bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability of Plant Protein Amino Acids
Condition: Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
Study type: Interventional

Summary: 
      This study aims to inform of the mechanism of action of plant-based protein by measuring the
      bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation
      following oral ingestion) of key amino acid and metabolic products that regulate skeletal
      muscle protein synthesis (MPS) in humans.
    

Detailed description: 
      Plant-based proteins contain several amino acids that are essential to signal muscle
      growth/repair and act as a substrate during muscle protein synthesis. However, compared to
      animal protein or free-amino acids, the bioavailability of certain essential amino acids may
      be compromised. Following selective processing (e.g. removal of carbohydrate and/or other
      anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater
      bioavailability and bioactivity in vivo. This project explores the bioavailability and
      bioactivity of selected plant-based protein concentrates following oral ingestion in young,
      healthy men and women.
    

Intervention name(s): Pea-protein concentrate; Fava-bean protein concentrate; Chickpea protein concentrate; Red lentil protein concentrate; Non-essential amino acid blend; Whey protein concentrate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Pea-protein concentrate; Fava-bean protein concentrate; Chickpea protein concentrate; Red lentil protein concentrate; Non-essential amino acid blend; Whey protein concentrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with partial seizures currently taking 1-3 antiepileptic medications will have a
      50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to
      their current medications for 3 months. Neither the study doctor nor the patient will know
      the medication assignment. Vision testing will be performed prior to receiving the study
      treatment and at the end of the study to see if there are any changes.
    


Intervention name(s): Lyrica (pregabalin); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg twice a day, oral administration; Twice a day, oral administration
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: epilepsy partial seizure treatment with pregabalin or placebo; vision testing
Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome
Condition: Hematopoietic Syndrome Due to Acute Radiation Syndrome
MeSH terms: Syndrome; Radiation Injuries; Acute Radiation Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether HemaMax is safe and well tolerated to
      support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated
      with the hematopoietic syndrome of acute radiation syndrome.
    

Detailed description: 
      This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center
      study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™
      (rHuIL-12) in healthy adult male and female subjects considered representative of U.S.
      population.
    

Intervention name(s): HemaMax; Placebo
Intervention type(s): Biological; Drug
Other intervention name(s): rHuIL-12, NM-IL-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HemaMax, NM-IL-12, HSARS, Safety
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
Condition: Pain; Cancer; Sickle Cell Anemia; Severe Burns
MeSH terms: Anemia, Sickle Cell; Breakthrough Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to monitor the safety (adverse event data) of longer-term use
      of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain
      associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who
      are receiving around the clock (ATC) opioid therapy.
    


Intervention name(s): ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle Cell
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multi-center, single arm study evaluating the blood pressure (BP)
      changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood
      pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
    

Detailed description: 
      This is an open-label, multi-center, single arm study evaluating the blood pressure (BP)
      changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood
      pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

      The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is
      to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects,
      and to provide subjects with study medication for the start of dosing. Visit 5 is to assess
      subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.
    

Intervention name(s): LPCN 1021
Intervention type(s): Drug
Intervention description(s): LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
Other intervention name(s): TLANDO
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      To demonstrate, during a prospective randomized medico-economic study, in morbidly obese
      patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to
      usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and
      peri-operative morbidity.
    

Detailed description: 
      On inclusion, comorbidities associated with obesity will be recorded. After recording of the
      informed consent patients will be randomized in two groups: usual care or intra-gastric
      balloon. In the latter, a second randomization will be performed between air-filled balloon
      or water-filled balloon. Six months later, after withdrawal of the balloon (if required),
      laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during
      6 months.

      On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a
      medical and biological evaluation will be systematically performed.

      The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during
      the 30 days following surgery.

      The secondary criteria of judgement is: the differences in pre-operative weight loss between
      the 2 groups, number of complications occurring during the 30 days after surgery, differences
      in different scales of quality of life (SF36, IWQOL-lite), differences in operative time,
      length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy
      and tolerance of each type of balloon (air-filled or water-filled) will be compared in the
      intra-gastric balloon group.
    

Intervention name(s): inflatable intra-gastric balloon
Intervention type(s): Device
Intervention description(s): inflatable intra-gastric balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Morbid obesity; Gastric balloon; Gastric by-pass; Morbid obesity with BMI > 45 kg/m²
A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019
      (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately
      2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and
      in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15
      sites across South Africa. A vaccine causes the body to have an immune response that may help
      prevent the infection or reduce the severity of symptoms. An adjuvant is something that can
      make a vaccine work better. This study will look at the protective effect, body's immune
      response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations.
      Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1
      adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular
      injections over the course of the study.
    


Intervention name(s): SARS-CoV-2 rS/Matrix-M1 Adjuvant; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.; Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
Other intervention name(s): NVX-CoV2373; Sodium chloride 0.9% (BP, sterile)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronavirus
BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the current study is to investigate the efficacy, safety and
      pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on
      therapy to on going metformin therapy in patients with T2DM with insufficient glycemic
      control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM)
      as add-on therapy to metformin.
    


Intervention name(s): BI 10773; placebo; sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin
Intervention model: Parallel Assignment
Primary purpose: Treatment
Online Cognitive Control Training for Remitted Depressed Patients
Condition: Major Depression in Remission
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of an internet-delivered cognitive control training as
      a preventive intervention for remitted depressed patients. Half of the participants will
      receive a cognitive control training, while the other half will receive a low cognitive load
      training that acts as an active control condition.
    

Detailed description: 
      Prospective studies have linked impaired cognitive control to increased cognitive
      vulnerability for future depression. Importantly, experimental studies indicate that
      cognitive control training can be used to reduce rumination and depressive symptomatology in
      MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted
      depressed patients form a high-risk group for developing future depressive episodes, the
      current study will explore whether an internet-delivered cognitive control training can be
      used to reduce vulnerability for future depression in remitted depressed patients.

      A computer training, consisting of 10 sessions of 15 minutes each, will be administered to
      participants, which are remitted depressed patients. This training can either be a cognitive
      control training, using an adaptive paced auditory serial addition task, or an active control
      training, with a low cognitive load task.

      Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after
      the training, and consist of depressive symptomatology, related variables and cognitive
      control measures.
    

Intervention name(s): Cognitive control training; Active control training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.; 10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression; Remission; Relapse prevention; Cognitive control training; Internet intervention
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioavailability in women of 2 tablet formulations containing
      Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single
      site with 36 subjects. Participants will take 2 tablets of the test product and reference
      product in 2 periods and 2 sequences (either test after reference or reference after test).
      There will be a washout of at least 14 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 15.0 mg and
      Ethinyl estradiol 0.03 mg and to demonstrate bioequivalence of both formulations in terms of
      rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Microgynon [Trademark], product of Bayer AG, Brasil. The 90%
           confidence intervals for the intra-subject coefficient of variation (Test versus
           Reference Product) for the main pharmacokinetic parameters área under the plasma
           concentration-time curve from time zero to time t (AUC0-t) and from time zero to
           infinite (AUC0-∞), and maximum plasma concentration (Cmax) for total Levonorgestrel and
           Ethinyl estradiol will be determined. Participants will be confined in the study site
           for approximately 34 hours during each study period (for 10 hours pre-dosing and for 24
           hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 21
           blood samples will be taken up to 24 hours after the administration in each period.
           Participants will return to the site to provide additional blood samples at 48 h, and 72
           h postdose. The washout period between the two study periods will be at least 14 days. A
           validated LC-MS/MS bio-analytical method will be used for estimation of plasma levels of
           Ethinyl-estradiol and Levonorgestrel. The safety objective is to evaluate the
           tolerability of both formulations in women by collecting adverse events.
    

Intervention name(s): Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug; Microgynon CD
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Microgynon CD will be used as a comparator drug for the BE study. Other Name: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active
      controlled, Dose-escalation Study to investigate the safety, tolerability, and
      Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous
      Administration in Healthy Male Subjects.
    


Intervention name(s): GC1113; Darbepoetin alfa
Intervention type(s): Drug; Drug
Intervention description(s): Each Group volunteers (n=10) will be administered GC1113 0.3ug/kg to 5ug/kg or Placebo (GC1113:placebo=8:2) once intravenously.
Each Group volunteers (n=10) will be administered GC1113 1ug/kg to 8ug/kg or Placebo (GC1113:placebo=8:2) once subcutaneously.; Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythropoietin; EPO-hFC
Role of Metabolomics in the Diagnosis of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Endometriosis is one of the most common benign gynecological, affecting about 10% of
      premenopausal women. The pathophysiology of this disease is still not completely clear.
      Despite its prevalence, there is no blood test available for the diagnosis of endometriosis
      and the average delay time to diagnosis is 9.4 years.

      Metabolomics is a scientific discipline that studies changes in metabolites related to the
      pathophysiology of the disease.

      Aim of the study is to identify an alteration in the expression of the metabolites in women
      with endometriosis
    


Intervention name(s): laparoscopic surgery, obtainment of biological samples
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women of childbearing age , patients of the University Hospital , suffering from benign
        gynecological disease
      
Biospecimen description: 
      urine samples, blood samples
    
Keywords: Endometriosis; Metabolomics
Evaluation of Specialized Water Dance Intervention
Condition: Spastic; Pain, Chronic; Stress; Quality of Life
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Individuals with profound intellectual and multiple disabilities (PIMD) have extensive health
      problems and need for personal assistance throughout the day. Few physical- and health
      promoting activities are available for them and among the activities, few have been
      scientifically evaluated. Specialized water dance intervention (SWAN) is a new method
      developed to relieve discomfort and promote physical wellbeing among people with PIMD. The
      aim of the study is to evaluate the effects of SWAN on stress, spasticity, pain, alertness,
      wellbeing and social interaction among individuals with PIMD.

      Individuals with profound intellectual and multiple disabilities (PIMD) have extensive health
      problems and need for personal assistance throughout the day. Few physical and health
      promoting activities are available for them. Among the activities, few have been
      scientifically evaluated. Specialized water dance intervention (SWAN) is a new method
      developed to relieve discomfort and promote physical wellbeing among people with PIMD. The
      aim of the study is to evaluate the effects of SWAN on stress, spasticity, pain, alertness,
      wellbeing and social interaction among individuals with PIMD.

      Prospective randomized controlled intervention study in which the effects of SWAN are tested
      in a two-group cross-over design with pre-, under- and post-measurements. The study is
      conducted as a multicenter study with four participating county councils/regions I Sweden
      (Varmland County Council, Region Orebro County, Region Ostergotland and Region Gavleborg).

      The SWAN intervention is given once a week for 3 months (12 occasions). Each SWAN session is
      45 minutes and is led by two SWAN leaders.
    


Intervention name(s): Specialized water dance intervention
Intervention type(s): Behavioral
Intervention description(s): Group activity in a warm pool (32-34 °C) led by two SWAN leaders. During each session, nine songs are played and the participants, assisted by a support person, perform dance movements rhythmically to the mood of the music. The songs are chosen to stimulate different movement patterns and to emphasize different emotions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants are first randomized to the intervention or control group and when the intervention for the first group is completed, the intervention is given to the second group (former control group). Since the prevalence of profound intellectual and multiple disabilities is low, the project is carried out as a multicenter study.
Masking: None (Open Label)
Primary purpose: Other