bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Motive-Oriented Therapeutic Relationship in the Early-Phase Treatment of Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The present research aims at examining the effectiveness of a specific set of therapist
      relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship
      (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients
      diagnosed with Borderline Personality Disorder.

      The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality
      Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers
      Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of
      Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne,
      Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition
      (General Psychiatric Management; Gunderson & Links, 2008) and 2) MOTR-condition. The
      investigators hypothesize better results in the MOTR-condition, as compared to the control
      condition in terms of symptom reduction pre-post.

      The conduct of the study represents a significant contribution to the understanding and
      enhancement of relationship aspects in the treatment of patients diagnosed with Borderline
      Personality Disorder which may be of potential benefit for these patients.
    


Intervention name(s): Psychiatric Management; Motive-oriented therapeutic relationship/Plan Analysis
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the use of benralizumab is effective in the
      treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of
      antihistamines.
    

Detailed description: 
      The aim of this study is to investigate the use of benralizumab as treatment for patients
      with chronic spontaneous urticaria (CSU) who are symptomatic despite the use of
      antihistamines. It is proposed that benralizumab will deplete eosinophils and basophils from
      affected skin, improve symptoms of CSU, and improve CSU-related quality of life. This Phase
      2b study is designed to evaluate induction and maintenance dosing regimens.
    

Intervention name(s): Benralizumab; Placebo and Benralizumab
Intervention type(s): Biological; Biological
Intervention description(s): 2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.; 2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.
Other intervention name(s): Benralizumab, Benra, Fasenra; Benralizumab, Benra, Fasenra
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic spontaneous urticaria,; skin lesion,; pruritus and wheals
Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain
Condition: Joint Pain
MeSH terms: Arthralgia; Nociceptive Pain
Study type: Interventional

Summary: 
      This study is designed to evaluate the effectiveness of a proprietary nutritional supplement
      that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and
      discomfort in participants, compared to an inert placebo (palm oil) control and to a positive
      control (glucosamine-chondroitin). The purpose of the study is to determine if the
      combination of KO, AX, and HA will benefit participants with joint pain.
    


Intervention name(s): Joint Health Product; Placebo; Glucosamine / Chondroitin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule; Palm oil Softgel capsule; Glucosamine 1500 mg, Chondroitin 1200 mg per day
Other intervention name(s): FlexPro MD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of African Leafy Vegetables on Nutritional Status of South African School Children.
Condition: Iron Status; Vitamin A Status; Zinc Status; Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The combination of poverty-related infectious and lifestyle-related non-communicable
      diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and
      nutritious diets for populations depend on availability and accessibility of a variety of
      plant and animal foods, within a context that promotes and supports healthy behaviour. Food
      based strategies, such as supplementation, food fortification, and diversification of crops,
      are used to achieve optimal dietary requirements to combat malnutrition, including
      micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use
      of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately,
      several studies from all over Africa have shown that there is a shift from traditional diets
      as result of the preparing techniques and the absence of women in homes. Furthermore,
      indigenous and traditional foods are considered as "poor people's food".

      Against this background, a joint project between South Africa, Kenya and Benin is designed to
      fill the gaps in knowledge in these countries regarding the availability, acceptability and
      consumption and evidenced based benefits of foods from local biodiversity. The main aim of
      the study in South Africa is to provide empirical evidence of how the role of biodiversity
      can be translated into improved health status in contemporary poor rural and urban
      communities in the North West Province of South Africa. In order to achieve this it is
      important to gain knowledge on the possibility of using ALVs as a strategy to alleviate
      micronutrient deficiencies. Therefore an intervention study to determine the effect of
      selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of school
      children (grade R-4) residing in contemporary poor rural community in the North West
      Province, South Africa has been designed.
    


Intervention name(s): ALV
Intervention type(s): Other
Intervention description(s): Random allocation of children of two rural farm schools per grade to receive either 300 gram cooked ALVs and school meal starch or the normal school meal as daily meal (5 days/weeks) for 3 months.
Allocation: Randomized
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Condition: Moderate Depression; Menopausal and Postmenopausal Disorders
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to determine whether individualized homeopathic treatment and
      fluoxetine are more efficient than placebo for moderate to severe depression in peri- and
      postmenopausal women.
    

Detailed description: 
      Perimenopausal period is characterized by an increased risk of depressive symptoms. Major
      depression is one of the most disabling medical conditions worldwide. At present, it is
      becoming more difficult to prove that antidepressants actually work better than placebo in
      clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of
      clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous
      trials suggest that individualized homeopathic treatments improve depression in general
      population. The purpose of this study was to determine whether individualized homeopathic
      treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and
      postmenopausal women.
    

Intervention name(s): Individualized homeopathic treatment; Fluoxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.; 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.; Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
Other intervention name(s): Homeopathic remedies; Homeopathic medicines; Prozac; Fluoxetine placebo; Individualized homeopathic placebo
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Perimenopause; Postmenopause; Homeopathy
Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is to compare metabolic control, treatment satisfaction, and quality of life
      during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump
      system with multiple daily injections (MDI) therapy. Furthermore, this study will add
      clinical data originating from clinical investigation in a special population, i.e. children
      and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight
      insulin pump.
    


Intervention name(s): Accu-Chek Insight Pump System
Intervention type(s): Device
Intervention description(s): Continuous subcutaneous insulin infusion pump
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Flushing Reduction Associated With Nitrates
Condition: Menopausal Hot Flashes
MeSH terms: Hot Flashes; Flushing
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate
      therapy in 140 peri- or postmenopausal women who have frequent hot flashes. Women will be
      randomly assigned to uninterrupted use of transdermal nitrate therapy (participant directed
      dose-escalation of 0.2 to 0.6 mg/hr) or identical-appearing placebo patches for 12 weeks.
    


Intervention name(s): transdermal nitroglycerin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.; Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot flash
A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects
      of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring
      glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type
      2 diabetes mellitus on Metformin.
    

Detailed description: 
      This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in
      Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses
      of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to
      26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3
      portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2
      doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c)
      at 52 weeks. The final endpoint is 104 weeks.

      Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265
      doses until a dose decision is made based on quantitative analysis of the benefits and risks
      of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for
      change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic
      blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this
      end. After the dose decision, participants in the selected LY2189265 arms and the comparator
      arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional
      participants will be randomized to the selected and comparator arms. Regardless of the timing
      of randomization relative to the dose decision point, all participants in the selected and
      comparator arms are planned to receive treatment for 104 weeks; participants in the
      Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin
      100 mg for 78 weeks for blinding purposes only, and participants in the selected and
      Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain
      blinded to their study treatment throughout the study. Participants in the non-selected arms
      will discontinue from the study after the dose decision
    

Intervention name(s): LY2189265; Sitagliptin; Placebo solution; Placebo tablet; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Dulaglutide; Trulicity
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes, type 2 diabetes
Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty
Condition: Aging Frailty
MeSH terms: Frailty
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and
      efficacy of Lomecel-B for improving vaccine immune response.
    

Detailed description: 
      A pilot phase will consist of a 3 subject safety run-in, followed by 20 subject randomized
      phase to evaluate influenza vaccine response at 1 week and 4 weeks post infusion of Lomecel-B
      (Formerly LMSCs). This will be followed by a double-blinded, randomized, placebo-controlled
      phase.
    

Intervention name(s): Longeveron Mesenchymal Stem Cells (LMSCs); Fluzone High Dose Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intravenously delivered; Intramuscular injection
Other intervention name(s): Lomecel-B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for
      rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.
      The primary hypothesis is that the alteration in bone level is equal in patients randomized
      to 6 mm as to patients randomized to 11 mm implants.
    


Intervention name(s): OsseoSpeed™ length 6 mm; OsseoSpeed™ length 11 mm
Intervention type(s): Device; Device
Intervention description(s): OsseoSpeed™ dental implant, length: 6 mm; OsseoSpeed™ dental implant, length: 11 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair
Condition: Cleft Lip
MeSH terms: Cleft Lip
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efﬁcacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for
      infra-orbital nerve block in infants undergoing cleft lip surgery.
    

Detailed description: 
      Regarding patient registry; A prior G power analysis was done. Using the results obtained
      from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the
      study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases
      is expected, so; 22 cases per group will be required.

      Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social
      Sciences). Program version 22. Distribution of data will be first tested by Shapiro test.
      Data will be presented as mean and standard deviation (SD), median and range or numbers and
      percentages. For normally distributed data, unpaired t test will be used to compare between
      mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used.
      Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will
      be considered as the level of statistical significance.
    

Intervention name(s): Dexmedetomidine group; Dexamethasone group
Intervention type(s): Drug; Drug
Intervention description(s): 0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine; 0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Prevalence of Carriers of Genetic Diseases in the Mexican Jewish Community
Condition: Genetic Predisposition; Carrier, Gestational
MeSH terms: Genetic Diseases, Inborn; Genetic Predisposition to Disease
Study type: Observational [Patient Registry]

Summary: 
      The Jewish Population is at an increased risk for genetic diseases, especially autosomal
      recessive, thus, screening should be done to determine carrier status of several genetic
      diseases. In the Mexican Jewish Community, which is a very diverse community (regarding
      geographical origins), data of carrier status is unknown. The study aims to determine carrier
      prevalence for over 300 diseases using commercially available panels.
    

Detailed description: 
      Background: Preconceptional screening of genetic diseases is currently a underused and very
      useful tool, especially in populations that are at risk to be carriers of genetic diseases,
      such as the Jewish people, with carrier rates as high as 1:4 for any autosomal recessive
      disease. The Mexican Jewish Community is one of these populations at-risk, and there is no
      modern genetic research of the carrier rates in this community.

      Goals: This research project in the Mexican Jewish Community aims to determine the prevalence
      of carriers in the community in order to properly generate in the future, a systematic
      carrier screening in the community.

      Research Plan: The investigators propose a descriptive, observational, cross-sectional study,
      in which a representative sample of the Mexican Jewish Community (Which composes of
      Ashkenazi, Sephardic and Middle-Eastern Jews) of 250 patients, in which we´ll collect a
      saliva sample with a collection kit. Furthermore, the sample will be sent to a private
      commercial laboratory to perform the Comprehensive Carrier Screening to analyze the 301 genes
      included in the test plus the 13 add-on genes.

      Analysis: Other demographic variables will be collected from the patients at the time of the
      sample collection to identify possible risk factors (geographical origin, number of Jewish
      grandparents, history of genetic diseases, et. al) and a correlation analysis will be
      performed to verify the strength of those risk factors on the carrier status of the patients.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Representative sample of the Mexican Jewish Community of child-bearing age, of both sexes.
      
Biospecimen description: 
      Saliva samples for commercially available DNA carrier screening panels
    
Keywords: Carrier Screening; Jewish
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to
      placebo in subjects with osteoarthritis (OA) of the knee.
    


Intervention name(s): ABT-652; Placebo; Naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm; Placebo capsules - twice daily for 8 weeks; Naproxen capsules - twice daily for 8 weeks
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment