bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Aromatherapy on Anxiety in Patients
Condition: Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Preoperative anxiety is considered a potential and preventable risk factor for postoperative
      complications.
    

Detailed description: 
      Alot of patients face fear from intervention such as radiofrequency. The group of patients
      with chronic knee osteoarthritis already and mostly have some sore of psychological upset,
      radiofrequency itself , even in the presence of good periinterventional local anesthetic
      infiltration, the patients suffer pain and stress. It is well evidenced that aromatherapy
      specially with Lavender oil offers some sort of anxiety alleviation, pain alleviation and
      protection against postoperative nausea and vomiting
    

Intervention name(s): Lavender Oil
Intervention type(s): Drug
Intervention description(s): three drops of the designated lavender will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient was asked to inhale deeply for 5 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We hypothesized that the use of lavender aromatherapy before surgery would reduce preintervntion of radiofrequency anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective
      in relieving depression when it is added to standard kinds of antidepressants called
      serotonin reuptake inhibitors (SSRIs).
    

Detailed description: 
      The study consists of two phases, each lasting a total of four weeks (8 weeks total), with
      visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return
      two weeks later for a baseline visit, when they will be randomly assigned, like a flip of a
      coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a
      placebo is a pill that looks like a study drug but contains no active medication). They will
      have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8
      week study.

      Neither the subject nor the research staff will know which group the subject is in.

      All subjects will be asked to take the study medication in the morning, in addition to their
      ongoing SSRI treatment.
    

Intervention name(s): 6(S)-5-MTHF(Deplin); Placebo
Intervention type(s): Other; Other
Intervention description(s): Deplin is a medical food. Patients will take 15 mg/day of deplin.; Inactive substance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Medical food
Failed/Difficult Colonoscopy Outcomes
Condition: Colonoscopy
Study type: Observational

Summary: 
      Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal
      disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this
      removal is also known as polypectomy.

      Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from
      it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion
      of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a
      tertiary centre with extensive experience in difficult colonoscopy or have an alternative
      test such as CT scan. The investigators unit has accumulated significant experience related
      to previously failed colonoscopy and anecdotally appears to have a high success rate in
      completing the procedure.

      The purpose of this project is to describe the investigators technical approach to management
      of patients with previously failed colonoscopy. There is no additional intervention and the
      project is observational in nature. The investigators will collect data on patient
      characteristics, the reason for the failure and what technique was used to overcome the
      difficulty. The investigators will also note whether the final outcome of the technique had
      any impact on the overall management of the patient.
    


Intervention name(s): Colonoscopy
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For a small proportion of patients a complete colonoscopy is unsuccessful due to technical
        and physical reasons. This will be the study population which will be invited to
        participate in this study.
Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection
Condition: Renal Transplant Rejection
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the feasibility and efficacy of detecting kidney
      transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.
    

Detailed description: 
      This study will be divided into two stages. In the first stage the investigators will assess
      the transplant kidney with ultrasound after contrast injection (Sonazoid) to determine if
      contrast in the kidney is detectable by ultrasound and to determine if the amount of
      perfusion can be quantified directly or qualitatively. The investigators aim to have one to
      two subjects in this stage. If perfusion of the kidney can be assessed, then the
      investigators will move to stage two of the study.

      In stage 2, the investigators will look to determine the ability of the contrast enhanced
      ultrasonography method to detect renal transplant rejection using Sonazoid. For this stage
      the investigators will recruit subjects with biopsy confirmed renal transplant rejection.
      Once subjects are consented, they will undergo contrast enhanced ultrasonography with
      Sonazoid and have images taken. These images will be compared to images of renal transplant
      patients that have displayed no rejection or clinical issues. These clinically normal
      subjects will have previously consented to a medical record review so that the investigators
      may use their images.
    

Intervention name(s): Sonazoid; contrast enhanced ultrasonography
Intervention type(s): Drug; Device
Intervention description(s): Sonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles; Injection of intravenous ultrasound contrast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate
Condition: in Vitro Fertilization
Study type: Interventional

Summary: 
      The purpose of the study is to evaluated whether there is a difference in pregnancy rate when
      transferring frozen embryos between patietns having spontaneously ovulated versus those
      triggered to voulate with HCG.
    


Intervention name(s): HCG
Intervention type(s): Other
Intervention description(s): 250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
Condition: Cancer
Study type: Observational

Summary: 
      The investigators aim is to explore associations between specific types of cancer therapy,
      age at treatment and the presence of dental abnormalities in adolescence.

      The study will help identify unique dental changes, malformations and or missing teeth that
      appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy
      and or radiotherapy) given in childhood.

      Materials and methods:

        -  Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age
           of 0-10 years old.

        -  The following data will be collected: Demographic information, Medical Status, Cancer
           therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic
           examination.
    


Intervention name(s): Collecting data
Intervention type(s): Other
Intervention description(s): Collecting data from patient records
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
        The maximum time span of entering the study group-up to 20 years after last session of
        oncology treatment.
Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered
      intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is
      safe and will induce a therapeutic effect in autism patients.
    


Intervention name(s): Umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; umbilical cord; mesenchymal; stem cells
Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Condition: Peritoneal Carcinomatosis; Ovarian Cancer; Colon Cancer
MeSH terms: Ovarian Neoplasms; Colonic Neoplasms; Carcinoma; Peritoneal Neoplasms; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients
      with elevated levels of different inflammation cytokines show a worse prognosis at the time
      of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis
      and a comparison of these two different types of peritoneal invasion have not been conducted
      yet. We found interesting studying the role of immune response, in particular
      tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate
      also mitochondrial defects, such as mutations in mt-DNA, potentially involved in
      carcinogenesis.
    

Detailed description: 
      At the time of hospitalization all the patients will undergo a complete clinical evaluation
      with determination of biochemical parameters such as fasting blood glucose, blood count,
      hs-CRP, AST and ALT, uric acid, creatinine and BUN. An extra blood aliquot will be collected
      to assess the serum biomarkers under investigation.

      During surgery two samples of peritoneal tissue macroscopically undamaged will be collected.
      On those samples will be executed separation of adipocytes cells, RNA and protein extraction
      for measuring of inflammatory and neoplastic biomarkers, determination of P2X7R-inflammasome
      activity and mitochondrial DNA analyse.
    

Intervention name(s): Cytoreductive surgery
Intervention type(s): Procedure
Intervention description(s): Partial removal of peritoneal tissue involved by neoplastic invasion
Other intervention name(s): Debulking
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study consecutively enrolled 30 patients undergoing surgical treatment for peritoneal
        carcinosis: 15 patients affected by high grade ovarian cancer and 15 patients affected by
        colon cancer. Patients will be enrolled among those referring to the Gynaecologic Unit and
        the General Surgery Unit, University Hospital of Pisa, Italy.
      
Biospecimen description: 
      peritoneal biopsy
    
Keywords: peritoneal carcinomatosis; colon cancer; ovarian cancer; P2X7R-inflammasome
Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the efficacy and safety of sitaglipin in the
      treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using
      metformin and insulin.
    

Detailed description: 
      DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose
      homoeostasis. DPP-4 inhibitors have been proved to promote glycemic control without
      increasing risk of hypoglycemia and weight gain. In addition, they may improve beta-cell
      function and do not have any known associations with overt cardiovascular or hepatic safety
      risks.

      Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/-
      metformin has been shown to reduce HbA1c while being generally well-tolerated.

      It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on
      stable therapy with insulin & metformin. Apart from glycemic reduction, secondary effects
      like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk
      profile, etc. may be expected from addition of sitagliptin to treatment.
    

Intervention name(s): Sitagliptin; Glimepiride; Metformin; Insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg once daily for 6 months; 1 mg/2 mg/3 mg once daily; >=1000 mg twice daily; TDD > 10 IU once/twice daily
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Sitagliptin; Insulin
Physical Activity for a Long and Healthy Life
Condition: Overweight; Insulin Resistance; Diabetes Mellitus, Type 2
MeSH terms: Overweight; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study is to 1) delineate the molecular mechanisms behind the large variation
      in insulin sensitivity among apparently healthy subjects and to 2) establish the
      dose-response relationship between physical training and a) metabolic health, b) appetite and
      c) cultural health.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Daily exercise for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise
Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In the future, we plan to conduct an 8-week diet intervention to investigate whether a
      healthy Nordic diet improves depression symptoms. The present pilot study tested whether the
      planned meals and diets were well-liked and accepted by participants (both depressed and
      non-depressed) in order to ensure that the future diet intervention will be feasible and
      successful. We also investigated whether any changes in health occurred after 8 days of this
      diet intervention.
    

Detailed description: 
      After providing their written informed consent, participants were randomized to receive
      either a healthy Nordic diet or a control diet for 8 days. All meals were provided and
      minimal food preparation was required. Participants picked up their food outside the study
      kitchen every 3 days. Before and after the intervention, health-related self-rated
      questionnaires were completed. For every meal during the intervention, participants completed
      a questionnaire on their perceptions of the meal. Every evening a questionnaire was completed
      to assess dietary adherence. At the end of the study, a final evaluation questionnaire was
      completed to assess participants' perceptions of the diet and study as a whole.
    

Intervention name(s): Control Diet (CD); Healthy Nordic Diet (ND)
Intervention type(s): Other; Other
Intervention description(s): All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. A sugar-sweetened juice drink was provided for consumption of one portion per day. Water, milk, coffee, tea and alcohol were consumed as usual.; All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. Water, milk, coffee, tea and alcohol were consumed as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Depression; Major Depressive Disorder; Diet; Nutrition; Randomized controlled trial; Pilot study; Healthy Nordic diet
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the effects of soy and soy plus isoflavones
      on bone mineral Density and physical performance in post menopausal women.
    

Detailed description: 
      Post menopausal estrogen deficiency causes physiologic changes in body composition including
      decreased lean body weight and bone mass. A decrease in muscle strength along with
      osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable
      mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase
      muscle strength but given the concerns regarding its use, patients are looking for
      alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral
      density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to
      provide conclusive evidence. There is no evidence of its effects on physical performance.

      The aim of the present study is to investigate the effects of 25g of soy protein alone or
      with 90mg of isoflavones on bone mineral Density and physical performance indices in post
      menopausal women over a duration of 2 years.
    

Intervention name(s): Soy protein
Intervention type(s): Dietary Supplement
Intervention description(s): 25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months
Other intervention name(s): genistein, daidzein, glycetein
Intervention MeSH terms: Genistein; Daidzein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Soy Isoflavones, Bone Mineral Density, Post menopausal women
Impact of an Educational Program on Gingival Status and Oral Health Related Quality of Life
Condition: Gingival Disease; Oral Disease
MeSH terms: Mouth Diseases; Gingival Diseases
Study type: Observational [Patient Registry]

Summary: 
      This research targets the evaluation of the impact of oral health educational programs on the
      gingival status and oral health related quality of life in early adolescence of the Egyptian
      population. Each participant will benefit from the education of the proper oral hygiene
      practices under the supervision and follow up of the investigator in addition to the
      potential improvement of his/ her oral health related quality of life.
    

Detailed description: 
      The objective of this study is to improve the gingival status and oral health related quality
      of life in the Egyptian population's early adolescence. The intervention is an Oral health
      educational program based on the following:

        -  Tooth brushing: the modified bass technique is the method of choice the skill will be
           taught using a video followed by a model demonstration then a supervised brushing
           session done by the participants.

        -  Dietary recommendations and importance of visiting the dentist will be introduced in the
           form of power point presentation that will be set according to the American Academy of
           Pediatric Dentistry (AAPD).

        -  Participant will be asked to come for 4 visits one for base line data collection and
           administration of the intervention and another 3 follow up visits once per month.
    

Intervention name(s): Oral Health Educational Program
Intervention type(s): Behavioral
Intervention description(s): proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged from 11 to 14 years old seeking dental care at the educational hospital,
        Department of Pediatric Dentistry and Dental Public Health, School of Dentistry New Giza
        University.
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Condition: Orbital Fat Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      After enucleation or evisceration with placement of a dermis fat graft or integrated orbital
      implant as a primary procedure, there can be secondary loss of orbital fat volume causing
      regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques
      for correction require open surgery to place a sheet/block of biocompatible material or a
      macroaggregate of fat into the orbit to augment orbital volume for permanent correction.
      Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but
      these have proved to be temporary. The current study seeks to show that a permanent
      augmentation of orbital volume can be achieved using a closed cannula injection of autologous
      fat.
    

Detailed description: 
      To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3
      MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects
      (total 10) to increase the number of data for analysis.

      To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed
      fat injections. The study period has been extended to include MRIs at 2 and 5 years after
      injection.
    

Intervention name(s): autologous fat grafting to the orbit
Intervention type(s): Procedure
Intervention description(s): subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous; fat; orbit; atrophy; cannula