bioihbjkbjnl/mcl2 huggingface dataset:
A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA
      after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese
      participants with acne.
    

Detailed description: 
      This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither
      physician nor patient knows the name of the assigned drug), single dose ascending study of
      JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and
      pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the
      body and removed from the body over time) of M1 (active metabolite) in a total of eighteen
      (18) participants enrolled in the study, nine (9) in each group. Each participant will
      receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL
      application, to the face, neck, shoulders, chest and upper back areas. The investigational
      product will be washed off after the blood sampling at 24 hours after application. Safety and
      tolerability will be evaluated throughout the study and a topical dermatological assessment
      will be done by the dermatologists. The total duration of the study will be maximum 35 days.
    

Intervention name(s): JNJ 10229570-AAA 1.2%; JNJ 10229570-AAA 3.6%; Color-matched vehicle containing 0 mg of JNJ 10229570-AAA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.; One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.; One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; JNJ 10229570-AAA; Japanese patients; Topical treatment
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective:

      The objective of this study is to compare the efficacy of duloxetine in the treatment of
      patients with chronic low back pain with a radicular component to placebo.

      Study hypothesis:

      Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven
      its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The
      investigators therefore hypothesize that duloxetine will be efficacious in patients with
      chronic low back pain and a radicular component.

      Study Rationale:

      Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the
      condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in
      patients with neuropathic pain and may also be useful in chronic low back pain. If the
      investigators are able to show a benefit for patients in the duloxetine arm, the substance
      may constitute a further treatment alternative in chronic low back pain.

      Study Design:

      Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be
      administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will
      be medicated with placebo for 4 weeks. A second group of patients will receive the medication
      in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in
      the last week of each treatment period. Secondary endpoints are defined as use of rescue
      medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and
      side effects/adverse events.
    


Intervention name(s): Duloxetine; Duloxetine
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo)
day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg
day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg; 2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; Radicular component; neuropathic pain; duloxetine; CLBP
Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with
      recently surgically treated minimal to mild endometriosis.
    


Intervention name(s): Letrozole/IUI; CC/IUI
Intervention type(s): Drug; Drug
Intervention description(s): Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.; Patients received 100 mg lCC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: minimal to mild endometriosis; letrozole; clomiphene citrate; IUI
A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover,
      pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with
      endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin
      dihydrochloride with vitamin C and sapropterin dihydrochloride alone.
    

Detailed description: 
      This was a Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover,
      pharmacokinetic (PK) study designed to compare the plasma concentrations of BH4 in subjects
      with endothelial dysfunction following 14 days of treatment by each of 2 regimens:
      sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone. Each
      subject received each regimen; the 2 treatment groups varied only in the sequence of the 2
      regimens. The washout period between treatment regimens comprised the 1 day period between
      the last dose of study drug under the first regimen and the first dose of study drug under
      the second regimen (Day 14 morning to Day 15 morning).
    

Intervention name(s): Sapropterin Dihydrochloride; Sapropterin Dihydrochloride and Vitamin C
Intervention type(s): Drug; Drug
Intervention description(s): Sapropterin Dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.; Sapropterin Dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.
Other intervention name(s): 6R-BH4; 6R-BH4 and Vitamin C
Intervention MeSH terms: Vitamins; Ascorbic Acid; Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 6R-BH4; BH4; BH4 deficiency; sapropterin dihydrochloride; endothelial dysfunction; NO; Hypertension; Nitric Oxide; Vitamin C
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Condition: Stage III Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell
      lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising
      association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
    


Intervention name(s): Chemotherapy; ERBITUX; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles); The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes; 66 Gy (2 Gy by fraction, 5 fractions by week)
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.
Condition: Home Hospice
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      With the growth of hospice, older adults have the opportunity to receive home-based care
      aimed at reducing suffering and focusing on quality of life at the end of life. While use of
      technology and educational videos has yet to be fully developed, structured, and evaluated in
      home hospice care, it has shown promise to improve care in other settings. Therefore, this
      study aims to develop and evaluate a multi-component technology-based care intervention,
      i.e., Improving Home hospice Management of End of life issues through technology (I-HoME),
      that focuses on assessing and addressing patient symptoms and caregiver burden in the home
      hospice setting through synchronous live video visits and educational videos. The aim of the
      first phase of the project is to employ an iterative user-centered design process to develop
      I-HoME for home hospice patients and their caregivers prior to implementation.
    


Intervention name(s): I-HoME
Intervention type(s): Other
Intervention description(s): A multi-component technology-based care intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
Condition: Innate Immune Response; Endotoxemia; Inflammation; Sepsis
MeSH terms: Endotoxemia; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Excessive inflammation is associated with tissue damage caused by over-activation of the
      innate immune system. This can range from mild disease to extreme conditions, such as
      multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked
      contrast to adaptive immunity which is very sensitive to immune modulators such as steroids,
      the innate immune system cannot be sufficiently targeted by currently available
      anti-inflammatory drugs.

      The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human
      endotoxemia model can modulate the innate immune response.

      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,
      prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be
      sampled to determine the levels of markers of the innate immune response.
    


Intervention name(s): C1-esterase inhibitor; Endotoxin
Intervention type(s): Drug; Drug
Intervention description(s): intravenously; intravenously
Other intervention name(s): Cetor; 2 ng/kg E. coli reference endotoxin 11:H 10:K negative
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study explored whether exercise video distribution using metaverse space is effective in
      increasing physical activity among young people, along with mental health and locomotive
      function. This is a randomized parallel-group study. Participants will be assigned to 3
      groups: a metaverse group, a YouTube group, and a control group. The metaverse group will
      receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic
      equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will
      receive access to the same exercise videos as the metaverse group. The control group was
      given no specific instructions.

      The intervention period was 8 weeks, and physical activity and other items were measured
      before and after the intervention. These pre- and post-intervention measurements will be used
      to determine whether the delivery of exercise videos via Metaverse is effective in increasing
      physical activity in young adults.
    


Intervention name(s): Exercise video distribution of Metaverse; Exercise video distribution of YouTube
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received a 10-minute exercise video each week with a load of about 4 to 8 metabolic equivalents of task (METs) in the metaverse space, for eight videos delivered to encourage exercise.; Participants view exercise videos with the same content as the metaverse group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Condition: Heart Failure
MeSH terms: Heart Failure; Tissue Adhesions
Study type: Interventional

Summary: 
      The purpose of this study is to verify the impact of the educational intervention in the
      adhesion to therapeutic strategies for patients with heart failure.
    

Detailed description: 
      1. Characterize the socio-demographic and clinical aspects of heart failure patients;

        2. Awareness before and after nursing consultation, in relation to diet for heart failure,
           liquid and weight, general heart failure information, medication, physical activity,
           measures to improve disease control, signs of decompensated heart failure;

        3. Adhesion of patients before and after nursing consultation, related to medication,
           liquid and weight, use of alcohol and importance of returning for consultation and
           exams.

        4. Evaluated the impact of educational intervention at the levels of NT-proBNP, urea,
           creatinine, sodium, potassium, before and after nursing consultation;

        5. The 6 minute walk test performance before and after nursing consultation;

        6. The distance covered and time of the 6 minute walk test, until fatigue in heart failure
           patients before and after nursing consultation;
    

Intervention name(s): Adhesion-HF
Intervention type(s): Behavioral
Intervention description(s): The hypothesis that was investigated is whether the nursing consultation improves therapeutic strategies for membership, adherence to self-care, improved levels of NT-proBNP improves performance in 6-minute walk test, monitoring of biomarkers of laboratory tests (sodium , potassium, urea, creatinine and NT-proBNP) frequent occurrence of readmissions and mortality in patients with heart failure after 1 month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adhesion, Knowledge, Nursing
Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin
Condition: Pregnancy Related; Anaesthesia
Study type: Interventional

Summary: 
      A double-blinded randomised control trial conducted in the Department of Obstetrics and
      Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for
      two years duration from January 1st, 2012 till December 31st, 2013.

      The aim of the study is to compare the haemodynamic and cardiovascular effects between
      intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective
      Lower Segment Caesarean Section (EL LSCS).

      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly
      safe and has similar efficacy in comparison to a single injection of oxytocin.
    

Detailed description: 
      OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate
      (HR), saturation of oxygen (SpO2) in certain time after drug injection.

      The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such
      as ST depression and changes in T-waves.

      Hemoglobin and troponin-T level

      The need for additional oxytocin infusion and estimated blood loss

      The time interval between initial drug administration, type of additional oxytocic
      intervention that used and complication that happened.
    

Intervention name(s): Carbetocin; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.; 5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
Other intervention name(s): Duratocin for carbetocin; pitocin for oxytocin; pitocin
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; anaesthesia; caesarean section
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      Randomized controlled trial, a method used to implement the random allocation sequence is
      numbered containers.

      The aim of the study is to compare compression therapy with compression stockings and surgery
      eliminating superficial venous reflux in patients with duplex ultrasound verified superficial
      venous reflux without skin changes or ulceration.
    

Detailed description: 
      Superficial venous reflux is common in adult population. Uncomplicated disease, where there
      is no skin changes but varicose veins with or without leg swelling, can be totally
      asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually
      caused by increased venous pressure. Varicose veins may also cause cosmetic problem.
      Compression stockings relief the symptoms as they normalize venous pressure. In surgical
      treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim
      of the study is to compare conservative treatment with compression stockings with surgical
      treatment of superficial venous reflux. In operative treatment the great saphenous vein or
      lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the
      trunk. If the main trunk has been removes previously, axial refluating veins are removed or
      ligated according to the DUS finding. The patients in both groups are examined at the
      baseline and followed up to two years by ultrasound scanning. Patients clinical
      classification, venous disability score, venous disease severity score, anatomical path of
      reflux as well as quality of life are studied at the baseline, at one year follow-up and two
      years follow-up.
    

Intervention name(s): Operative treatment; conservative treatment
Intervention type(s): Procedure; Other
Intervention description(s): stripping of main trunk or if previously removed, removal or ligating the refluating trunk; Compression stockings class II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: venous surgery; compression therapy
Primary Progesterone Therapy for Operable Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test the effect of primary progesterone on overall and
      disease free survival in women with operable breast cancer. The study addresses two issues
      related to breast cancer surgery:

        -  Circulating progesterone at the time of surgery might counteract the detrimental effect
           of estrogen on survival of women with operable breast cancer.

        -  Events at the time of surgery may have an impact on the natural history of breast cancer
    

Detailed description: 
      This protocol addresses the issue of pre-operative hormone manipulation in women with
      operable breast cancer. The study has been designed after careful review of literature to
      assess the effect of unopposed oestrogen at the time of surgery and collect evidence that
      events at the time of surgery may have impact on the long-term survival of breast cancer
      patients. The meta-analysis of 37 studies on timing of surgery during the menstrual cycle
      showed a 15% + 3 improvement in survival for women who had undergone surgery during the
      luteal phase of their menstrual cycle. Three of the 37 studies where progesterone levels were
      estimated at the time of surgery showed 52% + 26 improvement in survival when circulating
      progesterone were > 1.5 ng/ml. The study aims to produce luteal milieu by injecting Hydroxy-
      progesterone 500 mg IM at the time of surgery. The timing of administration of progesterone
      in the neo-adjuvant setting is decided after collating data from large data-bases and
      randomised trials of screening suggesting that events at the time of surgery may alter the
      behavior of micro-metastases.
    

Intervention name(s): 500 mg of depot hydroxy-progesterone
Intervention type(s): Drug
Intervention description(s): An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
Intervention MeSH terms: Progesterone; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer of the Breast; Neoplasm