bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an
      adjunctive medication during pterygium surgery in preventing pterygium recurrence. A
      pterygium is a white fleshy growth on the surface of the eye, which can be removed
      surgically. However, after surgical removal, pterygia can recur. One way of minimizing
      recurrence is by applying a medication called mitomycin C to the surface of the eye during
      pterygium surgery. However, mitomycin is associated with certain side effects, such as
      thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of
      action and there is some evidence that it may be useful in preventing pterygium recurrence.
      In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and
      mitomycin C for preventing pterygium recurrence will be directly compared.
    


Intervention name(s): Bevacizumab; Mitomycin C
Intervention type(s): Drug; Drug
Intervention description(s): 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.; Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Other intervention name(s): Bevacizumab (Avastin)
Intervention MeSH terms: Bevacizumab; Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Brochure-Based Education on Patients Planned for Nose Surgery
Condition: Nursing Caries
Study type: Interventional

Summary: 
      The study was planned as a randomized controlled trial to determine the effect of
      brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is
      planned to collect research data in Hatay Mustafa Kemal University Hospital
      otorhinolaryngology clinic between June 2022 and June 2023.The population of the research
      will be the patients who are hospitalized in the otorhinolaryngology clinic of the
      aforementioned hospital and are planned for nasal surgery. The sample of the study, on the
      other hand, will consist of 52 patients who meet the inclusion criteria and agree to
      participate in the study verbally and in writing.The data of the study were collected by
      using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale,
      which were prepared in line with the literature.The data will be analyzed with the SPSS
      package program.
    


Intervention name(s): Educational intervention
Intervention type(s): Other
Intervention description(s): In addition to standard care, brochure-supported education will be given to patients who are scheduled for nose surgery.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Sleep Well for Healthy Brain
Condition: Poor Quality Sleep
Study type: Interventional

Summary: 
      The purpose of this study is to slow down the aging of the participant's brain by improving
      sleep quality.
    


Intervention name(s): Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate
      atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent
      individuals, who are healthy and are seeking treatment for their substance abuse, will be
      randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial
      lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve
      maintenance on the assigned active dose safely. Contingency management procedures will be
      used to reinforce attendance and compliance with study procedures. Primary outcome measures
      will include urinalysis data assessing cocaine use.
    


Intervention name(s): atomoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily oral dosing; Once daily oral dosing - matched placebo
Other intervention name(s): Straterra
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; dependence; stimulants
Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT
Condition: Lentigo Solar
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      CRYO (N° 21D588A0001) study aims to evaluate the tolerance and adjust the mode of
      administration of a cyto-selective difluoroethane-based cryotherapy in the treatment of brown
      spots.

      The study is a proof of concept on a small panel of subjects and has been designed to be
      interventional, monocentric, randomized and double blind.

      The study will include three device prototypes and a CE marked device (trademark URGO
      CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.
    

Detailed description: 
      Solar lentigo is a harmless patch of darkened skin. It results from exposure to ultraviolet
      (UV) radiation, which causes local proliferation of melanocytes and accumulation of melanin
      within the skin cells (keratinocytes). Solar lentigos or lentigines are very common,
      especially in people over the age of 40 years.

      CRYONOVE PHARMA develops and manufactures cryotherapy-based devices to improve skin
      appearance and treat lentigo spot. The mode of action of CRYONOVE devices consists to
      "provoke a selective cell death (melanocyte & melanosome) by thermic shock induced by a rapid
      decrease in skin temperature via the diffusion of difluoroethane gas to the skin".

      In this proof of concept study, the sponsor aims to assess the tolerance and the
      admininistration mode of cryogenic spray which could be used for lentigo treatment on the
      face.

      The study is exploratory, interventional, monocentric, randomized and double blind.

      Three prototypes of devices for face are compared to a CE marking device (trademark URGO
      CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.

      Twelve subjects with at least 4 spots on face are expected to be included, in order to
      evaluate a minimum of 48 brown spots. Volunteers are treated at T0 only with the reference
      device and at T0, T2, T4, T6 weeks with the prototype devices. The patient follow-up include
      10 visits from D0 to D56.
    

Intervention name(s): EC16 medical device (CE marked); device prototype (810A-v1); device prototype (810B-v1); device prototype (810C-v1)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Application on brown spots located on the face (1 treatment during the study).; Application on brown spots located on the face (4 treatments during the study).; Application on brown spots located on the face (4 treatments during the study).; Application on brown spots located on the face (4 treatments during the study).
Other intervention name(s): CNV Body
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cryotherapy
Effects of Pentazocine on Manic Symptoms
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The opiate neurotransmitter system is thought to be involved in many abnormal mood states.
      Some researchers have suggested that changes in this system may trigger the switch to/from
      manic and depressive states in bipolar disorder. One problem with most of the currently
      available opiate medications is that they can produce addiction/dependence. A particular kind
      of opiate medication known as kappa-opiates may be able to produce changes in this system
      with much less risk of addiction. This study looks at Talwin (a combination of pentazocine
      and naloxone), a medication which affects the kappa and mu opiate systems. The study will
      examine whether two doses of Talwin affect manic symptoms in people who have been admitted to
      the hospital. This study will give more information about the involvement of the opiate
      system in bipolar disorder, and give important information for use in developing new
      treatments.
    

Detailed description: 
      Opiates have a long history of treating mood disorders. Some researchers have suggested that
      changes in this system may trigger the switch to/from manic and depressive states in bipolar
      disorder. The clinical use of opiate medications has been limited by their abuse/dependence
      potential. Studies of opiate receptor subtypes have raised the possibility that medications
      targeting the kappa/dynorphin system could be used to target mood symptoms with
      reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists
      have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition,
      antimanic/antipsychotic medications regulate the activity of dynorphin cells. This study is a
      pilot open-label investigation using Talwin, a combination of pentazocine and naloxone.
      Pentazocine is a kappa agonist and mixed mu agonist. Two doses of Talwin will be given to
      acutely manic inpatients in a cumulative-dosing strategy. Measurements of manic symptoms will
      be conducted before, during, and after administration. This study will determine whether
      pentazocine has an immediate or sustained impact on acute mania symptoms.
    

Intervention name(s): Talwin Nx
Intervention type(s): Drug
Intervention description(s): Talwin NX 50mg po twice
Other intervention name(s): Pentazocine
Intervention MeSH terms: Pentazocine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; mania; manic state; opiate; kappa
The Effect of SCIM on Neonatal Resuscitation
Condition: Pregnancy
Study type: Interventional

Summary: 
      In this randomized controlled trial 48 students were randomly allocated in three groups SCIM,
      Video training (VT) and control group(no training). They had a workshops based on NRP and
      lasted 6 hours for each group. Before and after the workshops and one month later all
      students participated in a 7 station OSCE..
    


Intervention name(s): SCIM; video
Intervention type(s): Other; Other
Intervention description(s): after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation; video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Evaluation of The Fear of Childbirth
Condition: Fear of Childbirth
Study type: Observational

Summary: 
      Most pregnant women have fear of labor. The reasons of fear of labor are different according
      to women. The investigators will examine the relationship between the descriptive features
      and level of fear of labor of pregnant women by using the Oxford worries about labour scale
    

Detailed description: 
      The investigators will give a survey to pregnant women who go to the antenatal polyclinic.
      The survey is consisted by researchers. The survey has a few questions about pregnant women's
      descriptive features. Next the investigators will evaluate the level of fear of labor of
      pregnant women. After the investigators will analyze the relationship between pregnant
      women's fear and their descriptive features.
    

Intervention name(s): Survey Research
Intervention type(s): Other
Intervention description(s): Non-applicable. There is no intervention. This study is descriptive research.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        they are healthy pregnant women who are 18-35 years old. they do not have any obstetrical
        complications. they go to the antenatal polyclinic.
      
Keywords: fear; Parturition; midwifery; Pregnant Women
The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
Condition: Obesity Prevention
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the
      intervention. This will ensure that all aspects of the research protocol and procedures work
      as desired and are acceptable to families in preparation for the fully powered randomized
      controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and
      retain participants, 2) deliver the intervention, 3) implement study and assessment
      procedures 4) assess the reliability of the proposed measures in this sample, 5) determine
      whether modifications to the intervention, procedures, and measures are needed prior to
      conducting a fully powered study, and 6) willingness of participants to participate in the
      intervention.
    

Detailed description: 
      The current study employs a 2 group randomized control design (treatment and no-treatment
      control) with randomization occurring after baseline (time 0) and 3 additional evaluation
      periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention
      (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a
      trajectory toward overweight/obesity in elementary school, the impact of the intervention on
      change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be
      explored, identifying whether a maintenance intervention is needed. Following the
      intervention and final data assessment (time 1 and 3), qualitative interviews will explore
      the acceptability of the intervention, treatment barriers and facilitators, difficulties with
      study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A
      third treatment condition controlling for the effect of attention was beyond the scope of the
      current feasibility study.
    

Intervention name(s): i♥rhythm project
Intervention type(s): Behavioral
Intervention description(s): behavioral mobile health intervention, targeting parents of 5-8 year olds, designed to promote consistent behavioral rhythms in children through consistent bedtimes, light exposure, meal timing, and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Metabolic Effects of Rowing Multi-races Events
Condition: Diet; Nutritional Status; Fatigue; Maximal Exercise
MeSH terms: Fatigue
Study type: Observational

Summary: 
      The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization
      to detect nutrition-related risks of failure in competition in the particular population of
      rowers.

      In the morning, 60 to 90 minutes before the first race of a national level multi-races
      competition (three races for each subjects), body weight were measured and blood samples were
      collected with subjects at rest and in post-absorptive condition (last meal at least 2.5
      hours before blood collection). Body weight was also recorded in the same conditions six
      weeks before the competition to calculate weight state (actual weight /usual weight ´ 100)
      and subjects were asked to identify the date of diet beginning. Body weight was measured
      using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was
      calculated from the ratio of weight (in kg) by height squared (in meters) and training volume
      (total duration of training in a week) was determined after discussion with athletes and
      coaches.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Competitive athletes
      
Biospecimen description: 
      Serum samples
Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to determine whether different drugs metabolised by the liver
      have any effects on how NRL972 is processed within the body.
    


Intervention name(s): NRL972; NRL972; NRL972
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1; Reference test: Single intravenous administration of 2 mg NRL972; Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Treatment Benefits of Berberine Supplementation for Women With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological
      activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin
      sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence
      suggest that Berberine dietary supplementation helps in improvement of symptoms associated
      with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the
      treatment benefits of Berberine in women with PCOS.
    

Detailed description: 
      Berberine (BBR) is an isoquinoline derivative alkaloid that occurs in several plants
      including Oregon grape, barberry, tree turmeric, goldenseal, yellowroot, Amur corktree,
      Chinese goldthread, prickly poppy and Californian poppy.

      Berberine supplementation has been suggested to improve the symptoms associated with PCOS.
      Berberine;

      Reduces Insulin Resistance Lowers Blood Sugar Levels Aids in Weight Loss Improves Cholesterol
      Levels Regulates Menstrual Cycles Reduces Inflammation Helps Restore Hormonal Balance
      Improves Fertility Helps Combat Depression Helps Fight Fatty Liver Disease Improves Body
      Composition

      The present RCT is aimed to investigate the effect of Berberine on these symptoms associated
      with PCOS.
    

Intervention name(s): Berberine
Intervention type(s): Dietary Supplement
Intervention description(s): 550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury
Condition: Spinal Cord Injuries; Male Sexual Dysfunction
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Depression
Study type: Observational

Summary: 
      Aims: assess the relationship between sexual function and depressive symptoms in individuals
      with spinal cord injury.
    

Detailed description: 
      Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury
      time more than six months, sexually active and accompanied in Recife referral hospitals. The
      degree of neurological impairment was assessed using the revised version in 2011 ASIA
      Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory,
      and the evaluation of sexual function was obtained through the Erectile Function of
      International Index (IIEF). Descriptive statistics and bivariate analysis to assess the
      association were applied, with 0,05 significance level.
    

Intervention name(s): using questionnaires
Intervention type(s): Other
Intervention description(s): using questionnaires International Index Erectile Function and Beck Depression Inventory.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study included 44 men, aged between 18 and 60 years with a clinical diagnosis of
        traumatic spinal cord injury, injury time less than six months heterosexual and sexually
        active. The study excluded patients who had erectile dysfunction attributed to endocrine or
        metabolic disease order, those who underwent surgery in the genital area, such as radical
        prostatectomy or penile implant and cognitive impairment.
      
Keywords: Sexuality; Spinal cord injuries; Erectile dysfunction; depression
Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline
Condition: Subjective Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to examine the effect of polyamine supplementation on
      cognitive performance of individuals with subjective cognitive decline.
    

Detailed description: 
      Memory abilities are known to decline during aging, a process that is accelerated in
      pathological conditions like subjective, mild cognitive impairment (MCI) and Alzheimer's
      disease (AD), all of which are a growing public-health concern with devastating effects.
      Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular
      protein degradation pathways) may be a key target of intervention against age-related memory
      decline. The study will investigate whether a polyamine-enriched dietary supplementation
      (through capsule intake) could provide positive effects on the cognitive function of elderly
      individuals (60-80 years old) with subjective cognitive decline.
    

Intervention name(s): Polyamine supplementation; Placebo supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 months of polyamine supplementation (3 capsules/day); 3 months of placebo intake (3 capsules/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: subjective cognitive decline; dementia; lifestyle; polyamine; memory; elderly; prevention; treatment; dietary supplement; Polyamine-enriched diet