bioihbjkbjnl/mcl2 huggingface dataset:
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients
Condition: Infertility
MeSH terms: Infertility; Flushing
Study type: Interventional

Summary: 
      In this study, the investigators aimed to evaluate to the efficacy of the needle type used in
      follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.
    

Detailed description: 
      This study will include:

        1. women with less than four follicles on the day of hCG administration

        2. women between 20-45 age old

        3. The value of progesterone on the day of hCG administration will be under 1.5ng/ml
    

Intervention name(s): single lumen needle in oocyte retrieval; double lumen needle in oocyte retrieval
Intervention type(s): Procedure; Procedure
Intervention description(s): single lumen needle use during oocyte retrieval; after aspiration of follicles, 3 times flushing will be performed in double lumen needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: follicular flushing; IVF; poor responders; oocyte retrival
The Effect of Fish Oil Supplementation on Vocal Performance
Condition: Voice Range Profile; Reflux Symptom Index; Evaluation of Ability to Sing Easily; Body Composition
Study type: Interventional

Summary: 
      The purpose of this study was to determine if use of omega-3 PUFA supplement in combination
      with a singer's training regimen enhances training adaptations and body composition.
    


Intervention name(s): omega-3 PUFA supplement; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): participants were instructed to take 3.0 grams per day of omega-3 PUFA supplement; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
CAP-Ketamine for Antidepressant Resistant PTSD
Condition: PTSD; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as
      compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an
      active duty military and Veteran population.
    

Detailed description: 
      In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses
      of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who
      meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized
      to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants
      receive the study drug via intravenous infusion twice per week for 4-weeks.
    

Intervention name(s): Ketamine; Placebo/Saline
Intervention type(s): Drug; Drug
Intervention description(s): FDA approved anesthetic medication with rapid acting antidepressant effects.; This is a saline placebo/non-active solution.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Ketamine; Veteran; Military; Clinical Trial
Trial of Indomethacin in Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The researchers are trying to find a way to slow down the progression of chronic pancreatitis
      (CP) and investigate the possibility of the long term treatment of this disease.
    


Intervention name(s): Indomethacin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg twice a day by mouth.; Lactose capsules not containing active study drug will be taken twice a day.
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Subjects will be assigned to receive IN or placebo according to a computer generated randomization list composed of randomized blocks of sizes of 2 or 4. Two separate sets of blocks will be created, one for subjects with alcoholic CP and the other for those with other causes of CP. Within each block, equal number of subjects will be assigned to IN and placebo. Separate sets of blocks will be provided for Mayo and Ohio State. The randomization lists will be computer generated by the study statistician (Dr Li), and kept in a secure computer file and paper study binder in the Mayo and Ohio State Research Pharmacies. No investigators or study personnel other than Dr Li will have knowledge of the randomization list. Dr Li will not participate in any aspect of subject recruitment, subject allocation, conduct of the study, or data ascertainment, but will perform data analysis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Straberi Epistamp Needling Treatment For Skin Rejuvenation
Condition: Wrinkle; Elastic Skin; Collagen Degeneration
MeSH terms: Ehlers-Danlos Syndrome
Study type: Interventional

Summary: 
      This pilot study will expand knowledge and application needling using the Epistamp device for
      the improvement of a new vitalized epidermal layer with new vibrant active cells, supported
      by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.
    

Detailed description: 
      This pilot study will expand the knowledge and application needling using the Epistamp device
      and its benefits for improving the appearance of fine lines, deep wrinkles, and collagen
      production. The pilot aims to objectively measure skin quality using the Derma Scan,
      photographs and provide objective data showing improvement by way of the Universal Skincare
      Institute Blood Flow Scale.
    

Intervention name(s): Straberi Epistamp Microneedling Treatment
Intervention type(s): Device
Intervention description(s): The patient's entire face will be treated with the Straberi Epistamp needling device.
The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm
Other intervention name(s): Needling
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microneedling
Adj TC + Herceptin Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out what effects (good and bad)
      docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand
      name: Herceptin, or H) has HER2+ breast cancer.
    


Intervention name(s): Taxotere; Cytoxan; Herceptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.; On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.; On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Other intervention name(s): docetaxel; cyclophosphamide; trastuzumab
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
Condition: Pain
Study type: Interventional

Summary: 
      Pain during nuclear medicine breast lymphnode detection procedures has been reported as high
      as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain
      can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.

      In sites other then the breast, using Bicarbonate to make the injection's pH closer to
      natural, attempts to lower the pain levels will be performed.

      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be
      reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH
      7.40.
    


Intervention name(s): Standard of Care First; ph Altered first
Intervention type(s): Drug; Drug
Intervention description(s): For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40.; For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.
Other intervention name(s): Sodium Bicarbonate second; Sodium Bicarbonate first
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Alkalinization; Technetium 99m Sulfur Colloid; sentinel lymphoscintigraphy?
Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A
      study in healthy smokers.
    

Detailed description: 
      Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive,
      smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple
      doses of all study treatments are given either every 60 minutes or every 90 minutes,
      respectively. All products will be administered in accordance with labeling, on five separate
      treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and
      until the end of each visit.
    

Intervention name(s): Nicotine; Nicotine; Nicotine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 mg experimental Nicotine Replacement Therapy (NRT); 4 mg marketed Nicotine Fruit Gum (NFG); 4 mg marketed nicotine mint lozenge (NIQ)
Other intervention name(s): Not yet marketed; Nicorette® Freshfruit Gum; NiQuitinTM Mint lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To compare the effect of low-glycemic index versus control lunches and dinners intake on
      indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2
      diabetes under metformin therapy.
    


Intervention name(s): Low-glycemic index; Control
Intervention type(s): Other; Other
Intervention description(s): Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.; Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLYCEMIC INDEX; NAFLD; METABOLIC PARAMETERS; SATIETY
Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      This randomized trial is designed to assess the effectiveness of nasal elevator as a
      presurgical infant orthopedics on improvement of nose esthetics vs taping alone.
    


Intervention name(s): Nasal Elevator; Taping Alone
Intervention type(s): Device; Device
Intervention description(s): A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.; Horizontal tape alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School.
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The incidence of type 1 diabetes is increasing worldwide and in France, including among young
      children.

      Type 1 diabetes has consequences for integration in community, especially on the management
      of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school
      trips.

      This works' purpose is to describe obstacles and difficulties to the integration in community
      before primary school (day care center, childminder, and nursery school) of a complete sample
      of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric
      Hospital, at the start of the school year 2018-2019. The investigating team will carry out a
      descriptive study, using different questionnaires addressed to the professionals (nursery
      school directors, day care nursery directors, childminders, school doctors, pediatricians and
      doctors of child and maternal protection centers) and to the parents of children with type 1
      diabetes. These different questionnaires will help to take into account different points of
      view, in order to identify all the obstacles to integration of children with type 1 diabetes
      in community.

      Through this work, secondary information actions through training and/or information leaflets
      will be carried out in order to facilitate the reception of these children in the community.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): The questionnaires have two parts: a general part and a second part focused on the integration in community of the type 1 diabetes children with specific questions about blood glucose, mealtimes, sporting activities and school trips.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children 1 year to 8 years old with Type 1 diabetes followed by the Diabetology Department
        of Lyon Pediatric Hospital.
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
Condition: Weight Change, Body
MeSH terms: Body Weight Changes
Study type: Interventional

Summary: 
      This trial will evaluate a healthy eating and weight gain prevention intervention for
      delivery through calls to the 2-1-1 number.
    

Detailed description: 
      It is now well-established that obesity and excess weight increase the risk of cancer (i.e.,
      colorectal and post-menopausal breast cancer), as well as other chronic diseases including
      diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and
      the American Institute for Cancer Research state "maintenance of a healthy weight throughout
      life may be one of the most important ways to protect against cancer". Unfortunately, adults
      generally gain weight as they age.

      Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment
      profile and a health coach working with participants to select and implement a series of
      healthy actions to create a home environment more supportive of healthy eating and physical
      activity.

      The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call
      for information and referrals to social services and other assistance in the United States.
      This study will evaluate a healthy eating and weight gain prevention intervention for
      delivery through 2-1-1 calls.
    

Intervention name(s): Health Homes/Healthy Families (HH/HF) Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.; Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Weight Gain Prevention; Cancer Prevention; Chronic Conditions; Obesity; Healthy Eating
Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Condition: Neutropenia; Cancer; Fever
MeSH terms: Neutropenia
Study type: Interventional

Summary: 
      Once-daily dose administration of aminoglycoside in adults is effective and economical.
      However, its value in febrile neutropenic children, especially in Thailand, is less well
      researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic
      children is low, the combination of cloxacillin and amikacin is an appropriate approach. This
      study would like to compare the efficacy and safety including cost between these two amikacin
      administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical
      therapy in febrile neutropenic children.

      Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic
      children in Khon Kaen, Thailand.
    

Detailed description: 
      Fever: a single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.

      Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to
      <500/mm3.
    

Intervention name(s): cloxacillin and amikacin (once or twice daily dosage)
Intervention type(s): Drug
Intervention MeSH terms: Amikacin; Cloxacillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: febrile neutropenia; once-daily; amikacin; cloxacillin; children
Mental Health and Aggression in Congolese Ex-combatants
Condition: Appetitive Aggression; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is examine, whether a treatment approach, which is specifically
      tailored for perpetrators who have participated in violence (a variant of Narrative Exposure
      Therapy) is effective in the reduction of instrumental aggression and symptoms of
      posttraumatic stress disorder.
    

Detailed description: 
      The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn
      countries. Former child soldiers and ex-combatants often suffer from mental health problems
      and show enhanced levels of aggression. The present study focuses on the reduction of
      appetitive aggression and the improvement of mental health in former child soldiers and
      ex-combatants in DR Congo.
    

Intervention name(s): A variant of Narrative Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): During the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts. All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the therapist and the client try to go through all important traumatic experiences and perpetrated violent acts. The sixth session is a group session with four to five clients. The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment of ex-combatants; Narrative Exposure Therapy for ex-combatants; Appetitive Aggression; Posttraumatic Stress Disorder
Acute Effect of Sound Healing on Pain, Fatigue and Mood
Condition: Pain; Fatigue; Mood Change
MeSH terms: Fatigue
Study type: Observational

Summary: 
      There is evidence that sound healing improves health and well-being. However, sound healing
      modalities, such as tuning forks, continue to be understudied, especially among people with
      chronic illnesses. This study examined responses to a single session of sound healing and
      explored whether responses varied based on analogue pain, fatigue, and mood.
    


Intervention name(s): Sound healing with tuning forks
Intervention type(s): Other
Intervention description(s): Over the course of a half-hour virtual session, a specially developed "triple OM track" created by tuning forks was played.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        People aged between 18-85, having long term illnesses for more than 6-month, completed
        30-mins selected sound healing track with tuning forks virtually and shared their impact
        post session, were evaluated retrospectively.
      
Keywords: Sound healing with tuning forks