using thin cortical porcine xenograft plates in combination with autogenous bone
      chips compared with thin autogenous cortical plates and autogenous bone chips.
    

Detailed description: 
      Materials and methods: 16 patients referred for implant placement and with insufficient
      bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received
      autogenous cortical plates (ACP) of either porcine xenogeneic (XCP). The aforementioned
      groups were compared in regards to bone augmentation using General Estimating Equations (GEE)
      and logistic regression. Demographic data, trabecular bone density, graft site, postoperative
      pain, and time consuming were also analyzed
    

Intervention name(s): split bone block technique
Intervention type(s): Procedure
Intervention description(s): A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study.. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the autogenous cortical plate group (ACP), and xenogeneic cortical plate group (XCP).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: split bone block; RCT
Multiple Dose Safety Study of SRX251 Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the second study to evaluate SRX251 in healthy volunteers and it represents the
      first multiple dose study. The primary objective of this study is to evaluate the safety and
      tolerability of escalating multiple oral doses of SRX251 capsules for 5 days in healthy adult
      volunteers. Levels of the drug in blood plasma will also be determined.
    


Intervention name(s): SRX251
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy volunteers