bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Periodontitis and Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Chronic Periodontitis
MeSH terms: Polycystic Ovary Syndrome; Periodontitis; Chronic Periodontitis; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Background: The aim of this study was to investigate the levels of malondialdehyde (MDA),
      total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and
      saliva samples in female patients with chronic periodontitis (CP) and to compared healthy
      individuals.

      Materials and Methods: A total of 88 women were into four groups each which were consisted of
      twenty-two subjects. Groups were designed as periodontally and systemically healthy women
      (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-),
      systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum
      and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS,
      8-OHdG levels were measured as biochemically.
    

Detailed description: 
      RESULTS:

      Salivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in
      both the PCOSPH and the PH groups (P < 0.05). There was no statistical difference between the
      PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P > 0.05). Highest
      serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P <
      0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both
      systemically healthy groups (PH and CP) (P < 0.05). Salivary TAS levels were highest (P <
      0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups,
      but serum TAS levels were lower than those in the PH group (P < 0.05).

      CONCLUSIONS:

      CP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in
      serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more
      prominent in serum levels than in salivary levels.
    

Intervention name(s): no intervention provided
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants were recruited among women at the Department of Obstetrics and Gynecology,
        School of Medicine, Ataturk University
      
Biospecimen description: 
      Serum and saliva samples were obtained and stored until biochemical analyses
    
Keywords: 8- hydroxy -2´- deoxyguanosine; Malondialdehyde; Total antioxidant status; Oxidative stres
REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS
Condition: Hemodialysis Complication
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The research sample consisted of 74 individuals, including the intervention group (n=37) and
      the control group (n=37), who received hemodialysis treatment at Sivas Cumhuriyet University
      Application and Research Hospital Hemodialysis Unit, Sivas Numune Hospital Hemodialysis Unit
      and Private ONR Dialysis Center. The data of the study were collected using the Patient
      Description Form, the Patient Clinical Parameters Form (Some Treatment Data and Laboratory
      Results, Measurement of Pain Intensity), Visual Analogue Scale (VAS), McGill Melzack Pain
      Questionnaire, Piper Fatigue Scale, and 5-D Itch Scale. A total of 10 sessions of reiki were
      applied to the patients in the intervention group twice a week for 5 weeks, lasting 40-45
      minutes during dialysis. No treatment was applied to the control group. The scales were
      administered to the individuals in the intervention and control groups three times in total.
    


Intervention name(s): Reiki apply
Intervention type(s): Other
Intervention description(s): The intervention group is the group in which reiki is applied. They receives 3 sessions of hemodialysis per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Study on the Response to Tetanus Vaccination of People Living With HIV
Condition: HIV Infections
MeSH terms: HIV Infections; Tetanus
Study type: Interventional

Summary: 
      The response to primary tetanus immunization of HIV-infected children is lower than that of
      uninfected children.

      Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received
      primary vaccination prior to infection is not known.

      Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10
      years. In general population, this recall is made only at 25, 45 and 65 years, then every 10
      years.
    


Intervention name(s): additional blood sampling
Intervention type(s): Diagnostic Test
Intervention description(s): additional blood sampling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Follow up by General Practitioner After Self-poisoning
Condition: Suicidal and Self-injurious Behaviour
MeSH terms: Poisoning; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The study hypothesis is that follow up from general practitioner after hospitalization for
      self poisoning will decrease suicidal behaviour.
    

Detailed description: 
      Patients hospitalized after an episode of self poisoning will be randomly assigned into
      intervention an control groups. The intervention is close follow up by general practitioner
      six months. Both groups will receive treatment as usual.
    

Intervention name(s): Follow up
Intervention type(s): Behavioral
Intervention description(s): Follow up, consultations with general practitioner, written guidelines, supervision.
Other intervention name(s): General Practitioner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Hopelessness; Suicidal ideation
Root Coverage Using a Xenograph for Treatment of Gingival Recession
Condition: Localized Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 1

Summary: 
      Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental
      root coverage procedures.
    

Detailed description: 
      PriMatrix (TEI Medical Inc) is a promising collagen membrane derived from fetal bovine
      dermis. The acellular porous structure of the membrane permits rapid re-vascularization and
      cellular re-population. The membrane contains a high proportion of type III collagen. Type
      III collagen helps regulate tissue healing by promoting neoepithelialization and
      angiogenesis. Wounds grafted with PriMatrix exhibited significantly faster healing rates
      compared to control wounds while having a minimal foreign body response and early
      repopulation by progenitor cells.

      The ability of PriMatrix to permit neovascularization, reepithelialization, minimal immune
      response, and population by progenitor cells suggests that it may serve as an ideal
      alternative to CTG under CPF for root coverage. In this regard, the current study aims to
      serve as a pilot to test the feasibility of the use of PriMatrix as a graft material under a
      CPF to attain root coverage of Miller Class I & II defects.
    

Intervention name(s): PriMatrix
Intervention type(s): Device
Intervention description(s): Use of PriMatrix under a coronal positioned flap to obtain root coverage.
Intervention model: Single Group Assignment
Intervention model description: Bovine collagen matrix -PriMatrix
Masking: None (Open Label)
Primary purpose: Treatment
Treatment Decision Intervention for Veterans With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Newly diagnosed localized prostate cancer patients face difficult decisions about treatment
      and management; including radiation therapy, radical prostatectomy, brachytherapy, and
      observation. Previous studies have cited patient preference and physician recommendation for
      treatment as major roles in treatment decisions.
    

Detailed description: 
      Background:

      Newly diagnosed localized prostate cancer patients face difficult decisions about treatment
      and management; including radiation therapy, radical prostatectomy, brachytherapy, and
      observation. Previous studies have cited patient preference and physician recommendation for
      treatment as major roles in treatment decisions.

      Objectives:

      This grant will be used to develop and evaluate a decision analysis based intervention to
      improve decision-making among veterans with newly diagnosed localized prostate cancer. While
      the ultimate goal of this study is to improve decision-making among these patients, factors
      influencing physician recommendations for treatment will be sought. The former will be
      achieved by evaluating the efficacy of providing physicians with information incorporating
      patient preference for alternative health states with probabilities of treatment outcomes.
      Factors influencing physician recommendations for treatment will be determined through
      qualitative interviews with physicians.

      Methods:

      Patients were accrued at the VA Chicago Health Care System Lakeside Urology Clinic. Upon
      consent for participation in the study, comorbidities, histologic grade of the biopsy, and
      age were obtained for 13 patients with newly diagnosed localized prostate cancer. Using a
      standard gamble technique, interviewers obtained patient utilities for 5 distinct health
      states related to prostate cancer treatment. Clinical and pathologic characteristics were
      incorporated into the decision analytic model, and the derived quality-adjusted life
      expectancies (QALEs) were shared with the treating urologist before patient-physician
      discussion of treatment options. The feasibility of the decision analytic intervention and
      unbiased estimates of the impact of the intervention was evaluated. The long-range objective
      of this proposal is to design an intervention for veterans that increases physician
      understanding of patient treatment preferences and patient understanding of choices in
      prostate cancer treatment.

      Status:

      Completed
    

Intervention name(s): Help with decision making on prostate cancer treatment
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
Condition: Adolescent Behavior
Study type: Observational

Summary: 
      The overall goal of this study is to investigate associations between sleep/circadian
      disturbances and psychiatric health among adolescents recruited from primary and specialty
      health clinics.
    

Detailed description: 
      This project will involve recruitment of 100 adolescents from primary and specialty health
      clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and
      follow-up visit.

      The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin
      Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit,
      participants and their parents will complete questionnaires regarding the adolescent's
      psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood
      pressure) will also be assessed and recorded.

      Eligible participants will enter the 7-day sleep study, during which they will be asked to
      wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a
      daily sleep diary.

      Following the final night of the sleep study, participants and parents will be asked to
      return for a follow-up visit and will complete questionnaires about the participants' sleep
      over the past week.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents will be recruited from primary and specialty health clinics.
      
Keywords: Adolescents; Sleep; Actigraphy; Psychiatric Health
RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome
Condition: Restless Leg Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap
      that produces adjustable targeted pressure on specific muscles in the feet, to reduce the
      symptoms of moderate to severe primary Restless Legs Syndrome.
    

Detailed description: 
      Restless legs syndrome (RLS), or Willis-Ekbom Disease, is a neurologic disorder causing
      unpleasant sensations and an urge to move the legs when the person is at rest. The sensations
      are relieved by movement. Loss of sleep associated with RLS can cause extreme fatigue,
      affecting concentration, which may produce anxiety and depression, resulting in a poor
      quality of life. Prevalence in the general population is 5% to 10%. In approximately 3%,
      symptoms are so severe that treatment is sought. Potent drugs, such as opioids, central
      nervous system depressants, anticonvulsants, and dopamine agonists have been used to ease
      symptoms, each with several side effects.

      Anecdotal evidence suggested that pressure on specific foot muscles decreases symptoms of
      moderate to severe primary restless legs syndrome. In the RESTIFFIC™ study, patients served
      as their own negative controls, wearing the RESTIFFIC™ devices intermittently, while
      completing surveys related to RLS throughout the study. Physicians also completed surveys
      related to quality of life. Meta-analysis was used to compare RESTIFFIC™ to historic reports
      of ropinirole and placebo pill. Demographics, disease severity,inclusion/exclusion criteria,
      assessment tools were similar among studies.
    

Intervention name(s): RESTIFFIC™ Brand Pressure Application System
Intervention type(s): Device
Intervention description(s): The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).
Other intervention name(s): Restless Leg Relaxer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RLS; Willis-Ekbom
Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The main objective of the present project is to develop an imaging-based tool to determine
      the origin and cause of persistent atrial fibrillation (AF). The result of the study is a
      diagnostic method which aids the medical work-up of patients suffering from this disease.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity
      and mortality in humans. Histopathological studies of persistent AF have reported
      extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation.
      The degree of the fibrosis might have a significant impact on wave propagation during AF. The
      main objective of the present project is to develop an imaging-based tool to determine the
      origin and cause of persistent AF. The obtained clinical parameters of patients and controls
      (electrocardiography, ecocardiography and MR imaging data) will be correlated with known
      markers in order to identify novel markers for AF diagnosis.
    

Intervention name(s): Electrocardiography, ecocardiography and MRI.
Intervention type(s): Diagnostic Test
Intervention description(s): AF patients and healthy adult volunteers will be examined by the study physicians and included in the study according to the inclusion criteria. After a general examination, an electrocardiography, an ecocardiography and an MRI will be performed on the AF-affected and healthy hearts, respectively.
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Adult population presented at the cardiologist with persistent, permanent or paroxysmal
        atrial fibrillation (AF).
      
Biospecimen description: 
      Blood
Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents
Condition: Safety
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4)
      15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age
      of 12 and 17 years + 2 months.
    

Detailed description: 
      This is a Phase 3, open-label, non-controlled study in healthy post-menarchal female
      participants who will be enrolled to receive once daily E4/DRSP 15/3 mg for six (6) 28-day
      cycles in a 24/4-day regimen (i.e. 24 days of active tablets followed by 4 days of placebo
      tablets [4-day hormone-free interval]). The study will include 6 visits:

      At screening visit (Visit 1), informed consent will be signed by the participants and their
      parent(s) or legal representative(s) and the screening procedures will be performed. The site
      will also complete an Eligibility confirmation phone call to the participant after Visit 1.
      During the enrollment visit (Visit 2, between Days 12 and 19 of the pre-treatment cycle),
      eligibility criteria will be reviewed and the participant participation will be confirmed.
      Participants will be trained in the use of an electronic diary and will receive the study
      drug. A follow-up call will be performed after Visit 2, within 7 days following the first
      investigational product intake. Afterwards, the participants will attend 3 on-treatment
      visits at the clinical site [between Days 14 and 21 of the Cycle 1(Visit 3), Cycle 3 (Visit
      4), and Cycle 6 (Visit 5)] and one visit after end of Cycle 6 (Visit 6).

      For participants who consent to participate in a pharmacokinetics sub-study, blood samples
      for this sub-study will be taken at Visit 3 and Visit 5.

      Adverse events will be followed throughout the study.
    

Intervention name(s): E4/DRSP 15/3 mg combined tablet
Intervention type(s): Drug
Intervention description(s): One E4/DRSP 15/3 mg combined tablet once per day for 24 days followed by 4 days of placebo tablets; this 28-day cyclic regimen should be taken for 6 consecutive cycles.
Other intervention name(s): 15 mg estetrol monohydrate/3 mg drospirenone combined oral contraceptive
Intervention MeSH terms: Drospirenone; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estetrol; Drospirenone; Combined oral contraceptive; Oral contraception; Cycle control; Pharmacokinetics
VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, first-in-human dose-ranging study to evaluate the safety and
      pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single
      dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.
    


Intervention name(s): VNRX-7145; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10); Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: VNRX-7145; Safety; Pharmacokinetics
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to study the safety and tolerability of a HIV drug and
      to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected
      patients
    

Detailed description: 
      Masking: Open-Part B. Double Blind-Parts A and C

      Gender: Both female and male participants for Parts A and C. Male participants for Part B.

      HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid
    

Intervention name(s): BMS-955176; Placebo matching with BMS-955176; Atazanavir; Ritonavir; Tenofovir; Emtricitabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BMS-955176; Placebo matching with BMS-955176; Atazanavir; Ritonavir; Tenofovir; Emtricitabine
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; BMS-955176
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vascular Effect of CIMICIFUGA RACEMOSA
Condition: Postmenopausal Symptoms
Study type: Interventional

Summary: 
      Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the
      effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.
    

Detailed description: 
      The interruption of the secretion of ovarian steroids after menopause, determines a change in
      the vascular pattern in several levels. Thus, several vascular effects might interfere with
      women's health. The use of hormone replacement therapy has contributed to the improvement in
      these effects. In previous studies, the investigators observed the effects of hormonal
      replacement therapy in improving such effects in postmenopausal women. The aim of the present
      study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of
      the brachial artery.
    

Intervention name(s): Cimifuga Racemosa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental group will use 160mg of Cimifuga Racemosa for 28 days; patients of the placebo group will use placebo once a day for 28 days
Other intervention name(s): Clifemin; Acteia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postmenopause; vascular effects; CIMICIFUGA RACEMOSA
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 6 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment