bioihbjkbjnl/mcl2 huggingface dataset:
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Condition: HIV Infections; Pneumococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate
      vaccine have more local reactions at the site of injection and systemic reactions than
      placebo subjects. To assess whether this vaccine is more immunogenic than placebo following
      the third vaccination.

      Children with HIV infection are at increased risk for invasive pneumococcal infection,
      particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited
      number of serotypes. The maximum number of pneumococcal serotypes that can be included in a
      new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent
      pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular
      saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin
      mutant carrier protein.
    

Detailed description: 
      Children with HIV infection are at increased risk for invasive pneumococcal infection,
      particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited
      number of serotypes. The maximum number of pneumococcal serotypes that can be included in a
      new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent
      pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular
      saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin
      mutant carrier protein.

      Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or
      placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age.
      Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months
      of age.
    

Intervention name(s): Pneumococcal Vaccine, Polyvalent (23-valent); Pneumococcal Conjugate Vaccine, Heptavalent; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered as an injection at 24 months of age; Administered as an injection at 0, 2, 4, and 15 months of age; Administered at 0, 2, 4, and 15 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Pneumococcal Infections; Bacterial Vaccines
Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic
      effects on the experimental rats and no obvious toxicity was found.This is a randomized,
      doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy
      and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore
      the optimal dosage of Tang-min-ling pills.
    

Detailed description: 
      Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had
      stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into
      3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g
      Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively.
      Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma
      glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these
      groups were measured and analyzed. Some safety indexes such blood and urine and stool routine
      examination, electrocardiogram (ECG)and liver and kidney function tests were measured and
      analyzed during the experiment. The treatment period is 12 week.
    

Intervention name(s): Tang-min-ling pills low dosage; Tang-min-ling pills high dosage; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.; high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.; Tang-min-Ling pills analogue 6g,tid,po
Other intervention name(s): Tang min lin pill; Tang min lin pills; Tang-min-Ling pills analogue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tang-min-ling pills;; overweight type 2 diabetes mellitus;; blood glucose; Traditional Chinese Medicine; Clinical Trial; Intervention Studies
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
Condition: Iron Absorption
Study type: Interventional

Summary: 
      The objective of this study was to compare the iron absorption from ferric pyrophosphate
      enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous
      sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.
    

Detailed description: 
      Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally.
      Consequences such as decreased cognition, growth impairment, and morbidity and mortality
      arise from inadequate iron intake. Many technological challenges are presented in fortifying
      foods with iron, as inorganic iron salts are known to cause organoleptic problems in the
      food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability
      of the food is ideal, however most suitable iron fortificants contain low bioavailability.
      Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both
      studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2
      mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon.
      Participants were randomized to consume either meal A or B, followed by B or C. In study I,
      subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three
      consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as
      ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status
      indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days
      following final isotope dosing, whole blood samples were collected and the fractional iron
      absorption of each iron fortificant containing labelled stable isotopes was measured via
      thermal ionization mass spectrometry with estimation of 80% incorporation into the
      hemoglobin.
    

Intervention name(s): Ferric pyrophosphate; Aspiron; Ferrous sulfate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 57 Iron isotopically labeled FePP powder.; 58 Iron isotope intrinsically labeled Aspergillus oryzae.; 57 Iron isotopically labeled FeSO4 powder.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Iron Bioavailability; Iron Fortification; ferrous sulfate; ferric pyrophosphate; aspergillus oryzae; stable isotope
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single Rising Dose (SRD) part:

      The main objectives of the SRD part of this trial are to investigate safety, tolerability,
      and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral
      administration of single rising doses.

      Food Effect (FE) part:

      The main objective of the FE part is to assess the influence of food on the relative
      bioavailability of the BI 1584862 tablet.
    


Intervention name(s): BI 1584862; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1584862; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SRD-Part: parallel-group design FE-Part: two-way crossover design
Masking: Single (Participant)
Primary purpose: Treatment
Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects
Condition: Cicatrix; Lipodystrophy; Plaque
MeSH terms: Lipodystrophy; Cicatrix
Study type: Interventional

Summary: 
      The Research Question of the present study is the following: in a population of men and women
      presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed
      plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly
      decrease and / or improve their appearance, results observed after 4 and 8 weeks?
    

Detailed description: 
      Jalucomplex® action is to increase the volume of dermal-epidermal tissue, based on the
      natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many
      times greater than their weight. This allows to fill the intradermal spaces and integrate the
      intercellular matrix, conferring turgidity to the tissues. Linear hyaluronic acid is a
      polymer that represents one of the essential components of human skin, subcutaneous and
      connective tissue; its ability to form complexes with water molecules increases the level of
      tissue hydration, turgidity and plasticity. These characteristics allow Jalucomplex® to be
      used as a temporary filler for subcutaneous areas to correct small defects in the dermal
      tissue due to lipodystrophies or the presence of fibrotic tissues as scars, caused by
      pathologies or trauma. Non-crosslinked hyaluronic acid generates a lower reactivity that
      crosslinked forms, biocompatibility of hyaluronic acid-based materials decreasing with an
      increase in the number of modifications to this polysaccharide
    

Intervention name(s): Jalucomplex
Intervention type(s): Device
Intervention description(s): Device: Jalucomplex Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, open-label, non-randomized clinical investigation
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pain Catastrophizing
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study proposes to experimentally manipulate pain catastrophizing in order to investigate
      the neural mechanisms by which pain catastrophizing influences the experience of pain among
      non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA).
      Therefore, participants will be randomized to either a single session cognitive-behavioral
      intervention to reduce pain catastrophizing or a pain education control group.
    


Intervention name(s): Cognitive-Behavioral Intervention; Pain Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.; General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: catastrophizing; cognitive-behavior therapy
Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a culturally adapted
      internet-administrated cognitive behaviour therapy (ICBT) in Arabic for anxiety and
      depression
    

Detailed description: 
      The study will compare the effect of the intervention against a wait-list control. The
      intervention tested is based on cognitive behavior therapy delivered over the internet via a
      secure treatment platform. Participants in the study are recruited from the general public
      via social media. The intervention is in Arabic.
    

Intervention name(s): Internet-delivered CBT
Intervention type(s): Behavioral
Intervention description(s): Culturally adapted transdiagnostic internet-delivered CBT in Arabic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants get randomly assigned to either treatment or wait-list control.
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
Condition: Candidiasis, Esophageal; HIV Infections
MeSH terms: Candidiasis; Esophagitis
Study type: Interventional

Summary: 
      The purpose of this study is to see if it is safe to give L-743,872 to men with candidal
      esophagitis, an AIDS-related yeast infection in the esophagus.
    

Detailed description: 
      In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of
      three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the
      final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.
    

Intervention name(s): L-743,872
Intervention type(s): Drug
Intervention MeSH terms: Caspofungin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Antifungal Agents; Candidiasis; Esophageal Diseases; MK 0991
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to obtain a first clinical assessment of the safety of
      dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
    


Intervention name(s): Dersalazine sodium; Mesalazine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dersalazine sodium 2400 mg daily; Mesalazine 2400 mg daily; Placebo matching active and experimental treatments
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
State-wide Health Approach to Increase Reach and Effectiveness: Study 3
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators have shown that adding an internet behavioral weight loss program to a
      statewide campaign improves weight loss outcomes. However, our follow-up data suggest that
      once the intervention is stopped, participants begin to experience weight regain. Thus, the
      purpose of this project is extend this line of work and pilot test health coaches and
      monetary incentives for weight loss maintenance. The investigators hypothesize that coaching
      and incentives will improve longer-term weight outcomes.
    


Intervention name(s): Shape Up Rhode Island; Shape Up Rhode Island + Professional Coach + Incentives; Shape Up Rhode Island + Peer Coach + Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple oral dose, open-label study to assess the safety, tolerability, and
      pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.
    

Detailed description: 
      This multicenter study will be conducted in 2 parts (Part 1 and 2). This is an ascending
      multiple oral dose, open-label study assessing the safety, tolerability, and pharmacokinetics
      of SEP-363856 in male and female subjects with schizophrenia. In part 1, subjects will have
      up to two visits, including a screening visit, and a 17-day in-clinic period. Eligible
      subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of
      their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1,
      after subjects have successfully completed the taper/washout of prior medication, subjects
      will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 10
      days in-clinic dosing. From Day 11 through Day 13, inclusive, subjects will be restabilized
      on their adequate antipsychotic medication(s) before clinic discharge on Day 14. Some
      subjects may require a longer restabilization process based on Investigator judgment.
      Subjects who discontinue the study prior to Day 13 will require an in-clinic stay for 3 days
      (or longer based on Investigator judgment) for restabilization on prior medications. In Part
      2, Subjects will have up to two visits, including a screening visit, and a 21-day in-clinic
      period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a
      taper/washout of their prior antipsychotic medication(s) under the supervision of the
      Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior
      medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will
      continue once-daily for 14 days in-clinic dosing. From Day 15 through Day 17, inclusive,
      subjects will be restabilized on their adequate antipsychotic medication(s) before clinic
      discharge on Day 18. Some subjects may require a longer restabilization process based on
      Investigator judgment. Subjects who discontinue the study by Day 17 will require an in-clinic
      stay for 3 days (or longer based on Investigator judgment) for restabilization on prior
      medications.
    

Intervention name(s): SEP-363856
Intervention type(s): Drug
Intervention description(s): An oral 25 or 50mg dose of SEP 363856
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Community-Based Integrated Treatment for Adolescents
Condition: Depression; Alcohol Use
MeSH terms: Depression; Depressive Disorder; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effectiveness of an integrated treatment for adolescents who are
      depressed and use alcohol in an intensive outpatient setting in the community.
    

Detailed description: 
      Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders
      are related in adolescence. For example, in a community sample, teens who reported a history
      of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD)
      than teens with no history of AUD. The scientific community has only recently begun to
      examine how to treat adolescents with both AUD and MDD. Reviews have concluded that
      depression negatively affects treatment for substance abuse. At the same time, substance use
      issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that
      protocols are needed to specifically address substance abusing, depressed adolescents. This
      study is designed to determine if an integrated (CBT-I) protocol designed to treat both
      substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce
      better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and
      CBT-SC conditions will be delivered by licensed mental health workers at a community mental
      health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat
      adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4
      years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by
      reporting both depressed mood and substance abuse, these eligible families will complete a
      thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The
      baseline battery will be repeated at the end of treatment, and 6 and 12 months after
      treatment completion to determine how families in the study do over time.
    

Intervention name(s): Integrated Cognitive Behavioral Therapy; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.; Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
Other intervention name(s): CBT for adolescents and parents; Intensive Outpatient Therapy; Treatment As Usual (TAU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Alcohol Use; Outpatient Therapy