bioihbjkbjnl/mcl2 huggingface dataset:
The Role of Expectations in Experimentally Induced Sadness
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The study aimed at identifying whether different expectations have an impact on experiencing
      emotions in the form of sadness.
    


Intervention name(s): Placebo nasal spray; Film Sequence
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Corona Mortis in Patients Undergoing TEP for Inguinal Hernia
Condition: Inguinal Hernia; Pelvic Fracture; Acetabular Fracture; Bleeding
MeSH terms: Hemorrhage; Hernia; Hernia, Inguinal; Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      This study aim to describe the presence, type and size of Corona mortis (CMOR) in patients
      undergoing total extraperitoneal (TEP) inguinal hernia repair procedures. This study also aim
      to describe the preperitoneal vascular anatomy of inguinal area and provide in vivo knowledge
      about CMOR.
    

Detailed description: 
      Corona mortis is classically defined as the arterial and/or venous vascular anastomosis
      between the obturator artery and external iliac artery (most commonly the inferior epigastric
      artery) that crosses the posterior aspect of the superior ramus of the symphysis pubis. It
      runs along the posterior aspect of the superior pubic ramus and its laceration can prove life
      threatening in trauma cases or in scheduled operations.

      CMOR is clinically important due to the potential risk of bleeding in pelvic fractures,
      pelvic and acetabular operations, surgery for urinary incontinence, oncologycal pelvic
      dissections and laparoscopic hernia repair. It requires special interests from different
      surgical branches, such as orthopedics, oncologic surgery, urogynecology and general surgery.
      Vascular anatomy of retropubic area, especially CMOR, should be kept in mind by surgeons
      performing laparoscopic surgery for hernia repair. In literature, the anatomical data have
      usually been come from studies performed on cadavers. The aim of this study was to provide in
      vivo knowledge about the presence, type (venous and/or arterial) and size of CMOR in patients
      who underwent TEP repair.

      300 patients will undergo TEP procedure for unilateral or bilateral inguinal hernias. TEP
      procedures will be performed with three ports and one or three skin incisions. The presence
      and type of CMOR will be evaluated, and picture will be made. The size of the CMOR will be
      defined with ruler inserted true the 10 mm port.
    

Intervention name(s): TEP
Intervention type(s): Procedure
Intervention description(s): Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients male and female, undergoing TEP inguinal hernia repair.
      
Keywords: Corona Mortis; TEP; Inguinal Hernia; Laparoscopic Surgery; Anatomy; Inguinal region anatomy; Bleeding
A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects
Condition: Healthy; Pharmacokinetic of Digoxin
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in
      healthy subjects.
    

Detailed description: 
      The study will be of a double blind, randomized, two period crossover design. Two treatments,
      digoxin in combination with YM150, and digoxin in combination with placebo, will be
      evaluated. Each subject will receive both treatments in random order. Placebo will be used to
      maintain the blind. Males and females will be equally divided over the treatment orders.

      Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady
      state. In the second period the subjects will receive digoxin and the alternate treatment.
      There will be a washout period of at least 10 days between the consecutive treatments. In
      both study periods the subjects will be admitted the day prior to study drug administration
      (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last
      discharge, the subjects will return to the unit for a post study visit.
    

Intervention name(s): YM150; placebo; digoxin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral - modified release formulation of YM150; oral; oral
Other intervention name(s): darexaban
Intervention MeSH terms: Digoxin; Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: YM150; digoxin; drug-drug interaction; Plasma concentration; darexaban; Pharmacokinetics of digoxin
Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
Condition: Acquired Immunodeficiency Syndrome; Anemia; Hematologic Diseases; HIV Infections; Blood Disease
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome; Anemia; Hematologic Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether administration of human recombinant erythropoietin (REPO) improved or
      eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after
      therapy with zidovudine (ZDV).
    

Detailed description: 
      BACKGROUND:

      Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency
      Syndrome treated with zidovudine for four to six months developed significant bone marrow
      toxicity, requiring zidovudine dosage alterations, blood transfusions, or cessation of
      therapy. While zidovudine efficacy had been demonstrated in patients with AIDS or ARC, it was
      also evaluated in patients with AIDS-related illness, as well as in asymptomatic HIV-infected
      individuals. The clinically significant zidovudine-induced anemia developing in a substantial
      number of these patient groups and requiring blood transfusions could cause a significant
      drain on the blood supply in the United States.

      The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow
      Suppression in AIDS or AIDS-Related Complex. The concept was approved at the May 1987
      National Heart, Lung, and Blood Advisory Council. The Request for Applications was released
      in December 1987.

      DESIGN NARRATIVE:

      Double-blind, placebo-controlled. Patients received intravenous REPO (1000 IU/kg) or placebo
      twice per week. The five patients in Group A had no transfusion history. The five patients in
      Group B had a history of transfusions. Prior to the study, the authors determined that
      treatment would continue for twelve weeks or until the hemoglobin reached 12.5 g/dl. After
      the twelve week study period, patients were eligible to receive open label erythropoietin
      (500 IU/kg, twice a week). For numerous reasons, recruitment of patients was a major problem
      in this trial. The study originally estimated a total of 64 patients.
    

Intervention name(s): erythropoietin, recombinant
Intervention type(s): Procedure
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
Condition: Supraspinatus Injury
Study type: Interventional

Summary: 
      The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the
      surgery, the patient will be randomized into group A (brace) or group B (normal sling).

      Both groups will be also treated according to standard of care with physiotherapy and
      progressive introduction of movements.
    

Detailed description: 
      The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the
      surgery, the patient will be randomized into group A (brace) or group B (normal sling).

      Both groups will then perform only passive movements according to pain for the first 6 weeks
      supported by the physiotherapy, according to standard therapy. The following six weeks
      passive movements will be associated with active movements . No brace nor normal sling will
      be used anymore.

      Patients are in study for 6 months. During this period quality of life and pain
      questionnaires are submitted to the patients and a MRI will be done at the end of the study.
    

Intervention name(s): Brace; Normal sling
Intervention type(s): Procedure; Procedure
Intervention description(s): A brace to be weared according to protocol; A normal sling to be weared according to protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized 1:1
Masking: None (Open Label)
Primary purpose: Treatment
Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine dose-dependent effects of Vitabeard on various
      parameters of facial hair growth.
    

Detailed description: 
      Primary and secondary assessments of efficacy will be made based on information obtained
      through hair measurements using Dermoscan and Trichoscan smart software. The device includes
      a camera handpiece with 5MP USB high resolution camera (Full HD) for standardized images and
      reproducible measurements. The Trichoscan smart software will be used for the measurement of
      hair parameters including hair count, hair density, hair width and hair length. Each subject
      will receive a permanent ink marking underneath the chin to standardize the location of
      assessments. Assessment periods over a 5 day period prior to baseline and a 5-day period at
      the end of the study. On the first day of each period, subjects will shave in the clinic and
      image is capture to demonstrate the clean shave of the area (Day 0), subjects do not shave
      for the following 5-days and images will be taken on Days 2 and 5 of each assessment period.
      Day 5 values will be used for comparing supplement effects (baseline to end of study, between
      groups). Day 2 will be used to calculate rate of growth during each assessment period, and
      will be used to compare supplement effects (baseline to end of study, between groups).
    

Intervention name(s): Multivitamin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitabeard; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Facial Hair
BTT1023 in Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous
      doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the
      pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups
      will occur at random, and the actual treatment will not be revealed to the investigator or to
      the patient during the trial.
    


Intervention name(s): BTT1023; Placebo; BTT1023
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous, three infusions over three weeks; intravenous, three infusions over three weeks; Test challenge
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plaque psoriasis; BTT1023; safety; pharmacokinetics
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Investigators hypothesized that goal-directed fluid therapy using stroke volume variation
      will improve postoperative recovery in patients undergoing free flap reconstruction after
      head and neck cancer resection. Investigators will compare the effect of goal-directed fluid
      therapy using stroke volume variation on recovery in patients undergoing free flap
      reconstruction after head and neck cancer resection.
    


Intervention name(s): Standard fluid therapy; Conservative fluid therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.; In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fluid Therapy; Head and Neck Neoplasms; Surgical Flaps
Relationship Between Constipation and Inguinal Hernia
Condition: Inguinal Hernia; Constipation
MeSH terms: Hernia; Constipation; Hernia, Inguinal
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to asses the effect of chronic constipation on formation of
      inguinal hernia using Constipation Severity Scale.
    

Detailed description: 
      Causes of inguinal hernia are known to be multifactorial, although not fully understood.
      Besides family history, and connective tissue diseases, the sudden increase in abdominal
      pressure as heavy lifting, chronic constipation , coughing, straining , situations such as
      difficulty urinating facilitate the formation and emergence of hernia.

      Constipation severity scale(CSS) was developed by Varma et al in 2008. CSS is a scale to
      determine the individuals defecation frequency, the intensity and difficulty during
      defecation.CSS has three subscales including Pain, Congestion stool and Large Intestine
      laziness(0-73 points).High scores indicate that serious symptoms.

      Investigators found no studies that show how constipation impact on groin hernias.
      Investigators are planning to understand the effect of constipation on direct and indirect
      hernia formation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy
        volunteers
      
Keywords: Nyhus classification; constipation severity scale; groin hernia
Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC)
      administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic
      migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of
      TEV-48125 (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agree to
      participate in this study; and new participants meeting eligibility criteria (not rolling
      over from pivotal studies), will be enrolled in this study.
    


Intervention name(s): Fremanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
Other intervention name(s): TEV-48125
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study
      at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of
      the 3 dose levels. In each dose level, subjects will be administered a single dose in the
      fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess
      Pharmacokinetics (PK) following multiple dosing.
    

Detailed description: 
      This is a single-center, open-label, randomized, single- and multiple-dose, 3-way sequential
      study at 3 dose levels in healthy subjects. For logistical purposes subjects will be admitted
      to the unit to be dosed in groups of approximately 16 or fewer. Subjects will be randomized
      into one of the three dose levels. Within each dose level, subjects will be administered a
      single dose in the fasted state and then a single dose in the fed state, followed by 14 days
      of dosing to assess PK following multiple dosing.

      Subjects will undergo preliminary screening procedures for the study at the screening visit
      (Day -28 to Day -2). Subjects will be admitted to the clinical unit on the evening prior to
      investigational medicinal product (IMP) administration (Day -1) and will remain on site until
      72 h post-final dose. Subjects will receive a single dose of sparsentan in the fasted state
      on Period 1, Day 1 (Study day 1) and a single dose of sparsentan in the fed state (high-fat
      breakfast) on Period 2, Day 1 (Study day 8), followed by multiple doses of sparsentan in the
      fed state on Period 3, Day 1 to 14 (Study days 12 to 25). On PK sampling days for the
      multiple dose treatment period (Period 3, Days 7, and 14; Study days 18 and 25), subjects
      will consume a high-fat breakfast before dosing; on other days, a standard breakfast will be
      provided.

      A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing
      wellbeing of the subjects.
    

Intervention name(s): RE-021, sparsentan
Intervention type(s): Drug
Intervention description(s): RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Focal Segmental Glomerulosclerosis (FSGS); Immunoglobulin A Nephropathy (IgAN)
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing
      in comparison with the efficacy of standard dressing in terms of prevalence of surgical site
      infections (SSI) in patients who underwent colorectal resection for malignancy.
    


Intervention name(s): AQUAGEL Ag Hydrofiber Wound Dressing; Mepore Self-adhesive absorbent dressing
Intervention type(s): Device; Device
Intervention description(s): Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure; Standard dressing: medication performed as for frequency and duration according standard procedure
Other intervention name(s): AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surgical site infections (SSI); Advanced antimicrobial dressing and clean surgery; Hydrofibre dressing
Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label program of Remicade in the treatment of patients with active rheumatoid
      arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy
      of infliximab.
    


Intervention name(s): Infliximab (Remicade)
Intervention type(s): Biological
Intervention description(s): Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6. All patients will continue to receive the same dose of MTX they were receiving at entry throughout the subsequent treatment period.
Other intervention name(s): Remicade; SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Abnormalities in HIV-infected Persons
Condition: Lipodystrophy; HIV Infection
MeSH terms: HIV Infections; Lipodystrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the relationship between insulin resistance and
      changes in body fat distribution in HIV-infected persons. This study measures insulin
      sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the
      effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body
      fat in this population.
    

Detailed description: 
      Although HIV antiretroviral medications have helped patients live longer, they have also been
      associated with side effects including insulin resistance and changes in body fat
      distribution. Changes in body fat distribution associated with HIV antiretroviral medications
      may result in increased fat in the abdomen, neck, and upper back, which is often called
      central fat deposition. HIV antiretroviral medications may also result in loss of fat in
      legs, arms, and face, which is often called peripheral fat atrophy.

      This study will obtain preliminary data on the effect of 12 weeks of metformin on insulin
      sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin
      resistance and central fat deposition. Similarly, this study will obtain preliminary data on
      the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral
      muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.

      This study involves taking a drug that has been approved by the U.S. Food and Drug
      Administration (FDA) for use in humans for a period of 3 months.
    

Intervention name(s): Metformin; Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.; Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Other intervention name(s): Fortamet; Glucophage; Glumetza; Riomet; Actos
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipodystrophy; Insulin resistance; HIV infection