bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Liposuction on Menses: a Retrospective Study
Condition: Menstrual Irregularity
MeSH terms: Menstruation Disturbances
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an
      effective shaping method, to be performed more frequently. Liposuction is a surgical
      procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat
      layer through a small incision. Analyzing a large sample sizes of patients who had
      liposuction, we found that some female patients underwent menstrual irregularity after
      liposuction. In 2004, Carolyn et al. reported several cases in which there was a connection
      between liposuction and an early onset of menses. Further studies showed that an early onset
      of menses may be related to the volume of adipose tissue extracted, the amount of anesthesia
      given, the area of liposuction, and body weight. However, the sample of that study was small,
      as there were only 17 cases included in the statistical model, and there are few articles in
      which the impact of liposuction on menses has been studied. To better understand whether
      menstrual irregularity will occur after liposuction, patients with postmenopausal or
      preoperative menstrual irregularity were excluded, leaving a sample of 518 female patients to
      be reviewed. A better understanding of the impact of liposuction on menses may help clinical
      doctors predict the underlying risk of menstrual irregularity after liposuction and identify
      individuals at higher risk. The findings may contribute to further understanding of menstrual
      irregularity.
    


Intervention name(s): Liposuction; Other plastic surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.; Other plastic surgery like blepharoplasty or keloid excision.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Body Image Issues in Boys Being Treated at the Royal Marsden
Condition: Cancer
Study type: Observational

Summary: 
      In adolescence, the effects of cancer and its treatment can lead to bodily changes such as
      hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for
      childhood cancers improve and life expectancy increases, more adolescents have to deal with
      the effects of cancer and the treatment on their bodies throughout their lives.

      Body image can be defined as "The mental image we hold of our bodies". There are two aspects
      to this, how we "see" our size/shape/weight etc, and then how we feel about this. Often the
      actual change in body does not always predict how people cope with it, or how they feel about
      it.

      Prior research suggests, and clinical experiences suggests that body image issues arise for
      at least some adolescents with cancer, however it is unknown whether a disturbance in body
      image is seen as distressing for the adolescent, or how this affects them psychologically.

      Body image problems were always seen as a typically female problem, and therefore researchers
      have often neglected to look at the issues for men. There is currently no research
      specifically addressing the impact of body image in adolescent boys with cancer.

      This research will involve interviewing adolescent males with cancer with the aims to find
      out;

        1. What the body image issues are, if any for this group.

        2. How any body image issues might affect them, particularly psychologically.

        3. What helps or hinders this group maintain a positive body image, or stop it having a
           negative impact on them psychologically.

      It is hoped that this will help to inform psychological treatments for body image
      difficulties in the future.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescent males who have been treated for cancer at the Royal Marsden Hospital within the
        past 5 years.
      
Keywords: Cancer; Body image; Adolescent
A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays
Condition: Meningococcal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to collect serum samples for use as quality control samples in
      GSK assays. The serum samples need to include samples with low, medium and high antibody
      titers/concentrations, which cover the assay range.
    

Detailed description: 
      The purpose of this protocol is to source human serum from plasma from healthy adults for use
      as control samples in the assays supporting the clinical development of GSK Biologicals'
      vaccines for the prevention of invasive infections caused by Neisseria meningitidis,
      Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella
      pertussis. At the final visit, a small volume of whole blood will be obtained in addition to
      plasma, to allow for head to head comparison of serum obtained from whole blood (off-clot
      serum) and from plasma (serum derived from re-calcified plasma). In addition, sera generated
      in this clinical trial could potentially be used as control samples for other vaccine
      programs to help assure the quality of the analytical methods.

      Subjects 18 through 49 years of age (have not yet achieved 50th birthday) will be randomized
      to receive Menveo + Boostrix and subjects 50 to 55 years of age will be randomized to receive
      either Pneumovax 23 or Prevnar 13 and will serve as donors of human serum in this study.
    

Intervention name(s): Menveo®; Boostrix®; Pneumovax 23®; Prevnar 13®
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One dose administered intramuscularly (IM) in the upper left deltoid of the arm.; One dose administered intramuscularly (IM) in the upper right deltoid of the arm.; One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.; One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Healthy adults; Tetanus; Human serum samples; Streptococcus; Diphtheria; Plasma; Meningococcus
Rizatriptan 10 MG RPD in the Treatment of Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicentre, open label, prospective, randomized, two-attack study with active
      comparator in patients reporting inadequate response to analgesics and/or triptans to examine
      the efficacy of Rizatriptan 10 mg RPD in this group of patients.
    


Intervention name(s): Rizatriptan
Intervention type(s): Drug
Intervention description(s): use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
Condition: Drug Safety; Heart; Disease, Activity
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Phase: Phase 1

      Primary Objective:

      • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in
      healthy subjects

      Secondary Objectives:

        -  To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral
           doses of CARD-024

        -  To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin
           activity (PRA) and blood pressure (BP), biological markers of activity, following
           ascending single oral doses of CARD-024
    

Detailed description: 
      Study Design: This is a single-center, double-blind, randomized, placebo-controlled study of
      single oral doses of CARD-024. Four planned cohorts of 8 subjects each will be dosed
      sequentially and randomized to receive a single dose of active drug (6 subjects) or placebo
      (2 subjects). Cohort 4 will have 10 subjects randomized to receive active drug (7 subjects)
      or placebo (3 subjects). Each cohort will be divided into at least 2 groups; the first group
      will have 2 subjects, 1 receiving active drug and 1 receiving placebo. Dosing of the
      remaining 6 subjects in each cohort will be completed in a manner agreed upon by the Sponsor
      and the Principal Investigator in keeping with the randomization schedule and blinded
      conditions.

      The planned cohorts are:

      Cohort CARD-024 Dose*

        1. 3 μg

        2. 9 μg

        3. 27 μg

        4. 81 μg
    

Intervention name(s): CARD-024; Drug Carrier
Intervention type(s): Drug; Other
Intervention description(s): Comparison of different dosages of drug; Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
Other intervention name(s): 1α-Hydroxy-Vitamin-D5; 1αVitD5; Placebo, Drug Carrier
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose
      immune system is impaired it causes severe infection. The people who are particularly at
      high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those
      with acute leukaemia who are having chemotherapy and those post bone marrow transplantation.
      Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with
      Invasive Aspergillosis die.

      The main reason for this high death rate is that our current diagnostic tests are not good at
      detecting infection or often only detect the infection at advanced stages when treatment is
      ineffective. Because of the limitations of current diagnostic tests the current practice is
      to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis.
      However studies have demonstrated that this therapy has only resulted in a minor reduction in
      the mortality rates and it also causes significant drug toxicity. It is a suboptimal
      treatment modality.

      New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are
      for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA
      in blood. Available data suggests that these new tests make an early diagnosis and seem to be
      able to monitor responses to treatment. However no study has been reported to date which
      demonstrates that the use of these tests can impact on important patient outcomes. This trial
      is being performed to determine whether the use of the new diagnostic tests to guide
      antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug
      toxicity and reduce the death rate in the high-risk patients as compared with the current
      standard method of diagnosis and treatment with EAFT.
    


Intervention name(s): Culture and histology; Aspergillus galactomannan and PCR
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
AR08 for Treatment of ADHD in Children
Condition: ADHD
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced
      titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio.
      One-hundred twenty (120) patients are planned to be randomized. Each patient will receive
      AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
    


Intervention name(s): AR08; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; AR08; adrenergic receptor agonists; randomized, placebo-controlled clinical trial
Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of rising oral single-doses of BIA 6-512 (25 mg, 50 mg, 100 mg and
      200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of
      immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of
      Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the
      tolerability and safety of rising single oral doses of BIA 6-512 when administered in
      combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25
      plus a single-dose of Comtan® 200 mg.
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled study in four sequential groups
      of healthy subjects. Eligible subjects were admitted to the UFH on the day prior to receiving
      the first study medication. On the morning of the first dosing day (Day 1), subjects received
      BIA 6-512/Placebo concomitantly with Sinemet® 100/25; on the morning of the second dosing day
      (Day 2), subjects received BIA 6-512/Placebo concomitantly with Sinemet® 100/25 and Comtan®
      200 mg. Products were administered in fasting conditions (at least 8 hours). Subjects
      remained confined in the UFH from admission (Day 0) until at least 24 h post last dose (Day
      3); then, they were discharged and will return for the follow-up visit.
    

Intervention name(s): Placebo oral capsule; Sinemet® 100/25; Comtan®; BIA 6-512 25 mg; BIA 6-512 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matching placebo capsules. Oral administration.; Single-dose of immediate release levodopa/carbidopa 100/25 mg consisted of 1 tablet of Sinemet® 100/25. Route of administration: Oral.; Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.; BIA 6-512 capsules strengths 25 mg. Oral administration.; BIA 6-512 capsules strengths 100 mg. Oral administration.
Intervention MeSH terms: Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
Condition: Wound Healing; Scarring
MeSH terms: Cicatrix; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether topical application of calcium
      glycerophosphate will result in superior wound appearance and scar minimization.
    


Intervention name(s): Topical calcium glycerophosphate lotion
Intervention type(s): Other
Intervention description(s): 2g once daily for 6 weeks (post-op day 3 thru 42)
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Drug to Drug Interaction Study With ASP1941 and Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when
      ASP1941 is administered as add-on therapy to metformin.
    


Intervention name(s): ASP1941; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Intervention MeSH terms: Metformin; Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: pharmacokinetics; metformin; Drug to drug interaction; ASP1941
RELAXaHEAD for Headache Patients (Phase II)
Condition: Migraine; Headache; Multiple Sclerosis; Insomnia
MeSH terms: Multiple Sclerosis; Migraine Disorders; Sleep Initiation and Maintenance Disorders; Headache
Study type: Interventional

Summary: 
      The goal of this research is to assess the utility of smartphone-based progressive muscle
      relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially
      available electronic diary and mind-body intervention apps for headache, there is little data
      showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully
      used in an earlier epilepsy study and beta tested with headache specialist and migraine
      patient input. It also is an electric headache diary. The app has been studied and findings
      have been reported in multiple peer reviewed publications. Also, the app has been updated
      based on prior feedback from the studies. Now, this 2-arm randomized controlled study will
      evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine
      and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other
      arm will be a monitored usual care (MUC) group (this group receives standard of care and uses
      the electronic daily symptom reporting diary). The goals are to assess the feasibility and
      adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to
      gather exploratory data on the effects of the RELAX intervention on headache and sleep
      related outcome measures (Aim 2).
    


Intervention name(s): Smartphone-Based Progressive Muscle Relaxation Therapy (PMR); Monitored Usual Care (MUC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Relaxation technique delivered via RELAXaHEAD app.; Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Progressive Muscle Relaxation Therapy; Migraine; Insomnia
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.
Condition: Colorectal Cancer; Quality of Life
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This study is collecting data on quality of life, (care)needs and socio-economic factors in
      colorectal (ex-)cancer patients via a written questionnaire completed by the patient
      him/herself. The collected data will be linked with the patient- and tumour characteristics
      available in the database of the Belgian Cancer Registry and with the facturation data
      supplying information about diagnostic techniques and performed treatments (available via the
      insurance companies).

      Based on the selection criteria, 1220 patients were finally selected from the database of the
      Belgian Cancer Registry. These patients received an invitation letter by regular mail, a
      detailed questionnaire and an informed consent.

      The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction
      with the provided information, care needs, quality of life, anxiety and depression, financial
      situation etc.

      The patients were asked to complete the questionnaire and send it back, together with the
      signed informed consent, to the study-collaborators.

      After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient
      doesn't want to participate in this study, a reason can be mentioned on the reply card.

      The collected data are linked with the clinical data. The dataset will be coded before
      analyses will start.
    


Intervention name(s): Questionnaire on Quality of Life
Intervention type(s): Other
Intervention description(s): The patients were asked to complete a questionnaire on Quality of Life
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of colorectal cancer (ICD-10: C18-C19-C20) with incidence in 2008-2010 were
        selected for this study. Patients are at least 18 years old at diagnosis and maximal 90
        years old when completing the questionnaire.

        Patients are living in Flanders, speak Dutch and are followed in 1 of the 7 participating
        hospitals.

        The patients are able to complete the questionnaire themselves: patients with cognitive
        problems are excluded.
      
Keywords: Colorectal Cancer; Quality of life; Questionnaires