bioihbjkbjnl/mcl2 huggingface dataset:
Studies of States With Resistance to Vitamin D and Parathyroid Hormone
Condition: Hypocalcemia; Pseudohypoparathyroidism; Osteomalacia; Rickets; Pseudopseudohpoparathyroidism
MeSH terms: Rickets; Osteomalacia; Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism; Hypocalcemia
Study type: Observational

Summary: 
      Patients with confirmed or suspected states with resistance to vitamin D or parathyroid
      hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for
      modifications to the current or new treatment and for inclusion in other protocols. These
      states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a
      factor is manifested by deficient bioeffect despite high levels of the factor in blood.
      Patients will be tested with multiple indices of mineral metabolism to establish the
      diagnosis and examine the spectrum of the underlying disorder. The principal therapies will
      be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have
      localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients
      will also be considered for entry into other research protocols.
    

Detailed description: 
      Patients with confirmed or suspected states with resistance to vitamin D or parathyroid
      hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for
      modifications to the current or new treatment and for inclusion in other protocols. These
      states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a
      factor is manifested by deficient bioeffect despite high levels of the factor in blood.
      Patients will be tested with multiple indices of mineral metabolism to establish the
      diagnosis and examine the spectrum of the underlying disorder. The principal therapies will
      be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have
      localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients
      will also be considered for entry into other research protocols.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with confirmed or suspected states with resistance to vitamin D or parathyroid
        hormone (PTH)
      
Keywords: Rickets; Hypocalcemia; Albright Hereditary Osteodystrophy; Pseudohypoaldosteronism; Natural History
Bioequivalence Study of an Amoxicillin-Clavulanic
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of amoxicillin and clavulanic
      acid (suspension) are bioequivalent.

      Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo
      Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic
      acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 35 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): 400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml; 400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): AUGMENTIN 12H suspension GlaxoSmithKline Mexico; AUGMENTIN 12H suspension GlaxoWellcome Production France
Intervention MeSH terms: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Clavulanic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mexico; Respiratory infections; Amoxicillin-Clavulanic Acid; Bioequivalence
SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Observational

Summary: 
      In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues,
      explored the biological functions of SREBP1 in thyroid cancer cells.
    

Detailed description: 
      qRT-PCR and immunohistochemistry were used to detect the expression of SREBP1 in 96 pairs
      thyroid cancer tissues and the adjacent normal tissues. The following methods, including the
      MTS, colony-forming assay, flow cytometry and hoechst staining were used to detect the
      biological function of thyroid cancer cells based on SREBP1 interference or not.
    

Intervention name(s): pathologic
Intervention type(s): Other
Intervention description(s): All the enrolled patients were treated with whole resection and diagnosed by the Pathology Department based on the pathological evidence.
Other intervention name(s): radioiodine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        all of this patients were recruited from the Affiliated Cancer Hospital of Xiangya Medical
        School
      
Biospecimen description: 
      Tissue samples were snap-frozen and stored in liquid nitrogen immediately after surgery.
    
Keywords: thyroid cancer; SREBP1
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Condition: Contraception
Study type: Observational

Summary: 
      Knowledge about the impact on quality of life of women initiating IUD in the Spanish
      population at baseline and after 12 months of use.
    


Intervention name(s): Levonorgestrel IUD or Copper IUD
Intervention type(s): Drug
Intervention description(s): Women who initiate the use of an IUD at the time of the study.
Intervention MeSH terms: Copper; Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who starts contraception with an IUD.
      
Keywords: HRQoL; IUD; Contraception; SEC-QoL
FoCo: Evaluating a Training to Increase Attention and Awareness of Healthcare Professionals
Condition: Attention; Self-compassion
Study type: Interventional

Summary: 
      Introduction: A significant increase in the risk of injury and illness at work has been
      associated with fatigue, stress, haste, distraction, emergency situations, excessive noise,
      complex procedures and anger among other factors.

      Most of these factors are related to the lack of attention to work in progress, which can be
      improved by training attention and awareness during daily activities, as it would encourage a
      resumption of focus on the task at hand and the possible risks associated with it. . The
      primary objective of this project is to evaluate the effects of training to increase
      attention and awareness for daily activities - FoCo - outlined for healthcare professionals
      in their work schedule. Method: Health professionals from 18 to 60 years of age, of both
      sexes, will participate in the study, working in 3 units, one in the care of patients in a
      Emergency Care Unit (UPA), in an Elderly Residential and in a Center. Intensive Care (ICU).
      In the UPA will be included 25 professionals in group A and 25 in group B; In the Residential
      of Elderly, 40 professionals will be included in group A and 40 professionals in group B; In
      the ICU will be included 30 professionals in group A and 30 in group B. They will be
      randomized in both groups. Group A will receive training in the FoCo program and group B will
      be a waiting group. After a period of one month, group B will receive training in FoCo and
      group A will be instructed to continue on their own to apply FoCo in their daily lives
      (Fig.1). Participants will be evaluated before, after one month and after two months.
      Expected Outcomes: After training, an increase in mindful, attention and awareness scale,
      self-compassion scale, positive affect, speed of digit and symbol test is expected. It is
      also expected to reduce negative affects, perceived stress and an increased perception of
      possible incidents.
    


Intervention name(s): FoCo; No intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is an attention, care and self-care training.; This is a waiting list
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group A will receive training in the FoCo program and group B will be a waiting list group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making
Condition: Obesity, Adolescent
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how food commercials influence food choices in
      children and their parents.
    

Detailed description: 
      The proposed research will investigate food decision-making in youth. Childhood obesity is a
      risk factor for health issues, thus preventing adverse effects of childhood obesity by
      promoting healthy eating habits and providing effective interventions are important.
      Television food commercials advertising calorie-dense and high in salt and sugar foods are
      known to contribute unhealthy food choices and obesity. Thus the proposed study will examine
      how the advertising intervention focusing on increasing advertising knowledge and changing
      affective attitudes toward commercials impacts susceptability to commercials and food
      decisions in youth.
    

Intervention name(s): Commercial Advertising Literacy Training; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children were shown food commercials and in between those commercials they saw and heard statements such as "These foods won't make you happy" and "Those foods are so unhealthy."; Children were shown food commercials that were the same length as the other group but did not receive any information about whether the content was truthful.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Metacognitive Training in Schizophrenia
Condition: Delusions; Schizophrenia
MeSH terms: Schizophrenia; Delusions
Study type: Interventional

Summary: 
      Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered
      both in a group and individually, is compared to cognitive remediation (CogPack training).
      Blind to treatment assignment, both groups are assessed before intervention and four weeks
      later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales
      (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is
      assumed that MCT will improve delusion severity to a greater extent than CR in the course of
      4 weeks taking medication into account.
    

Detailed description: 
      Metacognitive training for schizophrenia patients (MCT) is a manualized group intervention
      that can be obtained cost-free online. MCT seeks to sharpen the awareness of schizophrenia
      spectrum patients on cognitive biases (e.g. jumping to conclusions) contributing to delusion
      formation and maintenance and conveys cognitive strategies to counter these. The present
      trial combines group MCT with an individualized cognitive-behavioral oriented approach
      entitled MCT+. Patients with schizophrenia are randomly allocated to either metacognitive
      treatment (MCT) or cognitive remediation (CogPack training). Blind to treatment assignment,
      both groups are assessed prior to intervention and four weeks later with the Positive and
      Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tasks.
      Delusion scores derived from the PANSS and PSYRATS serve as main outcome parameters. We also
      explore if MCT improves jumping to conclusions with a probabilistic reasoning task. To make
      results as generalizable as possible to a typical inpatient population, broad inclusion
      criteria are chosen. Patients are only excluded if age is < 18 and > 65 years and diagnoses
      do not meet criteria of a schizophrenia spectrum disorder.
    

Intervention name(s): Metacognitive training; Cognitive Remediation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level; Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; delusion; paranoia; psychosis
Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single
      ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in
      healthy male and female participants.

      The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile
      of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity
      of REGN5069 in healthy participants administered single IV or SC doses of REGN5069
    


Intervention name(s): REGN5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): REGN5069 will be administered by IV infusion or SC injection; Placebo-matching REGN5069
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited
      from general medical clinics, family planning clinics, groups/organizations working with
      persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and
      product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had
      to be abstinent or in a seroconcordant relationship with only one partner for the study
      period.
    

Detailed description: 
      Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a
      randomized, controlled trial in Chiang Rai, northern Thailand. Safety of daily product use
      determined by symptoms of irritation, effect on vaginal flora, vaginal epithelial disruption
      as determined by naked eye inspection (Day 7 and Day 14 of each arm) and colposcopic
      inspection on (Day 7), and other adverse effects, which may include UTI or other unforeseen
      problems (Day 7 and Day 14).

      Genital tract HIV will be measured using samples collected by CVL (Day 7 and Day 14 of each
      arm) and vaginal swab (Day 7 and Day 14).

      Product acceptability will be assessed through an interview-administered questionnaire once
      each study arm at the first follow-up visit (Day 7 of each arm), after using the product
      daily for 7 days.
    

Intervention name(s): Carraguard (PC-515)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Microbicides; HIV prevention; HIV-positive women; safety; carrageenan; HIV
Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Main Study Objectives:

      The study is conducted to

        -  evaluate the minimal allopurinol and azathioprine doses that, in combination, produce
           therapeutic 6-TGN levels

        -  evaluate the safety and tolerability of the different allopurinol/azathioprine dose
           levels

        -  assess if concomitant allopurinol affects TPMT activity

        -  assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the
           included patients
    


Intervention name(s): Azathioprine / Allopurinol
Intervention type(s): Drug
Intervention description(s): Both drugs are applied orally. A pre-specified dose escalation regimen will be chosen.
Azathioprine: Imurek (R) 50 mg and 25 mg tablets
Allopurinol: Mephanol (R) 100 mg tablets
Other intervention name(s): Azathioprine: Imurek (R) 50 mg and 25 mg tablets; Allopurinol: Mephanol (R) 100 mg tablets
Intervention MeSH terms: Azathioprine; Allopurinol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
Condition: Respiratory Depression
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore and compare VRH after administration of Belbuca,
      Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double
      -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and
      women self identifying as recreational users. This study will consist of a screening phase,
      treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
    


Intervention name(s): Belbuca 300 µg; Belbuca 600 µg; Belbuca 900 µg; Oxycodone 30 mg; Oxycodone 60 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Belbuca 300 µg buccal film; Belbuca 600 µg buccal film; Belbuca 900 µg buccal film; Oxycodone 30 mg capsule; Oxycodone 60 mg capsule; placebo buccal film and oral placebo
Intervention MeSH terms: Oxycodone; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Chronic Pain; Ventilatory Response to Hypercapnia (VRH)
An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy.
      Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may
      improve patient satisfaction and adherence to therapy. The objectives of this study are to
      evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing
      multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.
    

Detailed description: 
      This is an observational, international, multicenter study planned to be conducted in RMS
      subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The
      participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France,
      Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the
      United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif
      multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility
      criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif
      will be titrated during the initial four weeks of treatment. The planned observational period
      per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6
      (Visit 2), and Month 12 (Visit 3).

      OBJECTIVES

      Primary objective:

        -  To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject
           Rebif in a multi-dose cartridge

      Secondary objectives:

        -  To assess effectiveness and convenience of treatment in subjects with RMS using
           RebiSmart to self-inject Rebif in a multi-dose cartridge.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose
        injected by RebiSmart for no more than 6 weeks
      
Keywords: Multiple Sclerosis, Relapsing-Remitting; RebiSmart; Rebif; Interferon beta-1a