bioihbjkbjnl/mcl2 huggingface dataset:
Foot Reflexology on Premenstrual Syndrome
Condition: Reflexology; Dietary Modification
MeSH terms: Premenstrual Syndrome
Study type: Interventional

Summary: 
      : Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that
      start during the week preceding menstruation and are alleviated when the menstrual flow
      begins. Reflexology is one of the most popular complementary therapies
    

Detailed description: 
      This study was aimed to determine the effect of foot reflexology in the treatment of
      premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with
      premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and
      gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to
      share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI)
      did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The
      group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8
      weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in
      both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual
      Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present
      study revealed that there was statistically significant improvement in both pain and
      premenstrual related symptoms in group (A) than in group (B).
    

Intervention name(s): foot reflexology; dietary modification
Intervention type(s): Other; Dietary Supplement
Intervention description(s): foot reflexology session which takes about 20 minutes. The position of the patient during reflexology session was a relaxed comfortable supine lying position. The therapist was sitting position at the level of the feet. The Session of reflexology was done on three points at both feet.; diet must be rich in vitamins as fish and beans, calcium as milk and chess, low fat food through decrease oil in meals, high fiber food through all types of vegetables and fruits and restrict caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks
Masking: Single (Investigator)
Primary purpose: Treatment
Chronic Pain After Inguinal Hernia Repair
Condition: Inguinal Hernia; Chronic Pain
MeSH terms: Chronic Pain; Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic pain after inguinal hernia repair has become a major concern. Although tension-free
      Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40
      % of patients complain of some kind of pain even one year after surgery. The necessity of
      mesh-fixation using sutures, could be causative. However, current data do not provide
      evidence whether suture fixation in Lichtenstein repair might be the reason for chronic
      postoperative pain.

      A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal
      hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid
      gripping system. Thereby the rate of chronic postoperative pain could be decreased.

      Two techniques of inguinal hernia repair will be evaluated:

        1. open anterior mesh repair using conventional Lichtenstein technique (sutures for
           mesh-fixation)

        2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for
           mesh fixation)

      Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at
      the 10th day, as well as 3 and 15 months postoperatively.
    


Intervention name(s): selfgrip mesh; lightweight mesh with suture fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): inguinal hernia repair using a selfgrip mesh; inguinal hernia repair using a lightweight mesh with suture fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the effect of repeated dosing of PF-05175157 on the
      pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
    


Intervention name(s): Simvastatin; PF-05175157
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157); Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive
      function and coping skills. Several studies have recently demonstrated that CR improves
      cognitive and occupational function in patients with schizophrenia and with depression (e.g.
      Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive
      and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what
      impact this might have on these people's abilities in terms of work, coping strategies,
      quality of life, and everyday safety.

      The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive
      and socio-occupational function in patients with previous mania and depression who experience
      persistent cognitive difficulties. Such effects would suggest implementation of CR in future
      treatment of bipolar disorder in order to facilitate the patients' ability to cope with the
      responsibilities related to work and everyday life. The hypotheses of the present study are
      that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and
      2) improve sustained attention, executive function and psychosocial function.
    


Intervention name(s): Cognitive Remediation
Intervention type(s): Other
Intervention description(s): All subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bipolar disorder; Cognitive Remediation; Cognition; Cognitive function; Mood disorders; Affective disorders
Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how much of apremilast is found in the blood unchanged
      when administered as an oral suspension compared to when it is administered as a tablet
      formulation. The effect of food on apremilast oral suspension will also be evaluated. In
      addition, information on the safety and tolerability of apremilast will be obtained.
    

Detailed description: 
      This is a phase 1, open-label, randomized, three-period, six-sequence crossover study in
      healthy subjects. The study will consist of a screening phase, baseline (Day -1), three study
      periods, and a follow-up phone call. Each study period will be four days in duration (Day 1
      through Day 4) followed by a five-day washout between doses.

      Eligible participants will be admitted into the study center on Day -1 of study Period 1 for
      baseline measurements. During each study period, participants will receive a single 30 mg
      oral dose of apremilast on Day 1 according to the assigned treatment sequence. Participants
      will be confined at the study center from Day 1 of study Period 1 through Day 4 of study
      Period 3, including the 5 day washout between doses. All participants will be discharged from
      the study center on Day 4 of study Period 3 following completion of required study
      procedures. A follow-up phone call will occur approximately four days after the discharge
      from the study center.

      The study will be conducted in compliance with International Conference on Harmonisation
      (ICH) Good Clinical Practices (GCPs).
    

Intervention name(s): Apremilast Tablet; Apremilast Oral Suspension
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg tablet; 30 mg oral suspension
Other intervention name(s): Otzela; CC-10004; Otzela; CC-10004
Intervention MeSH terms: Thalidomide; Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Apremilast; Healthy volunteers; Bioavailability; Food effect; Pharmacokinetic
Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Only to a limited extent has been compared the effectiveness of physical exercise and
      psychological interventions in subjects with chronic pain. Knowledge about this is necessary
      in order to compose optimal multimodal rehabilitation programs at different health care
      levels. Moreover, assuming that both types of interventions have effects, these effects may
      necessarily not concern the same outcome variables. Therefore it may be important to
      understand to what extent the effects overlap and the extent to which the effects are
      isolated to an intervention.

      The overall strategic purpose of the present study is to develop effective multimodal
      rehabilitation programs. In this study the effectiveness of following three interventions are
      compared.

        -  Group-based rehabilitation according to a concept based on an Acceptance and Commitment
           Training -Stress Management Intervention (ACT-SMI)

        -  Group-based rehabilitation compromised of physical exercise (Exercise).

        -  Group-based discussion concerning pain and its consequences (i.e., the control group,
           CON) The effectiveness is investigated with respect to long-term effects on pain and its
           consequences, including perceived health and return to work / sick leave.

      The overall hypothesis is that the former intervention means better long-term results because
      it clearly helps the individual to process the psychological aspects of itself likely to have
      long lasting effects.
    


Intervention name(s): ACT; Physical activity
Intervention type(s): Behavioral; Other
Intervention description(s): ACT is a type of Cognitive behavioral Therapy (CBT) that focuses on acceptance and mindfulness. The aim is to prevent avoidance and control of negative private events such as anxiety or pain. The treatment consists of 7 weekly group sessions, 2 hours a week. The participants are given homework between sessions.; Participants are going to perform a training programme including aerobic exercise as well as endurance and strength training for the neck, shoulders, low back, core and leg muscles. The training is group-based and supervised by a physiotherapist two times a week, one hour a time for eight weeks. Home exercises twice a week are also a part of the intervention. It is possible to individually adjust movements and intensity to the participants' capacity if needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; rehabilitation; exercise; psychological; intervention
A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason
      Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with
      histopathology results
    

Detailed description: 
      This multi-centre, open label, prospective, pilot study was designed to assess the ability of
      BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The
      binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in
      signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to
      be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.
    

Intervention name(s): BR55
Intervention type(s): Drug
Intervention description(s): Ultrasound contrast agent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate cancer; Ultrasound Imaging
The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
Condition: Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple
      Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
    

Detailed description: 
      This will be an open label study conducted in healthy male participants at a single centre.
      Each participant will participate in a screening visit and 2 study periods. At the first
      study period, all participants will receive a single dose of BCT197 and at study period 2,
      all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.
    

Intervention name(s): BCT197; Itraconazole 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of BCT197; Single dose of itraconazole
Other intervention name(s): Acumapimod; Sporanox
Intervention MeSH terms: Itraconazole; Acumapimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Male Volunteers
Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™
      insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure
      performed in the in-office setting is as safe as LINQ™ insertions performed in the
      traditional hospital setting (operating room, cardiac catheterization or electrophysiology
      (EP) laboratory).
    

Detailed description: 
      RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk
      study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive
      their LINQ™ insertion in the office setting or in the traditional hospital environment.
      Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the
      complication rate compared to in hospital insertion procedures, however, moving the LINQ™
      insertion procedure out of the traditional hospital setting may benefit the patient and
      reduce the burden to the healthcare system.
    

Intervention name(s): office setting; hosptial setting
Intervention type(s): Other; Other
Intervention description(s): An office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers; A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Cocoa Intake and Muscle Pain Sensation
Condition: Muscle Pain
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      This experimental randomized, double-blind, and controlled study included fifteen young,
      healthy, and pain-free men and 15 age-matched women.

      It lasted for three visits with at least one-week washout. Pain was experimentally induced,
      twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before
      and after intake of one of the different chocolate-types; white (30% cocoa-content), milk
      (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and
      pressure pain threshold were assessed every fifth minute after each injection, between the
      time-points 5 to 30 min.

      Prior to inclusion, all participants underwent an examination in a dental chair. This
      included a clinical examination of the orofacial region according to the Diagnostic Criteria
      for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also
      examined regarding their psychosocial status prior to inclusion, this included depression,
      somatization, anxiety, pain catastrophizing and stress.
    


Intervention name(s): before - hypertonic saline 5%; after - hypertonic saline 5%
Intervention type(s): Other; Other
Intervention description(s): pain was induced by intramuscular injections of hypertonic saline (5%); pain was induced by intramuscular injections of hypertonic saline (5%)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Myalgia; Experimental pain; Human; Temporomandibular disorders; Cocoa
Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a
      recombinant protein vaccine, for the prevention of COVID-19 in healthy adults
    


Intervention name(s): EuCorVac-19; Normal Saline
Intervention type(s): Biological; Other
Intervention description(s): Two intramuscular doses (0.5mL per dose) at 3-week interval; Two intramuscular doses (0.5mL per dose) at 3-week interval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess Incidence of ONJ in Pts With Bone Mets Starting Zoledronic Acid Treatment
Condition: Cancer
MeSH terms: Necrosis
Study type: Observational

Summary: 
      Prospective observational multi central cohort study to assess the incidence of osteo
      necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment
    

Detailed description: 
      Prospective observational multi central cohort study to assess the incidence of osteo
      necrosis of jaw (ONJ) in pts with bone metastasis starting Zoledronic acid treatment
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Bone Metastases
      
Keywords: Osteo necrosis of the Jaw
To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244;
      ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
    

Detailed description: 
      A randomized, Open-label, Single-center, Crossover Study to Assess the Effect of Food on the
      Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886)
      (Hyd-Sulfate) in Healthy Volunteers.
    

Intervention name(s): selumetinib (oral)
Intervention type(s): Drug
Intervention description(s): Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses.
Other intervention name(s): AZD6244
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetics, food effect.
Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol
      on patients from Thailand with high cholesterol.
    


Intervention name(s): Atorvastatin; Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.; Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.; Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment