bioihbjkbjnl/mcl2 huggingface dataset:
Teverelix Evaluated in Advanced Prostate Cancer
Condition: Prostatic Adenoma
MeSH terms: Adenoma; Prostatic Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of teverelix TFA in the
      treatment of advanced prostate cancer
    

Detailed description: 
      After being informed about the study and potential risks, all patients giving written
      informed consent will undergo an up to 7 day screening period to determine eligibility for
      study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an
      open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC)
      injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will
      then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or
      6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks
      after their last maintenance dose injection.

      The initial dosing regimen to be tested (Group 1) is:

      Loading Dose = 120 mg teverelix TFA SC + 120 mg teverelix TFA IM Maintenance Dose = 120 mg
      teverelix TFA SC every 6 weeks

      If this dosing regimen is unsuccessful (more than 2 (of 20) patients fail treatment) then
      recruitment to Group 1 will end and enrollment in Group 2 will open.

      The dosing regimen that may be tested (Group 2) is:

      Loading Dose = 180 mg teverelix TFA SC + 180 mg teverelix TFA IM Maintenance Dose = 180 mg
      teverelix TFA SC every 6 weeks

      If this dosing regimen is unsuccessful (more than 6 (of 60) patients fail treatment) then
      recruitment to Group 2 will end and the study will be terminated.
    

Intervention name(s): teverelix TFA 120 mg; teverelix TFA 180 mg
Intervention type(s): Drug; Drug
Intervention description(s): Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24; Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Intervention MeSH terms: Antarelix
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Adaptive design - enrollment will open in Group 1 (6-weekly dosing regimen). Only if Group 1 dosing regimen is unsuccessful will enrollment open in Group 2 (4-weekly dosing regimen)
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is designed to test the effectiveness of intranasal carbetocin (LV-101) in
      participants with Prader-Willi syndrome (PWS). Carbetocin is an oxytocin analog (a man-made
      chemical that is like oxytocin). This study will also evaluate the safety and tolerability of
      LV-101.
    

Detailed description: 
      This is a Phase 3 randomized, double-blind study with an 8-week, placebo-controlled period
      designed to test the effectiveness, safety, and tolerability of LV-101 in participants with
      PWS.

      Effectiveness will be measured using both caregiver-reported and clinician-reported measures
      of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. Safety and
      tolerability will be measured by adverse events, laboratory tests, and physical exams.

      After the 8-week placebo-controlled period, there will be a long-term follow-up period of 56
      weeks and an optional extension period after study week 64 during which all participants will
      receive active treatment with LV-101. At Week 8, participants who were randomized to placebo
      in the placebo-controlled period will be randomized to one of the two LV-101 doses,
      administered three times per day before meals.
    

Intervention name(s): 3.2 mg intranasal carbetocin; 9.6 mg intranasal carbetocin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): three times per day with meals; three times per day with meals; three times per day with meals
Other intervention name(s): LV-101; LV-101
Intervention MeSH terms: Carbetocin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three parallel groups (two different doses of carbetocin and placebo) for the first 8 weeks; two parallel groups (two different doses of carbetocin) during 56 weeks of follow-up and the optional extension period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PWS; Prader-Willi syndrome; carbetocin
Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
Condition: Multiple Sclerosis; Rheumatoid Arthritis
MeSH terms: Arthritis; Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The main objective of this study is to measure, in patients with MS or Chronic Inflammatory
      Arthritis (CIA), the correlation between two calcium intake assessment methods: A self
      assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a
      reference (gold standard) and based on data from CIQUAL *.

      * CIQUAL Data: Nutritional food composition table available on the website of the ANSES
      (National Agency for Sanitary Security of Food, Environment and Labour), published by the
      Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58
      nutritional components. The data is integrated into the software (DATAMEAL) for calculating
      the ingesta parameters at the Nîmes University Hospital.
    

Detailed description: 
      The secondary objectives of this study are:

      A. To estimate the average calcium intake and variability in a population of MS patients and
      the proportion of patients at risk for osteoporosis.

      B. To estimate the average calcium intake and variability in a population of CIA patients and
      the proportion of patients at risk for osteoporosis.

      C. To describe the dietary changes observed in MS or CIA patients .

      D. To estimate the administration time of the QALCIMUM® self-questionnaire.

      E. Estimate calcium intake means and variability in a population of patients with MS or CIA
      and the proportion of patients at risk of osteoporotic fracture

      F. To assess the quality of life of patients with MS or CIA

      G. To evaluate endogenous mean vitamin D production in a population of patients with MS or
      CIA
    

Intervention name(s): QALCIMUM questionnaire; Determination of calcium intake by a dietician interview
Intervention type(s): Other; Other
Intervention description(s): All patients will fill out the QALCIMUM questionnaire.; All patients will have an interview with a dietician who performs a food survey serving as a reference (gold standard) and based on data from CIQUAL *.
* CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.
Intervention MeSH terms: Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women
Condition: Hypertension; Postmenopausal Disorder
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine the effect of calcium and vitamin D supplementation on oxidative
      status and blood pressure profile of postmenopausal patients with high blood pressure in
      Yaoundé, Cameroon.

      This study is a double-arm, double-blind, randomized and parallel clinical trial conducted at
      the Yaoundé Central Hospital
    

Detailed description: 
      Aim: to determine and compare the short term effect of calcium and vitamin D supplementation
      on oxidative status and blood pressure profile of postmenopausal patients with high blood
      pressure in Yaoundé, Cameroon.

      Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the
      Yaoundé Central Hospital. Postmenopausal hypertensive blacks women who are taking taking
      antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease
      or hypercalcemia, are randomize into 2 groups. Depending on the group, the intervention
      consisted of the administration of Calcium 1000 mg daily or Vitamin D/Calcium 1000 mg/800 UI
      daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant
      marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).

      Progress: Recruitment for this study was completed in May 2019 with 22 patients.
    

Intervention name(s): Calcium Arm; Vitamin D/Calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; 1000 mg/800UI of the association Vitamin D/Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood pressure; Oxidative status
The Safety and Immunogenicity of a Potential HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The potential HIV vaccine has two components: a protein immunogen based on the coat protein
      of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The
      immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous
      formulation (GLA-AF).

      We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response
      stimulated by the vaccine) when it is given in two different dose regimens:

      Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2
      and 12.

      Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5
      micrograms of GLA-AF.

      We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the
      vaccine by monitoring the occurrence of adverse events in the participants. We will assess
      the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood
      and in genital mucosal secretion samples.
    


Intervention name(s): CN54gp140 mixed with GLA-AF
Intervention type(s): Biological
Intervention description(s): Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human immunodeficiency disease; HIV; Vaccine; CN54gp140; Glucopyranosyl lipid adjuvant; GLA; GLA-AF
Usability Evaluation - Reassure Respiration Rate Device: Home User Study
Condition: Ease of Use
Study type: Observational

Summary: 
      This is a usability evaluation of the Reassure device. The device is a non-contact device
      which passively monitors breathing.

      The purpose of this usability evaluation is to understand any issues that the intended user
      population have while using the device unsupervised in the home and to determine if the
      device can collect data that is of sufficient quality to be successfully analysed for
      respiration rate.
    

Detailed description: 
      The aim of the set of Reassure Home User Trials is to understand any usability issues that
      users have while using the Reassure non contact monitor in their home environment.

      Other objectives:

        -  To gather useful feedback on the user interface and suggestions for its improvement.

        -  To gather information on the device stability in the more variable conditions of the
           home user environment.

        -  To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1

      The users had the device for a minimum of 10 nights, to confirm if the device could be used
      for an extended period and the likely compliance rates of users
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Up to 60 volunteers, all naïve to the device. The majority of the volunteers to be >65
        years old, to represent the likely user profile: person with a set of chronic diseases, and
        not necessarily technically adept
Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.
Condition: Healthy, Pregnant Women
Study type: Interventional

Summary: 
      The primary objective of this research is to assess the agreement between INVU™ and IUPC (the
      gold standard) during prenatal monitoring of uterine contractions and to assess the safety of
      INVU™. Additional information comparing INVU™ to TOCO (the standard of care) was also
      collected.
    

Detailed description: 
      This multi-center, prospective, comparative, open-label study will be performed in two steps:
      A training step where up to 40 subjects will be enrolled to confirm uterine contraction
      performance level.

      In the second, validation step, the performance of the uterine contraction detection
      algorithm will be validated. The validation phase will involve up to 80 subjects.

      Sub-study will be implemented in the sites that will monitor the uterine activity of the
      subjects with TOCO, in addition to INVU™ and IUPC.

      Following the screening process, participants subject will undergo continuous recording of
      the uterine contraction and the fetal heart rate (FHR) for 30 to 60 min using INVU™,
      Cardiotocograph ((TOCO / CTG), and Intrauterine Pressure Catheters (IUPC). The collected data
      will be downloaded and comprehensive analysis of the values will be performed offline. Each
      participant will undergo continuous monitoring by the medical team to identify any safety
      issue, including but not limited to irritation, sensitization, and potential harmful misuse.
    

Intervention name(s): INVU™; IUPC; TOCO
Intervention type(s): Device; Device; Device
Intervention description(s): The subject will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) for 30 to 60 min using INVU™.; The study participants will undergo continuous recording of the uterine contractions by IUPC.; Some of the study participants will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) by TOCO as well.
Other intervention name(s): CTG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Remote Intercessory Prayer
Condition: Remote Intercessory Prayer
Study type: Interventional

Summary: 
      Intercessory prayer can improve the outcome of pregnancies?
    


Intervention name(s): Intercessory Prayer; Intercessory Prayer
Intervention type(s): Other; Behavioral
Intervention description(s): A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.; A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intercessory Prayer, pregnants
An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab®
      PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain
      medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after
      undergoing knee replacement surgery.

      Another goal of this study is to assess the safety and effectiveness of this non-invasive,
      sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient
      experiences following knee replacement surgery.
    


Intervention name(s): Sufentanil NanoTab PCA System/15 mcg
Intervention type(s): Drug
Intervention description(s): 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Intervention MeSH terms: Sufentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up
      and processed by healthy male participants. The study consists of two parts, called study
      periods. In Period 1, participants will take one dose of PF-07081532 by mouth. In Period 2,
      participants will take one dose by mouth and one dose as an injection through a vein at the
      study clinic.

      In Period 1, participants will stay at the clinic site for up to 21 days. In Period 2, they
      will stay at the clinic site for 7 days. During their stays, participants will have their
      blood, urine, and feces collected by the study doctors several times. We will measure the
      level of PF-07081532 in participants' blood, urine, and feces samples. This will help us know
      how much the study medicine is getting taken in by the body. At the end of the study,
      participants will be contacted by phone to check in. Participants will be involved in this
      study for about 12 weeks.
    


Intervention name(s): Oral [14C]PF-07081532; Oral PF-07081532 and IV [14C]PF-07081532
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of [14C]PF-07081532, will be administered as a liquid formulation in study period 1.; In study period 2: a single, oral, unlabeled dose of PF-07081532 will be administered as a liquid formulation. Approximately 1 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-07081532 will be administered via intravenous infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Absorption; Distribution; Metabolism; Elimination; Bioavailability; Fraction absorbed; Mass balance; Healthy Males
Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      CINS is a large multicentre study which aims to test out the effect of 4 different
      interventions, namely a brief cognitive intervention (BI), a more extensive cognitive
      behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and
      soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.
    

Detailed description: 
      The treatment principles for low back pain, and also other types of non-specific muscle pain,
      have changed dramatically over the last 10 to 15 years; from traditional treatment like bed
      rest and inactivity to more active treatment strategies ("the back pain revolution"; Waddell
      et al 1997). Norwegian research has been in the forefront, particularly in demonstrating the
      clinical and cost effective brief interventions (BI) (Indahl et al., 1995, 1998; Hagen et al
      2000, 2004, Brox et al 2003, Storheim et al 2003). However, about 30% of the patients do not
      recover or return to normal social and working life. The aim of this study is therefore to
      see if a longer cognitive behavioural intervention (CBT) has an additional benefit to BI, and
      to compare this with a potentially beneficial dietary supplement.
    

Intervention name(s): Brief Intervention; Cognitive Behavioural Therapy; Seal oil; Soy oil
Intervention type(s): Behavioral; Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): Physical examination, education and follow up by a physiotherapist; 7 sessions of CBT over a period of 2 months, included a booster session after 3 months; 20 capsules per day for 3 months; 20 capsules per day for 3 months
Other intervention name(s): Brief Education; Light mobilization treatment; Cognitive behavioral treatment; Cognitive rehabilitation; Marine oil; Nutritional supplement; Vegetable oil; Nutritional supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic low back pain; Brief cognitive intervention; Cognitive behavior therapy; Seal oil
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and
      preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with
      durvalumab in Japanese patients with advanced solid malignancies.
    


Intervention name(s): AZD9150, Durvalumab
Intervention type(s): Drug
Intervention description(s): After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT
Intervention MeSH terms: Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment