bioihbjkbjnl/mcl2 huggingface dataset:
An RCT Comparing Xenograft and Allograft for Ridge Preservation
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked
      collagen membrane with xenograft + non-cross-linked collagen membrane for posterior
      extraction socket ridge preservation.
    

Detailed description: 
      Buccal bony wall loss is a common sequela following tooth extraction, and guided bone
      regeneration (GBR) is a common treatment for the regeneration of ridge form and volume
      preservation allowing dental implant placement. Many bone augmentation biomaterials are
      employed to accomplish GBR, and both the medical/ dental community and, subsequently,
      patients benefit from understanding whether a given GBR biomaterial might be more
      efficacious. To this end, a randomized, case series comparison of allograft + x-linked
      collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to
      both the dental community and patients.

      The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked
      collagen membrane with xenograft + non-x-linked collagen membrane for posterior region
      extraction socket ridge preservation.
    

Intervention name(s): allograft + x-link collagen membrane; xenograft + non-x-link collagen
Intervention type(s): Device; Device
Intervention description(s): Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.; Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Buprenorphine Detoxification - BBDVI - 19
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the long-term efficacy of alternate-day dosing
      schedules in promoting treatment compliance in the absence of confounding behavioral
      contingencies.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
1H Magnetic Resonance Spectroscopy in Migraine Patients
Condition: Migraine Disorders; Migraine Without Aura; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
MeSH terms: Migraine Disorders; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Headache Disorders; Migraine without Aura; Headache Disorders, Primary; Headache
Study type: Interventional

Summary: 
      To investigate the glutaminergic system in the onset of migraine-like attacks.
    

Detailed description: 
      Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female
      migraine without aura patients. Apart from migraine without aura patients healthy female
      controls are also included as a control group. Over the course of a single day these females
      (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN
      infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are
      acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32
      channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS)
      with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other
      metabolites will be assessed. The primary endpoint; glutamate level changes towards the
      pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as
      secondary endpoints.
    

Intervention name(s): Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
Condition: Stomach Cancer; Corona Virus Infection
MeSH terms: COVID-19; Coronavirus Infections; Stomach Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to analyze whether COVID-19 causes a delay in the diagnosis of
      gastric cancer patients particularly in the TNM staging of the tumor, or not and to compare
      the number of newly diagnosed patients with gastric cancer before and during the COVID-19
      pandemic period.
    

Detailed description: 
      The study included the patients diagnosed with gastric cancer during the period between March
      1, 2020, and December 31, 2020, in the pandemic group at the Adana City Training and Research
      Hospital, Department of General Surgery, Divisions of Gastroenterological Surgery and
      Surgical Oncology. For the baseline group, patients diagnosed with gastric cancer between
      January 1, 2019, and December 31, 2019, was included in the same department.

      Clinical and pathological data of the patients were retrospectively collected from the
      hospital medical records. The following parameters were compared between the pandemic and
      baseline periods; age and gender distributions, mean monthly numbers of newly diagnosed
      patients, CEA and CEA-19.9 levels, the type of the surgery, the location of the tumor, the
      frequency of the patients receiving neoadjuvant treatment, American Society of
      Anesthesiologists (ASA) score, length of the hospital stay, clinical staging and pathologic
      TNM staging.
    

Intervention name(s): Gastric cancer surgery
Intervention type(s): Procedure
Intervention description(s): Appropriate gastric cancer surgery types for the convenient patients
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        newly diagnosed gastric cancer patients
      
Keywords: gastric surgery; COVID-19; SARS-COV-2; pandemic; stomach surgery; cancer surgery
PROOF: PROtein OverFeeding Effect on Body Weight
Condition: Obesity
Study type: Interventional

Summary: 
      This study is designed to determine the effects of dietary protein content on overfeeding.
    

Detailed description: 
      When body weight increases, the expenditure of energy increases as a mechanism to dissipate
      the excess calories. The role of diet composition in over-feeding/energy dissipation in
      humans is unknown. We propose that:

        1. High and low protein diet will result in less weight gain as compared to a moderate
           protein diet during a 56d high fat overfeeding.

        2. Increase in energy expenditure and spontaneous physical activity, adjusted for lean and
           fat mass will be greater in the high and low protein diets as compared to a moderate
           protein diet.

        3. the average size of the fat cells and the pattern of genes expressed in the adipose
           tissue, skeletal muscle, and peripheral blood mononuclear cells will "predict" which
           group of subjects will gain the most weight (and fat mass) independent of the level of
           the protein in the diet.
    

Intervention name(s): PROOF
Intervention type(s): Behavioral
Intervention description(s): dietary overfeeding with high, low or normal protein content
Other intervention name(s): Overfeeding with different protein levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal
      sensitivity, assessed by the multimodal stimulation.
    


Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of buspirone to assess esophageal sensitivity; Administration of placebo to assess differences in esophageal sensitivity
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
Condition: Neoplasm of Uncertain Malignant Potential; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neurofibroma; Neurofibroma, Plexiform
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon
      alfa-2b in treating young patients with plexiform neurofibroma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with
           unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual
           as of 2/2005.)

        -  Determine the toxicity profile of this drug in these patients.

      Secondary

        -  Obtain, preliminary, information about the efficacy of this drug in these patients.

        -  Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in
           patients treated with this drug.

        -  Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.

      OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study
      closed to accrual as of 2/2005.)

      Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence
      of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1
      of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at
      the MTD.

      After completion of study treatment, patients are followed every 6 months.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
    

Intervention name(s): PEG-interferon alfa-2a
Intervention type(s): Biological
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Primary purpose: Treatment
Keywords: neoplasm of uncertain malignant potential; unspecified childhood solid tumor, protocol specific
The Assessment of Movement Disorders Utilizing Live Two-Way Video
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Movement Disorders; Tardive Dyskinesia
Study type: Observational

Summary: 
      The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS)
      and tardive dyskinesia (TD) examinations conducted via live two-way video versus live
      examinations completed in-person
    

Detailed description: 
      Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and
      troublesome adverse events when taking antipsychotic agents. The investigators aim in this
      study to determine if the investigators can conduct examinations for EPS and TD remotely
      using live two-way video. It is potentially beneficial for patients, especially those who are
      located far away from psychiatrists if they could be seen by trained clinicians and assessed
      for EPS and TD via two-way video in the future. Participants will be asked to have a medical
      assessment which consists of simple questions and some examination of their movements via
      two-way video and in person. The investigators will compare the results of video examinations
      with the results of live examinations.
    

Intervention name(s): Two way video assessment
Intervention type(s): Other
Intervention description(s): Participants will be assessed extrapyramidal symptoms and tardive dyskinesia
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service
        of The Zucker Hillside Hospital.
      
Keywords: Schizophrenia; Extrapyramidal symptoms; Tardive dyskinesia; Two Way Video Assessment
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the
      effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial
      drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at
      steady-state conditions in subjects with type 1 diabetes mellitus.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.; Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare long-term outcomes among patients randomized on the BMT CTN
      0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without
      Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for
      Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents
      will improve long-term progression-free survival (PFS) after high-dose melphalan followed by
      autologous hematopoietic cell transplantation (HCT) as compared to a second autologous
      transplantation.
    

Detailed description: 
      This study is designed to compare long-term outcomes among patients randomized on the BMT CTN
      0702 protocol (NCT01109004). All patients who consent will be followed for death,
      progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do
      not consent to the long-term follow-up mechanism or who have experienced progression on the
      BMT CTN 0702 study will be followed through the standard Center for International Blood and
      Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who
      are eligible and are willing to continue with lenalidomide as maintenance therapy will be
      provided lenalidomide free of charge. These patients will continue to receive lenalidomide as
      maintenance therapy until disease progression or discontinuation due to toxicity, death, or
      withdrawal from the study. The endpoints assessed will include progression-free survival
      (PFS), overall survival (OS), event-free survival (EFS), incidence of second primary
      malignancies (SPM) and health quality of life (QOL).
    

Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention description(s): In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
Other intervention name(s): Revlimid™
Intervention MeSH terms: Lenalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Lenalidomide; Maintenance Therapy; Progression; Long-term; Anti-Myeloma Agents; Hematologic Disorders
Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Condition: Influenza; Healthy
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or
      without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated
      locally and systemically and by using haematological, biochemical and immunological screening
      tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local
      and systemic antibody and cellular immune responses. In a pandemic situation, an important
      aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of
      the immune response will be investigated. The capacity of the vaccine to elicit long lasting
      immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the
      quality of the immune response induced by the vaccine will be studied. The vaccine will be
      administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a
      dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with
      adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine
      (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating
      doses will be separated by a period of one week. Four groups each containing 15 subjects will
      receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing:

      Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3
      7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg
      3rd generation ISCOM™ IM.
    


Intervention name(s): Influenza vaccine
Intervention type(s): Biological
Intervention description(s): Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza A; pandemic; vaccine; immunogenicity; Virus; H5N1
The Effects of Short Message Notifications on Middle-Aged Diabetic Patients
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of our study was to assess awareness-raising of medication adherence (MA),
      physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values
      by providing information on diabetes via short message (SMS) technology.
    

Detailed description: 
      The study investigates T2DM patients who have not had surgery or cardiac event in the last 3
      months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10
      years and oral antidiabetic therapy for at least 1 The study design is a single-blinded
      randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul
      University Medical Faculty Hospital.

      Patients randomly assigned to the intervention group, in addition to traditional treatment
      received three to four informative SMS messages per week during the 6-month period, while the
      control group was followed in accordance with the traditional treatment schedule.
    

Intervention name(s): Informative messages
Intervention type(s): Other
Intervention description(s): In addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months.
The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Diabetes mellitus; Public health
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of
      escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a
      randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that
      will have two parts; Part A and Part B.
    


Intervention name(s): GSK3352589; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.; It will be available across all strengths to match active drug in the form of tablet for oral administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: REarranged during Transfection
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Condition: Pandemic H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived
      Influenza Vaccine in Adult Subjects.
    


Intervention name(s): Adjuvanted H5N1 pandemic influenza vaccine
Intervention type(s): Biological
Intervention description(s): Comparison of two doses of aH5N1c vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza, Pandemic, H5N1, Adults